【正文】 on 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(diǎn) ?????????????????? ????? 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(lái)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(jiǎn)介 ?????????????????? ?????? 11 濕法制粒工藝簡(jiǎn)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 最佳方案的實(shí)施 ??????????????? ???????? 20 一步制粒機(jī)選擇 ??????????????? ??????? 20 正交實(shí)驗(yàn)設(shè)計(jì) ??????????????? ???????? 20 小試結(jié)果分析 ??????????????? ???????? 21 最佳生產(chǎn)工藝 ????? ?????????????????? 22 V 穩(wěn)定性實(shí)驗(yàn) ????? ??????????????????? 22 效果鞏固 ?????????????????? ????????? 23 結(jié)果與討論 ???????????????????? ?????? 25 全文 結(jié)論 ????? ???????????????????? 26 參考文獻(xiàn) ?????????????????????? ?? ? 27 致謝 ????? ??????????????????????? 28 1 第一章 緒論 顆粒劑（ Granules）是將藥物與適宜的輔料配合而制成的顆粒狀制劑，一般可分為可溶性顆粒劑、混懸型顆粒劑和泡騰性顆粒劑，若粒徑在 105－ 500 微米范圍內(nèi)，又稱為細(xì)粒劑。 特點(diǎn)： 其主要特點(diǎn)是可以直接吞服，也可以沖入水中飲入，應(yīng)用和攜帶比較方便，溶出和吸收速度較快。加輔料量一般不超過(guò)清膏量的 5 倍。 提取方法 因中藥含有效成分的不同及對(duì)顆粒劑溶解性的要求不同，應(yīng)采用不同的溶劑和方法進(jìn)行提取。系將藥材加水煎煮取汁的方法。煎煮法為目前顆粒劑生產(chǎn)中最常用方法，除醇溶性藥物外，所有顆粒劑藥物的提取和制稠膏均用此法。 浸漬法適宜于帶粘性、無(wú)組織結(jié)構(gòu)、新鮮及易于膨脹的藥材的浸取，尤其適用于有效成分遇熱易揮發(fā)或易破壞的藥材。其一般操作方法如下：進(jìn)行滲漉前，先將藥材粉末放在有蓋容器內(nèi)，再加入藥材量 60％－ 70％的浸出溶劑均勻潤(rùn)濕后，密閉，放置 15 分鐘至數(shù)小時(shí)，使藥材充分膨脹以免在滲漉筒 內(nèi)膨脹。滲漉時(shí)，溶劑滲入藥材的細(xì)胞中溶解大量的可溶性物質(zhì)之后，濃度增高，比重增大而向下移動(dòng)，上層的浸出溶劑或較稀浸出溶煤置換其位置，造成良好的細(xì)胞壁內(nèi)外濃度差 。浸出溶劑的用量一般為 1： 4— 8(藥材粉末：浸出溶劑 )。它實(shí)現(xiàn)了瞬間干燥，防止了有效成分損失，同時(shí)保證了顆粒和性狀的均一性，使顆粒具有較穩(wěn)定的崩解性和溶散性，從而克服了濕法造粒工藝的溶媒殘留、變色、儲(chǔ)存不穩(wěn)定等缺點(diǎn)。如桂枝芍藥湯中的有效成分桂皮醛，采用冷凍濃縮法可保留該成分為一般真空加熱濃縮法的 50 倍之多。 (1)干法成型。 (2)濕法成型。系由濕法成型演變而來(lái)，特點(diǎn)是煉合成軟材，造粒與干燥三道工序同時(shí)進(jìn)行，即流化造粒 濕顆粒的干燥 4 濕粒制成后，應(yīng)盡可 能迅速干燥，放置過(guò)久濕粒易結(jié)塊或變質(zhì)。生產(chǎn)中憑經(jīng)驗(yàn)掌握，即用手緊捏干粒，當(dāng)在手放松后顆粒不應(yīng)粘結(jié)成團(tuán)，手拳也不應(yīng)有細(xì)粉，無(wú)潮濕感覺(jué)即可。烘盤(pán)置于擱架上或烘車擱架上，集中送入干燥箱內(nèi)干燥。又名流化床干燥，沸騰干燥是流化技術(shù)在干燥上的一個(gè)新發(fā)展。 整粒 濕粒用各種干燥設(shè)備干燥后，可能有結(jié)塊粘連等，須再通過(guò)搖擺式顆粒機(jī)，過(guò)一號(hào)篩 (12－ 14 目 )，