Study On The Preparing Procedures And Quality Standards Of Ganyankang Capsules

Purpose:To study the preparing procedures and the quality standard of Ganyankang capsules. Furthermore, these results will provide an experimental basement for turning into new drug.Methods:Firstly, the main influencing factors of the preparing process for Ganyankang capsules were studied by the single factor design. Secondly, the effects of several extraction methods on preparing Ganyankang capsules were investigated by orthogonal experiment method. Those methods were as follows:ethanol-extracting procedures, the ethanol-extracting with water precipitation procedures and the decoction with ethanol precipitation procedures. Finally, quality standards of Ganyankang capsules were established by character, identification and content determination method respectively.Results:The main influencing factors of the preparation process for Ganyankang capsules were ethanol, extracting duration, extracting times, ethanol volume, decoction duration, decoction times and water volume respectively. The optimized ethanol-extraction process was that the herbs were extracted by 15 times amount of 80% ethanol for 2 times with 1.5 hours each time; the optimized ethanol-extracting with water precipitation procedure was that the herbs were extracted by 15 times amount of 80% ethanol for 2 times with 1 hours each time; the optimized decoction with ethanol precipitation procedure was that the herbs were decocted 2 times with 12 times amount of water for 2 hours each time and the ethanol concentration was ajusted to 50%. The best preparation process of Ganyankang capsules was that the herbs were extracted by 15 times amount of 80% ethanol for 2 times with 1.5 hours each time, and the residues were decocted by 10 times amount of water for 3 times with 2 hours each time.Rhizoma Polygoni Cuspidati, Radix Astragali, Radix Pseudostellariae, Herba Scutellariae Barbatae, Oldenlandia diffusa willd, Radix Salviae Miltiorrhizae and Radix Bupleuri in the product were identified by thin layer chromatography (TLC) respectively. Spots were clear. The results were not interacted by negative herb sample and the methods were specific. The contents of Emodin, Quercetin, Tanshinone Ⅱ and Oleanolic acid were determined by high performance liquid chromatography (HPLC). The content of the Emodin in the capsules was 2.05 mg/g with good linear relationship in the range of 2.34-74.88 μg/mL (r=0.999 4), the average recovery was 100.5%　with RSD=1.52%; The content of Quercetin in the capsules was 0.415 mg/g (r=0.999 9) with good linear relationship in the range of 3.7-236.8 μg/mL, the average recovery was 99.8% with RSD=1.68%; The content of Tanshinone Ⅱ in the capsules was 0.149 mg/g with good linear relationship in the ranges of 1.96-62.72 μg/mL (r=0.999 9), the average recovery was 100.0% with RSD=1.50%; The content of Oleanolic acid in the capsules was 1.516 mg/g (r=1.000 0) with good linear relationship in the ranges of 3.52-112.64 μg/mL, the average recovery was 100.9% with RSD=1.36%. The results showed that the content of Emodin was the highest and it could be chosen as the quantitative index of Ganyankang capsules.Conclusion:The optimized preparation process of Ganyankang capsules was rational, feasible and the extraction rate of active components were relatively perfect. The quality standards of Ganyankang capsules were specific, stable and convenient. And it could be used to control the quality of Ganyankang capsules.