Study On The Preparation Of Chinese Traditional Medicine Compound Shenqi

Compound shenqi preparation’s formula is compose of five traditional Chinese medicine with radix astragal、atractylodes macrocephala、heterophylly falsestarwort root、stir-baked fructus hordei germinatus arid divaricate saposhnikovia root. It’s added on the base of famous ancient prescription "Jade Screen Powder", and compound shenqi preparation has the efficacy of nourishing qi to invigorate spleen and antihidrotic. We selected the formula as model medicine, designed and prepared granules、soft gelatin capsule、self-emulsifying drug delivery systems.Astragaloside and atractylodis control medcine, as typical principles are qualitalively analyzed with simple and proper TLC methods. Astragaloside is used as typical principles to determine the content of compound shenqi soft gelatin capsule by HPLC-ELSD methods. All of these methods are accurate and sensitive. To optimize the extraction process for compound shenqi preparation, orthogonal design was used. The content of astragaloside and dry extract rate were used as index to evaluate the extraction efficacy; To optimize the extraction process of volatile oil, orthogonal design was also used to investigate factors including the size of the herbal, distillate liquid amount, extracting times, solvent volume, soaking hours; Alcohol precipitation method was used to optimize purification process. The content of polysaccharide and dry paste ratio were used as index to evaluate the purification efficacy. The investigation factors including relative density, alcohol concentration, sediment temperature, sediment time. The results indicated that the quality of the extraction intermediate was good and the intermediate ensured the compound shenqi preparation’s clinical therapeutic effects.Traditional wet granulation was used to prepare compound shenqi granules and the quality of granules were satisfactory. With the vegetable oil as the diluents bases, compound shenqi soft gelatin capsules were prepared. In order to find the effect of the formulation factor on the dissolution rate of gelatin shell, UV method was set up to determine the release of lemon yellow from the gelatin shell. The effect of some additions on the dissolution rate of gelatin shell was studied. The results showed that the dissolution rate changed irregularly with the increase of the ratio of the gelatin to glycerine. The acid, glycine can raise the solubility of the gelatin shell. And the plasticizer, titanium and chocolate pigment have little effect on the dissolution rate. The quality control methods can control the quality of compound shenqi soft capsule efficiently and ensure the safety of clinical medication.The compare study of compound shenqi granules and soft gelatin capsule on stability test was carried out. The results of accelerated tests and long-term tests proved the good stability of granules. The result of stress tests showed that the compound shenqi soft gelatin capsules were unstable under high humidity condition and it was stable when exposed to strong light, high temperature. Six months tests under room temperature or twelve months under accelerated circumstance indicated that the preparations were stable. The stability test results of volatile oil in different preparation manifested that the content ofβ-eudesmol in compound shenqi soft gelatin capsule was stable than in granules.The compare study of compound shenqi granules and soft gelatin capsule indicated that they had definite therapeutic effectiveness on anti-hypoxia, anti-fatigue, strengthening immunization and neglectable side effects. Compound shenqi preparation can improve the immunological functions of normal and immunosuppressed mice, can enhance the anti-stress capability of anti-high temperature、anti-low temperature、anti-fatigue and serum antioxidation also. They had a certain amount of dose-effect relationship. The results of pharmacodynamics study between compound shenqi granules and compound shenqi soft capsule indicated that compound shenqi soft capsule can raise the body weight in normal mice obviously, can extend the anti-high temperature and anti-low temperature capability in normal mice, can increase the serum SOD activity also. All of these indexes had significant deviation which compared with compound shenqi granules.From the results of the clinical trial, we can conclude that compound shenqi soft capsule can increase the immune index of IgG and lymphocyte conversion ratio and improve the clinic symptom obviously in adult and children patient of vital energy deficiency, and have no significant deviation compared with compound shenqi granules. It’s better than granules on the therapeutic effect in children patient of spleen-QI deficiency. The effective power of compound Shenqi soft capsule on immune function deficiency, repeat respiratory tract infection, cacogastric patient were 43.1%,67.3% and 73.3%. The two compound shenqi preparation have not showed any adverse effect during the test and follow-up visit period. The results of laboratory examination had no abnormality.