| Objective:liver protecting and Lipid-lowing capsule contains eight kinds of traditional Chinese herbal medicines, is used in the treatment of hyperlipid-emia.In order to make this drug more suitable for clinical applications and transportation,we carried out experiments in the light of DRUG REGIST-RATIO REGULATION and natural medicine research technique guiding principles.By adopting modern pharmaceutical technology,we have done thorough research on its preparation process,quality control and stability,which made it,effective,stable,controllable,and to meet the needs of traditional Chinese medicine modernization.Methods:1 preparation technology was studied1.1 extraction technology was studiedVarious herbs contain the main effective components in evaluation indexes, through the single factor investigation, first determine the best extraction solvent herbs. Will be part into three groups, with various herbs contain the main effective components and the extract rate of the evaluation index, with extraction frequency, extraction time, extraction solvent volume to examine factors, using L9(3)4 orthogonal test for each medicine extraction process was optimized, and connecting with the actual situation of each extraction process validation tests are carried out, according to the results of the validation test to determine the final extraction process.1.2 preparation technology was studiedBelt type vacuum drying, dry legal system grain of craft, preparations molding technology was studied. According to the determined technological process, production batch 3, pilot study. According to Chinese pharmacopoeia method, and the three batch of pilot sample routine examinations.2 Studies on quality standardIn 3 batch of pilot products as the research object, from the aspects of thin layer identification and content determination, establish the quality standards of liver protecting and Lipid-lowing capsule.2.1 thin layer identification methodBy thin layer chromatography, respectively for the preparation of test sample solution method, developing solvent system, examining method etc, on prescription in TCM in 2 thin layer identification study.2.2 content determination methodTo establish HPLC method for determination of paeoniflorin in liver protecting and Lipid-lowing capsule at the same time and the content of curcumin, and research methodology; Formulate corresponding content is determined by transferring rate limit, eventually develop liver protecting and Lipid-lowing capsule quality standard draft, as an important basis toevaluate the quality of liver protecting and Lipid-lowing capsule.Results:1 The studies of the preparation process1.1 The studies of the herbs extractionTake Chinese traditional medicine, net respectively choose dry, coarse crushing.Take turmeric plus, fructus schisandrae and 10 times the amount of 80% ethanol extract twice, first to extract 2 hours, the second extraction for 1 hour, extract reduced pressure recovery of ethanol, condensed into a relative density of 1.20-1.25) (60℃ hot test cream.)Take fleece-flower root, cassia seed, add 50% ethanol, heating reflux extraction twice, add 10 times the amount of extracted 2 hours for the first time, the second plus eight times extraction for 1 hour. Extract reduced pressure recovery of ethanol, condensed into a relative density of 1.20-1.25) (60℃ hot test cream.)Take root of herbaceous peony, chrysanthemum, burdock root, adding 8 times amount of water decoction twice, each time 2 hours, Fried fluid filtration, merger, condensed into a relative density of 1.15-1.20) (60℃ hot test cream).1.2 The studies of the extraction technologyTo raise alcohol extract and water extract merged, belt type vacuum drying (vacuum degree<0.1Mpa, the temperature is 50 to 60℃). Will dry paste is crushing screening and 5 cattail pollen mix, use dry granule (16 mpa pressure roll, roll speed 12 r/min), particles with 2 screen whole grains. The particles obtained dry granule into capsule, every grain of 0.4 grams, quick. Three batch of pilot samples accord with the related provisions on under a capsule.2 The studies of the quality standard2.1 The studies of TLC identificationThin layer chromatografic(TLC) was established to identify Fruit of Chinese magnoliavine、turmeric, these two kinds of herbal medicine. The methodology tests indicated the motheds had good specificity and reproducibility.2.2 The studies of the assayingHigh performance liquid chromatography(HPlC) was established to determinate the content of paeoniflorin and curcumin, which were active ingredients in liver protecting and Lipid-lowing capsule. The methodology tests indicated that paeoniflorin showed good linear relationship at a Sample quantity of 0.5～2.5ug,with the regression equation y=11.671x+3.0281, the correlation coefficient R2=0.9991; curcumin showed good linear relationship at a Sample quantity of 0.36-1.8ug,with the regression equation y= 107.21x-3.3811, the correlation coefficient R2=0.9996.The RSD of paeonif-lorin repeatability experiment was 1.90%, and the RSD of recovery test was 99.81%(n=5);the RSD of curcumin’s repeatability experiment was 1.91%,and the RSD of recovery test was 99.97%(n=5). Based the average transfer rate of effective ingredients and the concentration limits of medical materials, a reasonable product concentration limits was established to strengthen the production process control and ensure product quality.Conclusions:The optimal extraction and preparation technique for liver protecting and Lipid-lowing capsule were ascertained,and the technique was stable and feasible.It is suitable for industrial production.The method was found to be accurate,sensitive and stable.It can be used to control quality for liver protecting and Lipid-lowing capsule. Stability studies of three batehes of samples demonstrated the every checks all meet the standard,and the end product was stable. The research result can also be used to suggest a basis for determining expiry date of pharmaceuticals. |
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