加强中药浸膏生产质量管理之管见

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《中国药典》一九八五年版一部的制剂通则中载有中药煎膏剂、流浸膏剂(1:1醇提物)、浸膏剂(1:2~5醇提物)三种剂型.这三种制剂可直接作为药品生产、销售.此外,还有一种中药浸膏,是中西药品制剂的初级产品.许多药厂为降低药材运输费用,减少厂区占地面积和环境污染,在外地加工订购中药浸膏.有些药厂或未获《药品生产企业许可证》的浸膏加工厂将生产的中药浸膏直接出售给中成药厂.这些自产自销或委托加工的浸膏,多数无质量标准,有的照订购单位提供的提取浓缩工艺和自拟的内控标准进行加工,其中包括含毒性药材和贵细药材的复方半成品浸膏. In the General Principles of the Pharmacopoeia of the 1985 edition of the Chinese Pharmacopoeia, three dosage forms of traditional Chinese medicine decoction, liquid extract (1:1 alcohol extract), and extract (1:2 to 5 alcohol extract) are included. The three preparations can be directly used as pharmaceuticals for production and sales. In addition, there is a traditional Chinese medicine extract that is the primary product of Chinese and Western medicine preparations. Many pharmaceutical companies order to reduce the cost of medicine transportation, reduce the factory area and environmental pollution, and order processing in the field. Chinese herbal extracts. Some pharmaceutical companies or extract manufacturing plants that have not obtained the “Drug Manufacturing Enterprise License” will directly sell the Chinese herbal extracts produced to the Chinese patent pharmaceutical factories. Most of the extracts produced or commissioned for self-produced or consigned products have no quality. Standards, some according to the ordering unit to provide the extraction and concentration process and self-designed internal control standards for processing, including the compound semi-finished extract containing toxic herbs and precious herbs.
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