Research Of Sanhuangqianbizhi Capsules

Sanhuangqianbizhi Soft Capsule is made of Astragalus membranaceus(Fisch.) Bge.var:mongholicus Hsiao,Phellodendron chinense schneied,Sophora flavedcens Ait and so on,which has the effects of Sterilization,pain-relieving,used in prostitutes' treatment.The product was made into soft capsule based on clinical application,by choosing and proving of prescription and dosage form.This subject mainly deal with:(1)establishment the content of principal ccmponent;(2)extraction technolcgy of crude drug;(3)preparation technology of soft capsule;(4)quality standard and stability of preparation.In order to establish foundation of studying on Astragalosideâ…£,Berberine hydrochloride in herbs and sanhuangqianbizhi soft capsules.Compared with controls and herbal controls,the sample had the pot of same cooler in the corresponding position.Negative sample had not any interference.The method of Dual-Wavelength TLCS and HPLC were built up determine the content of Berberine hydrochloride and Astragalosideâ…£main ingredients.The two methods were accurate,reliable and repeatable.According to the property of herbs,ten five senses raw materials for medicine were extracted and refined in different ways.(1) Extraction of fat-soluble components:They were extracted by boiling with alcohol.Experiment was designed according to L9(34) orthogonal experiment which containing four factors---alcoholic consistency,alcoholic amount,extraction time and frequency,there levels were chosen in every factor,and the concentration of Bebeerines hydrochloride and Total Alkaloid as evaluation index to optimizing extraction technology.The results showed that the best extraction technology was extracted 3times by 7folds 80%alcohol(l hour per time).(2) Supercritical -CO2 Fluid(SCF) was applied to extract essential oils of Angelica sinensis(Olive.).Experiment was designed according to L₉(3⁴) orthogonal experiment containing four factors-------Extraction intensity of pressure,time and frequency.Three levels were chosen in every factor.The concentration of ferule acid as evaluation index to optimizing extraction technology.The results showed that the best extraction technology was that ferule acid was extracted 30mp intensity of pressure,temperature was 45(4 hours per time).(3) Extraction of water-soluble components.We did experiment according to L9(34)orthogonal experiment containing three factors ----the amount of water,extraction time and frequency.Three levels were chosen in every factor.The concentration of Astragalosideâ…£and Total Soap Glucosidal as evaluation index to optimizing extraction technology.The results showed that the best extraction technology was that herbals were extracted 3times by 8 folds water(1 hour per time).(4) Studying on alcoholic depositing method.Merging the extracting of water,Fueniculum vulgare Mil1 and Angelica sinensis(Olive.) Diels.The results showed that the most proper technology was that,concentrating under the room temperature to the relative density is 1.10---1.15,alcoholic concentrate is 60%,depositing time is 12 h.The research on formation of soft capsule,we chosen suspending agent and wetting agent according three factors---granularity of extracts,the amounts of the suspending agent and wetting agent.The best prescription was,extracting powder passed through 200 mesh:Soybean oil:Beeswax:Phosphate (l:1.4:5%:4%).In different conditions and ensured the formation of capsule shell was,gelatin:glycerol: PEG400:lemon yellow(1:0.5:0.075:0.08).Quality of Sanhuangqianbizhi soft capsule was showed that based on appearance,property, identification,limit test of disintegration and assay.Preliminary stability test showed that the stability of this product is good.