The Research And Development Of Mibao Soft Capsule

The progress of human civilization and the rapid development of The Times is a amazing thing, while bringing the enormous improvement in lifestyle, quietly many diseases are brought to people’s health life, making it more and more prominent medical problems. Constipation is one of them. What is a constipation? In short, is not smooth,defecation cycle is long, often some auxiliary a laxative or drugs are needed to maintain normal defecation. Constipation seriously affect the quality of people’s lives,patients will often appear dizziness, nausea, mood be agitated, abdominal pain,abdominal distension and other reactions, which can induce or aggravate other diseases, such as colon cancer, cardiovascular disease, and even life threatening.Constipation has become a disease that cannot be ignored.Based on this situation, our laboratory developed Mibao soft capsule. The soft capsule by combination, fire maren, acid-insoluble ash of the three traditional Chinese medicine, by promoting gastrointestinal peristalsis to auxiliary aperient effect.This topic main research of this paper is to study the extraction of the soft capsule, preparation process, quality standard and test, etc., and the result was investigated. Final results are as follows:Extraction technology: based on the amount of ethanol concentration, extraction times and alcohol for investigation and extraction time, the design of orthogonal test table L9(34), acid-insoluble ash medicinal materials through orthogonal test the best technology of ethanol extraction conditions as follows: 60% ethanol concentration,extraction times for 3 times, add alcohol content is 5 times, extracting time is 3 hours.Combination, cannabis use CO2 supercritical extraction technology, the traffic volumes of CO2, extraction time, extraction temperature and extraction pressure to investigate factors, through orthogonal test, determine the optimum extraction process was extraction time is 2 hours, 12 times as much CO2 flow for extracting tank volume and 25 mpa extraction pressure, temperature of 50 ℃.Preparation process: through the analysis of the nature of the three herbs extracts,combined with the characteristics of various dosage forms, determine the preparation of soft capsule preparation, after screening, selected using sesame oil as the solvent inside the soft capsule, to join the other accessories and the main medicine,preparation of cost capsule preparation.The establishment of quality standard: according to "Chinese pharmacopoeia" 2010 version of this soft capsule on quality criteria. Quality standards include several aspects, such as character, disintegration time limit, identification, content determination and stability test etc. This soft capsule in combination of extract of radix aucklandiae hydrocarbon lactone and hydrogen to costus lactone content detection index, using high performance liquid chromatography(HPLC) method for determination. The linearity, precision, reproducibility, stability, and investigates methodology sample recovery rate were performed well. And hemp kernels and definite in TLC method to identify as its quality standard. Among them, the definite reference substance, contrast medicinal materials, soft capsule in the same position of the test shows that the same color spots, indicate the presence of soft capsule acid-insoluble ash medicinal materials, and the method with good reproducibility,negative without interference, soft capsule is suitable for the things of the medicinal material qualitative identification of frutus aurantii immaturus.Stability study: the normal temperature test and accelerated test to evaluate the stability of the soft capsule, the contents include the character, identification, content determination and quantity differences and investigation of the project such as microbial limit. In the three months after the normal temperature test and accelerated test observation, soft capsule has no obvious change, it has a good stability.Soft capsule of functional studies: things including three dose groups of compound diphenoxylate cause constipation mice model showed obviously promote the movement of small intestine propulsion in mice, significantly shortened the first defecation time in mice, increased weight, defecate soft capsule have the function of the auxiliary purge explain things.Soft capsule of the above studies have shown that extraction and preparation technology is reasonable, quality control, stability is good, compared with western medicine has side effects, small curative effect because of its health care products features, can play the role of prevention before diseases.