| Objective:Hyperplasia of mammary glands is a non-inflammatory non-neoplastic proliferative lesions. The disease incidence rate is high, and has a certain canceration rate, serious harm to the health of women. Clinical practice indicated that the western medicine for the treatment of the disease is still a lack of satisfactory. Chinese medicine treatment at that accumulate a wealth of experience, has good curative effect exactly. Xiawang Sanjie capsule prescription derived from clinical experience. It has a soft firm fights, facilitating pain relief, promoting blood circulation to remove blood stasis, phlegm and the effect of detumescence. In this paper, under the guidance of Chinese medicine theory, combined with the nature of each medicine in the prescription, to study the extraction process, molding process, quality standards and initial stability, in order to develop the Xiawang Sanjie capsule to develop new Chinese medicine, for the wider patient service.Methods:According to the characteristics of clinical medication and the nature of the prescription, the dosage form is the capsule. Study on extraction process:According to the effective components and pharmacological action of the drug in TCM,combining the characteristics of clinical medication, each medicinal prescription groupedextraction. The Prunella, Vaccaria, Fritillaria, indica, Bupleurum five taste medicine combined with ethanol extraction, rosemary acid, Vaccaria flavonoid glycosides, saikosaponin a, saikosaponin d, Baptist yield, uses the multi index comprehensive evaluation method, determined by orthogonal experiment the optimum ethanolextraction process. Curcuma, Atractylodes, Cyperus three herbs combined for the extraction of volatile oil, to the extraction of volatile oil content as index, orthogonal test was designed to optimize the extraction process of volatile oil. The inclusion compound of volatile oil was prepared by grinding method, and the inclusion rate of volatile oil was as the index, and the optimum inclusion process was optimized by orthogonal experiment. Then, Curcuma, Atractylodes, Cyperus extracted volatile oildregs and oysters, kelp common water extraction, with water saturated n-butanol extract,ethanol extract and the extract yield as the index, uses the multi index comprehensive evaluation method, based on orthogonal tests, to determine the best extraction process. Study on the forming process:The angle of repose as index, to determine the materials selection and dosage. Pre filled,determine the capsule packing specifications and dosage.Study on quality standard:For TLC identification of Curcuma, Atractylodes, Cyperus, Fritillaria by thin layer chromatography. Using HPLC method to establish the method for content determination of Rosemary acid, Vaccaria flavonoid glycosides, saikosaponin a, d,complete the methodological study.Study on the preliminary stability:On Xia Wang Sanjie capsule for preliminary study on the stability of three months, indexing traits, disintegration time, content authentication.Results:Study on Preparation Technology:Prunella, Vaccaria, Fritillaria, indica,, bupleurum 70% ethanol refluxing extraction for two times, two times and 10 times the amount of solventrespectively,8 times the amount each time, extracting 3H; filtering, merging filtrate; vacuum concentrating, vacuum drying; crushing into fine powder, spare. Curcuma, Atractylodes, Cyperus crushed into coarse powder, soak 2h, with 6 times amount of water reflux extraction 6h, collecting volatile oil. Volatile oil and 8 times the amount of β-cyclodextrin mixture, adding 3 times amount of water,grinding 90min; inclusion compound was vacuum drying. Oysters, kelp and Curcuma, Atractylodes, Cyperus Volatile oilextraction residue, after water immersion 1H, extracting for two times, the amount of solvent is respectively 8 times,6 times the amount of the amount of each extraction,2h; filtering, merging filtrate; concentration of the filtrate, vacuum drying; crushing into fine powder, spare. The ethanol extract of dry extract powder, water extraction and dry extract powder dry clathrate uniformly mixed to obtain raw powder. Molding process materials selection starch and microcrystalline cellulose, the angle of repose test showed that the particles meet liquidity requirements. Take No.0 filled capsules, each capsule filled with 0.5g.Study on quality standard:Established a TLC method for identification of Curcuma, Atractylodes, Cyperus, Fritillaria. The results showed, in the chromatography of samples, the control herbs or contrast position chromatograph corresponding, the same color spots, without the interference of negative control. To establish a method for determination of HPLC content of rosmarinic acid, Vaccaria flavonoid glycosides, saikosaponin a, saikosaponin d, the results are stable, reliable method, high precision. Among them, rosmarinic acid regression equation for y=58333020.66x-284012.42, r=0.9998; Vaccaria flavonoid glycosides regression equation for y=32533583.26x-7986.39, r=0.9998. Saikosaponin a, saikosaponin d respectively for y=9212423.77x+122395.20, r=0.9997; y=9592159.86x+92163.99, r= 0.9999. According to the Chinese Pharmacopoeia requirements for capsules, moisture content, the amount of difference to Xiawang dissolving capsule, the disintegration time for testing, are in line with requirements. Study on the preliminary stability:Appearance of samples, disintegration time, identification, content had no obvious change, in accordance with the regulations, within three months of preliminary stability is good.Conclusion:The results show that extracts Xiawang Sanjie capsule, the preparation process is reasonably practicable, the established qualitative and quantitative detection method is accurate and reliable, and can effectively control the quality of dissolving capsule, and laid the foundation for the study of pharmacodynamic... |
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