Pharmaceutical Research Of Yinqu Soft-Capsules

Yinqu soft-capsule is a traditional chinese compounds medicine,which is made up by the extractive of Ginkgo Leaf and Monascus.It is named by the key words of two medicinal materials and dosage form.The prescription of Yinqu soft-capsule includes the extract of Ginkgo Leaf,which active ingredients,ginkgolides and flavonoid,have the unique effectiveness for the cardiac cerebral and vascular diseases,especially to the cardiac cerebral and vascular diseases patients who need to be cured for long terms.Lovastatin is included in the Monascus.It can restrain the activity of hydroxyl methylglutaryl coenzyme A reductase(HMG-CoA)and low down the level of cholesterol in the body.Two materials both have the effective cure result to the cardiac cerebral and vascular diseases.We make use of the synergistic effect and complementary action of two materials and develop the Yinqu soft-capsule.The procedures is described:The Prescription's Pharmacodynamics Study:Feed the laboratory mice with high-fat forage and Yinqu capsule for two weeks;after feeding the laboratory mice with high-fat forage for two weeks,rise the blood lipid of laboratory mice,feed the mice Yinqu capsule in high,medium,low,three different dosage;feed the domestic rabbit with Yinqu capsule in high,medium,low,three different dosage group,test the T-CHOL,TG,LDL-C,VLDL-C and T-CHOL/HDL-C data in the blood serum,the result shows that the Yinqu capsule can prevent and regulate the blood lipid of the high-fat mice,regulate the blood lipid of domestic rabbit.The results show that the Yinqu prescription have preventive effects for high lipid disease and can regulate plasma blood lipids.The Preparation Process Research on the Yinqu soft-capsule:The main ingredient in Monascus-stains,easily dissolved in the organic solvent of methanol and ethanol and alkaline water.According to the traditional extraction process,stains are safely and completely extracted by alkaline water and ethanol.Monascus is a fermentative product on the base of rice nutrient pad;use the alkaline water to extract,the rate of extraction will be higher;and the transfer rate of active ingredients is higher,but the extraction rate can reach the 33.0%when the extraction is carried out in the hot alkaline water.It may be the reason that the hot alkaline water dissolve the starch,etc materials in the rice.use the alkaline water to extract will increase the dry-paste quantity,it's not facilitate to prepare the preparation we take the traditional ethanol extraction way.Choose ethanol concentration,ethanol quantity,extraction time,extraction times,four elements,each individual element choose three different levels,take the transfer rate of lovastatin and extraction rate as target,choose the best proper extraction process for Monascus.In order to assure the safety of Ginkgo biloba leaf extract,we supplement the testing of the residual organi c solvent on the base of Chinese Pharmacopoeia.Choose soft capsule as its form,because the extract of Monascus is oil matter,soft capsule is easily made with proper accessory.Soft capsule is easily dissolved,high bioavailability and stable.According to the documentation and experimental result,0.5h,filter,concentrate,add the prescription amount of Ginkgo Leaf extract,the mixture is oily,we try to add proper proportion and sort material.On the base of pre-screening,prepare 11 prescription to select,count the content quantity 100g in each group,observe the mixture's stability within 3 days,select the best prescription content of the soft capsule.Yinqu soft-capsule Quality Standard:In order to control the quality of Yinqu soft-capsule,we do the quality standard research on the three batches samples.According to the testing items of the soft-capsule in the Chinese pharmacopeia,set the draft of the quality standard.Identify the crude medicines and indicated ingredient by taking the TLC method,the result shows that the chromatographic spots of the indicated ingredient are clear,special,reproducible;take the HPLC to test the content of Lovastatin,Total Flavonoids,lactone,assess the similarity of Yinqu soft-capsule by taking the traditional Chinese medicine chromatographic fingerprints assessment system,the result is in accordance with the technical requirements of chromatographic fingerprint research.The Stability Research:The thesis with deal of the primary stability research on the Yinqu soft-capsule,in order to make a proper expiry date.The author does the accelerated testing and retention testing in room temperature.We do the research on the sample's characters,identification,moisture,disintegrating time,microbial limit and assay when the sample is in 0 month,1st month,2d month,3rd months.