Study On The Preparation And Quality Control Of Qishenqiangxin Granules

Qishenqiangxin Granules, which are developed based on clinical experiences,contain six traditional Chinese herbs including Red Ginseng, Astragalus and Salvia.They have such functions as improving health, strengthening the heart and removing meridian obstruction. Clinically they are used to treat chronic heart failure.Originally the formula was decocted; however, to make it convenient for patients to carry and take it, it has been especially made into traditional Chinese medicine granules. In this paper, we have extracted and prepared the herbs of Qishenqiangxin Granules and developed quality control methods, to provide more basis for the development of the formula.Objectives: Find the optimal preparation technology of Qishenqiangxin Granules;make quality control plan; observe the preliminary stability of Qishenqiangxin Granules, to provide certain scientific basis for new drug development.Method: With the ratio of extraction and tanshinone IIA content as the observation and research indicators, adopt the orthogonal test to find the optimal alcohol-extraction technology of Salvia; with the ratio of extraction and total saponins of ginseng as indicators, adopt the orthogonal test to find the optimal alcohol-extraction technology of Red Ginseng; with the ratio of extraction and the content of astragaloside Ⅳ as indicators, adopt the orthogonal test to find the optimal water-extraction technology of herbs like Astragalus; study the edulcoration,concentration and drying technology; with fluidity, hygroscopicity and formability as main indicators, study the accessories and formation technology of the preparation;conduct the pilot experiment of Qishenqiangxin Granules.Perform the qualitative identification of Astragalus,Red Ginseng,Angelica Sinensis and Salvia used in the formula with thin layer chromatography(TLC); in the meantime determine the contents of ginsenoside Rg1, ginsenoside re, ginsenoside Rb1 and astragaloside Ⅳ of Qishenqiangxin Granules with the HPLC-ELSD method;determine the contents of aconitine, mesaconitine and hypaconitine in Qishenqiangxin Granules with the HPLC method to control the amount of the toxic ingredient- monkshood in the formula; adopt acceleration test and sample observation test on the samples of the three batches of pilot experiment products, to find out the preliminary stability of Qishenqiangxin Granules.Results: The optimal alcohol-extraction technology of Salvia is: to add 12 times amount of 90% alcohol and extract the herb twice, each for 1.5h; the optimal alcohol-extraction technology of Red Ginseng: add 10 times amount of 80% alcohol and extract the herb two times, each for 1h; the optimal water-extraction technology of Astragalus and other herbs: add 10 times amount of water and extract the herbs three times, each for 1.5h; the formation technology is: to select lactose and soluble starch as accessories and make granules with 80% alcohol; all of the samples of the three batches of pilot experiment products meet the requirements; the TLC for Red Ginseng,Astragalus,Salvia and Angelica Sinensis is easy, feasible and specific; the HPLC-ELSD has been adopted to determine the contents of ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1 and astragaloside Ⅳ,which is accurate, feasible and specific. The HPLC method, which has been used to determine the contents of aconitine, mesaconitine and hypaconitine and control the amount of the toxic ingredient-monkshood in the formula, is convenient, accurate and easy to control.After three months of preliminary stability test, it’s found that all indicators of the three batches of samples meet the requirements. Subsequent observation will continue.Conclusion: The optimal technology of Qishenqiangxin Granules is reasonable and easy to carry out; the quality control method is accurate, feasible and specific and can effectively control the quality of the drug; the preliminary stability test of the three batches of samples shows that the quality of Qishenqiangxin Granules is basically stable in three months.