(-)-ErythroMycin, Eur.Ph. - Names and Identifiers
Name | Erythromycin
|
Synonyms | EMU knin ERYC Emgel E.E.S Aknin Ergel T-Stat Retcin Erycin Erymax Inderm P.C.E. Erycen Ilocap E-Base ERY-PED Eryacne ERY-TAB Drmysin Statcin E-mycin Erythro Ilosone Erycinum Ak-Mycin Ery Derm Staticin Ilotycin Erycette Eritocina Robimycin Stiemycin Wintrocin abboticin abomacetin Abomacetin Eritrocina Erythromid Torlamicna Wyamycin-s Erthrogran Pediamycin Torlamicina Erythromast Erythromycin Erythroguent Erythromast 36 Ilotycin, ErythroMycin StreptoMyces erythreus ERYTHROMYCIN THICYANATE (-)-ErythroMycin, Eur.Ph. L-alpha-Egg-phosphatidylcholine 6-{[4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl]oxy}-14-ethyl-7,12,13-trihydroxy-4-[(5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl)oxy]-3,5,7,9,11,13-hexamethyloxacyclotetradecane-2,10-dione (non-preferred name) (3R,7R,9R,11R,13S,14R)-6-{[(3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl]oxy}-14-ethyl-7,12,13-trihydroxy-4-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl]oxy}-3,5,7,9,11,13-hexamethyloxacyclotetradecane-2,10-dione (non-preferred name) (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-6-{[(2R,3S,4R,6S)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl]oxy}-14-ethyl-7,12,13-trihydroxy-4-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl]oxy}-3,5,7,9,11,13-hexamethyloxacyclotetradecane-2,10-dione (non-preferred name) (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-6-{[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl]oxy}-14-ethyl-7,12,13-trihydroxy-4-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl]oxy}-3,5,7,9,11,13-hexamethyloxacyclotetradecane-2,10-dione (non-preferred name) (2S,3R,4S,6R)-4-(dimethylamino)-2-{[(3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-14-ethyl-7,12,13-trihydroxy-4-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl]oxy}-3,5,7,9,11,13-hexamethyl-2,10-dioxooxacyclotetradecan-6-yl]oxy}-6-methyltetrahydro-2H-pyran-3-yl propanoate (non-preferred name) (2S,3R,4S,6R)-4-(dimethylamino)-2-{[(3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-14-ethyl-7,12,13-trihydroxy-4-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl]oxy}-3,5,7,9,11,13-hexamethyl-2,10-dioxooxacyclotetradecan-6-yl]oxy}-6-methyltetrahydro-2H-pyran-3-yl ethyl butanedioate (non-preferred name)
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CAS | 114-07-8
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EINECS | 204-040-1 |
InChI | InChI=1/C37H67NO13/c1-14-25-37(10,45)30(41)20(4)27(39)18(2)16-35(8,44)32(51-34-28(40)24(38(11)12)15-19(3)47-34)21(5)29(22(6)33(43)49-25)50-26-17-36(9,46-13)31(42)23(7)48-26/h18-26,28-32,34,40-42,44-45H,14-17H2,1-13H3/t18-,19-,20+,21?,22-,23+,24+,25-,26+,28-,29?,30?,31+,32?,34?,35-,36-,37-/m1/s1 |
InChIKey | HIYRERIGRWIODP-PNFGZDISSA-N |
(-)-ErythroMycin, Eur.Ph. - Physico-chemical Properties
Molecular Formula | C37H67NO13
|
Molar Mass | 733.93 |
Density | 1.1436 (rough estimate) |
Melting Point | 133 °C |
Boling Point | 719.69°C (rough estimate) |
Specific Rotation(α) | -74.5 º (c=2, ethanol) |
Flash Point | 448.8°C |
Water Solubility | Soluble in water at 2mg/ml |
Solubility | Melt in ethanol, methanol, acetone, chloroform, acetonitrile and ethyl acetate, moderately soluble in ether, dichloromethane and amyl acetate. Insoluble in water. Slightly wet, odorless and bitter. Unstable in case of acid. Solubility in water: /- 3 MG/ML |
Vapor Presure | 4.94E-31mmHg at 25°C |
Appearance | White powder |
Color | white to faint yellow |
Merck | 14,3681 |
BRN | 8183758 |
pKa | 8.8(at 25℃) |
Storage Condition | Inert atmosphere,Room Temperature |
Refractive Index | -74 ° (C=2, EtOH) |
MDL | MFCD00084654 |
Physical and Chemical Properties | Melting Point: 138 - 140 |
Use | This product is a macrolide antibiotic derivative intermediate is a bacteriostatic antibiotic, antibacterial spectrum and similar to the Green |
(-)-ErythroMycin, Eur.Ph. - Risk and Safety
Risk Codes | R42/43 - May cause sensitization by inhalation and skin contact.
R36/37/38 - Irritating to eyes, respiratory system and skin.
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Safety Description | S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.)
S37 - Wear suitable gloves.
S24 - Avoid contact with skin.
S36 - Wear suitable protective clothing.
S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
S24/25 - Avoid contact with skin and eyes.
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WGK Germany | 2 |
RTECS | KF4375000 |
FLUKA BRAND F CODES | 3-4.3-10 |
HS Code | 29415000 |
Hazard Class | 3 |
Toxicity | LD50 oral in rat: 4600mg/kg |
(-)-ErythroMycin, Eur.Ph. - Upstream Downstream Industry
(-)-ErythroMycin, Eur.Ph. - Reference
Reference Show more | 1. Li Yonghui, Zhang Zhiqiang, Wu Tonglei, et al. Study on the mechanism of Chinese medicine chebula inhibiting the formation of Staphylococcus aureus biofilm [J]. Chinese Journal of Hospital Infectious Sciences 2019 029(005):646-649. 2. Zhang Zheng, Li Panjie, Jiang Caiyun, et al. Investigation and Research on Metals and Antibiotics in Urban Sewage Treatment Process [J]. Journal of Nanjing Normal University (Engineering Technology Edition), 2018, 018(002):86-92. 3. Gao Minjun, Liu Genqi, Xue Yafeng, Chen Xiaojuan, Shi Weijiang, Fan Xiaodong. Study on Erythromycin Molecularly Imprinted Two-dimensional Photonic Crystal Hydrogel Sensor [J]. Analytical Chemistry, 2017,45(05):727-733. 4. Han Jinling, Chen Kui, Wu Bin, Ji Lijun, Wu Yanyang, Zhu Jiawen. Preparation of Mesoporous Magnetic Composite Carbon Spheres with High Adsorption Performance [J]. Fine Chemicals, 2020,37(04):689-695 709. 5. Xu Shuangyan, Zhang Tao, Zhang Cheng, Lin Hui, Shui Xianlei, Zheng Huabao. Screening, Identification and Degradation Characteristics of an Erythromycin Degrading Strain [J]. Journal of Zhejiang Agriculture, 2021,33(01):131-141. 6. Zhou Qing. Analysis of Lipid A of Vibrio parahaemolyticus and Study on Related Genes [D]. Jiangnan University, 2020. 7. Jiang Lijie, Liu Jian, Dong Yan. Distribution and drug resistance of pathogens causing nosocomial infection in children [J]. Chinese Journal of Pathogenic Biology, 2019,14(07):840-843 847. 8. Chen Shuxin, Wang Jing, He Shichong, Liu Zhengzheng, Feng Huajun, Mu Pengqian. Determination of 17 Antibiotics in Water by Ultra Performance Liquid Chromatography Tandem Mass Spectrometry [J]. China Environmental Monitoring, 2020,36(06):119-126. 9. Pei Jia, Tong Bu, Xinyu Sun, Yingnan Liu, Jinghan Liu, Qinzhi Wang, Yuhang Shui, Shuwen Guo, Li Wang,A sensitive and selective approach for detection of tetracyclines using fluorescent molybdenum disulfide nanoplates,Food Chemistry,Volume 297,2019,124 10. Zhang, Fangxing, et al. "The Endogenous Alterations of the Gut Microbiota and Feces Metabolites Alleviate Oxidative Damage in the Brain of LanCL1 Knockout Mice." Frontiers in microbiology 11 (2020): 2126.https://doi.org/10.3389/fmicb.2020.557342 11. [IF = 13.281] Yingnan Liu et al. "Antimonene Quantum Dots as an Emerging Fluorescent Nanoprobe for the pH-Mediated Dual-Channel Detection of Tetracyclines." Small. 2020 Oct;16(42):2003429 12. [IF = 7.514] Pei Jia et al. "A sensitive and selective approach for detection of tetracyclines using fluorescent molybdenum disulfide nanoplates." Food Chem. 2019 Nov;297:124969 13. [IF = 2.461] Huang Xue-Jiao et al. "The Antibacterial Properties of 4, 8, 4 ′, 8 '-Tetramethoxy (1,1'-biphenanthrene) -2,7,2 ', 7'-Tetrol from Fibrous Roots of Bletilla striata." Indian J Microbiol. 2021 Jun;61(2):195-202 14. [IF = 4.952] Yuanyuan Cao et al. "Fluorescent detection of tetracycline in foods based on carbon dots derived from natural red pigment." Lwt Food Sci Technol. 2022 Mar;157:113100 15. [IF = 2.896] Zhongqi Xu et al. "Simultaneous separation of 12 different classes of antibiotics under the condition of complete protonation by capillary electrophoresis coupled contactless conductivity detection." Anal Methods-Uk. 2021 Dec;:
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(-)-ErythroMycin, Eur.Ph. - Standard
Authoritative Data Verified Data
This product is calculated by anhydrous, and the titer of each lmg shall not be less than 920 erythromycin units.
Last Update:2024-01-02 23:10:35
(-)-ErythroMycin, Eur.Ph. - Trait
Authoritative Data Verified Data
- This product is white or off-white crystal or powder; Odorless; Slightly hygroscopic.
- This product is easily soluble in methanol, ethanol or acetone, and slightly soluble in water.
specific rotation
take this product, precision weighing, plus absolute ethanol dissolution and quantitative dilution to make a solution containing about 20mg per lml, placed 30 minutes after the determination according to law (General 0621), the specific rotation is from one 71 ° to one 78 °.
Last Update:2022-01-01 11:54:57
(-)-ErythroMycin, Eur.Ph. - Introduction
Inhibit the extension period in the peptide transfer step, inhibit bacterial protein synthesis by binding to the ribosome, and induce erythromycin resistance to bacteria. Antibacterial spectrum: Gram-negative and positive bacteria. Macrolide antibiotics
Last Update:2022-10-16 17:12:19
(-)-ErythroMycin, Eur.Ph. - Differential diagnosis
Authoritative Data Verified Data
- in the chromatogram recorded under the erythromycin component item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the standard solution.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 167). If there is any difference, take an appropriate amount of this product and the standard sample, add a small amount of chloroform to dissolve, water bath to dry, put the phosphorus pentoxide dryer under reduced pressure to dry and measure, except for the wavelength range of 1980cm-1 to 2050cm-1, the pattern should be consistent with that of the standard.
Last Update:2022-01-01 11:54:57
(-)-ErythroMycin, Eur.Ph. - Exam
Authoritative Data Verified Data
alkalinity
take 0.lg of this product, add 150ml of water, shake, and measure according to law (General rule 0631). The pH value should be 8.0~10.5.
Related substances
take about 40mg of this product, put it in a 10ml measuring flask, add 4ml of methanol to dissolve it, and use pH 8.0 phosphate solution (take 11.5g of Dipotassium hydrogen phosphate and add ml of water to dissolve it, adjust the pH value to 10% with 8.0 phosphoric acid solution, dilute to ML with water), dilute to the scale, shake, as a test solution; Take 1 ml of precision, put it in a 100ml measuring flask, dilute to the scale with the above pH 8.0 phosphate solution-methanol (3:2), shake, as a control solution; Take the appropriate amount of control solution, A solution containing about 4ug per 1 ml was prepared as a sensitivity solution by quantitative dilution with pH 8.0 phosphate solution-methanol (3:2). According to the chromatographic conditions under the erythromycin component check item, measure the sensitivity solution l00ul and inject the human liquid chromatograph, record the chromatogram, and the high signal-to-noise ratio of the main component chromatographic peak should be greater than 10. The sample solution and the control solution were respectively injected into the liquid chromatograph, and the chromatograms were recorded. If there are impurity peaks in the chromatogram of the test solution, the peak area of impurity c shall not be more than 3 times (3.0%) of the main peak area of the control solution, the Peak area of impurity E and impurity F after correction (multiplied by correction factor 0.08) shall not be greater than 2 times (2.0%) the main peak area of the control solution, the peak area after impurity D correction (multiplied by Correction Factor 2) shall not be greater than 2 times (2.0%) the main peak area of the control solution, impurity A, the Peak area of impurity B and other individual impurities shall not be more than 2 times (2.0%) of the main peak area of the control solution, the sum of the peak areas of each impurity after correction shall not be greater than 7 times (7.0%) of the main peak area of the control solution. The peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored.
thiocyanate
take about 0.lg of this product, weigh it accurately, put it in a 50ml brown bottle, add methanol 20ml to dissolve, add 1ml of ferric chloride test solution, dilute it to the scale with methanol, shake it well, as a test solution; Take 2 parts of potassium thiocyanate dried at 105°C for 1 hour, each about 0.lg, precision weighing, respectively, put in two 50ml measuring flasks, add 20ml of methanol to dissolve and dilute to the scale, shake well, take 5ml of precision, put it in 50ml measuring flask, dilute to the scale with methanol, shake well, then take 5ml of precision, add 1ml ferric chloride test solution to 50ml brown bottle, dilute to the scale with methanol, shake well, use as reference solution; Take lml ferric chloride test solution and put it in 50ml brown bottle, dilute to the scale with methanol as a blank solution. According to UV-Vis spectrophotometry (General rule 0401), respectively, at the wavelength of 492mn absorbance (test solution, control solution and blank solution should be measured within 30 minutes), the ratio of the absorbance per weight of the two reference solutions should be 0.985 to 1.015. The content of thiocyanate in erythromycin should not exceed 0.3%. The molecular weights of thiocyanate and potassium thiocyanate were 58.08 and 97.18, respectively.
moisture
take about 0.2g of this product, add 10% imidazole anhydrous methanol solution to dissolve, according to the determination of water content (General 0832 first method 1), the water content shall not exceed 6.0%.
ignition residue
not more than 0.2% (General rule 0841).
erythromycin components
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler (XTerra RP Cl8 column, 4.6mm X 250mm, 3.5um or performance equivalent column); using acetonitrile -0.2mol/L dipotassium hydrogen phosphate solution (adjust pH to 7.0 with phosphoric acid)-Water (35:5:60) as mobile phase A, using acetonitrile -0.2mol/L dipotassium hydrogen phosphate solution (adjusted to pH 7.0 with phosphoric acid)-Water (50:5:45) as mobile Phase B, immediately after completion of erythromycin B elution, linear gradient elution was carried out according to the following table, with a flow rate of 1.0ml per minute, a detection wavelength of 210nm, and a column temperature of 65°C. Accurately weigh about 40mg of erythromycin standard, put it in a 10ml measuring flask, add 4ml of methanol to dissolve it, dilute it to the mark with pH 8.0 phosphate solution under the items of related substances test, shake it well, lool was injected into the liquid chromatograph and the chromatogram was recorded. The tailing factor of erythromycin A peak should not be more than 2.0. Take 40mg of erythromycin system applicable reference, put it in a 10ml measuring flask, add 4ml of methanol to dissolve, dilute to the scale with the above pH 8.0 phosphate solution, shake, take 100u1 and inject human chromatograph, the chromatogram should be consistent with the standard chromatogram of erythromycin system applicable reference substance. The retention time of erythromycin A peak is about 23 minutes, impurity A, impurity B, impurity C, impurity D, the relative retention times of impurity E and impurity F were about 0.4, 0.5, 0.9, 1.6, 2.3 and 1.8, respectively. The relative retention times of erythromycin B and erythromycin C were about 1.7 and 0.55, respectively, the degree of separation between impurity B peak and erythromycin C peak, erythromycin B peak and impurity F peak should be not less than 1.2, and the degree of separation between impurity C peak and erythromycin A peak should meet the requirements.
- determination method: weigh about 40mg of this product accurately, put it in a 10ml measuring flask, add 4ml of methanol to dissolve, dilute to the scale with the above pH 8.0 phosphate solution, shake well, as a test solution; Weigh about 40mg of erythromycin standard accurately, put it in a 10ml measuring flask, add 4ml of methanol to dissolve, dilute to the scale with the above pH 8.0 phosphate solution, shake well, as a standard solution (1); Accurately measure the standard solution (1) 1 ml, put it in a 100ml measuring flask, dilute to the scale with the above pH 8.0 phosphate solution-methanol (3:2), shake well as standard solution (2). The sample solution, standard solution (1) and standard solution (2) with 100 u1 were respectively injected into the liquid chromatograph, and the chromatograms were recorded. The content of erythromycin A in the test sample shall be calculated by the peak area of erythromycin A in the standard solution (1) According to the external standard method, and shall not be less than 93.0% based on the anhydrous substance; The standard solution (2) shall be calculated according to the external standard method the content of erythromycin B and erythromycin C in the sample shall be calculated by the peak area of erythromycin A, and shall not exceed 3.0% based on the anhydrous substance.
Last Update:2022-01-01 11:54:58
(-)-ErythroMycin, Eur.Ph. - Content determination
Authoritative Data Verified Data
precision weigh the appropriate amount of this product, add ethanol (lOmg plus ethanol lml) dissolved, with sterilized water quantitatively made in each lml containing about 1000 units of solution, according to the microbiological assay of antibiotics (General Principles 1201) determination, confidence limit rate shall not be greater than 7%. 1000 erythromycin units are equivalent to 1 mg of C37H47N013.
Last Update:2022-01-01 11:54:59
(-)-ErythroMycin, Eur.Ph. - Category
Authoritative Data Verified Data
Last Update:2022-01-01 11:54:59
(-)-ErythroMycin, Eur.Ph. - Storage
Authoritative Data Verified Data
sealed and stored in a dry place.
Last Update:2022-01-01 11:54:59
(-)-ErythroMycin, Eur.Ph. - Erythromycin Enteric-coated Tablets
Authoritative Data Verified Data
This product contains erythromycin (C37H67NO13) should be labeled the amount of 90.0% to 110.0%.
trait
This product is an enteric-coated tablet or an enteric film-coated tablet, which shows white or almost white color after removing the coating.
identification
- take an appropriate amount of the fine powder of this product, add methanol to dissolve erythromycin and dilute to prepare a solution containing about 2.5mg of erythromycin per 1 ml, filter, and take the continued filtrate as the test solution. An appropriate amount of erythromycin standard was taken, dissolved in methanol and diluted to prepare a solution containing about 2.5mg per 1 ml as a standard solution. According to the thin layer chromatography (General 0502) test, absorb 10ul of each of the above two solutions, respectively point on the same silica gel G thin layer plate, with three gas methane-methanol (85:15) as the developing solvent, it was developed, dried, sprayed with a mixed solution of ethanol-p-methoxybenzaldehyde-sulfuric acid (90:5:5), and heated at 100 ° C. For about several minutes, until black to reddish purple spots appeared. The position and color of the main spot displayed by the test solution should be the same as the position and color of the main spot of the standard solution.
- in the chromatogram recorded under the erythromycin A component, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the standard solution.
- two items (1) and (2) above can be selected as one item.
examination
- dissolution dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method 2 ), the first hydrochloric acid solution (9-1000)900ml as the dissolution medium, speed of 100 revolutions per minute, according to the law, after 2 hours, discard the hydrochloric acid solution, check each piece of intestinal membrane are not cracked, followed by phosphate buffer (pH 6.8)(Take 0.2mol/L potassium dihydrogen phosphate solution 250ml, add 0.2mol/L sodium hydroxide solution 118ml, dilute to 1000ml with water, shake, get) 900ml as dissolution medium, after 45 minutes, take 10ml of solution, filter, take appropriate amount of filtrate, dilute quantitatively with phosphate buffer (pH 6.8) to make a solution containing about 55ug of erythromycin per lml; Take another 10 tablets of this product, grind, accurately weigh an appropriate amount (equivalent to the average tablet weight), add an appropriate amount of ethanol (10 mg plus 1 ml of ethanol) to dissolve erythromycin, and then use phosphate buffer (pH 6.8) according to the labeled amount. A quantitative dilution was made to give a solution containing approximately 55ug per 1 ml. Take 5ml of each of the above two solutions, add 5ml of sulfuric acid solution (75-100) respectively, mix well, place for about 30-40 minutes, and let cool, the absorbance was measured at a wavelength of 0401 nm by ultraviolet-visible spectrophotometry (general), and the elution amount of each tablet was calculated. The limit is 80% and shall be in accordance with the provisions.
- erythromycin component A: Take 20 tablets of this product, remove the coating, precisely weigh it, grind it finely, precisely weigh an appropriate amount (equivalent to erythromycin 0.lg), add methanol 5ml to dissolve erythromycin, dilute quantitatively with phosphate buffer (pH 7.0)-methanol (15:1) to make a solution containing about 4mg of erythromycin per 1 ml, filter, and take the continued filtrate as the test solution, the erythromycin component was determined according to the method described under erythromycin. The content of erythromycin A shall not be less than 83.5% based on the labeled amount.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
take 4 tablets of this product, grind them finely, use an appropriate amount of ethanol (about 0.25g of erythromycin and 25ml of ethanol), and grind them in several times to dissolve erythromycin, A solution containing about 1000 units per 1 ml of sterilized water was quantitatively prepared, and the solution was shaken and allowed to stand. An appropriate amount of the supernatant was accurately measured and determined according to the method of erythromycin.
category
Same as erythromycin.
specification
- 0.125g (125,000 units)
- 0.25g (250,000 units)
- 50mg (50,000 units)
storage
sealed and stored in a dry place.
Last Update:2022-01-01 11:55:00
(-)-ErythroMycin, Eur.Ph. - Erythromycin Enteric—coated Capsules
Authoritative Data Verified Data
This product contains erythromycin (C37H67NO13) should be labeled the amount of 90.0% to 110.0%.
trait
The content of this product is white or white enteric coated pellets or granules.
identification
- take the contents of this product, triturate, take about 5mg, add acetone 2ml to dissolve, add hydrochloric acid 2ml, that is, orange yellow, gradual to purple, then add chloroform 2ml to shake, the chloroform layer was blue.
- take an appropriate amount of the contents of this product, grind it, add methanol to dissolve erythromycin and dilute it to make a solution containing about 2.5mg of erythromycin per 1 ml, filter it, and take the continued filtrate as the test solution; an appropriate amount of erythromycin standard was taken, dissolved in methanol and diluted to prepare a solution containing about 2.5mg per 1 ml as a standard solution. The above two kinds of solutions were mixed in equal amounts as a mixed solution. According to the thin layer chromatography (General 0502) test, absorb the above three solutions of 10 u1, respectively, on the same silica gel G thin layer plate, with three chlorine methyl-methanol (85:15) to develop, spread, dry, spray with a mixed solution of ethanol-p-methoxybenzenesulfonic acid (90:5:5), heated at 100°C for several minutes, black to red-purple spots were noted. The main spot displayed by the mixed solution should be a single spot, and the position and color of the main spot displayed by the test solution should be the same as the position and color of the main spot of the standard solution or mixed solution.
- in the chromatogram recorded under erythromycin A component, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the standard solution.
- two items (2) and (3) above can be selected as one item.
examination
- moisture the content of this product was taken, dissolved by adding 10% imidazole in methanol solution, and measured according to the moisture measurement method (General rule 0832, Method 1). Water content should not exceed 7.5%.
- dissolution dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method 2), the first hydrochloric acid solution (9-1000)900ml as the dissolution medium, the rotation speed is 50 revolutions per minute, and the operation is carried out according to the law. After 60 minutes, 10ml of the solution is taken, filtered, and the filtrate is taken as the test solution (1). Discard hydrochloric acid solution, followed by phosphate buffer (pH6.8)(take 0.2mol/L potassium dihydrogen phosphate solution 250ml, add 0.2mol/L sodium hydroxide solution 118ml, dilute with water to 1000ml, shake, then) 900ml as the dissolution medium, after 60 minutes, take 10ml of the solution, filter, take the appropriate amount of filtrate, with phosphate buffer (pH 6.8) quantitative dilution is made into a solution containing about 55ug of erythromycin per 1 ml, which is used as the test solution (2); The content under the item of difference in loading is separately taken and ground, take an appropriate amount (equivalent to the average loading), put it in a 50ml measuring flask, dissolve it in ethanol and dilute it to the scale, shake it well, filter it, and take the continued filtrate as the control stock solution, an appropriate amount of erythromycin was quantitatively diluted with hydrochloric acid solution (9-1000) to prepare a solution containing about 14UG (0.125g specification) or 28UG (0.25g specification) of erythromycin per 1 ml as a control solution (1). An appropriate amount of the control stock solution was accurately weighed and quantitatively diluted with phosphate buffer (pH 6.8) to prepare a solution containing about 55ug of erythromycin per 1 ml as a control solution (2). 5ml of the test solution (1), (2) and the control solution (1), (2) were accurately added with 5ml of human sulfuric acid solution (75-100) respectively, and mixed well, after allowing to stand for 30 to 40 minutes, the solution was cooled, and then the absorbance was measured at a wavelength of 0401 nm by ultraviolet-visible spectrophotometry (general) to calculate the elution amount of each particle. The amount of dissolution in acid should not be more than 10%, and the amount of dissolution in buffer solution should not be less than 80%, which should comply with the provisions.
- the contents of erythromycin component A under the item of load difference were extracted and finely divided, and an appropriate amount (equivalent to erythromycin 0.lg) was accurately weighed, and methanol (5ml) was added to dissolve erythromycin, followed by phosphate buffer (pH 7.0).-Methanol (15:1) is diluted quantitatively to make a solution containing about 4mg of erythromycin per 1 ml, filtered, and the filtrate is taken as the test solution, the erythromycin component was determined according to the method described under erythromycin. The content of erythromycin A shall not be less than 83 * 5% based on labeled amount.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
take the contents under the item of difference in loading amount, grind them finely, weigh an appropriate amount of fine powder (about 0.25g equivalent to erythromycin), and add an appropriate amount of ethanol (1 ml of ethanol for erythromycin 10 mg), the solution containing about 1000 units per 1 ml was prepared by quantitative dilution with sterile water, and then was shaken and allowed to stand, according to the method under the item of erythromycin, obtained.
category
Same as erythromycin.
specification
- 0.125g (125,000 units)
- 0.25g (250,000 units)
storage
sealed and stored in a dry place.
Last Update:2022-01-01 11:55:01
(-)-ErythroMycin, Eur.Ph. - Erythromycin ointment
Authoritative Data Verified Data
This product contains erythromycin (C37H67N013) should be 90. 110.0% of the label amount.
trait
This product is a white to yellow ointment.
identification
take this product about 0.5g, add 0.1 mol /L sulfuric acid solution 5ml, heated on a water bath to dissolve, cool, pour the water layer, add sulfuric acid 2mU slowly shake, that is, red-brown.
examination
should comply with the relevant provisions under ointment (General rule 0109).
Content determination
take an appropriate amount of this product and weigh it accurately (about 10 mg of erythromycin), place it in a separatory funnel, add 20ml of petroleum ether, and slowly shake it to dissolve the matrix, extract 4 times with phosphate buffer (pH 7.8~8.0), about 25ml each time, combine the extracts, put in a ml measuring flask, dilute to the scale with phosphate buffer (pH 7.8~8.0), shake, according to the method under the item of erythromycin, obtained.
category
Same as erythromycin.
specification
1%
storage
sealed, stored in a cool and dry place.
Last Update:2022-01-01 11:55:02
(-)-ErythroMycin, Eur.Ph. - Erythromycin Eye Ointment
Authoritative Data Verified Data
This product contains erythromycin (C37H67N013) should be labeled the amount of 90.0% to 110.0%.
trait
This product is a white to yellow ointment.
identification
take this product about 0.5g, add 0.1 mol /L sulfuric acid solution 5ml, heated on a water bath to dissolve, cool, pour the water layer, add sulfuric acid 2ml, slowly shake, that is, red-brown.
examination
should comply with the relevant provisions under Ophthalmic Preparations (General rule 0105).
Content determination
take an appropriate amount of this product and weigh it accurately (about 10 mg of erythromycin), place it in a separatory funnel, add 20ml of petroleum ether, and slowly shake it to dissolve the matrix, extract 4 times with phosphate buffer (pH 7.8~8.0), about 25ml each time, combine the extracts, put in a ml measuring flask, dilute to the scale with phosphate buffer (pH 7.8~8.0), shake, according to the method under the item of erythromycin, obtained.
category
Same as erythromycin.
specification
0.5%
storage
sealed and stored in a cool and dry place.
Last Update:2022-01-01 11:55:03
(-)-ErythroMycin, Eur.Ph. - Reference Information
EPA chemical information | Information provided by: ofmpub.epa.gov (external link) |
introduction | erythromycin (Erythromycin,EM,Er) is produced by streptomycin and is an alkaline antibiotic. Including erythromycin A(Er A), erythromycin B(Er B), erythromycin C(Er C), erythromycin D(Er D), erythromycin E(Er E) and erythromycin F(Er F). Its free alkali is for oral use, and lactobionate is for injection. It belongs to macrolide narrow-spectrum antibiotics. It is often used as a substitute for penicillin-resistant Gram-positive bacteria infections and penicillin allergies. The antibacterial spectrum is similar to penicillin. |
Clinical application | Clinically, it is often used in patients with penicillin-resistant gram bacterial infections and penicillin allergies, against Legionella pneumonia, mycoplasma pneumonia, and Chlamydia trachomatis Infant pneumonia and colitis, skin and soft tissue infections can be used as the first choice, and can be used for respiratory infections caused by hemolytic streptococcus and pneumococcus, for white throat carriers, this product is effective in combination with diphtheria antitoxin. |
mechanism of action | erythromycin is a motilin receptor agonist. the spatial structure of the dimethylamine group and 14-membered lactone ring on the glycoside chain of erythromycin molecule is similar to that of motilin. it can be used as a motilin receptor agonist to produce a simulated motilin effect and induce MMC phase iii contraction in fasting state to occur in advance, cause contraction of smooth muscle of stomach and duodenum. The motivating effect of erythromycin is related to the dose. Low-dose erythromycin induces gastric contraction similar to spontaneous MMC, while high-dose erythromycin causes strong irregular gastric duodenal contraction to induce vomiting, which is also the cause of gastrointestinal reactions caused by erythromycin. Therefore, the dose of erythromycin for promoting gastric motility should not be too large. |
use | erythromycin can treat digestive system diseases, and EM has different degrees of driving effect on the whole gastrointestinal tract. There are mainly the following effects: promote esophageal contraction and increase esophageal lower sphincter pressure (LESP); promote gastric antrum contraction, improve the coordination of gastric antrum and duodenal function; induce gastrointestinal migration compound movement; promote colon movement and gallbladder contraction, etc. Therefore, it can effectively treat gastrointestinal diseases. Erythromycin can affect the protein synthesis of bacteria, and is generally effective for gram-positive bacteria. It is mainly used to treat infections caused by penicillin G-resistant Staphylococcus aureus. Erythromycin is a commonly used macrolide antibiotic. Its antibacterial spectrum is similar to penicillin. It is mainly used for patients with penicillin allergy or Staphylococcus aureus infection resistant to penicillin. It can also be used for streptococcus, pneumococcal infection and white throat carriers. This product is an intermediate of macrolide antibiotic derivatives. It is a bacteriostatic antibiotic. Its antibacterial spectrum is similar to that of green bacteria. In the step of transferring peptides, it inhibits the extension period, inhibits the synthesis of bacterial protein by binding to ribosomes, and induces erythromycin resistance to bacteria. Antibacterial spectrum: Gram-negative and positive bacteria. Macrolide antibiotics (Macrolide antibiotic) |
traits | white or white-like crystalline powder; No odor, bitter taste; Slightly hygroscopic. |
production method | this product is an alkaline antibiotic extracted from the culture solution of streptococcus red (Streptomyces erythreus). When purifying, it uses its characteristics of dissolving in different solvents with different pH values, repeated extraction with butyl acetate and aqueous solution to achieve the purpose of concentration and purification, and finally freeze and crystallize in butyl acetate solution to obtain erythromycin base. Produced by fermentation of Erythromycin Streptomyces (Streptomyces erythreus). It is obtained by extraction of butyl acetate and cooling crystallization. |
toxic substance data | information provided by: pubchem.ncbi.nlm.nih.gov (external link) |
Last Update:2024-04-09 20:49:11