本文關(guān)鍵詞：正交試驗優(yōu)化銀翹敗毒片的干法制粒工藝　出處：《中國藥房》2017年25期 　論文類型：期刊論文

  更多相關(guān)文章： 銀翹敗毒片 干法制粒 正交試驗 顆粒得率 休止角 轉(zhuǎn)移率 綠原酸

【摘要】：目的:優(yōu)化銀翹敗毒片干法制粒的工藝條件。方法:以制粒難易程度和崩解時限等為考察指標,對銀翹敗毒片中輔料微晶纖維素和可壓性淀粉的配比、用量及噴干粉的含水量進行篩選;以顆粒得率和休止角為指標,采用L9(34)正交試驗對干法制粒工藝中壓輪壓力、轉(zhuǎn)速及送料速度等條件進行優(yōu)化并進行驗證試驗。結(jié)果:微晶纖維素與可壓性淀粉的比例為7∶3(m/m),二者與(噴干粉+包合物)的混合比例為1∶5;控制噴干粉含水量在1%~2%之間。干法制粒最優(yōu)工藝參數(shù)為壓輪壓力3.5 MPa、壓輪轉(zhuǎn)速4 r/min、送料速度10 r/min。驗證試驗中顆粒平均得率為69.2%,平均休止角為31.5°,綠原酸轉(zhuǎn)移率達92%以上,且各指標RSD均在2.53%以下(n=3)。結(jié)論:按優(yōu)化輔料處方和工藝制備的顆粒各項指標均具有較好的重現(xiàn)性和可行性,且工藝穩(wěn)定,適合工業(yè)生產(chǎn)。
[Abstract]:Objective: to optimize the technological conditions of dry granulation of Yinqiao Baiduu tablets. Methods: the ratio of microcrystalline cellulose and compressible starch in Yinqiao Baiduu tablets was studied by taking the degree of granulation difficulty and disintegration time as the index. The dosage and moisture content of dry powder were screened. Based on the particle yield and angle of repose, the pressure of dry granulation process was studied by using L9 / 34) orthogonal test. The results showed that the ratio of microcrystalline cellulose to compressible starch was 7: 3 m / m). The mixing ratio of the two to (spray powder inclusion compound) is 1: 5; The water content of dry powder was controlled in the range of 1% and 2%. The optimum parameters of dry granulation were as follows: wheel pressure 3.5 MPA, wheel speed 4 rmin. The average particle yield was 69.2, the average angle of repose was 31.5 擄, and the transfer rate of Lv Yuan acid was more than 92%. The RSD of each index is less than 2.53%. Conclusion: the parameters of the granules prepared by optimizing the prescription of excipients and the preparation of the process have good reproducibility and feasibility, and the process is stable. Suitable for industrial production.
【作者單位】： 江蘇聯(lián)合職業(yè)技術(shù)學院連云港中醫(yī)藥分院;江蘇康緣藥業(yè)股份有限公司中藥制藥過程新技術(shù)國家重點實驗室;
【基金】：國家重大新藥創(chuàng)制項目-現(xiàn)代中藥創(chuàng)新集群與數(shù)字制藥技術(shù)平臺基金資助項目(No.2013ZX09402203)
【分類號】：R283.6
【正文快照】： 銀翹敗毒片是用于治療風熱感冒的國家級新藥。其制備方法是先提取方中金銀花、連翹、薄荷等藥材的揮發(fā)油,再將揮發(fā)油經(jīng)β-環(huán)糊精包合,其他藥材經(jīng)水提取、采用噴霧干燥方法制顆粒,二者加輔料均勻混合,干法制粒、壓制成片即得。由于提取物中含有較多的多糖及皂苷類成分,制成的噴

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