本文選題：雙參平肺顆粒 + 制備工藝��； 參考：《南京中醫(yī)藥大學(xué)》2017年碩士論文

【摘要】：近年來(lái),隨著中國(guó)經(jīng)濟(jì)飛速發(fā)展,城市污染進(jìn)一步加重,導(dǎo)致空氣質(zhì)量直線下降。污水、汽車尾氣、霧霾無(wú)疑加快了生態(tài)環(huán)境惡化的步伐,嚴(yán)重影響到人體呼吸健康,肺部疾病成為現(xiàn)代社會(huì)中的一種高發(fā)病。雙參平肺方源于臨床治療肺痹的經(jīng)驗(yàn)總結(jié),由人參、丹參、知母、天冬、橘紅、地骨皮、桑白皮、甘草八味藥組成,制成具有清肺潤(rùn)燥,鎮(zhèn)咳止嘔之功效的顆粒劑,用于治療心火刑肺,咳嗽喘嘔,痰涎壅盛,胸膈痞滿。本課題全面系統(tǒng)的綜述了雙參平肺顆粒的工藝及質(zhì)量標(biāo)準(zhǔn)研究。論文主要分為五個(gè)部分:第一部分文獻(xiàn)綜述:查閱文獻(xiàn)并綜述了雙參平肺顆粒處方方解、組方藥物的化學(xué)成分及藥理作用等。第二部分雙參平肺顆粒制備工藝研究:針對(duì)組方藥材不同藥效成分分析,分別甄選合適的醇提和水提工藝。以丹酚酸B含量為評(píng)價(jià)指標(biāo),正交法優(yōu)選人參、丹參醇提工藝;以芒果苷含量為評(píng)價(jià)指標(biāo),基于復(fù)方配伍優(yōu)選知母提取工藝;以甘草酸含量為評(píng)價(jià)指標(biāo),正交法優(yōu)選桑白皮、天冬、橘紅、地骨皮、甘草水提工藝。同時(shí),在雙參平肺顆粒制備工藝研究中,通過(guò)組方拆方提取研究發(fā)現(xiàn),知母中芒果苷可能與桑白皮中的成分形成締合降低了芒果苷從藥材中的轉(zhuǎn)移率。因此,確定工藝為:取知母飲片,水提取二次,第一次加水12倍,第二次加水10倍,每次1.5小時(shí),濾過(guò),濾液合并,減壓濃縮得浸膏一,備用;取人參、丹參二味飲片,加70%乙醇提取二次,第一次為6倍量,第二次為5倍量,每次1.5小時(shí),濾過(guò),濾液合并,減壓濃縮得浸膏二,備用;藥渣與其它五味藥材合并,加水提取二次,第一次加水12倍,第二次加水10倍,每次1.5小時(shí),濾過(guò),濾液合并,減壓濃縮得浸膏三,與上述浸膏一、浸膏二合并,混勻,減壓濃縮至相對(duì)密度1.16-1.28(50℃)的稠膏,加入糊精及適量阿斯巴甜,混勻,制成顆粒,干燥、整粒,分裝,即得。第三部分雙參平肺顆粒質(zhì)量標(biāo)準(zhǔn)研究:因?yàn)殡p參平肺顆粒屬于新藥研發(fā),之前沒(méi)有相關(guān)的質(zhì)量標(biāo)準(zhǔn)研究,所以,以方中主要藥效成分芒果苷與丹酚酸B為含量測(cè)定的主要成分并進(jìn)行方法學(xué)研究,同時(shí)優(yōu)選各味藥材薄層鑒別方法,最終確定:以乙腈(A)-0.1%三氟乙酸水(B)系統(tǒng)梯度洗脫進(jìn)行色譜分析,檢測(cè)波長(zhǎng)為245nm,柱溫為30℃。該方法方便可靠,可同時(shí)測(cè)定丹酚酸B與芒果苷。第四部分雙參平肺顆粒穩(wěn)定性初步研究:對(duì)雙參平肺顆粒進(jìn)行了初步穩(wěn)定性試驗(yàn),結(jié)果表明,本品安全可靠,質(zhì)量穩(wěn)定。第五部分基于LC-MS-MS雙參平肺顆粒溯源性初步研究:雙參平肺顆粒甲醇提取,以甲醇-酸水系統(tǒng)為流動(dòng)相進(jìn)行液相分析,共選出21個(gè)峰,并進(jìn)行方法學(xué)考察,實(shí)驗(yàn)證明,該指紋圖譜方法具有較好的重復(fù)性、穩(wěn)定性。采用中藥指紋圖譜相似度評(píng)價(jià)系統(tǒng)對(duì)不同批次樣品進(jìn)行相似度分析,結(jié)果表明,各批次樣品均為0.95以上,說(shuō)明雙參平肺顆粒制劑工藝穩(wěn)定。采用HPLC-DAD對(duì)制劑樣品與藥材樣品進(jìn)行檢測(cè)后,將21個(gè)共有峰進(jìn)行藥材歸屬,并結(jié)合HPLC-MS進(jìn)行成分確認(rèn),共找出制劑與藥材中同時(shí)存在的31個(gè)成分。結(jié)論:通過(guò)雙參平肺顆粒的制劑工藝研究、質(zhì)量標(biāo)準(zhǔn)研究、穩(wěn)定性初步研究、溯源性研究等,表明雙參平肺顆粒工藝合理,質(zhì)量可控,安全可行。
[Abstract]:In recent years, with the rapid development of China's economy and the further aggravation of urban pollution, the air quality has declined linearly. Sewage, automobile exhaust, and fog haze undoubtedly accelerated the pace of ecological environment deterioration, seriously affecting the health of the human body, and the lung disease has become a high incidence in modern society. The summary of the experience is made up of eight drugs of ginseng, Salvia miltiorrhiza, Anemarrhena, asemine, asparagus, tangerine, ground skin, mulberry skin, liquorice, and liquorice, which have the effect of clearing lung and relieving cough and antiemesis. It is used for the treatment of heart fire and lung, cough and vomiting, phlegm congestion and full chest diaphragm. This subject is a comprehensive and systematic review of the study on the technology and quality standard of double ginseng lung granules. The paper is divided into five parts: the first part of the literature review: consulting the literature and summarizing the prescription of double ginseng lung granule prescription, the chemical composition and pharmacological action of the prescription drugs. The second part of the preparation technology of the double ginseng lung Granule: according to the analysis of different medicinal ingredients in the herbal medicine, select the appropriate alcohol extraction and water extraction process. The content of phenolic acid B was the evaluation index, the orthogonal method was used to optimize the alcohol extraction process of ginseng and Salvia miltiorrhiza. With the content of mangiferin as the evaluation index, the extraction technology of Anemarrhena was optimized based on the compound compatibility. The extraction process of mulberry white skin, asparagus, orange, ground skin, and Glycyrrhiza was optimized by orthogonal method. It was found that mangiferin in the rhizoma Anemarrhena may be associated with the formation of the ingredients in the cortex Morus and reduce the transfer rate of mangiferin from the medicinal materials. Therefore, the process is as follows: extraction of Anemarrhena from Rhizoma Anemarrhena, two times of water extraction, 12 times of water in the first time, 10 times of water adding second times, filtration, filtrate merge, and decompression of extract one, Take ginseng, ginseng, Salvia miltiorrhiza two flavors and 70% ethanol to extract two times, 6 times for the first time, second times 5 times, 1.5 hours each time, filtrate, filtrate merge, decompress concentrated extract two, combined with other five herbs, two times, 12 times of water, second times, second times, filtrate and filtrate merge. Extract three of the extract, combined with the extract one, the extract two, mixing, mixing, reducing the pressure to the relative density 1.16-1.28 (50) thick paste, adding dextrin and a proper amount of aspartame, mixing, making particles, drying, whole grain, dividing, getting. Third parts of double ginseng lung granule quality standard study: because double ginseng lung granule is a new drug research and development, There is no related quality standard research, so the main component of the prescription, mangiferin and salvianolic acid B, is the main component of the content determination, and the method is studied. At the same time, the TLC identification method is selected. Finally, the chromatographic analysis is carried out with the gradient elution of acetonitrile (A) -0.1% three fluoroacetate water (B) system, and the detection wavelength is 245nm. The column temperature was 30 C. The method was convenient and reliable. A preliminary study on the stability of both salvianolic acid B and mangiferin. A preliminary study on the stability of double Shen lung granules in fourth parts: the preliminary stability test of double Shen Ping lung granules showed that the product was safe and stable. The preliminary Study on the traceability of lung granules in the fifth part was based on the double reference plane. The extraction of lung granule methanol was carried out with methanol acid water system as the liquid phase analysis. 21 peaks were selected and the method was investigated. The experiment proved that the fingerprint method had good repeatability and stability. The similarity evaluation system of Chinese traditional medicine fingerprint was used to analyze the similarity of different batch samples. The results showed that each batch was batch. All the samples were more than 0.95, indicating that the technology of double ginseng lung granule preparation was stable. After testing the preparation samples and medicinal materials by HPLC-DAD, 21 common peaks were assigned to the medicinal materials, and the components were confirmed with HPLC-MS. Conclusion: the preparation process of the preparation and the medicinal materials was found through the preparation process of double ginseng lung granules. Research, quality standard research, stability preliminary study and traceability study showed that the technology of Shuang Shen Ping lung granule is reasonable, quality controllable, safe and feasible.

【學(xué)位授予單位】：南京中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R283.6;R286.0

【參考文獻(xiàn)】

相關(guān)期刊論文 前10條

1 丁嘉華;馮毅凡;李衛(wèi)民;高英;;UPLC-Q-TOF-MS對(duì)桑白皮總黃酮提取物的快速分析[J];中國(guó)實(shí)驗(yàn)方劑學(xué)雜志;2017年06期

2 劉慧穎;姜長(zhǎng)濤;馮娟;王憲;;丹參酮類化合物研究進(jìn)展[J];中國(guó)藥理學(xué)通報(bào);2016年12期

3 陳紅梅;恩和蘇仁;長(zhǎng)春;美麗;王秀蘭;王曦?zé)?;基于液質(zhì)聯(lián)用的代謝組學(xué)方法研究天冬滋補(bǔ)保健作用的活性成分[J];中國(guó)藥師;2016年11期

4 劉妍如;史鑫波;陳永琴;黃文靜;李智成;吳景濤;葛秋萍;宋忠興;宋小妹;唐志書;;HPLC-ESI-MS/MS法同時(shí)測(cè)定珠子參中15種皂苷類化合物[J];中草藥;2016年19期

5 趙國(guó)欣;劉萌;李領(lǐng)川;周曉莉;;超高效液相色譜-質(zhì)譜聯(lián)用同時(shí)測(cè)定丹參中7種成分含量[J];中國(guó)實(shí)驗(yàn)方劑學(xué)雜志;2017年01期

6 趙威;曹彥剛;楊雁蕓;王小蘭;匡海學(xué);鄒忠梅;馮衛(wèi)生;鄭曉珂;;UPLC法同時(shí)測(cè)定桑白皮中8種成分[J];中成藥;2016年08期

7 楊曉靜;陳麗娜;秦瑤;李賽男;唐英;李森林;劉春明;;UPLC-MS/MS法測(cè)定中藥材中齊墩果酸與熊果酸的含量[J];分析測(cè)試學(xué)報(bào);2016年06期

8 邱昆成;孫振剛;何倩梅;李丹;劉奕明;林愛華;;LC-MS-MS測(cè)定配伍黃柏對(duì)知母中4種有效成分含量的影響[J];中國(guó)實(shí)驗(yàn)方劑學(xué)雜志;2016年14期

9 趙春草;吳飛;張繼全;陳群力;;知母的藥理作用研究進(jìn)展[J];中國(guó)新藥與臨床雜志;2015年12期

10 石晶;顧強(qiáng);乙小娟;羅印;劉一軍;殷月;;高效液相色譜-質(zhì)譜法測(cè)定橄欖油中β-谷甾醇的含量[J];食品科技;2015年06期

相關(guān)會(huì)議論文 前1條

1 孫雪飛;趙海娟;夏青;吳玲芳;王坤鳳;張?zhí)m珍;;丹參的化學(xué)成分研究進(jìn)展[A];中華中醫(yī)藥學(xué)會(huì)中藥化學(xué)分會(huì)第八屆學(xué)術(shù)年會(huì)論文集[C];2013年

相關(guān)博士學(xué)位論文 前1條

1 張靜嫻;中藥地骨皮的化學(xué)成分與質(zhì)量控制方法研究[D];沈陽(yáng)藥科大學(xué);2013年

相關(guān)碩士學(xué)位論文 前8條

1 黃彬彬;知母化學(xué)成分的研究[D];吉林大學(xué);2015年

2 王玉帥;人參花蕾中皂苷類成分的研究[D];中國(guó)農(nóng)業(yè)科學(xué)院;2015年

3 李映萱;芪丹顆粒的制備工藝及質(zhì)量標(biāo)準(zhǔn)研究[D];武漢理工大學(xué);2014年

4 張宇霞;三種中草藥中皂苷類化合物的液質(zhì)聯(lián)用分析[D];東華大學(xué);2013年

5 張鮮票;枸芪顆粒制劑工藝及質(zhì)量標(biāo)準(zhǔn)研究[D];山東中醫(yī)藥大學(xué);2012年

6 孫峰;人參皂苷Rg3和Rh2的分離制備研究[D];延邊大學(xué);2009年

7 周昊;復(fù)方青藤片的藥學(xué)研究[D];南京中醫(yī)藥大學(xué);2007年

8 張銳;知母菝葜皂苷元的分離純化以及體外誘導(dǎo)肝癌細(xì)胞HepG2凋亡的研究[D];浙江大學(xué);2006年

，

本文編號(hào)：1880993