Pharmaceutical Studies On Shenghuatang Oral Liquid Preparation

Shenghua decoction, composed of Radix Angelica Sinensis , Rhizome Chuanxiong, baked ginger, Semen Persicas and grilled Glycyrrhiza, stemmed from the famous work "Gynecology" by Fu Qing-zhu. It had notable curative effects of promoting blood circulation to remove blood stasis and warming meridian to relieve pain on postpartum hemostagnant syndrome and lochiorrhea, especially postpartum hemorrhage and contraction acute abdominal pain, etc., which caused by debility of uterine contraction and subinvolution in clinical practice for a long period. As decoction has many disadvantages, such as large of volume dosage, non-convenient taking and difficult preservation, it was to be changed into oral liquid. In this study, we researched the Shenghuatang Oral Liquid extraction process and quality standard.The optimum extraction conditions were investigated by the orthogonal design using ferulic acid (FA) as the content index. The optimal extraction conditions obtained was decocting the medicine twice, for 0.5h each time and adding 10(8)-fold of water.The effects of the water abstract of Shenghua Decoction (SD) and the water abstract deposited by alcohol (SDA) were studied using the time of blood coagulation and hemorrhage in vitro as the evaluation indices. The results showed that the effects of SD was approximately the same as those of SDA. Both them had the effect of hemostasis (shortening the time of blood coagulation and hemorrhage, p>0.01). The high income and high mucosity of SD depositer (26.5%) could affect the clarification and the stability of the oral liquid. So the decoction should be deposited by alcohol. The result of the single factor test showed that the water-extraction was condensated to 1.0g/mL concentration, adding ethanol to 60%. The amount of the flavoring has also been screened.According to the nature of the crude drugs, boiling, cooling , water alcohol and alcohol water methods were used to deposit the impurities, respectively. The results showed that purification method chould keep more effective contents, but also ensure the stability of the product, shorten the time of preparing process and reduce the cost.As for the quality standard, qualitative analysis and quantitative analysis were used TLC was applied to identify Radix Angelica Sinensis and Rhizome Chuanxiong. The ferulic acid (FA) in the product was determined by PR-HPLC. FA was linear within the range of 0.202～1.210μ g(r=0.9998), and the average recovery was 98.41% with RSD of 1.1%. The above methods were accurate and reliable, and could be used for the qualitycontrol of the preparation. Other quality indices of Shenghuatang Oral Liquid conformed to all requirements preliminary recorded in the C. P. 2000.The accelerate tests on preliminary stability (40 °C , 75%) showed that Shenghuatang Oral Liquid was stable.