Study On Pharmaceutical Sections Of Enema-Compound Huangqi Changning Granules

Objective: To study the preparation precedure of compound huangqi changning granules, establish the quality standard and investigate the preliminary stability.Methods: The preliminary extraction technology was chosen by the indexes of the changes of physical sign, the numbers of colonic ulcer, caliciform cells, and inflammation lymphocyte by the application of the experimental ulcerative colitis animal model of rat. Orthogonal test was employed for selecting the optimum of extraction technology by the indexes of the contents of ginsenoside Rg₁, ginsenoside Rb₁, notoginsenoside R₁ of the herbs of Radix Notoginseng. Orthogonal test was also employed for selecting the optimal extraction technology of Radix astragali and other herbs with colligation score by the indexes of Astragaloside IV, total solid matters and total flavone in water extraction. And they were also used to investigate the purification technology of water extraction. The concentrated and dried technology of water extraction and ethanol extraction by the contents of Astragaloside IV, total flavone and Panax Notoginseng Saponins. The kind and dosage of adjuvant were investigated by the index of improved hygroscopicity with the experiment of hygroscopicity of powdered extract. The granules were prepared by the method of wet granulation. Radix Astragali, Radix Notoginseng, Radix Sanguisorbae and Fructus Psoraleae in compound huangqi changning granules were identified by TLC; The content of Astragaloside IV in this preparation was determined by HPLC-ELSD in the study of quality standard. And the content of Panax Notoginseng Saponins in this preparation was determined by HPLC. Preliminary stability of the preparation was investigated by accelerated test and long-term testing. Results: Six volumes of 70% ethanol, extracting 3 times with 0.5 hour for each time was considered the optimum extraction technology of the herbs of Radix Notoginseng. And nine volumes of water, extracting 3 times with one hour for each time was considered the optimum extraction technology of Radix astragali and other herbs. Water extraction was purified by ethanol precipitation, and it was condensed to the relative density of 1.05 under the condition of 60℃, and the content of ethanol was adapted to 50%, standed by 24 hours, filtrated. The water extration and ethanol extraction were concentrated and then vacuum dried under the condition of 70℃, vacuum=0.08～0.1Mpa. 70% weight of dry powered extraction was applied to prepare the granules. And the granules were brown. The bulk density was 0.53g/ml. The angle of repose was 35.1 degree. The critical relative humidity was 62%. Granularity, moisture content, and solubility were qualified all the rules of granule in《Chinese Pharmacopoeia》2005ed Vol I. The quality identification by TLC was specific,having a good separation and a clear spot in each thin layer plate. Astragaloside IV was linear with the logarithm of the peak area in the range of 1.430μg～14.30μg, and the average recovery was 100.6%, RSD=1.1%(n=6). The content of Astragaloside IV was no less than 0.15mg/g. Ginsenoside Rg₁, ginsenoside Rb₁ and notoginsenoside R₁ were linear with the peak area in the range of 1.285μg～12.85μg, 1.193μg～11.93μg, 0.6220μg～6.216μg respectively, and the average recovery of Panax Notoginseng Saponins was 99.6%, RSD=1.9%(n=6). The content of Panax Notoginseng Saponins was no less than 6.5776mg/g. Aluminium foil was chosen to be packing material, and it was PET/Al/PE. The granules were seal up to preserve. Every bag was filled to 15g. It was dissolved by using 40ml of boiled water and retation enema when it was lowered to body temperature for two times a day. The charater, identification, moisture content, solubility, granularity, assaying of Astragaloside IV hadn't been changed obviously by accelerated test and long-term testing.Conclusion: The preparation precedure of compound huangqi changning granules was reasonable, practical. The evaluation methods are simple, specificity, reproducible and can be used in the quality control of compound huangqi changning granules. And the quality of the sample was steady as well.