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目的:研制前列宁片纯中药制剂的组方设计、提取制备工艺、质量标准制订。方法:根据祖国医药学理论,设计了新处方,采用了沉淀工艺制备中成药片剂,同时采用TLC法和规格检验法制定了质量标准。结果:减少了用药剂量,提高了药物的有效性、稳定性,显微鉴别法实用性强,TLC法结果可靠,无干扰。结论:处方合理、用药独特、制剂稳定、质量标准可靠。
OBJECTIVE: To develop the prescription design of the pure Chinese medicine preparation of the formerly Lenin tablet, to extract the preparation technology and to establish the quality standard. Methods: According to the theory of the motherland medicine, a new prescription was designed and the traditional Chinese medicine tablets were prepared by the precipitation process. At the same time, the quality standard was determined by TLC method and specification test. Results: The dosage was reduced, the effectiveness and stability of the drug were improved, and the microscopical method was practical. The TLC method was reliable and non-interfering. Conclusion: The prescription is reasonable, the medication is unique, the preparation is stable and the quality standard is reliable.