Studies On Qishenyuyei Capsules

The capsule of qishenyuyei is composed of Radix Astragali, Radix Salviae Miltiorrhizae, Kudzu Root, Anemarrhena Asphodefoides, Radix Rehmanniae, Rhizoma Dioscoreae, Endothelium Corneum, Snakegourd Root , Schisandra Fruit, etc. It has many pharmacologic actions, such as nourishing spleen and kidney, nourishing Yin and clearing the heat, moistening dryness and quenching thirst, and it has been used in the treatment of diabetes mellitus extensively at present. The original prescription derived from the book "Yi Xue Zhong Zhong Shen Xi Lu". In our research, Radix Salviae Miltiorrhizae and Radix Rehmanniae were added in the capsule. This paper was focused on extraction, preparation, identification in qualitation, fixed quantity analysis and inspection in quality.In order to extract much more active substance, the extraction method of alcohol followed by water was used. In alcohol extraction, orthogonal experimental design was applied to optimize the process parameters which affected result of extraction seriously such as concentration of alcohol time of extraction, volume of solvent and times of extraction. Based on the criterious of the contents of astragaloside IV and tanshinone II_A, and ratio of extractum, The optimal extraction process was as follows: reflux extraction with 6-fold 70 % alcohol for 2 times, 1.5 h per time. Orthogonal experimental design was still used in water extraction. Three main factors such as time of extraction, volume of solvent and times of extraction were considered. The research on protocatechuic aldehyde showed that the best extraction technology was eight times of medical residue, and extract two times and 1.5h per times. Decompression condense and decompression dry technology were used to make sure active substance was not destroyed. Temperature, pressure, relative density and speed which material comes into tower were optimized in the process of condense and dry.The variety and quantity of adjuvant were screened on the basis of hygroscopicity in preparation technology.The result showed that the best adjuvant was dextrin and the desirable quantity was 0.3 times of extractum.We prepared qi shen yu yei granules according to preparation technology and inspected a series of character.The results were as follows:bulk density was 0.5717g/ml, angle of repose was 33.4°, critical relative humidity was 58%. The results indicated that fluidity of granules was good and humidity should be controlled below 55% in case of excessive water in granules.During quality research, Radix Astragali, Radix Salviae Miltiorrhizae, Kudzu Root, Radix Rehmanniae,Schisandra Fruit in this prescription were identified by TLC. Negative was not disturb medical material and spot of active substance was very clear. According to standard on version 2005 of Chinese pharmacopeia, moisture, content uniformity, disintegration time and microbial limit were inspected. The results showed that three batch of samples were up to standard. A HPLC method for determination of astragaloside IV in the capsules was established. A good linear relationship between Natural Logarithan of Injected Sample Volume and Natural Logarithan of peak area of astragaloaside IV was found within the range of 2.024～10.12ug (r=0.9998), the average recovery was 99.42% and RSD=1.59%. This method was found to be sensitive and accurate for the measurement, and can be used for the quality control of qi shen yu yei capsules. The results of three batch of samples indicated the content limit of astragaloaside IV shouldn't be lower than 0.25mg per capsule. A HPLC method for determination of salvianolic acid B in the capsules was established. A good linear relationship between Injected Sample Volume and peak area of salvianolic acid B was found within the range of 0.1455～0.7275ug (r=0.9997), the average recovery was 99.03%and RSD=0.911%. This method was found to be sensitive and accurate for the measurement and can be used for the quality control of "qishenyuyei" capsule. The results of three batch of samples indicated that the content limit of salvianolic acid B shouldn't be lower than 0.40mg per capsule.