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目的:降脂通便胶囊质量控制方法的提高。方法:采用显微鉴别方法,对制剂中大黄、人参、灵芝、肉桂进行鉴别。采用TLC,对制剂中大黄、人参、肉桂进行定性鉴别并检查大黄的真伪。采用HPLC,对制剂中甘草进行定性鉴别,对制剂中酒大黄中总大黄素和总大黄酚的总量以及结合蒽醌中大黄素和大黄酚的总量进行定量;色谱柱为Welch Materials Eclipse XB-C_(18)(4.6 mm×250 mm,5μm),流动相为乙腈-甲醇-0.1%磷酸溶液(42∶23∶35),流速1.0 m L·min~(-1),检测波长254 nm,柱温35℃。结果:定性鉴别方法专属性强,效果佳。采用HPLC法进行含量测定,大黄素质量在13.02~130.2 ng范围内与峰面积呈良好的线性关系(r=0.999 7),大黄酚质量在30.29~302.88 ng范围内与峰面积呈良好的线性关系(r=1.000);测定总大黄素和总大黄酚总量的平均回收率(n=6)为103.4%(RSD=1.3%),测定游离大黄素和游离大黄酚总量的平均回收率(n=6)为101.9%(RSD=1.0%)。10批样品,总大黄素和总大黄酚的总量为3.70~5.55 mg·粒~(-1),结合蒽醌中大黄素和大黄酚的总量为1.55~3.08 mg·粒~(-1)。结论:本方法提高完善了降脂通便胶囊的质量标准,可更有效地控制其质量。
Objective: To improve the quality control method of Jiangshitong Capsule. Methods: The method of microscopic identification, the preparation of rhubarb, ginseng, Ganoderma lucidum, cinnamon identification. Using TLC, the preparation of rhubarb, ginseng, cinnamon qualitative identification and check the authenticity of rhubarb. The content of total emodin and total chrysophanol and the total amount of anthraquinone-conjugated emodin and chrysophanol in the rhubarb wine were quantified using HPLC. The column was Welch Materials Eclipse XB The mobile phase consisted of acetonitrile - methanol - 0.1% phosphoric acid solution (42:23:35), the flow rate was 1.0 mL · min -1 and the detection wavelength was 254 nm , Column temperature 35 ℃. Results: Qualitative identification method is highly specific and effective. The content of emodin in the range of 13.02 ~ 130.2 ng showed a good linear relationship with the peak area (r = 0.999 7). The mass of chrysophanol showed a good linear relationship with the peak area in the range of 30.29 ~ 302.88 ng (r = 1.000). The average recovery of total emodin and total chrysophanol (n = 6) was 103.4% (RSD = 1.3% n = 6) was 101.9% (RSD = 1.0%). The total amount of emodin and total chrysophanol in the 10 batches of samples was 3.70-5.55 mg · kg -1. The total amount of emodin and chrysophanol in anthraquinone ranged from 1.55 to 3.08 mg · kg -1 ). Conclusion: This method improves and improves the quality standard of Jiangzhi Tongmai Capsule, which can control the quality more effectively.