胰激肽原酶肠溶片效价测定的质量评价研究

目的对部分厂家的胰激肽原酶肠溶片的效价进行质量评价,为严格质量控制及临床选择用药提供科学的依据。方法按《卫生部药品标准》(二部)第六册及中国药典(1998)第86号文,对4个厂家各3个批次的胰激肽原酶肠溶片的效价进行测定。结果4个厂家的胰激肽原酶的效价测定结果表明,A、B厂各3个批次的产品均合格,C厂3个批次中有1个批次产品不合格,D厂3个批次的产品均不合格。结论A厂的产品质量较好,其次为B厂的产品,C厂的产品质量不稳定,D厂的3个批次的产品均不合格。

Quality Evaluation of the Potency of Pancreatic Kallidinogenase Enteric-coated Tablets

Objective In order to provide the scientific instructions for quality control and clinic, the qualities of Pancreatic Kallidinogenase Enteric-Coated Tablets obtained from several pharmaceutical factories were evaluated. Methods According to the medical criterion of Ministry of Health(volumn Ⅱ)& pharmacopoiea dispatch(1998)the 86th,the potency of 3 batches of Pancreatic Kallidinogenase Enteric-coated Tablets from each of four pharmaceutical factories were determined respectively. Results The results of the determined potency showed that each batch from factories A and B was up to standard, one of the three batches from factory C was unqualified, 3 batches from factory D were all unqualified. Conclusion The quality of the products from factory A is best, the second is from factory B, but the quality produced by factory C is unstable, and all of 3 batches provided by factory D were unqualified.