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降脂灵片(南京中医学院制药厂产品)是制首乌、决明子、制黄精、山楂、金樱子、桑寄生、木香、盐制泽泻八味中药经提取精制而成的糖衣片,具有滋肾平肝的功用。据临床检验,对降低总胆固醇、甘油三酯等,均有相当疗效。为了提高中成药的质量稳定性,确保临床疗效,特对降脂灵片的质量标准作如下定性、定量试验研究。一、定性试验 1.性状:本品为柠檬黄色糖衣片。除去糖衣后显棕色,味微酸,略甜。 2.重量差异:基片重0.3g,按《中国药典》(85版)一部附录片重差异项下检查,重量差异限度±5.0％。 3.崩解度:按《中国药典》(85年版)一部附
Jiangzhiling Tablets (Nanjing Traditional Chinese Medicine Factory Product) is a sugar-coated tablet made from the extracts of Radix Scutellariae, cassia seed, Huangjingjing, Hawthorn, Rosa laevigata, Morus alba, woody, and salty Alisma. With the function of kidney and liver. According to clinical tests, it is quite effective in reducing total cholesterol and triglycerides. In order to improve the quality stability of Chinese patent medicines and ensure clinical curative effect, the qualitative and quantitative experimental studies on the quality standards of Jiangzhiling Tablets are as follows. First, qualitative test 1. Properties: This product is a lemon yellow sugar-coated tablets. Removed sugar brown, taste slightly sour, slightly sweet. 2. Weight difference: The weight of the substrate is 0.3g. According to the “Chinese Pharmacopoeia” (85th Edition), an appendix weight is checked under the discrepancy weight, and the weight difference limit is ± 5.0%. 3. Disintegration degree: According to “Chinese Pharmacopoeia” (85th edition)