Study On Extraction Techniques And Quality Standard Of Medicinal Herb Concrete In Zhili Pellet

Purpose:Zhili pellet consists of Radix Puerariae, Radix Scutellariae, Rhizoma Coptidis, Radix Aucklandiae, reca catechu, Betel Nut and Humifuse Euphorbia Herb. It as alleviates fever the disintoxicating, regulating qi to alleviate dysentery function, etc. The pharmaceutical preparation can be used for drugs against acute dysenteric, bacterial, viral and damp heat diarrhea and other diseases. The prescription has been recorded in ministerial standard (see Chinese ministerial standard 05 on page Z5-35; standard number: WS3-B-0904-91). Since the original items in the contents of ministerial standards are not perfect, Such as the preparation of the amount of water, extraction time and extraction times and other factors need to study the added, the subject, regarding the principal of traditional Chinese medicine as the conduct, makes use of the modern science and technology and methods, for the production technique of extractum to have an overall standard study on qualities in the process of producing anti-dysentery pellet which means to improve the production techniques and quality standard. This is to ensure safe and effective drug formulations, stable and controllable.Methods:1. Study on the Techniques of extraction:take the L9(34) orthogonal experiment method for optimization of extraction conditions. Puerarin content and extractum yield rate are the main indexes for the study of Zhili pellet extractum processing. It conducts a systematic investigation on the soak time, water usage, and time consumption in extracting the efficacious ingredients.2. On Quality Standard of Herbs'extractum:This paper, by adoption of thin layer chromatography, carries out four flavor identification of Zhili pellet, i.e.Radix Puerariae, Radix Scutellariae, Rhizoma Coptidis, Radix Aucklandiae. Furthermore, In addition, take the high performance liquid chromatography to determinate the puerarin in Zhili pellet extract content. Determination of puerarin methods were as follows:18 alkyl silane bonded silica gel as a filler, Methanol:water (25:75) as mobile phase; Column temperature was 30℃, etection wavelength 250nm;The flow rate was 1. OmL/min. At last, do the reasearch of including the standard curve, precision, stability, reproducibility, recovery and a series of methodological study.3. Examine the limit of the sample for heavy metals, arsenic salt and microbe.Results:1. Through analyzing the experiment result and the effect from main index, it is concluded that the best extracting processing is:soaking the six types of raw material with 1.8 times more of the medicine quantity in water for 30min, then decocting with 8 times water for 2 hours, in two such cycles. (The relative density of extract concrete is defined as to be 1.10g/mL,80℃)2. The results of TLC show that for the same corresponding position between the samples and the control group, there are speckles in same color with sample group themselves or fluorescent spots; while the negative control group do not present any spot whether in their own or fluorescent colors. Chromatographic spots of the method the resolution is good, reproducible and specific, for the qualitative identification of four kinds ingredients to provide a reference;At the same time, the determination of puerarin experimental results show that:puerarin in the range of 0.8-2.8μg there are a good linear relationship, r= 0.9998, recovery was 97.24%, RSD 1.03%, this product per gram of dry extract containing puerarin is not less than 13.28mg /g. The results of methodological study show that:The method of stability, precision, recovery are in line with requirements, and analysis method is simple, sensitive, reproducible, and to control the quality of the product extract provide quantitative basis, and this method can be used as indicators of the quality control of extractum.3. the limit of the sample for heavy metals, arsenic salt and microbe are in line with pharmacopoeia requirements.Conclusions:In this paper, Preparation process of the intermediate during the preparation of Zhili pellet are optimized and validated, and improves the quality standards, This method is simple, with high extract rate for effective ingredients, providing a scientific basis for getting preparations that safe,effective and quality controlled.