本文選題：暗黑鰓金龜甲性信息素 + 乙酸順式-3-己烯酯　； 參考：《青島科技大學(xué)》2017年碩士論文

【摘要】：本課題以暗黑鰓金龜性信息素L-異亮氨酸甲酯鹽酸鹽和芳樟醇,及對其有增效作用的植物源揮發(fā)物乙酸順式-3-己烯酯和乙酸反式-2-己烯酯為目標(biāo)藥物,進(jìn)行氣體增效緩釋凝膠劑的制備和工藝優(yōu)化,并制定了四種增效緩釋凝膠劑的質(zhì)量標(biāo)準(zhǔn)體系草案,具體分為五部分。第一部考察了暗黑鰓金龜性信息素的吸濕性和揮發(fā)性,確定其有較強(qiáng)的吸濕性和揮發(fā)性,具有制備氣體緩釋凝膠劑的可行性。并以暗黑鰓金龜性信息素主藥復(fù)合成分1為代表確定了所用凝膠基質(zhì)為羧甲基纖維素鈉、溶劑為無水乙醇,并確定了其比例范圍和藥物比例范圍。第二部分為暗黑鰓金龜性信息素增效緩釋凝膠劑的處方和工藝優(yōu)化,以藥物殘余量為指標(biāo),采用正交實(shí)驗(yàn)法篩選出最優(yōu)處方,結(jié)果表明四種暗黑鰓金龜性信息素增效緩釋凝膠劑30d內(nèi)緩釋效果良好。采用紅外色譜法對所制備的緩釋凝膠劑進(jìn)行結(jié)構(gòu)表征,表明所用輔料不影響藥物的化學(xué)結(jié)構(gòu)。第三部分將四種暗黑鰓金龜性信息素增效緩釋凝膠劑在自然環(huán)境中的釋放數(shù)據(jù)與6種釋藥模型(零級、一級、Higuchi、Ritger-Peppas、Baker-Lonsdale和Hixon-Crowell模型)相擬合,表明四種暗黑鰓金龜性信息素增效緩釋凝膠劑中活性成分的釋放分別符合Baker-Lonsdale、Hixon-Crowell、Hixon-Crowell和一級模型,釋藥機(jī)制以擴(kuò)散為主,溶蝕為輔。第四部分建立了暗黑鰓金龜性信息素增效緩釋凝膠劑的質(zhì)量標(biāo)準(zhǔn)檢測體系,參照《中國藥典》2015版制劑質(zhì)量標(biāo)準(zhǔn)的內(nèi)容,對四種增效緩釋凝膠劑的性狀、鑒別、酸堿度、粘度、粒度等項(xiàng)目進(jìn)行了考察,采用紫外分光光度法和氣相色譜法對活性成分進(jìn)行含量分析方法的建立,方法學(xué)考察結(jié)果表明,兩種方法操作簡單準(zhǔn)確,精密度、穩(wěn)定性和回收率均良好,紫外分光光度法適用于工業(yè)化生產(chǎn),氣相色譜法適用于精密分析。第五部分對所制備暗黑鰓金龜性信息素增效緩釋凝膠劑進(jìn)行了穩(wěn)定性研究,結(jié)果表明,四種增效緩釋凝膠劑的影響因素、加速和長期試驗(yàn)中,四種增效緩釋凝膠劑的外觀形狀、pH值、含量等指標(biāo)均無顯著變化,低溫條件下保存9個(gè)月性質(zhì)穩(wěn)定。綜上所述,本課題成功研制的四種暗黑鰓金龜性信息素增效緩釋凝膠劑,外觀均勻細(xì)膩,性質(zhì)穩(wěn)定,pH值、粒度等均符合藥典要求,分析方法簡便準(zhǔn)確,適用于工業(yè)化生產(chǎn)。
[Abstract]:In this study, the target drugs were methyl L-isoleucine methyl ester hydrochloride and linalool, and their synergistic plant volatiles, cis-3-hexene acetate and trans--2-hexene acetate.The preparation and process optimization of gas synergistic sustained-release gel were carried out, and the draft quality standard system of four synergistic slow-release gels was formulated, which is divided into five parts.In the first part, the hygroscopicity and volatility of the sex pheromone were investigated. It was confirmed that the pheromone had strong hygroscopicity and volatility, and it was feasible to prepare the gas sustained-release gel.The gel matrix is sodium carboxymethyl cellulose and the solvent is anhydrous ethanol.The second part is about the formulation and process optimization of the synergistic slow-release gel with the pheromone. The best prescription was screened by orthogonal experiment with the drug residue as the index.The results showed that the slow release effect of four kinds of sex pheromones was good within 30 days.The structure of the prepared sustained-release gel was characterized by IR chromatography, which showed that the chemical structure of the drug was not affected by the excipients.In the third part, the release data of four kinds of black-branched tortoise sex pheromone synergistic slow-release gel in natural environment were fitted to six drug release models (zero stage, Ritger-Peppaspas-Baker-Lonsdale and Hixon-Crowell model).The results showed that the release of active components from the four kinds of pheromones were in accordance with the Baker-Lonsdalesier Hixon-Crowellerian Hixon-Crowell model and the first-order model. The drug release mechanism was mainly diffusion and the dissolution was secondary.In the fourth part, the quality standard system of the synergistic slow-release gel was established. According to the content of the quality standard of the 2015 edition of Chinese Pharmacopoeia, the properties, identification, acidity, alkalinity and viscosity of the four synergistic slow-release gels were studied.The content of active components was analyzed by UV spectrophotometry and gas chromatography. The results showed that the two methods were simple, accurate and accurate.The stability and recovery are good. Ultraviolet spectrophotometry is suitable for industrial production and gas chromatography is suitable for precision analysis.In the fifth part, the stability of the four synergistic slow-release gels was studied. The results showed that the factors affecting the four synergistic slow-release gels were accelerated and long-term tests were carried out.The appearance shape, pH value and content of the four synergistic slow-release gels did not change significantly, but the properties of the four kinds of synergistic slow-release gels were stable at low temperature for 9 months.To sum up, four kinds of synergistic slow-release gel with pheromone were successfully developed in this paper. They are uniform in appearance, stable in pH value and particle size. The analytical method is simple and accurate and suitable for industrial production.
【學(xué)位授予單位】：青島科技大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：TQ453

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