The Study And Preparation Of Qingxin Anshen Soft Capsules

Insomnia refers to a disease often can not get normal sleep certificates[1].This is a common and frequently-occurring disease,had a higher prevalence in the world,and showed a gradually rising trend. Jiaotai pills from the Ming Dynasty"Han Yee Tong "--a book written by Han Mao.Which is composed of coptis and cinnamon prescription,it can tranquillization and cleared the heart fire, inducing fire to the origin, restoring normal coordination between heart and kidney, for disharmony between the heart and kidney insomnia have a significant effect.The " Qingxin Anshen Soft Capsule " is to the secondary development of traditional Chinese prescription of Jiaotai pills, which is combined with modern manufacturing technology and developed become to a new Chinese traditional patent medicine.Because the clinical efficacy is very precise, Jiaotai pills regularly used for insomnia,neurasthenia,etc.Objective:This study is to development the traditional Chinese medicine " Qingxin Anshen Soft Capsule "preparation process,and to establish the quality standards of the Traditional Chinese Drug" Qingxin Anshen Soft Capsule ".Methods:In this study, using the method of orthogonal design experiments berberine, cinnamon herbs extraction technology research, and by single-factor parallel to the experimental methods to inspect various affecting the soft capsule molding factors.Using TLC method to identify the coptis and cinnamon herbs in " Qingxin Anshen Soft Capsule ", Using HPLC quantitative analysis of aldehyde berberine and cinnamic.Result:1. Cinnamon and supercritical CO2extraction process:15MPa extraction pressure, extraction temperature of40℃, resolve pressure8MPa, analytical temperature is50℃for the extraction time is about4h. Coptis extract the best technology:70%ethanol six times the amount of reflux extraction three times, each time1h.2. The best preparation technique for the "Qingxin Anshen Soft Capsule":take the peanut oil328g, add20g of beeswax and heated to a molten state, wait for the coo ling, joined100mesh sieve coptis extract and tween (-80)2.5g, mixed evenly,and then add the cinnamon extrac,Fully mixed and pressing of into the1000soft capsul, each one is0.5g。3. TLC can be used for qualitative identification of the " Qingxin Anshen Soft Capsule " coptis and cinnamon ingredients.This method has good at separation and highly on specificity.HPLC method using column:Phenomenex luna C18(5μm,250mm×4.60mm); Mobile phase:Acetonitrile—0.05mol/mL Potassium dihydrogen phosphate solution (25:75); Flow rate:1mL/min; Detection wavelength280nm; Column temperature:30℃; Determination of berberine hydrochloride in the linear range for0.6412μg-6.412μg (r=0.9997, n=7), the average recovery was97.57%(RSD=0.81, n=6); Determination of Cinnamic aldehyde in the linear range for0.2148μg～2.148μg (r=0.9998, n=7), the average recovery was97.70%(RSD=0.88, n=6).Conclusion:1. In this study, under the guidance of Chinese medicine theory, the nature of the active ingredients of the herbs, flexible use of traditional Chinese medicine modernization technology of soft capsules of pure heart and soothe the nerves to the improvement of the extraction process.2. This project to determine the " Qingxin Anshen Soft Capsule " preparation process.The "Qingxin Anshen Soft Capsule" cover up the bitter taste of coptis extract and the special smell cinnamon oil, enhanced the adaptability of the patient’s,avoided cinnamon oil seeping out of excipients, ensured the stability of the drug.The finished product of "Qingxin Anshen capsule" appearance was nice, no bad odor,to consecutive in trial three times and all met the pharmacopoeia requirements. This study suggests that the " Qingxin Anshen Soft Capsule " preparation process is feasible, suitable for industrial production.3.Establish the ways of TLC test " Qingxin Anshen Soft Capsule " coptis and cinnamon herbs;Methodology inspection showed that,this method for the determination of berberine hydrochloride and cinnamon aldehyde in " Qingxin Anshen Soft Capsule ",have a good linear relationship in that concentration range of the test, simple and good reproducibility, provided a reliable method for the quality control of " Qingxin Anshen Soft Capsule ".