| 摘要: |
| 目的：采用现代制剂工艺技术与科学评价方法，将补肝健腰方由传统汤剂开发为颗粒剂，优化制备工艺并建立制剂的专属质量标准。方法：通过多因素试验优选最佳工艺条件，确定制剂的提取、成型工艺；采用TLC鉴别方法对方中代表性药味进行定性鉴别。结果：优选了剂型及制剂工艺，建立了产品质量标准，按确定的工艺参数进行验证试验，各项指标均符合要求，表明该工艺及质量标准稳定可行。结论：新制剂较原方汤剂而言，具有储存运输与服用方便、稳定性好、质量可控、有效期长且药效显著等特点，为制剂的产业化提供了科学依据。 |
| 关键词: 补肝健腰方 颗粒 工艺研究 质量标准 |
| DOI： |
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| Development of the preparation for the famous old TCM doctor Qiu Xiangzhong’s empirical prescription liver-tonifying and lumbar-invigorating prescription |
| YUAN Qingzhao,XU Qian,YANG Ying |
| (The Affiliated Hospital of Hunan Academy of Chinese Medicine，Changsha 410006，Hunan，China) |
| Abstract: |
| Objective：To develop the granules of liver-tonifying and lumbar-invigorating prescription using modern preparation techniques and scientific evaluation methods，to optimize the preparation process，and to establish the specific quality standard for this preparation.Methods：The multifactorial experiment was used to select the optimal process conditions and determine the extraction and forming techniques of the preparation，and thin layer chromatography was used for the qualitative identification of representative herbs in the prescription.Results：The formulation and preparation processes were optimized，and quality standard was established for the product.A validation test was performed according to the process parameters determined，and all indices met the requirements，suggesting that this process and quality standard were stable and feasible.Conclusion：Compared with the decoction of this prescription，the new preparation has the advantages of convenient transportation and medication，good stability，controllable quality，a long shelf life，and a marked clinical effect，which provides a scientific basis for the industrialization of this preparation. |
| Key words: liver-tonifying and lumbar-invigorating prescription granule process study quality standard |
