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本文介绍了生脉注射液经改进制备工艺后,针剂质量稳定,临床应用安全有效。为提高药品质量,制订药品质量标准,对鉴别试验、检查项目和含量测定进行了研究。采用薄层层析鉴定主药红参有效成分——人参皂甙,提高了鉴别试验的专一性。拟定了检查项目。人参总皂甙含量测定采用薄层一比色法,回收率试验:本品每ml含人参总皂甙量1.436～2.154mg时,回收率为99.16±4.38～96.13±5.77%。抽检药厂批量生产针剂8批,每ml含人参总皂甙在1.36～1.92mg者达7批。为进一步完善药品质量标准提供了技术资料。
This article describes the Shengmai injection after an improved preparation process, the injection quality is stable, clinical application is safe and effective. In order to improve the quality of drugs, drug quality standards were formulated, and identification tests, inspection items, and content determinations were studied. Thin-layer chromatography was used to identify the active ingredient of red ginseng, ginseng saponin, to improve the specificity of the identification test. Proposed inspection items. Determination of ginsenosides total saponin content using a thin layer of colorimetric method, the recovery rate test: This product per ml containing ginseng total saponin amount 1.436 ~ 2.154mg, the recovery was 99.16 ± 4.38 ~ 96.13 ± 5.77%. Sampling pharmaceutical companies mass production of injections 8 batches, containing ginsenosides per ml of 1.36 ~ 1.92mg up to 7 batches. Technical information was provided to further improve the drug quality standards.