Efficacy Verification Of Lipid-lowering Compound And Research On Particle Preparation Proces

Hyperlipidemia is a metabolic diseases,which caused by abnormal lipid metabolism in the body,one or more lipid levels higher than the normal,including high triglyceride,hypercholesterolemia and both are high mixed hyperlipidemia.Hyperlipidemia is a systemic disease,with hidden and progressive features.The most direct damage caused by hyperlipidemia is atherosclerosis.Because the arteries are responsible for supplying blood to the body.Once the artery is clogged,it will lead to serious adverse consequences to the body.Such as atherosclerosis-induced renal failure.A large of number of sdudies confirmed that,hyperlipidemia is an important factor in cardiovascular and cerebrovascular diseases such as coronary heart disease,stroke,sudden cardiac death.In addition,hyperlipidemia is also closely associated with high blood pressure,fatty liver,diabetes,hyperuricemia.In resent years,due to economic development and changes in people’s habits.The incidence of hyperlipidemia continues to rise and grow towards younger age.Due to the rise of incidence rate,hyperlipidemia has become the focus of clinical attention,prevention and treatment of hyperlipidemia related products have become a research hotspot of pharmaceutical research.In this paper,high hypolipidemic model was used to screen the compound of Chinese medicine with significant hypolipidemic effect.And carrying out process research to the screened compound.,prepared the compound as a simple and easy to serve granules.The results of this paper are as follows:Group selection:In this study,golden hamster hyperlipidemia model was established by feeding with high fat diet.And the hamsters were divided into normal group,model group,positive drug group,compound 1 group,compound 2 group,compound 3 group.Give different groups of high fat gerbils daily corresponding compound daily.Serum TC,TG,LDL-L and HDL-L were measured every two weeks,and compared with serum indicators of the model group.To observe the effect of different Chinese medicine prescription on blood lipid of hyperlipidemic hamsters.The results show that,three Chinese herbal prescriptions showed a significant reduction in serum TC,TG,LDL-L after four weeks administration.After six weeks of administration,compound 1 and compound3 has no significant differences in blood lipid levels with model groups,but compound2 have a more significant effect until the tenth week.Indicating that the compound2 lipid-lowering effect is relatively stable,can be used as lipid-lowering product.Extraction process:In this paper,the method of water decoction was used to extract lipid-lowering compound 2.The content of total flavonoids,total saponins and the dry weight of medicinal herbs were selected as the indexes of the extraction of the water-soluble functional components.UV was used to detect the content of the total flavonoids and the total saponins in the extract under the orthogonal test.The effects of soaking time,extraction time,extraction times and adding water on the three indexes of water extraction were studied.And finally determine the best extraction program:the amount of water is 8 times of the herbs,extracted 2 times,0.5 hours each time.Finally,the process is verified to ensure that the process is stable and feasible.Granule forming process:In this paper,the moisture absorption rate,the forming rate and the dissolution rate of the granules were investigated.It was found that the granules produced by lactose had good dissolution rate and moisture resistance,the particles produced by starch have a good molding rate.Then,through a single factor test to inspect the ratio of filler to dry extract,the concentration of ethanol,and the ratio of ethanol to extract.Finally,the optimum granulation conditions were obtained:the ratio of dry extract to filler is 0.8:1,the concentration of ethanol is 80%,the ratio of ethanol to extract is 1:0.5.According to the best technology to produce three batches,three batches of granules were tested for related items.The results show that the technical parameters of the three batches of samples are stable and meet the requirements of each inspection of granules.Quality Standard:This paper refers to the《Chinese Pharmacopoeia》of 2015 edition.Using thin layer chromatography to identify Poria,Dried tangerine peel,Hawthorn,Wolfberry,Raspberry on the original ingredients and particles.The results show that the thin layer chromatographic conditions are reasonable,the method is stable and reliable,the separation effect is good,the sensitivity is high and the specificity is strong.In this paper,the method of ultrasonic extraction of compound lipid-lowering granules was established.The contents of total flavonoids and total saponins were determined by UV.The results of the methodological investigation and sample determination show that the method is accurate,stable and reliable,and the quality control system of lipid-lowering compound particles has been established comprehensively.This paper has the following characteristics and innovation:(1)In this paper,we selected a stable and effective Chinese medicine prescription to reduce blood lipid TC and TG by hamster hyperlipidemia model.(2)In this paper,taking the content of active ingredients and the yield of dry cream as an index,screened out the best decoction of lipid-lowering compound.The optimum granulation process of lipid-lowering compound particles was screened out by the rate of formation,moisture absorption and dissolution rate.(3)In this paper,an ultrasonic extraction method for efficient extraction of granular active components was established,and the quality of lipid-lowering compound particles could be controlled easily and accurately.