Name | Hydroxypropyl-beta-cyclodextrin |
Synonyms | HBC HPCD HPBCD hpbcd HP-beta-cyclodextrin HYDROXYPROPYL-β-CYCLODEXTRIN Hydroxypyle beta cyclodextrin HYDROXYPROPYL-BETA-CYCLODEXTRIN Hydroxypropyl-beta-cyclodextrin 2-hydroxypropyl-beta-cyclodextrin 2-Hydroxypropy-.beta.-cyclodextrin (2-hydroxypropyl)-beta-cyclodextrin beta-Cyclodextrin, 2-hydroxypropyl ether beta-Cyclodextrin 2-hydroxypropyl ethers |
CAS | 94035-02-6 128446-35-5 136019-12-0 |
EINECS | 618-994-5 |
InChI | InChI=1/C105H196O56/c1-50(106)22-127-43-71-78-85(134-29-57(8)113)92(141-36-64(15)120)99(148-71)156-79-72(44-128-23-51(2)107)150-101(94(143-38-66(17)122)86(79)135-30-58(9)114)158-81-74(46-130-25-53(4)109)152-103(96(145-40-68(19)124)88(81)137-32-60(11)116)160-83-76(48-132-27-55(6)111)154-105(98(147-42-70(21)126)90(83)139-34-62(13)118)161-84-77(49-133-28-56(7)112)153-104(97(146-41-69(20)125)91(84)140-35-63(14)119)159-82-75(47-131-26-54(5)110)151-102(95(144-39-67(18)123)89(82)138-33-61(12)117)157-80-73(45-129-24-52(3)108)149-100(155-78)93(142-37-65(16)121)87(80)136-31-59(10)115/h50-126H,22-49H2,1-21H3 |
Molecular Formula | C54H102O39 |
Molar Mass | 1375.36 |
Melting Point | 267°C (dec.) |
Solubility | H2O: 45% (w/v) |
Appearance | White powder |
Storage Condition | 2-8°C |
MDL | MFCD00069372 |
Physical and Chemical Properties | This product is white or white amorphous or crystalline powder; odorless, slightly sweet taste; strong wetting. This product is very soluble in water, easily soluble in methanol and ethanol, and almost insoluble in acetone and chloroform. |
Safety Description | 24/25 - Avoid contact with skin and eyes. |
WGK Germany | 3 |
RTECS | GU2293332 |
This product is an etherate of beta-cyclodextrin and 1, 2-epoxypropane. The hydroxypropoxy group (-OCH2CHOHCH3) should be 19. 6% to 26.3% based on the anhydrous.
take 0.5ml of 5% aqueous solution of this product, put it in a 10ml test tube, add 2 drops of 10% tr • naphthol ethanol solution, shake well, slowly add human sulfuric acid lm l along the tube wall, at the interface of the two liquids, a purple ring appears.
take this product L. 0g, add water 40ml dissolved, according to the law (General 0631), p H value should be 5.0~7. 5.
Take 2. 5g of this product, add water 25M l to dissolve, check according to law (General rule 0901 and general rule 0902), the solution should be clear and colorless.
take 0. lg of this product and check it according to law (General rule 0801). Compared with the control solution made of 5. 0ml of standard sodium chloride solution, it should not be more concentrated (0. 05%).
take this product about l .O g, precision weighing, put it in a 10ml measuring flask, add water to dissolve and dilute to the scale, shake well, as a test solution; Another 50mg of beta-cyclodextrin reference, precision weighing, put 100ml measuring flask, add water to dissolve and dilute to the scale, shake, as a reference solution. According to high performance liquid chromatography (General rule 0512), amino bonded silica gel was used as filler; Acetonitrile-water (65 : 35) was used as mobile phase; column temperature 35°C. The reference solution and the test solution were injected into the liquid chromatograph, and the chromatograms were recorded. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of the peak of beta cyclodextrin, the peak area shall be calculated by the external standard method, and the beta cyclodextrin containing 0 .5% shall not be used.
take about lg of this product, accurately weigh it, put it in a 10ml measuring flask, add methanol to dissolve and dilute it to the scale, shake it well, and use it as a test solution. Take another 1, 2-propanediol about 501«8, weigh it accurately, put it in a measuring flask, dilute it to the scale with methanol, shake it well, and use it as a reference solution. Determined as residual solvent assay (General 0861). Using 100% polydimethylsiloxane chemical cross-linked capillary column for the column, the initial temperature is 7 0°C, at the rate of 10°C per minute heating to 100°C, then the temperature was increased to 2 20°C at a rate of 40 */min for 4 minutes; The inlet temperature was 2 50°C; The detector temperature was 2 8 0 1; theoretical plate number 1,2-propylene glycol peak calculation should not be less than 3000. The reference solution and the test solution were injected into the gas chromatograph respectively, and the chromatograms were recorded. According to the external standard method to calculate the peak area, containing 1,2-propylene glycol shall not exceed 0.5%.
take this product, according to the determination of moisture (General rule 0832 first method 1), the water content shall not exceed 6 .0%.
The l.O g of this product shall be taken for inspection according to law (General rule 0841), and the remaining residue shall not exceed.
The residue left under the item of taking the ignition residue shall not contain more than 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).
hydroxypropyl base take this product about O.lg, precision weighing, according to the methoxy, ethoxy and hydroxypropoxy determination method (General 0712), that is obtained.
pharmaceutical excipients, packaging agents and stabilizers, etc.
light shielding, closed storage.
physical properties | hydroxypropyl-β-cyclodextrin has lower toxicity than the parent cyclodextrin, oral non-toxic, hemolytic is also very low, after a large number of animal experiments and clinical experiments have proved that it can be used for oral and injection, the United States Food and Drug Administration has approved its application in food and medicine. The semi-lethal dose of general pharmaceutical grade hydroxypropyl-β-cyclodextrin to rats was more than 2000mg/kg, and the toxicity test was repeated for 90 days after oral administration of 4400 mg/kg per day, which showed no effect on the health of rats. Irritation experiments on the skin and eyes of experimental rabbits showed no irritation to the skin and eyeballs of the test subjects. The sensitivity experiment showed that it had no sensitization to the skin of the experimental pig. Hydroxypropyl-β-cyclodextrin is well tolerated in animal experiments such as rats, mice and dogs, especially orally, showing only limited toxicity. In the short-term experiment, the subjects had only slight physiological changes, while in the relatively long-term (three months) experiment, the subjects had small hematological changes, but there was no histopathological change. When administered intravenously, Histopathological changes are found in the lungs, liver and kidneys, but these changes are reversible and recover quickly after discontinuation without adverse effects on the body. Carcinogenicity studies have shown that experimental rats have an increased chance of developing tumors in the pancreas and intestines, but this is considered a rat-specific phenomenon. Experiments on rats and rabbits showed that hydroxypropyl-β-cyclodextrin had no effect on embryos. In clinical trials, hydroxypropyl-β-cyclodextrin was well tolerated by the human body, and the main discomfort was Diarrhea. The data showed that hydroxypropyl-β-cyclodextrin had no effect on renal function. |
Use | hydroxypropyl-B-cyclodextrin in food manufacturing, mainly used to eliminate odor, improve the stability of flavor and pigment, enhance the ability of emulsification and moisture resistance. To improve the taste of food, is a drug, food, cosmetics manufacturing good stabilizer and flavor agent. In medicine, the solubility and bioavailability of the drug can be improved, the efficacy of the drug can be increased or the dosage can be reduced, the release rate of the drug can be adjusted or controlled, and the toxic and side effects of the drug can be reduced, enhance the stability of the drug, mainly used in oral liquid, the highest degree of safety. |
Application | mainly used in medicine, food, cosmetics industry, in medicine can improve drug solubility, bioavailability, it can adjust or control the release rate of the drug, reduce the toxic and side effects of the drug, and enhance the stability of the drug. |