【摘要】：本研究在中醫(yī)理論的基礎(chǔ)上,依據(jù)臨床經(jīng)典驗(yàn)方,針對(duì)奶牛產(chǎn)后疾病的發(fā)病率高、危害大,采用現(xiàn)代制劑技術(shù)開(kāi)發(fā)研制出一種服用劑量小、毒副作用小、便于攜帶、能提高機(jī)體免疫力,適用于奶牛產(chǎn)后保健的制劑——中草藥復(fù)方片劑。本論文主要從制劑的制備工藝、質(zhì)量標(biāo)準(zhǔn)、穩(wěn)定性及安全性、抗體水平監(jiān)測(cè)及臨床療效等方面進(jìn)行研究,試驗(yàn)結(jié)果表明：1、根據(jù)臨床驗(yàn)方,藥片的主要配方組成為：黨參、黃芪、當(dāng)歸、丹參、枸杞子、靈芝、白芍、益母草、紫花地丁、干姜、炙甘草；通過(guò)正交試驗(yàn)對(duì)輔料進(jìn)行篩選,優(yōu)化本制劑的處方及制備工藝。結(jié)果表明：片劑輔料配方為,藥粉50%、預(yù)膠化淀粉20%、MCC 15%、糊精5%、微粉硅膠2%、羧甲基纖維素鈉1.5%、硬脂酸鎂0.3%、及十二烷基硫酸鈉0.2%。制備工藝采用濕顆粒制粒法,噴以3%PVPK3o無(wú)水乙醇溶液過(guò)40目篩干燥制粒后壓片。驗(yàn)證試驗(yàn)的結(jié)果均符合藥典規(guī)定的質(zhì)量標(biāo)準(zhǔn)要求,說(shuō)明此制備工藝流程具有可行性。2、通過(guò)對(duì)中藥復(fù)方片劑的物理性狀,即外觀性狀、崩解時(shí)限及分散均勻度檢測(cè),結(jié)果均符合藥典規(guī)定。此外,同時(shí)又對(duì)益母草、枸杞子、紫花地丁、當(dāng)歸、白芍、靈芝等主要成分用TLC法進(jìn)行檢測(cè),結(jié)果顯示：供試品溶液均與對(duì)照品溶液和藥材對(duì)照溶液在相應(yīng)的位置顯出相同的斑點(diǎn)。HPLC法測(cè)定中藥復(fù)方片劑中鹽酸水蘇堿的平均含量為2.3910 mg/g左右。各項(xiàng)質(zhì)量考察指標(biāo)的結(jié)果證實(shí)中藥復(fù)方片劑的質(zhì)量控制標(biāo)準(zhǔn)穩(wěn)定,符合藥典規(guī)定。3、通過(guò)小鼠急性毒性試驗(yàn)對(duì)中藥復(fù)方片劑進(jìn)行了毒理評(píng)價(jià),結(jié)果表明：小鼠腹腔注射半數(shù)致死量LD50=42884 mg/kg,標(biāo)準(zhǔn)誤SlogLD50=0.0397, LD5095%的可信限范圍35222.77～50545.23mg/kg。根據(jù)毒理學(xué)評(píng)價(jià)標(biāo)準(zhǔn),該片劑毒性遠(yuǎn)遠(yuǎn)小于國(guó)家規(guī)定毒性標(biāo)準(zhǔn),證實(shí)該藥片安全無(wú)毒,可在臨床上安全使用。4、臨床上使用中藥復(fù)方制劑,對(duì)產(chǎn)后牛的各種指標(biāo)做了監(jiān)控和檢測(cè),結(jié)果顯示：試驗(yàn)組比對(duì)照組的牛只抗體水平顯著提高(P0.05),經(jīng)統(tǒng)計(jì),試驗(yàn)組產(chǎn)后奶牛的胎衣滯留的發(fā)生率相對(duì)降低了50%,惡露排凈天數(shù)比對(duì)照組提前了1.3天；試驗(yàn)組奶牛好評(píng)率比對(duì)照組高出10%,奶牛乳房炎的發(fā)病頭數(shù)明顯下降,并且對(duì)奶牛乳房炎概率也減少了17.9%,治療有效率達(dá)到75%。產(chǎn)后牛的子宮內(nèi)膜炎概率也減少了16.7%,治療有效率達(dá)到66.7%,奶牛胎衣不下的概率減少了23.3%,治療有效率達(dá)83.3%。證實(shí)中藥復(fù)方片劑能有效的提高機(jī)體的免疫力,促進(jìn)了產(chǎn)后奶牛機(jī)能的快速恢復(fù),對(duì)奶牛產(chǎn)后疾病具有治療和保健作用。
[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.
【學(xué)位授予單位】：寧夏大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2015
【分類(lèi)號(hào)】：S858.23

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