【正文】 I 連云港職業(yè)技術(shù)學(xué)院 畢 業(yè) 論 文 題 目： 胃蘇顆粒的 制備 工藝 研究 作 者： 單小丹 學(xué) 號： 100203116 院 、系： 醫(yī)藥與化學(xué)工程學(xué)院 專業(yè)班級： 化學(xué)制藥 101 班 指導(dǎo)教師： 許同桃 . 2020 年 5 月 1 日 胃蘇顆粒的 制備工藝研究 摘 要 工藝創(chuàng)新 前，胃蘇顆粒使用 95%乙醇進行濕法制粒，制粒結(jié)束后，在使用熱風(fēng)循環(huán)烘箱對顆粒進行干燥時 ,操作間有大量乙醇蒸汽產(chǎn)生。而安全常識顯示：乙醇蒸汽爆炸的濃度范圍為 ％ — 18%。經(jīng)過對車間乙醇濃度檢測，發(fā)現(xiàn)有多次乙醇蒸汽濃度超標(biāo)，如果車間電路老化等原因產(chǎn)生火花那么將會引發(fā)安全事故，從而給操作人員造成較大的傷害，給企業(yè)也會帶來難以估計的損失。因此，我們決定對制粒工藝進行創(chuàng)新，通過減少或取消乙醇的使用來達到提高安全性的目的。 胃蘇顆粒采用濕法制粒，需要消耗大量的 95%乙醇而相對于其它制粒方法，生產(chǎn)周期長，花費人工多， 從而使得胃蘇顆粒的總體成本較高。 使用搖擺式顆粒機進行制粒 ， 顆粒劑中偶爾有金屬異物，因為篩網(wǎng)平均使用周期為 小時，篩網(wǎng)容易斷裂，導(dǎo)致金屬絲進入顆粒中。 基于以上原因，為了向員工提供良好的工作環(huán)境，進一步提高產(chǎn)品質(zhì)量，降低生產(chǎn)成本，為公司創(chuàng)造更大的效益， 根據(jù)車間實際生產(chǎn)狀況、產(chǎn)品性質(zhì)和工藝創(chuàng)新的思路，經(jīng)過討論，與專家進行了分析， 我們決定研究胃蘇顆粒制粒的新工藝。并且提出了兩個目標(biāo)： ，消除乙醇蒸汽爆炸隱 患 。 ，采用其他方法進行制粒，保證顆粒質(zhì)量合格。 經(jīng)過查找資料，發(fā)現(xiàn)中 藥制劑制粒的方法除了濕法制粒，還有干法制粒、一步制粒、高速攪拌制粒等。因為各有優(yōu)缺點，我們從可行性、經(jīng)濟性、安全性、預(yù)計效果四個方面對上述三種方法分別進行打分評估，發(fā)現(xiàn)一步制粒法最高，所以 選用得分最高的一步制粒法作為最佳方案，將高速攪拌制粒作為后備方案，并開展了一系列關(guān)于一步制粒生產(chǎn)胃蘇顆粒的工藝創(chuàng)新活動。 關(guān)鍵詞： 顆粒劑 胃蘇顆粒、 制備 新工藝、一步制粒 II Stomach Sue Granule Preparation Technology Research Abstract Technological innovation, the stomach Sue particles using 95% ethanol for the wet legal system grain, after granulating, in the use of hot air circulation drying oven to dry particles, preparation there is a lot of ethanol steam is generated. And safety mon sense shows that: ethanol vapor explosion concentration range of % to % . Ethanol concentration after the workshop inspection, found that the ethanol vapor concentration exceeds bid for several times, if workshop circuit aging cause sparks will cause safety accidents, and large damage to the operating personnel, brings to the enterprise will be difficult to estimate losses. Therefore, we decided to granulating technological innovation, reduce or cancel the use of ethanol to achieve the goal of improve security. Sue particles using the wet legal system grain of stomach, you need to consume large amounts of 95% ethanol and relative to other granulating method, production cycle is long, artificial cost much, so as to make the stomach Sue particles have higher overall costs. Using swing type pellet machine for granulating, and occasional metal foreign bodies in the granules, because the screen use cycle for hours on average, screen is easy to break, lead to metal wire into the particles. Based on the above reasons, in order to provide a good working environment to employees, and further improve product quality, reduce production costs, create greater benefits for the pany, according to the actual production status and the nature of the product and process innovation, as a result of the discussion, and experts are analyzed in this paper, we have decided to study gastric Sue particles new technology of granulating. And put forward the two objectives: 1. Improve the operating environment, eliminate the hidden ethanol steam explosion. 2. Under the condition of invariable in prescription, using other methods to granulating, ensure the quality of particles. Through to find information, found that Chinese traditional medicine preparation granulating method besides the wet legal system grain, dry granulator, step system grain, high III speed stirring granulation, etc. Because each have advantages and disadvantages, we from the feasibility, economy, safety, four aspects of the above three methods expected effect scores evaluation respectively, found that the highest step granulating method, so the highest step granulating method chosen as the best solution, high speed stirring granulation as a backup plan, and carried out a series of step granulating production stomach Sue particle technology innovation activities. Keywords: granules stomach Sue particles, preparation of new technology, step granulating IV 目 錄 摘 要 ?????????????????????? ??????? I ABSTRACT????????????????????? ???? ? II 第一章 緒 論 ?????????????????????? ??? 1 顆粒劑 ??????????????????? ???????? 1 分類與特點 ?????????????????? ????? 1 顆粒劑制備 ???????????????????? ??? 1 顆粒劑質(zhì)量檢查 ??????????????? ?????? 4 影響顆粒 劑 質(zhì)量因素 ??????????????? ???? 6 胃蘇顆粒 ??????????????? ??????????? 7 課題來源 ??????????????? ??????????? 8 研究意義 ??????????????? ??????????? 9 第二章 胃蘇顆粒制備工藝 ?????????????? ????? 10 胃蘇顆粒（有糖型）工藝流程圖 ?????? ?????????? 10 工藝現(xiàn)狀簡介 ?????????????????? ?????? 11 濕法制粒工藝簡介 ?????????????????? ?? 11 工藝創(chuàng)新 ??????????????? ????????? 13 第三章 工藝優(yōu)化 ????????????????? ?????? 15 工藝目標(biāo) ???????????????????? ?????? 15 工藝優(yōu)化 ??????????????? ??????????? 15 方案的確定 ??????????????? ???????? 15 影響因素 ??????????????? ????????? 17 最佳方案的