Study On Production Process And Quality Standards Of The QingReTouTong Soft Capsule

Wind-hot and light headedness, migraine, stuffy nose, tooth ache are common and frequently-occurring diseases. Qing Re Tou Tong Pill, a Traditional Chinese Medicine, has better curative effects on the above diseases, and favored by the majority of patients. This pill, however, is difficult to be accepted by part of patients due to its strong smell, and effective components volatiling easily. To resolve these issues, we developed a new type Qing Re Tou Tong soft capsule, which provides the same curative effects and easys to take.The main ingredients of Qing Re Tou Tong soft capsule contained rhubarb, gardenia, georgi, glycyrrhiza uralensis, ephedra herb, forsythia, paeonia lactiflora pallas and so on. According to its characteristics, ethanol percolation and water extraction and alcohol precipitation are applied to extract rhubarb and the others, respectively. We found that the optimum processes of ethanol percolation were infiltration with 70% ethanol, 8:1 decoction liquid-medicine herbs, extraction for 24h, percolation rate with 1～3ml/min, and vacuum drying at 60～65℃. The optimum processes of water extraction and alcohol precipitation were as follows: extracting 2 h, firstly decocting for 2 h, and then 1h with 8-fold water, respectively. Meanwhile, the volatile oils were extracted during decoction. The relative density of the extract was about 1.05～1.10 at 60～65℃during ethanol precipitation process with ethanol 70%, and then the relative density of the concentration was 1.3 after ethanol precipitation for 12 h. The extractions were dried by vacuum at 65℃. The molding process is as following: the powders were suspended into liquid assistant materials, which are manufactured into suspensions or emulsifier. Then, the Qing Re Tou Tong soft capsule can be obtained by gelling, pelleting and drying successively. The capsule shell, which proportion of main ingredients is 1:0.35～0.45:1 (gelatin: glycerin: water), can be obtained after shaping 3～4 h, drying 16-18 h at 27～30℃. The final aquatic content in capsule shell is 10～12%.The quality standard of Qing Re Tou Tong soft capsule was explored. It was consist of qualitative analysis, quality difference test, disintegrating time test and content determination. In this work, samples were processed by macroporous adsorption resins so as to eliminate interference. Then qualitative analysis were studied with Proprietary and reliable methods, respectively. Further more, the testing standard was established as follows: the content of rhubarb, in term of the amount of physcion (C₁₅H₁₀O₅) and chrysophanol (C₁₅H₁₀O₄), was at least 0.30mg with HPLC. Based on these above methods, the effect and the stability of the production were satisfied. Finally, three batches trial-manufacturing production were tested in qualitative analysis, quality difference test and disintegrating time test, which meet the pharmacopoeia requirements. Taken together, the preparation processes of Qing Re Tou Tong soft capsule were set up, which will provide new insights into foundation for industrialization of the capsule and significant social and economic benefits.