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目的:评价市售的53批利胆片的整体质量情况。方法:根据质量标准,对53批样品的性状和鉴别、重量差异、崩解时限及微生物限度进行检查。结果:53批利胆片中有51批符合规定,合格率为96%;即使是合格品,不同厂家、不同批次样品的质量仍然存在很大差异。结论:应严格制定利胆片生产工艺及原料药材的质量控制体系,以保证成品制剂的质量;本次评价分析中,C厂生产工艺和产品质量均比较稳定,所以其市场占有率较高。
PURPOSE: To evaluate the overall quality of 53 licensed gallbladders available on the market. Methods: The traits and identification of 53 batches of samples, weight differences, disintegration time limits and microbial limits were examined according to the quality standards. Results: Of the 53 batches of Lidan tablets, 51 batches met the requirements and the pass rate was 96%. The quality of samples from different manufacturers and different batches was quite different even though they were qualified ones. Conclusion: The quality control system of Lidan tablets production process and raw material should be strictly established to ensure the quality of finished products. In this evaluation and analysis, the production technology and product quality of C factory are relatively stable, so its market share is higher.