双黄连颗粒剂制备工艺的研究摘要 研究目的：研究双黄连颗粒剂制备的现代化工艺，并对其所制备的双黄连颗粒进行质量考察，以确定制备工艺的科学性和合理性。 研究方法： 在本文的研究中，首先确定双黄连颗粒制备的处方用药量（金银花260g,黄芪260g,连翘520g,三者的用药比例符合1:1:2)。再深入研究金银花、黄芪、连翘的提取工艺和浓缩工艺，从而得到药物清膏约为160g(相对密度为1.22-1.26）。双黄连颗粒剂所选用的辅料为糊精和蔗糖，分别选取药物（清膏）：蔗糖：糊精不同的浓度配比，通过颗粒剂的制备工艺制备不同的双黄连颗粒，通过颗粒的疏松性状、吸湿性、溶化性、口感进行评价，筛选合理的药物（清膏）：蔗糖：糊精的配比浓度。同时对颗粒剂采用不同温度的烘箱进行干燥，通过干燥时间和成粒状态两个指标，测定颗双黄连颗粒烘干的最佳温度。对制成的双黄连颗粒进行崩解时间和含水量的检测，和通过中试工艺进行验证批量生产的可行性。研究结果：1. 3号颗粒（辅料配比为1:3.8:0.6）综合评定效果最为理想，颗粒性状疏松、而吸湿性在2天符合颗粒制剂的要求，溶化性为溶液澄清（药物的溶化性效果理想），口感为甜（符合矫味剂的特点）。2. 60和70烘干后，整粒效果最为理想，颗粒都能达到疏松状态，可直接过筛，然而60的烘干时间为48h,时间过长，从大批量工艺生产和效率的角度考虑，选择70作为颗粒制备的最好烘干温度。3. 3号颗粒和4号颗粒的含水量明显低于1号颗粒和2号颗粒，即3号颗粒和4号颗粒的防潮性明显强于1号颗粒和2号颗粒。而3号颗粒在崩解时间上为2.8分钟， 明显强于4号颗粒的4.6min,因此，可以确定辅料配比（药物：蔗糖：糊精）为1:3.8:0.6。4. 三批中试样品在水分、性状、溶化性、粒度和含量上都符合双黄连颗粒制剂的标准和规定。研究结论：1.双黄连颗粒制剂的合适辅料配比（药物：蔗糖：糊精）为1:3.8:0.6。2.从大批量工艺生产和效率的角度考虑， 70作为双黄连颗粒制备的最好烘干温度。3.本文以1:3.8:0.6的辅料配比，制备的双黄连颗粒中试试验效果理想，性状稳定，工艺简单，符合大批量生产的需要。关键词： 双黄连 颗粒剂 制备工艺 质量考察 Abstract Objective: Modernization Process of SHL granules prepared, and inspect the quality of their preparation Shuanghuanglian particles to determine the scientific and reasonable preparation process.Methods: In this study, the first to determine the amount of prescription drugs Shuanghuanglian granules prepared (honeysuckle 260g, Astragalus 260g, forsythia 520g, the proportion of the three drugs to 1: 1: 2). Further in-depth study of honeysuckle, astragalus, forsythia extraction process and concentration process to obtain the drug clear paste is about 160g (relative density of 1.22-1.26). SHL granules chosen accessories dextrin and sucrose were selected drugs (clear cream): sucrose: dextrin different concentration ratio, prepared by a different process for the preparation of granules Shuanghuanglian particles by loose particles traits hygroscopic, melting resistance, taste evaluation, rational drug screening (clear paste): sucrose: dextrin ratio of concentrations. While the granules with different temperature oven drying time by drying and granulation state two indicators to determine an optimum temperature drying stars Shuanghuanglian particles. Shuanghuanglian granules were subjected to the disintegration time and moisture testing, and to verify the feasibility of mass production through the pilot process.Results: Particles No. 1 3 (materials ratio of 1: 3.8: 0.6). The most comprehensive assessment of the effect of ideal traits loose particles, and hygroscopic granular formulation in two days in line with the requirements of the solution was clear melting (melting drugs of the results are satisfactory), the taste is sweet (in line with the characteristics of flavor). After 2. 60 and dry at 70 , whole effect is most ideal, particles can reach the loose state, can be directly screened, but the drying time 60 for 48h, too long, high-volume production process and efficiency from point of view, the drying temperature is preferably 70 select particles as prepared. No. 3.3 particles and moisture content on the 4th particles is significantly lower than the 1st and the 2nd granule particles, namely the 3rd particles and moisture resistance 4 particles was stronger than the 1st and the 2nd granule particles. And No.3 in the disintegration time of 2.8 minutes, significantly stronger than the 4th particles 4.6min, it is possible to determine the ratio of materials (drug: sugar: dextrin) is 1: 3.8: 0.6.4 three batches test a sample on the water, character, melting, particle size and content are consistent with the standards and regulations of SHL granular formulations.Conclusions: 1 ratio SHL granular formulation of appropriate materials. (Drug: sugar: dextrin) is 1: 3.8: 0.6.2 From high-volume production process and efficiency point of view, 70 granules prepared as SHL. The best drying temperature. 3. In this paper, 1: 3.8: 0.6 ratio of accessories, ideal Shuanghuanglian granules prepared pilot test results, trait stability, simple process, in line with the needs of high-volume production. Key words：SHL, granules, Preparation Process, quality investigation.目 录1.绪论51.1研究背景52. 实验材料与方法52.1实验材料52.2实验仪器52.3 处方用药量52.4中药材提取工艺52.4.1金银花和连翘提取工艺52.4.2黄芪提取工艺62.4.3浓缩工艺62.5双黄连颗粒制剂工艺62.5.1辅料的选择和配比62.5.2溶化性检测方法62.5.3吸湿性检测方法62.5.4口感测定方法62.5.5烘干温度的选择62.6质量考察方法62.6.1崩解时间和含水量的检测62.6.2中试工艺试验73. 实验结果73.1不同辅料配比制备的双黄连颗粒剂效果73.2不同烘干温度对颗粒剂制备的影响73.3不同颗粒崩解时间和含水量的检测83.4三批中试样品检测84. 讨论8结论9参考文献101.绪论1. 1研究背景双黄连由金银花、黄芩、连翘组成，传统中医认为其具辛凉解表、清热解毒作用，临床主要用于治疗外感风热引起的呼吸道感染、扁桃体炎、肺炎等1。因其是中药，可避免小儿滥用抗生素带来的不良反应，故目前成为了儿科临床抗感染的主要药物2。同时双黄连颗粒制剂在兽医临床中广泛应用，常被用于家禽（鸡、鸭等）和家禽（猪、狗、牛等）的发热风寒等病症，现在市面上常用的为散剂、口服液、粉针，而颗粒剂在兽医领域的应用和开发还较少3。而双黄连颗粒剂的药物稳定型、药物疗效、药物有效成分浓度等方面的优势，使得双黄连颗粒剂的开发和利用成为了现在研究的热点和难点。本文，试图通过对双黄连颗粒制剂工艺的处方用药量、提取和浓缩、辅料选择和配比、烘干温度等整个制备流程进行研究，确定双黄连制备工艺