Pharmaceutical Research Of Shen' AnKang Capsules

Shen' anKang Capsules are made up of seven Chinese herbs, including Radix et Rhizoma Rhei, Radix Codonopsis Pilosulae, Radix Salviae Miltiorrhizae, Poria cocos , Rhizoma Atractylodis Macrocephalae, Chrysanthemi flos and Cortex Cinnamomi. These capsuls can be used for the treatment of the Nitrogen period of hematuria and the early uremia of Chronic Renal Failure because they showed effects of invigorating the spleen and Qi, inducing diuresis, promoting blood circulation, removing blood stasis and reducing swelling. Based on the investigation of literatures, this article studies the preparation technology, quality specification and preliminary stability of Shen' anKang capsules. This article establishes preparation technology through learning the extracted, dry extract and preparation form, and sets up the quality specification according to the physico-chemical property of active components,preparation methods and requirements. The preliminary stability and common temperature stability methods show that the preparations are stable under packaging and normal environment. After the experiment, we could get a safe, useful and stable compound preparation for uremia, lay the foundation of production for Shen' anKang Capsules, provide perfect preparation technology and reference project for the same kind of medicines.In the study of preparation technology, we grinded the radix rhizome to fine powder with pulverizing method, and adopted modern SFE-CO₂ to extract the liposoluble constituent of chrysanthemi indici,atractylodes macrocephala and cassia. We used L₉ (3⁴) perpendicular sheet to choose the best abstraction pressure, abstraction temperature and abstraction time for SFE-CO₂ and established the best technology of SFE-CO₂. We chose traditional water abstraction methods to extract the water solubility composition of Codonopsis pilosula and poria cocos. L₉ (3⁴) perpendicular sheet was used to inspect the water amount, abstraction time and abstraction frequency, and to define the best water abstraction schema. We used the water abstraction and alcohol precipitation methods to abstract the group of water solubility composition of salvia miltiorrhiza,chrysanthemi flos,atractylodes macrocephala and cassia. We used the L₉ (3⁴) perpendicular sheet to determine the best water abstraction schema, and the single factor confrontation method to inspect the alcohol amount, precipitation time, relative density of extracta sicca and establish the best technology of alcohol precipitation and pressure-relief vacuum concentration methods by tracking detection of main constituent content. We adopted the spray drying through contrast test and use the L₉ (3⁴) to optimize the intake airflow temperature,extracta sicca relative density,exhalans airflow temperature and to established the best spray drying methods. Used granulation to make granula and define the preparation' s forming technology by learning the drying method, critical relative humidity, moisture absorption percentage and angle of repose. At last, we succeeded in doing semi-works production of 31. 38kg medical materials for three times. All the results showed the preparation technology was reasonable, the chemical composition aversion rate was high, active substance were protected and the practical production was feasible.In the second part, we studied the quality specification. On the basis of chemical composition and preparation technology of the medicine of Shen' anKang capsule, we determined the index and methods of quality control. The content was buffy or dark brown powder, fragrant, bitter and puckery flavor. We used TLC to identify the water solubility composition of salvia miltiorrhiza and liposoluble constituent of atractylodes macrocephala,chrysanthemi indici and cassia. The results showed that the spot was clear on the TLC picture and the negative control was non-interference, so we could use it as the qualitation identification. According to Pharmacopeia, We checked the arsenic salt, heavy metal, moisture and disintegration time of Shen' anKang capsules. HPLC was used to assay the chrysophanic acid,frangula-emodin,sodic tanshinol of adix et rhizome and salvia miltiorrhiza. The regression equation of frangula-emodin was Y=6105.76X+8.4034 , r=0.9996, and linear range was 0.02016～0.10080μg. The regression equation of chrysophanic acid was Y=8657.71X+6.9594, r=0.9999 , linear range was 0.03456～0.17280μg. The regression equation of sodic tanshinol was Y=1931.21149X+2.160000636 , r=0. 9996 , linear range was 0.1448～0.8688μg. The average recoveries of chrysophanic acid,frangula-emodin,sodic tanshinol were 97.7%,97.69%,97. 52%. The results showed the contents detection method was simple, reliable and the reproducibility was fine. The three semi-works productions were detected according to the quality specification and all items conformed to relevant regulations. It was said that the quality of this preparation was stable.In the research of initial stability, we selected sample characters, identification, the volume of capsule in containers, hygienic examination and assaying as the indexes. Under the sample packages, 40±2℃, RH=75±5%, we researched the preparations for 3 months and under ordinary temperature for 12 months, all the indexes had not changed. The result was that the preparations were stable under normal environment.Shen' anKang capsules were adopted with the method of pulverizing and combining SFE-CO₂ and water abstraction and alcohol precipitation. It not only suited the quality of the medicine, but also raised the percentage of active substances, decreased drug consumption for once, lowered the percentage of moisture absorption and facilitated the restoration and quality control and optimized the product' s stability. The result of this research will provide scientific data for further research and exploitation of Shen' anKang capsules.