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目的:应用现行标准及非标方法对11个生产企业共14批咳特灵胶囊(片)的性状、鉴别、马来酸氯苯那敏限度、浸出物和马来酸氯苯那敏含量进行检验考察,评价市售咳特灵胶囊(片)的质量情况。方法:《卫生部药品标准》中药成方制剂第十四册咳特灵(片)胶囊、《国家中成药标准汇编》中成药地方标准上升国家标准部分内科肺系(二)分册咳特灵胶囊(试行标准)以及本所研究的非标方法。结果:14批样品以上各项指标差异显著。结论:现行标准质控方法过于简单,质控指标不全面,建议提高药品质量标准,确保药品质量。
OBJECTIVE: To evaluate the traits, identification, chlorpheniramine maleate limits, extracts and chlorpheniramine maleate content of 14 batches of cough tracts in 11 manufacturing enterprises by using the current standards and non-standard methods Inspection and evaluation, evaluation of the market cough capsule (film) quality. Method: “Drug Standards for the Ministry of Health,” the Chinese medicine into the prescription of the fourteenth chapter cough Trane (tablets), “Chinese compilation of proprietary Chinese medicines,” the local standards of Chinese medicine rose some of the national standard internal medicine pulmonary (Trial Standard) and the non-standard methods studied by our institute. Results: There are significant differences between the above indexes in 14 batches of samples. Conclusion: The current standard quality control method is too simple, quality control indicators are not comprehensive, it is recommended to improve drug quality standards to ensure drug quality.