The Comparison Of Two Preparation Processes Of Jieyinjiedu Capsule And The Study On Its Preliminary Stability

The drug abuse brings great harm to the society and individuals, and detoxification is the only way to recover. At present, medicine detoxification is the most widely used method, and the main inadequacy of western medicine detoxification is the high rate of relapse.This prescription is formulated under the TCM (Traditional Chinese Medicine) theory of syndrome differnetiation, according to the etiology and pathogenesis of drug addicts, and based on the main therapeutic principles of sedation and hypnosis, invigorating qi and strengthening resistance. It is composed of10herbs, Radix Ginseng Rubra, Semen Ziziphi Spinosae and so on. It is showed the action of invigorating qi and relieving internal heat, tranquilizing the mind, strengthening resistance and suppressing hyperactive liver and subsiding yang. It could be used to eliminate and alleviate psychiatric symptoms such as protraeted withdrawal symptoms and drug craving.ObjectiveTo develop this description into a solid dosage form which is conveninent to administrate and carry(under the function and indication of the prescription, combining with the characteristics of the main components and the demands of clinic, this preparation is supposed to be capsule). Design preparation process routes, and compare their goods and bads to make sure the one is reasonable and feasible, stable and reliable. To ensure the feasibility and stability of the manufacture, to guarantee the effectiveness and stable quality of the preparation.MethodsAccording to the characteristics of the ingredients of the prescription, some are made into dry extract by water extraction and alcohol precipitation mathod, and the others are directly crashed into fine powder. Mix the above uniformly, used as medicines. Design two preparation process routes, and compare the applicability of the two processes on the macroscopic and microscopic way. The extraction rate, powder yield, drying rate and powder characteristics are the macroscopic indices, and the contents of ginsenoside Rgl,Re, Rbl and Jujuboside A are the microscopic indices, which are used to estimate the products of two processes. Study the simultaneous determination of four components by HPLC, including the extraction method, the gradient-elution condition and the systematic methodology. The transfer rate is taken as an iherent index while determining to contents. Using pilot scale production to check the feasibility and stability of the preparation process, and do the preliminary stability research of the pilot product by remaining samples observation method.Results1. extraction rate, the rates of two preparation processes are between14.90%and15.25%, analysis of variance, P=0.2775>0.05, the result indicates the difference is not statistically significant.2. Powder yield, yield of them are both about75%, analysis of variance, P=0.6421>0.05, the result indicates the difference is not statistically significant.3. Drying rate, they are significantly different, one needs36h to dried to constant weight, and the other needs24h.4. Powder characteristics, the ratio of the capsule contents is different, process A60%powder and40%starch, process B100%powder. The former percentages of extraction powder, herbs powder, and starch are26%,34%,40%. The latter percentages of extraction powder and herbs powder are17%,83%. The differences of the powder hygroscopicity and fluidity between the two processes are statistically significant. The strong hygroscopicity and poor fluidity of process A are not suitable to encapsulate. After adding starch, the hygroscopicity and fluidity are improved. The differences between it and process B are not significant, and both of them are suitable to encapsulate.5. The method of simultaneous determination of ginsenosides Rgl, Re, Rb1and Jujuboside A is determined. The results indicates the difference of the transfer rate between the two processes is statistically significant. The transfer rate of process A and B is about40%and82%.6. Preliminary stability research, there are no significant changes in the traits, moisture, disintegration, microbial limit tests and contents.ConclusionComparing the parameters of process A and process B, it was found that the powder of the former one is less than the requirement of the prescription, as its strong hygroscopicity and poor fluidity, starch must be added to improve its powder characteristics. The powder of the latter one meets the above requirements. The transfer rate of determination of contents shows that the former one is only about50%of the latter one, so the latter one is determined as the formal preparation process of the prescription. The results of three batches of pilot scale productions and the preliminary stability research indicate the preparation process is reasonable and practical, stable and reliable.