Preparation Of Shanzha Dropping Pills After Isolation And Purification Of Its Oral Solution

Shanzha oral solution has been proved to have good clinical effective in thetreatment of hyperlipidemia. However, this dosage form of oral solution on marketmust be taken at a larger volume and has many defects as unflavorful taste, turbidityand precipitation. In order to improve this oral solution under the guidance of thetheory of modernization of traditional Chinese medicine, we purified this oral solutionwith the modern methods of isolating and purifying to condensate the effectiveingredients . Thereafter, we prepared the dropping pills. The standard for its qualitycontrol was established. The main work in this dissertation were focused on thefollowing aspects:1. It was analyzed qualitatively and quantitatively the effective ingredients of Shanzhaoral solution and traditional Chinese medicinal materials, and the technology ofpurification for Shanzha oral solution was investigated. By the columnchromatography with polyamide, the solid content left is only 1/10 that of its originalamount, while after the purification, the effective ingredients were retained at the ratio90%.2. The optimum technology for the preparation of Shanzha dropping pills wasobtained by orthogonal design method with PEG 4000 as carrier and the purifiedingredient as model drug. The pills obtained were then coated with Slus. Andinvestigated the stability of Shanzha dropping pills, at ten days 40 ℃,RH 75% andlights , its appearance and content have no obvious variety;By the analysis methodsof TG-TDA,UV-VIS,IR,X-RD ,the purified ingredients were proved to be existingin molecular, microlite or amorphous form in the pills, which showed a betterdispersibility than its physical mixture. There was no interaction between the carrierand the active ingredients.3. The quality standard of Shanzha dropping pills was established. Four traditionChinese medicinal materials in pills including radix polygoni multiflori preparata,rhizoma allsmatis, pollen typhae and folium nelumbinis were identified by TLC;thetotal flavonids and anthraquinones content was determined spectrophotometrically;the stilbene glucoside was determined by HPLC.There has a systematical research of Shanzha oral solution. Shanzha droppingpills were made by the effective ingredients of Shanzha oral solution. The studiesimproved the levels and the quality standard of Shanzha oral solution's preparation.