本文選題：通便膠囊 + 糖尿病便秘　； 參考：《北京中醫(yī)藥大學(xué)》2017年碩士論文

【摘要】：實(shí)驗(yàn)?zāi)康慕┠?臨床上糖尿病便秘患者逐漸增多,發(fā)病機(jī)理復(fù)雜,中醫(yī)認(rèn)為其為人體氣血陰陽(yáng)失調(diào)的一種表現(xiàn)。目前市場(chǎng)已有通便保健食品,但配方和適用人群各不相同。本配方由番瀉葉、苦杏仁、西洋參三味中藥組成,具有通便,補(bǔ)氣生津的功能。期望對(duì)糖尿病便秘能有較好的改善效果。本課題結(jié)合現(xiàn)代制劑相關(guān)技術(shù),優(yōu)選出其提取工藝和成型工藝,并對(duì)其質(zhì)量標(biāo)準(zhǔn)進(jìn)行了研究。實(shí)驗(yàn)方法本課題從通便膠囊的提取工藝,成型工藝和質(zhì)量標(biāo)準(zhǔn)三個(gè)方面進(jìn)行研究。1提取工藝:經(jīng)查閱藥典和相關(guān)文獻(xiàn),確定三味藥中指標(biāo)性和藥理活性成分的提取溶劑和提取方法。番瀉葉為后下藥,在乙醇濃度、提取時(shí)間單因素實(shí)驗(yàn)基礎(chǔ)上設(shè)計(jì)四因素(乙醇濃度、乙醇倍量、提取時(shí)間、提取次數(shù))三水平正交實(shí)驗(yàn),以藥理活性成分番瀉苷A、番瀉苷B的含量為指標(biāo)確定最佳工藝;苦杏仁設(shè)計(jì)三因素(加水倍量、提取時(shí)間、提取次數(shù))三水平正交實(shí)驗(yàn)以《中國(guó)藥典》2015年版規(guī)定的成分苦杏仁苷的含量以及干膏得率為指標(biāo)確定最優(yōu)提取工藝;西洋參為另煎兌服藥,以人參總皂苷為指標(biāo)性成分設(shè)計(jì)四因素(乙醇濃度、乙醇倍量、提取時(shí)間、提取次數(shù))三水平正交實(shí)驗(yàn)來(lái)確定最優(yōu)提取工藝。2成型工藝:根據(jù)藥粉吸濕性,流動(dòng)性,制粒難易程度等確定輔料種類,對(duì)濕法制粒中的潤(rùn)濕劑的濃度,藥輔比等進(jìn)行了考察,對(duì)半成品顆粒的休止角和臨界相對(duì)濕度進(jìn)行了測(cè)定、控制。3質(zhì)量標(biāo)準(zhǔn):為保證制劑的穩(wěn)定性,方便對(duì)該制劑的質(zhì)量進(jìn)行控制,本課題從定性和定量?jī)煞矫娉醪街贫ㄆ滟|(zhì)量標(biāo)準(zhǔn)。采用薄層色譜法對(duì)制劑中番瀉葉、苦杏仁、西洋參進(jìn)行了定性鑒別;采用高效液相色譜法對(duì)通便膠囊中活性成分番瀉苷A、番瀉苷B進(jìn)行含量測(cè)定。實(shí)驗(yàn)結(jié)果1提取工藝結(jié)果:番瀉葉最佳醇提工藝:E1倍G1乙醇濃度,提取F1次,每次T1。濃縮至相對(duì)密度1.15左右,置于50℃、-0.10MPa烘箱干燥;苦杏仁最佳水提工藝:E2倍的水提取T2;西洋參最佳醇提工藝:E3倍的G2的乙醇,提取次數(shù)F2次,每次T3。2成型工藝結(jié)果:藥粉與糊精按J混合均勻,以K乙醇為潤(rùn)濕劑,環(huán)境相對(duì)濕度控制在L以下N目篩濕法制粒,H干燥顆粒T4,P篩整粒,灌裝膠囊,包裝即得成品膠囊。3質(zhì)量標(biāo)準(zhǔn)的建立:建立了番瀉葉、苦杏仁、西洋參的薄層色譜定性鑒別方法;建立了高效液相色譜法測(cè)定通便膠囊中番瀉苷A、番瀉苷B的含量測(cè)定方法。含量測(cè)定條件為:WatersSunf1reC18(250mm×4.6mm,5μm)色譜柱:以乙腈(A)-0.1%磷酸(B)作為流動(dòng)相,洗脫條件為:0→50min,(A)20%;50→51min,(A)20%→95%;51→60min,(A)95%;60→61min,(A)95%→20%;61→70min,(A)20%,流速 1.0mL/min,柱溫30℃,檢測(cè)波長(zhǎng)為271nm。通便膠囊每粒含番瀉苷A、番瀉苷B不得少于1.575mg。實(shí)驗(yàn)結(jié)論確定了通便膠囊的最佳制備工藝并建立了質(zhì)量標(biāo)準(zhǔn),方法合理可行,穩(wěn)定可靠,能有效控制該制劑的質(zhì)量,為其開發(fā)成保健食品奠定了基礎(chǔ)。
[Abstract]:Objective in recent years, the number of patients with diabetes mellitus constipation is increasing, and the pathogenesis is complicated, which is regarded by TCM as a manifestation of the disorder of qi and blood yin and yang. At present, the market has defecated health food, but different formulations and applicable population. This formula is composed of Senna leaf, bitter almond and American ginseng. It is expected to improve the constipation of diabetes mellitus. In this paper, the extraction process and molding technology were selected, and the quality standards were studied. Experimental methods: the extraction technology of Tongbian capsule, molding technology and quality standard were studied in three aspects: 1. After consulting pharmacopoeia and related documents, To determine the extraction solvent and extraction method of index and pharmacological active components in three kinds of drugs. Senna leaf was used as the later drug. Based on the single factor experiment of ethanol concentration and extraction time, three level orthogonal experiments were designed for four factors (ethanol concentration, ethanol doubling, extraction time, extraction times). The content of pharmacological active components of sennoside A and sennoside B was taken as the index to determine the optimum process, and the three factors of bitter almond design (water doubling, extraction time, extraction time) were used to determine the optimum process. The optimum extraction process was determined by the content of amygdalin and the yield rate of dried ointment in the 2015 edition of the Chinese Pharmacopoeia. Four factors (ethanol concentration, ethanol doubling, extraction time, extraction times) were designed to determine the optimal extraction process by using total ginsenosides as index components. The kinds of auxiliary materials were determined, the concentration of wetting agent and the ratio of wetting agent in wet granulation were investigated, and the angle of repose and critical relative humidity of semi-finished granules were measured. 3 quality control standard: in order to ensure the stability of the preparation and facilitate the quality control of the preparation, this paper preliminarily formulates the quality standard from the qualitative and quantitative aspects. Senna leaf, bitter almond and American ginseng were identified by TLC, and the active components of Tongbian capsule were determined by HPLC. Results 1 extraction of Senna leaves: the best alcohol extraction process was: 1. E1 times G1 ethanol concentration, F1 extraction times, each time T1. Concentrate to about 1.15, put in 50 鈩，

本文編號(hào)：2068490