基于国家评价性抽检的盐酸丙卡特罗片质量分析与研究

目的:通过对国内上市的盐酸丙卡特罗片的检验及研究,从安全性、有效性、刻痕及质量可控性等方面对其进行全面质量分析评价,进一步完善质量标准.方法:按照现行质量标准对盐酸丙卡特罗片进行法定检验,查阅国内外标准及文献,赴生产企业实地调研,开展有关物质、金属元素、崩解行为、溶出度与溶出曲线和刻痕等5个方面的探索研究.结果:111...

Quality Analysis and Study on Procaterol Hydrochloride Tablets on National Drug Evaluation Sampling Inspection

Objective: Through the inspection and study of domestic-listed procatrol hydrochloride tablets, the comprehensive quality analysis and evaluation were carried out in the respects of safety, effectiveness, notch and quality controllability in order to further improve the quality standard. Methods: According to the current quality standard, the legal inspection of procatterol hydrochloride tablets was carried out, the domestic and foreign standards and literature were consulted, the field investigation in the production enterprises was conducted, and the researches on related substances, metal elements, disintegration behavior, dissolution, dissolution curve and notch have been done. Results: The qualified rate of 111 batches of samples was 100%. In the exploratory study, a new method for determination of related substances was established. The impurities in the sampleswere generally high and positively correlated with the content of metal elements and moisture. The impurities mainly came from preparations and storage processes. The disintegration behavior and time of samples and original preparation in water were investigated by using visual technology. All samples disintegrated within 3 minutes; Referring to the Japanese Orange Book, the small cup method was revised to be paddle method, and the dissolution and dissolution curves of samples from various enterprises in four media were investigated. The results were similar with the original preparation as a reference. Except for one case where the sample of one enterprise caused the main drug to degrade in water due to incompatibility of raw auxiliary materials, the dissolution amount of the other samples have reached into 85% within 15 min. The reference preparation and some domestic samples have intermediate score lines, and the uniformity results of half tablets show that they can not be effectively divided, and the stability of the other half tablets is poor after being placed without inner packaging for 24 hours. Conclusion: The relevant substances in the current standards are missing and need to be improved urgently. The safety risks of the samples are greater, and the functional scores need to be improved.