中草药“宫得

发布时间：2018-09-01 11:25

【摘要】：本课题组依据中草药的药理作用研制了治疗子宫内膜炎的复方中草药制剂“宫得健”泡腾黏附栓。本研究运用现代检测技术对其质量标准、体外抑菌效果进行了探究,对其临床使用的安全性进行了评价,以便于有效控制其质量,提高用药安全性,为该制剂的规模化生产与应用提供科学依据。按2010版《中国兽药典》的规定,对栓剂进行了质量评价。复方中主要含有黄连、黄芩、黄柏、栀子、益母草和槟榔六味中药,泡腾崩解剂的酸碱源分别为酒石酸和碳酸氢钠,基质为聚乙二醇(PEG-4000、PEG-6000),黏附剂为羟丙基纤维素(HPC),填充剂为微晶纤维素,以现代新型制药工艺完成“宫得健”泡腾黏附栓的制备,并对其重量差异、pH值及发泡量进行了测定。结果表明,栓剂的重量差异在±5%以内,pH值平均为4.50±0.050,发泡量平均为23±3.0 mL,均符合2010版《中国兽药典》规定。通过系统研究,建立了复方中黄连、黄芩、黄柏、栀子、益母草和槟榔的薄层色谱(TLC)鉴别方法。结果显示,各味药材供试品色谱中与其标准药材及标准品对照色谱相应位置显相同颜色斑点,且阴性对照色谱在相应位置无干扰,试验证实鉴别方法操作简便、灵敏度高、专属性强、重现性好,可用于复方中各药材的鉴别。建立了高效液相色谱(HPLC)法测定复方中盐酸小檗碱、栀子苷和黄芩苷三种主要有效成分的含量,并完成了方法学考察；色谱条件：Wondasil C18 for Herbal Medicine(5μm,4.6×250 mm)色谱柱,乙腈(A)-0.2%磷酸水溶液(B)为流动相,梯度洗脱(0～12 min,5%A～18%A; 12～20 min,18%A～21%A; 20～30 min,21%A～25%A; 30～43 min,25%A～30%A),柱温30℃,检测波长240 nm；进样体积10μL,流速1.0 mL/min;结果栀子苷、盐酸小檗碱和黄芩苷的进样量分别在0.1-0.5 μg(r=0.9972、0.1-0.5μg(r=0.9978)、0.15～0.75 μg(r=0.9957)之间均与其峰面积呈现良好的线性关系,平均回收率分别为97.99%(RSD%=0.19)、98.23%(RSD%=0.19)、 101.01%(RSD%=0.25)。试验结果表明,本方法仪器精密度、稳定性、重复性、专属性均较好,且操作简便、灵敏度高,可用于“宫得健”泡腾黏附剂的质量控制。“宫得健”泡腾黏附栓对金黄色葡萄球菌、大肠杆菌和链球菌的体外抑菌试验：试验采取倍比稀释制成药物浓度分别为0.1、0.05、0.025、0.0125、0.006、0.003、0.0015、0.00075、0 g/mL的药物培养基,接种的细菌浓度为104cfu/mL。测得“宫得健”泡腾黏附栓对大肠杆菌的MIC为1.5 mg/mL,金黄色葡萄球菌的MIC为6 mg/mL,链球菌的MIC为25 mg/mL。“宫得健”泡腾黏附栓的安全性评价：家兔眼球刺激性试验,采取左右眼自体对照,结果所有家兔均未出现刺激性反应。家兔阴道黏膜刺激性试验,连续7d阴道内用药后,观察家兔生理活动,解剖检查阴道组织并做病理切片,结果“宫得健”泡腾黏附栓对家兔阴道黏膜无刺激性。皮肤过敏性试验,所有“宫得健”组和生理盐水对照组的家兔均未出现过敏反应症状,2,4-二硝基氯苯阳性对照组的家兔均出现过敏反应,表明“宫得健”泡腾黏附栓对家兔皮肤无过敏性。
[Abstract]:According to the pharmacological action of Chinese herbal medicine, our research group has developed the compound Chinese herbal medicine "Gong De Jian" effervescent adhesive suppository for treating endometritis.This study explored its quality standard and bacteriostatic effect in vitro by using modern detection technology, and evaluated its safety in clinical use in order to effectively control its quality and improve its use. The quality of suppositories was evaluated according to the provisions of Chinese Veterinary Pharmacopoeia (2010 edition). The preparation of Gong De Jian effervescent adhesive suppository with alcohol (PEG-4000, PEG-6000), hydroxypropyl cellulose (HPC) as adhesives and microcrystalline cellulose as fillers was studied. The weight difference, pH value and foaming amount of the suppository were determined. The results showed that the weight difference of the suppository was within (+) 5%, the pH value was 4.50 (+) 0.050, and the foaming amount was 4.50 (+) on average. TLC method for identification of Coptis chinensis, Scutellaria baicalensis, Cortex phellodendri, Gardenia jasminoides, Leonurus heterophyllus and Areca Catechu in compound prescriptions was established by systematic study. The results showed that the chromatographic positions of the samples were identical with those of the standard and standard reference materials. The method is simple, sensitive, specific and reproducible, and can be used for the identification of various medicinal materials in compound prescriptions. A high performance liquid chromatography (HPLC) method was established for the determination of berberine hydrochloride, geniposide and Baicalin in compound prescriptions. The chromatographic conditions were as follows: Wondasil C18 for Herbal Medicine (5 micron, 4.6 x 250 mm) column, acetonitrile (A) - 0.2% phosphoric acid aqueous solution (B) as mobile phase, gradient elution (0-12 min, 5% A-18% A; 12-20 min, 18% A-21% A; 20-30 min, 21% A-25% A; 30-43 min, 25% A-30% A), column temperature, detection wavelength 240 nm, sample volume 10 microL, flow rate 1.1%. Results The average recoveries of geniposide, berberine hydrochloride and baicalin were 97.99% (RSD% = 0.19), 98.23% (RSD% = 0.19), 101.01% (RSD% = 0.25)% and 0.15% ~ 0.75ug (r = 0.9978), respectively. The method has good precision, stability, reproducibility and specificity. It is easy to operate and has high sensitivity. It can be used for the quality control of Gong De Jian effervescent adhesive. The concentration of bacteria inoculated in the medium of 0.05,0.025,0.0125,0.006,0.003,0.0015,0.00075,0 g/mL was 104 cfu/mL. The MIC of "Gong Dejian" effervescent adhesive suppository to E.coli was 1.5 mg/mL, that of Staphylococcus aureus was 6 mg/mL, and that of Streptococcus was 25 mg/mL. Eye irritation test and autologous control of left and right eyes were used. No irritation reaction was found in all rabbits. The physiological activities of rabbits were observed after 7 days of vaginal administration. Vaginal tissues were dissected and pathological sections were made. Results Gong Dejian effervescent adhesive suppository was not irritative to vaginal mucosa. Skin allergy test showed that all the rabbits in Gongdejian group and normal saline control group had no allergic reaction symptoms, and all the rabbits in 2,4-dinitrochlorobenzene positive control group had allergic reaction, indicating that Gongdejian effervescent adhesive suppository was not allergic to rabbit skin.
【学位授予单位】：扬州大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：S853.7

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