奶牛产后保健复方中草药片剂的制备与防治试验

发布时间：2018-08-07 21:11

【摘要】：本研究在中医理论的基础上,依据临床经典验方,针对奶牛产后疾病的发病率高、危害大,采用现代制剂技术开发研制出一种服用剂量小、毒副作用小、便于携带、能提高机体免疫力,适用于奶牛产后保健的制剂——中草药复方片剂。本论文主要从制剂的制备工艺、质量标准、稳定性及安全性、抗体水平监测及临床疗效等方面进行研究,试验结果表明：1、根据临床验方,药片的主要配方组成为：党参、黄芪、当归、丹参、枸杞子、灵芝、白芍、益母草、紫花地丁、干姜、炙甘草；通过正交试验对辅料进行筛选,优化本制剂的处方及制备工艺。结果表明：片剂辅料配方为,药粉50%、预胶化淀粉20%、MCC 15%、糊精5%、微粉硅胶2%、羧甲基纤维素钠1.5%、硬脂酸镁0.3%、及十二烷基硫酸钠0.2%。制备工艺采用湿颗粒制粒法,喷以3%PVPK3o无水乙醇溶液过40目筛干燥制粒后压片。验证试验的结果均符合药典规定的质量标准要求,说明此制备工艺流程具有可行性。2、通过对中药复方片剂的物理性状,即外观性状、崩解时限及分散均匀度检测,结果均符合药典规定。此外,同时又对益母草、枸杞子、紫花地丁、当归、白芍、灵芝等主要成分用TLC法进行检测,结果显示：供试品溶液均与对照品溶液和药材对照溶液在相应的位置显出相同的斑点。HPLC法测定中药复方片剂中盐酸水苏碱的平均含量为2.3910 mg/g左右。各项质量考察指标的结果证实中药复方片剂的质量控制标准稳定,符合药典规定。3、通过小鼠急性毒性试验对中药复方片剂进行了毒理评价,结果表明：小鼠腹腔注射半数致死量LD50=42884 mg/kg,标准误SlogLD50=0.0397, LD5095%的可信限范围35222.77～50545.23mg/kg。根据毒理学评价标准,该片剂毒性远远小于国家规定毒性标准,证实该药片安全无毒,可在临床上安全使用。4、临床上使用中药复方制剂,对产后牛的各种指标做了监控和检测,结果显示：试验组比对照组的牛只抗体水平显着提高(P0.05),经统计,试验组产后奶牛的胎衣滞留的发生率相对降低了50%,恶露排净天数比对照组提前了1.3天；试验组奶牛好评率比对照组高出10%,奶牛乳房炎的发病头数明显下降,并且对奶牛乳房炎概率也减少了17.9%,治疗有效率达到75%。产后牛的子宫内膜炎概率也减少了16.7%,治疗有效率达到66.7%,奶牛胎衣不下的概率减少了23.3%,治疗有效率达83.3%。证实中药复方片剂能有效的提高机体的免疫力,促进了产后奶牛机能的快速恢复,对奶牛产后疾病具有治疗和保健作用。
[Abstract]:Based on the theory of traditional Chinese medicine, according to the classical clinical prescription, aiming at the high incidence and great harm of postpartum diseases in dairy cows, a kind of low dose, small toxicity and easy to carry was developed by using modern preparation technology. Can improve the body immunity, suitable for dairy cow postpartum health care preparation-Chinese herbal compound tablets. In this paper, the preparation process, quality standard, stability and safety, antibody level monitoring and clinical efficacy were studied. The results showed that according to the clinical prescription, the main formula of the tablet was: Codonopsis pilosula, Codonopsis pilosula, Radix Astragali, Angelica sinensis, Radix Salviae Miltiorrhizae, Fructus Lycii, Ganoderma lucidum, Radix Paeoniae Alba, Herba Leonurus, Purple, Ginger, Radix Glycyrrhizae; The results showed that the formula of tablet excipients was: powder 50, pregelatinized starch 20 and MCC 15, dextrin 5, silica gel 2, carboxymethyl cellulose sodium 1.5, magnesium stearate 0.33 and sodium dodecyl sulfate 0.2. The preparation process was made by wet particle granulation and 3%PVPK3o anhydrous ethanol solution was sprayed through 40 mesh screen to dry granulation and press tablets. The results of the verification tests all accord with the quality standards stipulated in the Pharmacopoeia, which shows that the preparation process is feasible. 2. The physical properties of compound Chinese medicine tablets, that is, appearance character, disintegration time limit and dispersion uniformity, are measured. The results were in accordance with the regulations of pharmacopoeia. In addition, the main components of Motherwort, Lycium medlar, Purple, Angelica sinensis, Radix Paeoniae Alba and Ganoderma lucidum were also detected by TLC. The results showed that the average content of stachydrine hydrochloride in Chinese herbal compound tablets was about 2.3910 mg/g. The results of various quality inspection indexes confirmed that the quality control standard of Chinese traditional medicine compound tablets was stable and in accordance with the pharmacopoeia regulation .3.The toxicological evaluation of Chinese traditional medicine compound tablets was carried out through acute toxicity test in mice. The results showed that the median lethal dose of LD50=42884 mg / kg was injected intraperitoneally, and the standard error of Slog LD50 was 0.0397,the confidence limit of LD5095% was 35222.77 / 50545.23 mg / kg / kg. According to the criteria of toxicology evaluation, the toxicity of the tablet was far less than that prescribed by the state. It was proved that the tablet was safe and non-toxic, and could be safely used in clinic. The compound preparation of traditional Chinese medicine was used clinically. The various indexes of postpartum cattle were monitored and tested. The results showed that the antibody level in the test group was significantly higher than that in the control group (P0.05). According to statistics the incidence of fetal coat retention in the experimental group was reduced by 50 times and the days of excretion of lochia were 1.3 days earlier than that of the control group. The evaluation rate of dairy cows in the test group was 10% higher than that in the control group. The incidence of mastitis in dairy cows was obviously decreased. The probability of mastitis in dairy cows was also reduced by 17.9. the effective rate of treatment was 75g. The probability of endometritis in postpartum cattle was also reduced by 16.7g, the effective rate of treatment reached 66.7%, the probability of cow placenta was reduced by 23.3and the effective rate of treatment reached 83.3%. It is proved that compound Chinese medicine tablets can effectively improve the immunity of the body, promote the rapid recovery of postpartum cow function, and have therapeutic and health care effect on postpartum diseases of dairy cows.
【学位授予单位】：宁夏大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：S858.23

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