Fiber-Optic In-situ Dissolution Test For Cardiovascular Drugs

Objective:The cardiovascular and cerebrovascular diseases is a common disease of a serious threat tohuman health, clinical cored higher frequency of cerebrovascular drug use, the original drugs as thepilot of the clinical use of drugs, generic drugs are still the main body of clinical use in China, the samespeciestend to have more than production. Different manufacturers in the preparation and productionprocesses of the existence of differences. How to take effective measures to ensure drug quality,efficacy, and bioequivalence as the focus of the pharmacy workers. The drug dissolution is animportant part of the evaluation of drug preparation process, the traditional sampling and analysis ofprocess analysis method is gradually being replaced. This experiment, the drug dissolution processanalysis techniques to establish the clinical cardiovascular drugs commonly used different formulations(immediate release, sustained release, controlled release, enteric-coated preparations) drug dissolutionmethod, the evaluation of the same specifications of different manufacturers to produce drugs drugdissolution; investigate the dissolution process analysis of the compound preparation of mathematicalmodels and individual dissolution process analysis. Objective evaluation of the clinical representationof the quality of the pharmaceutical preparations according to the data results from the in vitrodissolution. Internal quality evaluation of the clinical drugs commonly used to provide morecomprehensive scientific, objective and impartial, accurate and reliable evaluation methods and thepromotion of generic prescription process, enhance the market competitiveness of the Sinopharmpharmaceutical companies. Clinical use of drugs and ensure that the people safe, reasonable andeffective. Methods: Refer to the dissolution of the statutory standard measurement conditions (solvent,speed determination method, etc.), fiber optic sensing stripping process analyzers for the determinationof the device, according to the UV spectra and specifications of the drug to select the appropriatedetermination of the wavelength and the probe, according to the specificsituation, the establishment ofthe dissolution process of the six kinds of representative drug analysis method using dual-wavelengthmethod, dynamic coefficient ratio method to eliminate the excipients interference; the similarity of thecurve f2factor of eligible drugs; components of the compound preparationabsorption spectrum, amathematical model of separation analysis of the process of the active ingredient. Results: The trial offelodipine tablets in accordance with ministerial standards, speed200r/min, with the exception of six tablets7h, Hefei cubic production did not meet the release requirements, AstraZeneca, and Shanxicombo production of6the tablets are in line with the requirements of the drug release. Ministerialstandards and USP methods were quite different. In addition to the the Hefei cubic felodipine tabletsduring the evaluation of f2factor, the preparation of two other manufacturers do not meet the conditionsf2factor, calculate the f2factor is meaningless. Determination of isosorbide mononitrate sustainedrelease tablets results show that the three manufacturers of the pills1h,4h are in line with releaseprovisions not in line with the provisions of8h; Sandoz product reference preparation, AstraZeneca,and Tianjin He Su comparison of the f2factor were44.93and79.41. Three manufacturers ofnitroglycerin tablets in the FODT under the conditions established in this study,10min cumulativerelease percentage greater than70%. Two manufacturers of irbesartan tablets in HCl, pH6.8phosphatebuffer FODT were in line with ministerial standards, solubility in water and pH4.5phosphate buffercan not be the determination of dissolution; at pH60.8in the solvent, the product of the two plants donot meet the f2factor is the premise of the f2factor calculation meaningless. FODT determination ofthe dissolution results showed that Asian Bao Pharmaceutical indapamide tablets in water, pH4.5solvent are in line with the USP Dissolution Provisions, pH6.8and pH1.2in the non-compliance; FangMing, Shandong and Henan Jie, indapamide tablets in pH6.8, water, pH1.2are in line with USPdissolution requirement, pH4.5non-compliance; three manufacturers of the formulations do not meetthe required prerequisite for the f2factor, Respectively, using the mathematical model of separation andself-control method to establish allicin enteric-coated tablets release FODT Determination of elementsin real-time analysis of allicin release in the reaction process.Conclusion: Fiber drug dissolution testerfive common drugs of cardiovascular representative preparation process analysis methods, strippingformulations of the curve of response from different manufacturers are large differences in theproduction process, five representativecommonly used drugs, there is no one in full compliance withthe state promulgated the "evaluation of Medicinal sampling quality analysis of the guiding principlesfor the pharmacy is not equivalent.