| Shenzhuotang Granules is a new compound preparation of pureTraditional Chinese Medicine, which consists of Dried ginger, Poriacocos and other four herbs. It has the function of releasing coldtemperature and spleen and dehumidifying, for the treatment of lowback pain of cold dampness. This study is based on traditional Chinesemedicine theory as guidance, with applying modern pharmaceuticaltechnology and method, the soup in renal granular preparationtechnique and quality standard of the experimental study of the system,and the preparation process to ensure that scientific and reasonable,safe and effective drug preparations, quality is stable and controllable.1. Source of prescriptionShenzhuotang Granules also known as soup of Glycyrrhizauralensis, Zingiber officinale, Poria cocos, Atractylodes macrocephala. Fromthe writing of the eastern han dynasty ZhangZhongjing <Jin kui yaolue>, as one of the classics of traditional Chinesemedicine.Which is a classic prescription treat of low back pain of colddampness; Modern clinical syndrome and subtract for the treatment ofvarious diseases;Shenzhuotang Granules is derived from the ancient classicalprescription of traditional Chinese medicine compound preparations,The prescription does not contain toxic herbs in or compatibility tabooand prescription of traditional Chinese medicine has the legal standard.The production process almost as the traditionnal process. Drugdelivery approach is consistent with the recorded in ancient medicalbooks,daily amount of slices and recorded in ancient medical books arebasically identical;The functions are almost consistent with ancientmedical books; Scope does not include the critical case, does notinvolve the use of special drug groups such as pregnant women, infantsand young children.According to traditional Chinese medicineregistration manage-ment supplementary provisions article7and article8, this kind oftraditional Chinese medicine compound preparations, can only provideinformation of non-clinical safety studies and report directly to production.2. Study on preparation processAccording to traditional Chinese medicine registra-tion management supplementary provisions article7and article8, theproduction technology of Chinese medicine com-pound preparations should be consistent with the tradi-tional process, So we adopt the method of water extraction. Usingorthogonaltest method inspect add water,extraction time extrac-tion times, with liquorice glycosides, the content of glycyrrhizic acid asevaluation index, comprehensive usage, determine the water extractionprocess: add10times of water, reflux extraction of2times, each time3hours.The water extract enrichment process：Using the single factorexperiment method, with liquorice glycosides and the content ofglycyrrhizic acid as evaluation indicators in the thick cream, inspectedthe temperature of the reduced pressure concentration, the extent ofthe stress concentration effects on its content. Result:80℃decompression enrichment to the relative density is1.28(60℃).The molding process of preparations: Through the contrast test examines inspects the different excipients and the dosage influence ofgranulating conditions. Results: according to the raw material: material=1:1.5to add the dextrin,mixing, soft material, granulating,60℃dry,get particles.3. Study on quality standardStudy on TLC qualitative：identify the3species of crud drugGlycyrrhizauralensis,Zingiber officinale, Atractylodes macroce-phala in the preparation by TLC. Experimental results show that theproduct in reference substance chromategraphy corresponding controlmedicinal materials or position, all show the same color spots, and thenegative control in the corresponding positionis no interference. And after repeated experiments,the reproducibilityis good.Study on content of HPLC determination: the preparations weredetermined by HPLC method of Amygdalin content, with18alkyl silanebonding silica gel as the filling agent; Mobile phase: A acetonitrile,B0.05%phosphoric acid，The concentration of pump B:0min（81）'25min（56）'26min（0）'30min（81）37min（81）; Velocity1.0mL min-1; Column temperature30℃; detected wavelength250nm. And the methodology, the results show that this investigation is rational andfeasible, and good reproducibility, and can be used for the qualitycontrol of Shenzhuotang Granules.The content of Glycyrrhizic acid is not less than18.5mg in eachbag.4. Research on the long term toxicity studiesBy gastric gavage rats soup in renal granular thick paste samplesfor90days, to research the product produced by the long-term toxiceffects and their extent. During the entire test, the rats have a goodcondition, the weight is normal, body weight and food intake in eachdose group compared with the control group have no significantdifference; Viscera coefficient of each dose group compared with thecontrol group have no significant difference; Hematology index, serumbiochemistry, serum electrolytes in each dose group compared with thecontrol group had no significant difference; Histopathologicalexamination found no histologic changes in various organs. The resultsshowed that90days long term toxicity test on rats non-toxic injury inrats and the delayed toxicity reaction. |
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