| Fuzheng Kang'Ai Capsules are made on the basis of the experimental prescription of Hubei Hospital of Traditional Chinese Medicine, which is made up of several Chinese herbs, including Radix Astragali, Herba Violae, Radix Codonopsis, Rhizoma Curcumae Longae, Radix Lithospermic, Radix Glycyrrhizae, etc. It can be used in the aspect of AIDS because it has effects of reinforcing immunity and resisting virus. We were researching this drug according to the national new-drugs, dealing with the preparation procedure, quality standard and stability of the drug.The research on extraction technology of essential oil of Rhizoma Curcumae Longae: essential oil is one of the effective ingredients. We employ orthogonal design to evaluate the factors influencing the effects of extracting the oil. The results show that the best conditions are immersing the rough powder of Rhizoma Curcumae Longae with 8 times of water for 0.5 hour and distilling for 6 hours.The research on extraction technology of Radix Astragali and the rest Chinese herbs: the main effective elements of Radix Astragali and the rest are astragaloside and total astragalan. We extract them by water and do experiments according to L9(34) orthogonal table containing four factors -the amount of water, the time of extraction, the time of soaking and the frequency of extraction regarding the changing figure of dry grease, astragaloside IV and total astragalan as evaluation index to choose the most suitable conditions of extraction technology. The results show the best extraction conditions are extracting them with water of 8 times for 3 times, 2 hours once.The research on depositing the water extraction: In order to eliminate useless ingredients and reduce the dosage. We employ alcoholic depositing method to refine the concentrated extraction of Radix Astragali and the rest Chinese herbs, regarding the changing figure of dry grease, astragaloside IV and total astragalan as evaluation index, then use orthogonal design to examin the relative density, alcoholic amount and depositing time of the concentrated that influence the effects of alcoholic depositing. The results show that when the relative density is 1.20, alcoholic amount is 50%, time for depositing is 12 hours, it is the most reasonable .The research on formation technology: We choose the excipient of the contents according to the characteristics of the hard capsules. The results show that when we choose dextrin and soluble starch(1:1) as moistening agents, CaHPO4 as absorbents, magnesium stearate as lubricants, it assures the successful process of the packing and the stability of capsules.The research on quality standard: in order to control the quality of the product, we have researched its quality. We use TLC chromatography to identify RadixAstragali, Herba Violae and Radix Glycyrrhizae, which showed that the method is specialized to the drugs and has good ability of reoccurring. We use TLCS to determine the contents of astragaloside IV, the results show that the contents in every capsule of astragaloside IV shouldn' t be less than 0. 26mg. We use phenol- sulphuric acid to determine the contents of total astragalan, the results show that the contents in every capsule of total astragalan shouldn' t be less than 20mg.The research on mid-experiment: in order to test the rationality of the preparation, three batches of products were detected according to all the indexes from the quality control, the results are good and the received products rate is above 95%.The research on stability: in order to examine the stability of the medicine, determine the time of validity of the medicine and examine how the wrapping material affects the quality and stability of the medicine, we keep the wrapping material both at indoor temperature and at 40 °C (temperature) ,75%(relative humidity)for three months by accelerated experiments. The results show that the wrapping material has no bad effects on the quality and stability of the product.AIDS is one of the most threatening diseases to human health at present. The subject aims at rese... |
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