Study On The Technics And Priscription Of Clindamycin Hydrochloride Capsules Quality And Efficacy Consistency Evaluation

Clindamycin,developed and launched by Pharmacia & Upjohn Company(now merged with Pfizer Inc.),is a semi-synthetic macrolide antibiotic that can be administered orally or by injection.The clindamycin oral capsule preparation was first authorized by the FDA in February 1970,and the drug was marketed soon afterwards.The original clindamycin hydrochloride capsules are not currently available in China.In this thesis,a quality consistency evaluation study of clindamycin hydrochloride capsules and the original commercial reference preparation were carried outcombined with production practice.The aim is to achieve similar in vitro dissolution behavior of the original drug and consistent product quality indicators,and provide a basis for the pharmaceutical research data of the drug's application for generic drugs consistency evaluation.1.Pre-research on re-evaluation ofprescription technologyThis part summarized the quality attributes of re-evaluated drugs based on the relevant quality profile of the reference preparation.The target drug quality profile and key quality attributes required for the development of this product were proposed,and the re-evaluation of the raw and auxiliary materials of clindamycin hydrochloride capsules and reference preparations is studied.2.Redevelopment of formulationsThe study of physical and chemical properties of APIs provides guidance for prescription and process studies;the compatibility test of raw and auxiliary materials determines the types of auxiliary materials in the prescription.According to the existing process evaluation results,the reference preparations are analyzed,the prescriptions are screened and optimized,and the process parameters are compared and studied to determine the optimal prescriptions and process parameters.Confirmed by the pilot test,the quality of the produced products is controllable and reproducible.3.Consistency evaluation of clindamycin hydrochloride capsulesThrough the comparison test between the reference preparation and the self-made preparation,the determined prescription process and analysis method can effectively control the product quality of clindamycin hydrochloride capsules.In summary,based on the existing production process of clindamycin hydrochloride capsules,the product's prescription process and quality standards were studiedcombined with the analysis of the reference preparation.The key quality attributes,dissolution curve comparison and stability inspection of self-made preparations and reference preparations were also carried out.It is confirmed that the product quality of the two is consistent and the stability of the self-made preparation is good,which provides a reliable basis for the pharmaceutical information declared for the consistency evaluation of clindamycin hydrochloride capsules.