| Objective: Shenqiyangxin Granules is based on clinical empirical formula. In order to overcome the disadvantage of this decoction, the project has changed the dosage form for the medicine instead of granule. In addition, we studied on the preparation process and quality standard of the Granule. It would to be provided theoretical and experimental basis for decoction of further development and utilization.Methods: First, we used the orthogonal design method to optimize the best water extraction process based on the salvianic acid B and the yield of extraction. Second,we seleced the granulating difficulty, grain’s moisture absorption, liquidity and formability as the index, to investigate the molding craft parameters through the result of the optimiziation of excipients and their percentage, wetting agents specifications. Third, the TLC method was used to identify the characteristics of radix et rhizoma Salvia miltiorrhiza bge, radix Astragali, radix Pseudostellaria, radix Opliopogonis, Allium macrostemon bulbus, Trichmanthes fructus, and the content of astragaloside IV and salvianic acid B were determined by the HPLC method,respectively. Accordance to Pharmacopoeia of the P. R. China and the relevant provisions, the product of grain filling quantity difference, particle size, moisture,melting, heavy metals, arsenic salt and microorganism were inspected. Then, the stability experiments of three batches of the granules under package(pharmaceutical packaging composition film) for six months accelerated test and long-term stability test for three years have studied in according with technical requirements and quality stability research of new drug of TCM and the quality standard draft of Shenqiyangxin Granules.Results: The optimum preparation process for: prescriptions(the six herbs), with 10 times water as solvent, decocting extraction twice, each time 1.5 hours, filtering,merging of filtrates. After submerged for 24 h at room temperation, the supernatant was concentrated to the extract with the relative density of 1.10-1.15 at 80℃. Then70% dextrin were added to the extract, mixed, dried, grinded, and the rest of 20%dextrin added, with the amount of 85% ethanol granulation, drying, sorting granules,repacking, completed.In quality control, the TLC methods were established to identify the herbs of radix et rhizoma Salvia miltiorrhiza bge, radix Astragali and radix Pseudostellaria.The spots were clear and negmive contrast had no interference in the TLC pictures. In HPLC-UV determination of the Salvianolic acid B, linear regression equation was y =3858.4x + 35813, the range was at 61.8-412μg·ml-1, r = 0.9994, average recovery rate was 98.8%, RSD = 1.6 %(n = 6), with the minimum Salvianolic acid B content in the granules of each package should be not less than 50.0 mg; HPLC-ELSD determination of astragaloside IV, linear regression equation was y = 1.6528 x + 5.4,the range was at 56.4~ 376μg·ml-1, r = 0.9992, average recovery rate was 97.8%,RSD = 1.64%(n = 6),with the minimum astragaloside IV content in the granules of each package was not less than 1.0 mg. The established method is rapid, simple,accurate and suitable for the quality control of Shenqi Yangxin Granules. Stability tests show that the stability of this product is better.ConclusionFrom the results of the study, we can draw a conclusion that the preparation technology is reasonable, the quality ofthe product is stable and the testing method is scientific. Thus, the study meet the standard of a modem Chinese medicine. |
PDF Full Text Request