本文關(guān)鍵詞：槐葛降糖口腔速崩片的制備工藝及初步藥效學(xué)研究　出處：《陜西科技大學(xué)》2017年碩士論文　論文類型：學(xué)位論文

  更多相關(guān)文章： 槐葛降糖口腔速崩片 II型糖尿病 制備工藝 質(zhì)量控制 藥效學(xué)

【摘要】：本文以槐米—葛根配伍為主的治療糖尿病的民間驗方為基礎(chǔ)(原驗方為湯劑,其主要有效成分為蘆丁和葛根素),結(jié)合現(xiàn)代藥物制劑技術(shù),將蘆丁和葛根素等中藥提取物組合,制備出具有降糖作用的槐葛降糖口腔速崩片,對其進行質(zhì)量控制及初步藥效學(xué)研究。在制備工藝的研究中,采用正交實驗等方法,以粉末流動性、崩解時限、口感等為指標(biāo),分別對輔料的種類、比例、用量進行了考察,得到處方:崩解劑(45%,MCC:L-HPC為8:1)、填充劑(42%,甘露醇:乳糖為3:2)、發(fā)泡劑(2.4%,檸檬酸:NaHCO3為0.8:1)、矯味劑(0.3%,甜蜜素)、潤滑劑(0.3%,硬脂酸鎂)、主藥(10%)。制備的槐葛降糖口腔速崩片能在25s內(nèi)崩解,口感良好。采用薄層色譜法,對槐葛降糖口腔速崩片中的槐米和葛根進行定性鑒別,采用高效液相色譜法建立了槐葛降糖口腔速崩片中蘆丁和葛根素的含量測定方法,并進行了方法學(xué)考察,其回收率分別為98.70%和99.13%,RSD分別為1.66%和1.37%,該方法準(zhǔn)確可靠。根據(jù)三批次樣品測定結(jié)果,確定槐葛降糖口腔速崩片中蘆丁含量不少于30mg/g,葛根素含量不少于60mg/g。根據(jù)2015版《中國藥典》制劑通則對制劑進行了水分、崩解時限、脆碎度、片重差異、微生物限度等檢查,均符合藥典要求。在室溫下進行了槐葛降糖口腔速崩片的初步穩(wěn)定性研究,結(jié)果顯示在6個月內(nèi)三批樣品的各項指標(biāo)均符合規(guī)定。藥效學(xué)研究采用連續(xù)2d腹腔注射低劑量(75mg/kg?d)鏈脲佐菌素(STZ)的方法制備II型糖尿病小鼠模型,槐葛降糖口腔速崩片高(1.5g/kg?d)、中(1g/kg?d)、低(0.75g/kg?d)劑量灌胃給藥保護30d。以空腹血糖、糖耐量、血清總膽固醇(TC)、甘油三酯(TG)、高密度脂蛋白膽固醇(HDL-C)、低密度脂蛋白膽固醇(LDL-C)及主要臟器中丙二醛(MDA)、蛋白羰基化(PCO)、一氧化氮(NO)、谷胱甘肽(GSH)、超氧化物歧化酶(SOD)、過氧化氫酶(CAT)含量為測定指標(biāo),驗證槐葛降糖口腔速崩片的治療效果,探索其作用機理。結(jié)果顯示,中、高劑量的槐葛降糖口腔速崩片能夠顯著降低模型血糖(P0.01),增強糖耐量,改善小鼠體重下降的趨勢,降低血清中TC、TG、LDL-C的含量(P0.05),增加血清中HDL-C含量(P0.05),增強SOD、CAT、GSH活性(P0.05),降低MDA、PCO、NO含量(P0.05),并呈一定的劑量依賴性。槐葛降糖口腔速崩片能夠調(diào)節(jié)II型糖尿病小鼠的糖脂代謝,改善氧化應(yīng)激,對II型糖尿病小鼠有較好的保護作用。本文提出的槐葛降糖口腔速崩片制備工藝合理可行,質(zhì)量可控,抗糖尿病作用顯著。
[Abstract]:Based on the treatment of diabetes - Compatibility of Radix Sophorae folkremedy based (the original prescription for the decoction, the main active ingredient of rutin and Ge Gensu), combined with modern pharmaceutical technology, rutin and Ge Gensu extract of traditional Chinese medicine combination is prepared for the hypoglycemic Huai Ge Jiangtang oral disintegrating tablet studies on the quality control and preliminary efficacy. In the study of preparation process, orthogonal experiment method, the powder fluidity, disintegration time and taste as indexes, respectively, the ratio of the excipients, dosage were investigated, and get prescription: disintegrating agent (45%, MCC:L-HPC, 8:1) the filler (42%, mannitol: 3:2 lactose), foaming agent (citric acid: NaHCO3 2.4%, 0.8:1), correctant (0.3%, cyclamate), lubricants (0.3%, magnesium stearate), the main drug (10%). Huai Ge Jiangtang preparation of orally disintegrating tablets could disintegrate, in 25s in good taste. TLC of Huai Ge Jiangtang oral disintegrating tablet in the bud and root were identified, chromatographic method to establish a method for the determination of Huai Ge Jiangtang oral disintegrating tablets in Ge Gensu and the content of rutin by high performance liquid, and the method of study, the recovery rate was 98.70% and 99.13% respectively, RSD 1.66% and 1.37%, the method is accurate and reliable. According to the determination results of three batches of samples, determine the Huai Ge Jiangtang oral disintegrating tablets of not less than 30mg/g the content of rutin, Puerarin Content of not less than 60mg/g. according to the 2015 edition of < > of China Pharmacopoeia rules of preparations for the preparation of water, friability, disintegration time and tablet weight difference. Microbiological examination, the results met the Pharmacopoeia requirements. Preliminary study on stability at room temperature of Huai Ge Jiangtang oral disintegrating tablet. The results showed that in 6 months the indicators of the three samples were in accordance with the provisions. The study of pharmacodynamics even 緇，

本文編號：1357147