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双语推荐：薄膜包衣剂

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目的研究用薄膜包衣技术改进木香顺气丸的质量稳定性。方法采用薄膜包衣工艺技术，选取3种包衣液处方对本品素丸进行包衣，考察包衣前后丸子的相关质量指标。结果本品素丸包薄膜衣对溶散时限影响较小，对含量测定几无影响，稳定性试验表明包衣丸比未包衣素丸的吸湿率低。结论本品可以采用胃溶型薄膜包衣预混剂进行包衣，对提高其防吸湿性有明显效果，且工艺操作简单。
Objective Research in thin film coating technology to improve the quality of the qi-regulating pill of aucklandia stability.Methods Using thin film coating technology,selected three kinds of coating liquid prescription pill for coating this product element,balls before and after the inspection coating quality indicators.Results This hormone pills package film,about the time limit of soluble powder has little effect,influence on the content determination of little,pills for stability test showed that coating pigment than the low moisture absorption rate.Conclusions This product type gastric soluble premix membrane coating may be used for coating,to improve its anti-hygroscopicity have obvious effect,simple operation and process.

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研究适合硝苯地平片的薄膜包衣生产工艺方法。方法:用醇溶型薄膜包衣预混剂对该产品片芯进行包衣后,与该产品未包衣片芯同时进行稳定性考察对比。结果:用醇溶型薄膜包衣预混剂对该产品素片进行包衣后,当增重达到3.2%±0.3%时,本品加速试验6个月时的综合质量仍符合中国药典规定,而未包衣的片芯则呈现明显的质量变化。结论:按该工艺生产的硝苯地平片质量稳定可靠,该工艺适合大生产需要。
The method is suitable for the thin film coating production craft nifedipine tablets . Methods With alcohol soluble type thin film coating premix on the product core after coating , and the product is not coating tablet core stability test comparison at the same time . Results With alcohol soluble type thin film coating premix tablet after coating to this product , when the weight gain of 3 . 2% plus or minus 3 . 2%, the product the overall quality of accelerated test 6 months still conform to the requirement of Chinese pharmacopoeia , and did not show obvious coating of tablet core quality change . Conclusions According to the production of the nifedipine tablets is stable and reliable quality , the process is suitable for mass production needs .

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目的研究丙戊酸钠薄膜衣片的制备方法。方法分别用全水型和醇溶型薄膜包衣预混剂对该素片进行包衣,与该品种同规格糖衣片同时进行稳定性考察比较。结果用全水型和醇溶型薄膜包衣预混剂对该产品素片进行包衣后,当增重达到(3.5±0.3)%时,本品6个月时的水分含量分别为6.3%、6.6%,糖衣片为8.9%,其他项目比糖衣片也显出一定的优势,且均符合规定。结论按该工艺生产的丙戊酸钠薄膜衣片符合质量标准要求,工艺稳定可靠,适合大生产需要。
Objective?Study on Preparation of sodium valproate film-coated tablets. Methods With full water and alcohol soluble film coating premix is coated on the core, and the varieties of the same specifications sugar-coated tablets and stability comparison. Results With the water and alcohol soluble film coating premix is coated on the tablet core, when the weight reached 3.5%±0.3%, the moisture content of the product at 6 months were 6.3%, 6.6%, sugar-coated tablets for 8.9%, other than sugar coated tablets also shows some advantages, which are in line with the provisions. Conclusions According to valproate film-coated tablets produced by this technology to meet the required quality standards, the technology is stable and reliable, and suitable for the industrial production needs.

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通过采取不同预处理方式和检测手段,对薄膜包衣剂中砷含量进行测定。对不同消解方法中产生的结果差异进行分析,确立了薄膜包衣剂类物质中砷含量测定的准确试验方法,完全可以用于进行此类物质的砷元素安全性评价。
@@@@Arsenic content in the film coating agent has been determined by taking a different preprocessing methods and means of detection. A complete set of digestion method has been obtained by analysising of the difference between the results. And a full set of determination of arsenic content in a set of thin-film coating agentsubstances has been established, which can be used for arsenic-limitted safety evaluation of such substances.

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目的：制备利伐沙班片剂，优选适合中试生产的最佳处方。方法通过设计不同处方，对增溶剂、崩解剂、黏合剂、填充剂的用量及工艺进行考察，并进行了中试三批放大，测定在四种溶出介质中的溶出曲线、含量均匀度和有关物质等指标。结果用利伐沙班为主药，以乳糖、微晶纤维素为填充剂，以十二烷基硫酸钠为增溶剂，以交联羧甲基纤维素钠为崩解剂，以羟丙基甲基纤维素为黏合剂、以硬脂酸镁为润滑剂，以胃溶型薄膜包衣预混剂为包衣材料，制得利伐沙班片。结论该制剂工艺稳定，制得利伐沙班片（10 mg）与原研市售品溶出行为相似，质量符合规定。
Objective To prepare Rivaroxaban tablets and choose the best prescription for pilot scale production.Methods Through the design of different prescriptions and the selection of the amount of solubilizers, disintegrants, fillers and formulation process, three bat-ches of test product in pilot scale were prepared according to the optimized formulation.The dissolution curve, content uniformity, related substances and other indicators tested in four kinds of dissolution media were determined correspondingly.Results Rivaroxaban tablets were formulated with Rivaroxaban as the main drug,lactose and microcrystallinecellulose as fillers, sodium lauryl sulfate as solubilizer, roscarmellose sodium as disintegrant, stearic magnesium as lubricant, film coating premixed adjuvant(gastric-dissolving type)as the coat-ing material.Conclusion The present formulation process of newly developed Rivaroxaban tablets(10 mg) was stable.The dissolution behavior of newly developed formulation was simila

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目的：探讨薄膜包衣对西罗莫司（SRL）滴丸溶出度及稳定性的影响,以证实薄膜包衣的作用及合理性。方法：选用欧巴代为SRL滴丸的包衣材料进行包衣;对其体外释药及稳定性进行考察,并与未包衣的SRL滴丸进行比较。结果：与未包衣滴丸相比,在相同时间内,薄膜包衣SRL滴丸的体外释药量明显降低（P〈0.05）,而稳态释药速率并无显著影响（P〉0.05）;高湿条件下（75%±5%）包衣SRL滴丸的吸湿性显著下降,在强光环境中（4 500 lx±500 lx）,包衣SRL滴丸的稳定性也较好,而在高温条件下（40℃±2℃）,稳定性无显著提高。结论：欧巴代薄膜包衣可明显提高SRL滴丸的稳定性,而对其药物溶出无显著性影响。
Objective:To study the effect of membrane-coating on dissolution and stability of sirolimus ( SRL) dropping pills to prove the effect and rationality of the coating process. Methods:Opadry was used as the coating material for SRL dropping pills. Com-pared with those of uncoated SRL dropping pills, the dissolution and stability of membrane-coating SRL dropping pills were studied in vitro. Results:Compared with that of uncoated SRL dropping pills, the drug release amount of membrane-coating SRL dropping pills was lower (P 0. 05). After the membrane-coating, the stability of SRL dropping pills was notable enhanced under high humidity (75% ± 5%) and strong light (4500lx ± 500lx) conditions, however, the stability showed no improved under high temperature(40℃ ± 2℃) condition. Conclusion: The membrane-coating can enhance the stability of SRL dropping pills without significant effect on drug release in vitro.

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薄膜包衣可以提供防潮功能,通过降低因湿气侵入药片引起的活性降解而延长产品稳定性,本文研究了防潮性薄膜包衣工艺的制备、组成、特性,实验结果表明：防潮性薄膜包衣可达到良好的防潮效果,保证药品在贮存期内的稳定。
Film coating can provide moistureproof function and can extend the stability of products though reduce active degradation of pils leading by moisture intrusion. In this research, we study the preparation, constitution and character of moisture resistance film coating and we found that moisture resistance film coating has a better effect in moistureproofing and the stabilization of pils.

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目的：对富马酸替诺福韦二吡呋酯片的处方进行筛选，提取出最佳的处方配伍方案。方法参照国外上市片“VIREAD？”的处方工艺，对其稀释剂、崩解剂、粘合剂、润滑剂以及包衣工艺进行实验，并将自制样品与参比制剂在高温、高湿及光照条件下进行稳定性考察，筛选出合理的处方工艺。结果最终确定处方工艺为：富马酸替诺福韦二吡呋酯300mg；乳糖60mg；微晶纤维素165mg；预胶化淀粉100mg；交联羧甲基纤维素钠35mg；硬脂酸镁5mg；欧巴代薄膜包衣预混剂20mg；以纯化水为粘合剂。结论确定的处方工艺稳定，生产过程不苛刻，适合放大生产，稳定性研究结果与市售品性质相似，体外溶出行为相近，处方设计合理。
Objective To extract the best prescription compatibility program, the prescription of tenofovir disoproxil fumarate tablets were screened.MethodsAccording to prescription technology of foreign sales "VIREAD?", carried out experiments on its diluents, disintegrating agents, binders, lubricants and coating process, and homemade samples and reference preparation were stability studied under the conditions of high temperature, high humidity and illumination, screening a reasonable prescription process.ResultsPrescription process was ultimately determined including: tenofovir disoproxil fumarate 300mg; lactose 60mg; microcrystalline cellulose 165mg; pre-gelatinized starch 100mg; cross-linked sodium carboxymethyl cellulose 35mg; magnesium stearate 5mg; Opadry film coating premixes 20mg; purified water as a binder.Conclusion Prescription process determined is stable, production process is not harsh, suit amplification production, similar to the stability of the results and the nature of comme

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目的：对非那雄胺片（1mg）的处方工艺进行研究。方法：参照国外英文说明书中制剂所用的辅料，通过测定在四种不同溶出介质中的溶出曲线，使之达到与原研市售品溶出曲线相似，判断增溶剂、崩解剂、填充剂的用量及工艺进行考察，并对确定处方及制备工艺中试三批，测定在四种溶出介质中的溶出曲线、含量均匀度和有关物质等指标。结果：用非那雄胺为主药，以乳糖、微晶纤维素和预胶化淀粉为填充剂，以泊洛沙姆188为增溶剂，以羧甲淀粉钠为崩解剂，以硬脂酸镁为润滑剂，以胃溶型薄膜包衣预混剂为包衣材料，制得非那雄胺片。结论：本制剂工艺稳定，各种辅料均有合法来源，制得非那雄胺片（1mg）与原研市售品溶出行为相似。
Objective: To study the formulation and preparation process of Finasteride Tablets. Methods:Based on the excipients listed in the package insert of Finasteride Tablets (English version), dissolution curves in four kinds of dissolution medium were measured and made to show similar dissolution behavior as compared with the original commercial product. Through the selection of the amount of solubilizers, disintegrants, fillers and formulation process, three batches of test product in pilot scale were prepared according to the opti-mized formulation. The dissolution curve, the content uniformity, related substances and other indicators tested in four kinds of dissolution medium were determined correspondingly. Results:Finasteride tablets were formulated with finasteride as the main drug, lactose, micro-crystalline cellulose and pregelatinized starch as fillers, poloxamer 188 as solubilizer, sodium carboxymethyl starch as disintegrant, stearic magnesium as lubricant, film coating premixed a

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目的：对西罗莫司（ SRL）滴丸进行薄膜包衣,以期达到防潮的目的。方法：选用欧巴代？为SRL滴丸的包衣材料,对其使用溶剂、欧巴代浓度、增重及包衣工艺参数进行筛选,确定包衣处方及工艺；测定包衣SRL滴丸的临界相对湿度,并与未包衣SRL滴丸进行比较。结果：选用95%的乙醇作为溶剂系统,其中欧巴代的浓度为6.5%,增重为4%,进风温度为（35±2）℃,进液速度为12 ml·min^-1,喷雾压力为3.0 MPa。包衣SRL滴丸的临界相对湿度为63.1%,明显高于未包衣SRL滴丸（36.1%）。结论：欧巴代薄膜包衣可明显提高SRL滴丸的防潮性能,有利于其稳定性。
Objective:To coat sirolimus ( SRL) dropping pills with a membrane to enhance the ability of moisture proof. Meth-ods:Opadry was chosen as the coating material. The solvent, concentration and weight gain of the coating membrane were defined, and the coating parameters were screened. The critical relative humidity ( CRH%) of membrane-coating SRL dropping pills was detec-ted and compared with that of SRL dropping pills without coating. Results: The formula and coating parameters of membrane-coating SRL dropping pills were as follows:95% ethanol was used as the solvent, Opadry concentration was 6. 5%, the weigh gain was 4%, the inlet air temperature was (35 ± 2)℃, the inlet fluid rate was 12 ml·min-1 and the spraying pressure was 3. 0 MPa. The CRH%of memebrane-coating SRLs dropping pills was 63. 1%, which was much higher than that of uncoated SRL dropping pills (36. 1%). Conclusion:The membrane-coating can enhance the moisture proof of SRL dropping pills, which is beneficial t

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