影响盐酸吡格列酮载药包衣含量均匀度的关键工艺研究

Evaluation of Critical Process Parameters for Intra-tablet Coating Uniformity of Pioglitazone Hydrochloride

关键词:  片剂  载药包衣  响应面法  盐酸吡格列酮

Key words:  tablet  active coating  response surface method  pioglitazone hydrochloride

摘要:

目的 采用响应面法考察载药包衣关键工艺参数对包衣含量均匀度的影响，并优化载药包衣的工艺条件。方法 以盐酸吡格列酮为模型药物，自制的盐酸二甲双胍渗透泵缓释片芯为基础，用高效包衣机进行载药包衣实验。结果 在实验范围内，各因素对载药包衣含量均匀度影响的大小依次是包衣锅转速、喷液速率、雾化压力，控制包衣锅转速12 r·min^-1，喷液速率12~14 g·min^-1，雾化压力65~75 kPa，包衣片含量均匀度符合中国药典2015年版的要求。结论 模型优化的工艺条件适用于本品的载药包衣，包衣片含量均匀度符合中国药典的要求。

Abstract:

OBJECTIVE To evaluate the intra-tablet coating uniformity and the critical process parameters in an active coating process using response surface method, optimizing the process parameters of the active coating. METHODS Using pioglitazone hydrochloride as a model active substance, active coating on home-made metformin hydrochloride osmotic pump tablets using high efficiency coating machine. RESULTS In the range studied, the effect of pan speed, spray rate, and atomizing pressure on content uniformity decreased in turn. Coating with pan speed at 12 r·min^-1, spray rate at 12-14 g·min^-1, atomizing pressure at 65-75 kPa, the content uniformity of final product met the requirement of chinese pharmacopoeia. CONCLUSION Parameters optimized by the model is suitable for this product, the content uniformity meets the requirement of Chinese Pharmacopoeia 2015 edition.