注射用盐酸大观霉素的质量评价

目的评价国内原料与原研原料的质量差异及国内不同企业的注射用盐酸大观霉素的质量。方法按法定标准检验与探索性研究相结合,对国内原料、原研原料及国家计划抽验的31批次制剂进行检验,通过对有关物质、含量、粒径、包材相容性、苯甲醇注射液等的考察,分析国内和原研原料的质量差异及国内制剂的质量状况。结果法定标准检验31批次注射用盐酸大观霉素,合格率为100%;探索性研究揭示原研原料有关物质个数与总杂含量低于国内原料,效价含量高于国内样品,粒径较国内原料的小且分布均匀集中。影响因素结果显示,1个国内制剂企业的内包装玻璃材质对产品颜色有影响。苯甲醇注射液作为附带的溶解液,其使用必要性有待商榷。结论国内原料与原研原料在有关物质、含量及粒径方面质量不一致;国内制剂整体质量较好;建议现行标准增订4R-双氢盐酸大观霉素的限度标准;建议国内企业对原料工艺进行优化,以提高产品质量,并考察苯甲醇注射液使用的必要性。

Quality consistency evaluation of spectinomycin hydrochloride for injection

Objective To evaluate the quality of the domestic raw materials, the original raw materials, and the domestic spectinomycin hydrochloride for injection. Methods According to the legal standard tests and exploratory studies, 31 batches of preparations, domestic raw materials, and original raw materials were tested. Through the investigation of the related substances, the content, particle sizes, the compatibility of package, the benzyl alcohol injection, the quality differences between the domestic and the original raw materials, and the quality status ofdomestic preparations were analyzed. Results The pass rate of quality was 100% using the statutory methods in 31 batches of preparations. Exploratory research revealed that the number and total impurities of the original raw materials were lower than those of the domestic raw materials, the potency content of the original raw materials was higher than that of the domestic preparations, the particle sizes of the original raw materials were smaller and the distribution of the original raw materials is more even centralized. The results showed that the internal packaging glass materials of one domestic pharmaceutical company has an effect on the color of the product. The necessity of benzyl alcohol injection as a kind of dissolve solution is questionable. Conclusion The quality of domestic raw materials was not consistent with the original raw materials in the related substances, the content, and the particle sizes; The quality of domestic preparations is good. The addition of the standard of the 4R-dihydro spectinomycin hydrochloride was suggested in the present standard. It is suggested that the domestic enterprises should optimize the raw material process to improve the product quality, and to investigate the necessity of using benzyl alcohol