Molecular Formula | 2[C10H15NO].H2O4S |
Molar Mass | 428.543 |
Boling Point | 255ºC at 760 mmHg |
Flash Point | 85.6ºC |
UN IDs | UN 1544 |
Summary:
Objective To study the preparation method of pseudoephedrine sulfate, which is easy to industrialize. Methods Pseudoephedrine was refined from the crude pseudoephedrine, and then pseudoephedrine sulfate was synthesized with sulfuric acid. The factors affecting the refining of pseudoephedrine and the effects of different crystallization methods and sulfuric acid concentration on the quality of pseudoephedrine sulfate were investigated. Results Two crystallization methods and preparation conditions were determined. Conclusion All indexes of pseudoephedrine sulfate prepared conform to the standard of US Pharmacopoeia 23.
keywords:
pseudoephedrine sulfate production
DOI:
10.3321/j.issn:1001-2494.2005.23.020
cited:
Year:
2005
Summary:
objective to study the relative bioavailability and bioequivalence of pseudoephedrine sulfate in two compound loratadine sustained-release tablets. Methods The concentration of pseudoephedrine sulfate in plasma was determined by LC-MS assay in 20 healthy subjects, and the relative bioavailability and bioequivalence were studied. Results After a single dose of oral administration of the two preparations, Cmax was (404.2±115.5) and (403.6±170.4) ng · mL-1, Tmax was (4.8±2.0) and (5.9±1.6) h,AUC was (4 115.7±1 490.8) and (3 950.8±1 481.3) ng · h · mL-1, respectively, and the relative bioavailability was (106.8±18.7)%. The results showed that there was no significant difference in Tmax,Cmax and AUC between the two preparations of pseudoephedrine sulfate. After multiple doses of oral administration of the two preparations, Css was (343.7±81.4) and (351.3±63.8) ng · mL-1, AUCss was (4 124.6±977.1) and (4 215.9±765.7) ng · h · mL-1, DF was (1.32±0.26) and (1.26±0.34), respectively, and the relative bioavailability value was (97.9±17.1)%. Conclusion Statistical analysis shows that there is no significant difference in pharmacokinetic parameters between the two preparations, and the bioavailability of the two preparations is equivalent and has bioequivalence.
expand
keywords:
compound loratadine sustained release tablets pseudoephedrine sulfate pharmacokinetics relative bioavailability
DOI:
10.3969/j.issn.1006-8783.2005.05.015
cited:
Year:
2005
CN03109402.3
date of application:
2003-04-09
public/announcement number:
CN1535686A
date of publication/announcement:
2004.10.13
Applicant (patentee):
Beijing dezhong wanquan drug technology development co., ltd
Inventor:
national and provincial code:
CN110108
cited:
Summary:
A sustained-release preparation containing loratadine and pseudoephedrine sulfate and its preparation method, using the compression coating method, the rapid release outer layer is pressed outside the core of the sustained-release tablet to obtain the compression coating sustained-release tablet. Clinically, it is mainly used to relieve nasal congestion caused by allergic rhinitis and cold.