Zhong Qu Ma Soft Capsule Of Pharmaceutical And Pharmacodynamics Study

Due to diet,irregular work and other reasons lead to part of the people in the sub-health state.Hyperlipidemia is a risk of human the highest incidence of disease,effectively regulate blood lipid levels,to keep your body healthy is particularly important.The study found that most of the clinical regulation of blood lipid drugs are Western medicine,the role is strong but not lasting,and toxic side effects is obviously,not as the best choice for regulation of blood lipids.Traditional Chinese medicine(TCM)to treat hyperlipidemia curative effect is distinct,and the side effects is small,become one of the hot spot of current research.The main research contents:1、To research a kind of compound Chinese traditional medicine soft capsule which has the function of auxiliary fall hematic fat.The soft capsule contents is constitute of eucommia seed oil,flax seed oil,eucommia ulmoides male flower of superfine powder,red kojic rice,vitamin E and beeswax,according to the Chinese traditional medicine and new medicine naming principle named zhong qu ma soft capsule.Through the single factor investigation beeswax,colloid mill grinding time and the dosage of red kojic rice powder particle size to select out the best preparation process.The optimum preparation process: The suspended aid beewax liquid was the dosage of 2% of the liquid and the red kojic rice powder though 100 mesh sieve.When the eucommia seed oil,flaxseed oil,beeswax are melting,then added vitamin E,eucommia ulmoides male flower of superfine powder,red kojic rice under the condition of the temperature has dropped to 35℃.Then colloid mill grind the liquid for 15 minutes.2、The preparation process of capsular shell: the best capsular prescription was selected by examining the amount of gelatin and pigment solution.From the experimental results,when the gelatin: glycerol: water ratio of 1: 0.4: 1 and 0.65% of titanium dioxide,0.26% of the cocoa shell pigment made of shell elasticity,good shading.3、 The content of soft capsule’s active components were measured.The GC method was adopt to determine the α-linolenic acid in the soft capsule.The chromatographic conditions:Chromatographic column for TG-WAXMS;Column temperature for temperature programmed:160-250℃,10℃/min,160℃ keep 1min,250℃ keep 4min;the split ratio of 33.3 :1;Sample quantity for 3μL;Detector for hydrogen flame detector;Injection port temperature is 250℃;Detector temperature is 250℃.Results: Each grain soft capsule contains not less than 0.1g of α-linolenic acid.The content of lovastatin in the soft capsule was determined by high performance liquid chromatography(HPLC).The chromatographic conditions:Chromatographic column for Agilent TC-C18 chromatographic column(5μm,4.6x250mm);Detector: SPD-20A;The mobile phase: methanol-water-phosphoric acid,the ratio was 385: 115: 0.14;The mobile phase flow rate: 1.0 mL/min;Detector wavelength: 238 nm;injection volume: 10 μL.Results: The content of lovastatin in the soft capsule not less than 1.0mg.4、According to Chinese Pharmacopoeia and the technical specification for health care food inspection and evaluation for the Zhong qu ma soft capsule quality standard draft.5、The stability of the Zhong qu ma soft capsule was investigated by three months of experiment(temperature 25℃±2℃,relative humidity 60%±5%)for three batches of soft capsules(20161101,20161102,20161103),the appearance,acid value,peroxide value,microbial limit and the content of the active ingredient were tested on the basis of the draft quality standard.The results showed that the soft capsules in the three months of the indicators were no significant changes.6、The effect of soft capsule on hypolipidemic effect was studied,KM mice were randomly divided into 6 groups,by giving high fat feed made mould,divided into blank control group,lovastatin positive control group,high-fat model control group,the Zhong qu ma soft capsule low-dose group(167mg/(kg·BW)),medium group(333mg/(kg·BW)),high-dose group(1g/(kg·BW)).Using the method of orbital venous plexus blood to take blood.The results showed that Zhong qu ma soft capsule could control the growth of mice weight and liver weight,and could decrease the LDL-C,TC,TG and HDL-C in mice with hyperlipidemia,and the hypoglycemic effect is obvious.