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目的对氨苯喋啶片101批样品进行法定标准检验及探索性研究,对该品种的质量状况作出总体分析及评价。方法法定标准检验依据《中国药典》2010年版二部,其质量标准设定有性状、化学反应鉴别、溶出度、重量差异、UV法测定含量。探索性研究参照BP2010年版氨苯蝶啶原料项下有关物质检测方法,采用优化后的HPLC法考察各企业提供的氨苯蝶啶原料及101批片剂中的有关物质;采用HPLC法测定5个企业的样品在4种不同pH值介质中的溶出曲线,并与日本橙皮书中氨苯喋啶片溶出曲线进行比较;建立了溶出度测定的非标方法,并对全部样品进行检验;为考察辅料及各有关物质对氨苯蝶啶含量测定的影响,建立了HPLC法测定氨苯蝶啶片含量的方法。结果法定标准检验:101批样品,5批次不符合规定,不合格率为5%,不合格项目均为溶出度检查。探索性研究:有关物质研究表明制剂中的杂质来源于原料,检验101批样品,均检出已知杂质B、C和一个未知杂质,均未检出已知杂质A;溶出曲线及溶出度研究比较了该制剂在4种不同pH值介质中的溶出曲线,5家生产企业制剂溶出曲线与日本橙皮书上的相似性差异大,有3家生产企业的自身批间均一性相对较好;含量测定结果说明辅料及各有关物质对氨苯蝶啶含量测定基本无影响。结论各生产企业氨苯蝶啶片的质量参差不齐,总体质量状况与日本药品有差距,建议进一步进行生物等效性研究,改进制剂工艺,提高质量。
OBJECTIVE To test the statutory standards and exploratory studies of 101 batches of triamntopterin tablets and to make an overall analysis and evaluation on the quality status of the samples. Methods The statutory standard test was based on the 2010 edition of “Chinese Pharmacopoeia”. The quality standards of the Chinese Pharmacopoeia were set as traits, chemical reaction identification, dissolution rate and weight difference, and the content was determined by UV method. Exploratory research with reference to the BP2010 version of the bottom of the marine safety testing methods, using the optimized HPLC method to examine the raw materials of the triamterene and 101 batches of tablets of the relevant substances; Determination by HPLC The dissolution curves of the samples of enterprises in four different pH media were compared with the dissolution curves of triamterene tablets in the orange book of Japan. The non-standard method of dissolution determination was established and all the samples were tested. The influence of excipients and related substances on the determination of triamterene was investigated. A method for the determination of triamterene tablets by HPLC was established. Statutory standard test results: 101 batches of samples, 5 batches do not meet the requirements, the unqualified rate of 5%, unqualified items are dissolution test. Exploratory research: Related substances research shows that the impurities in the preparation come from the raw materials, and the 101 batches of samples are tested, the known impurities B and C and one unknown impurity are detected, and none of the known impurities A is detected. The dissolution curve and dissolution study The dissolution profiles of the preparations in four different pH media were compared. The dissolution profiles of the five manufacturers were quite different from those on the Japanese orange book. There was a good homogeneity among the three manufacturers. Content determination results show that accessories and related substances on the determination of triamterene basically no effect. Conclusion The quality of triamterene tablets varies from manufacturer to producer. There is a gap between the overall quality status and Japanese medicines. It is suggested that bioequivalence studies should be further conducted to improve preparation technology and improve quality.