糖尿康胶囊成型工艺的研究

目的筛选糖尿康胶囊的辅料及成型工艺，为大生产提供理论依据。方法考察浸膏粉的物理性状；以休止角和吸湿百分率为指标，考察不同辅料对浸膏粉流动性和吸湿性的影响。结果以加入浸膏量各5％的淀粉和微晶纤维素制成颗粒，在RH62％以下，填充于0号胶囊为宜。结论该成型工艺合理可行，三批成品质量稳定。     

活血安痛颗粒成型工艺研究

目的探讨活血安痛颗粒的成型工艺。方法考察可溶性淀粉、糊精和乳糖对浸膏粉吸湿性的影响,并建立动力学模型,提取吸湿速度参数。考察润湿剂及临界相对湿度。结果药粉及其与辅料所制颗粒的吸湿动力学模型符合Higuchi方程。通过比较吸湿百分率及休止角,最终确定乳糖为最佳辅料,润湿剂为90%的乙醇,临界相对湿度为63%。结论优良的辅料可改善浸膏粉的成型性和颗粒剂的抗湿性,有利于提高制剂的稳定性。     

夏黄颗粒提取浸膏粉的粉体学和稳定性研究

目的对夏黄颗粒提取浸膏粉进行处方前粉体学和稳定性研究,为设计优良的颗粒制剂处方提供参考。方法考察夏黄颗粒提取浸膏粉的主要粉体学参数,如堆密度、休止角、溶化性、pH值、吸湿性、临界相对湿度。以主要活性成分芦荟苷为指标,考察高温、高湿和强光照射的影响。结果夏黄颗粒提取浸膏粉流动性较差,休止角大于45°,水溶性较好,呈弱酸性,临界相对湿度为72%;不耐高温,易吸湿,不耐光照。结论夏黄颗粒提取浸膏粉应在密封、避光、干燥处储存。     

脉舒胶囊的成型工艺

以吸湿率、休止角和堆密度为指标,比较不同辅料及制粒工艺对脉舒胶囊剂成型特性的影响。结果表明,以糊精为填充剂,95%乙醇为润湿剂制软材,乙醇用量为浸膏粉混合物（浸膏粉-糊精=3∶2）的5%,所得颗粒流动性好,临界相对湿度约为63%,胶囊装量差异符合中国药典要求。     

安胆颗粒制粒方法的探讨

目前中药喷雾干燥浸膏粉制粒一般采用干压法和流化制粒法,但干压法制粒细粉多、颗粒形状不规则;流化制粒则颗粒细小疏松、吸湿速率快.本文以安胆颗粒为样本,与干压法、流化制粒法对比,探讨了中药喷雾干燥浸膏粉高速搅拌制粒法.     

噻托溴铵吸入粉雾剂的制备及稳定性研究

将噻托溴铵制备成胶囊型吸入粉雾剂，并对其稳定性进行研究。方法：对噻托溴铵进行了微粉化处理，以休止角、排空率和有效部位药物沉积量为指标对6种粉雾剂载体进行了处方筛选；并对标示量、有效部位药物沉积量、有关物质等指标进行了稳定性考察。结果：噻托溴铵18μg与结晶乳糖15mg等量递增混匀，再和10mg喷雾干燥乳糖混匀制成粉雾剂，其休止角为37．20、排空率93．0％、有效部位药物沉积量16．3％，产品有效期可达18个月。结论：按选定的处方和制备方法制得的粉雾剂流动性好、排空率合格、有效部位药物沉积量高，稳定性较好，有利于生产和使用。     

不同干燥工艺的六味地黄提取物的粉体学性能评价

目的考察不同干燥工艺对六味地黄提取物物理性质与粉体学性质的影响。方法选用六味地黄提取物考察了真空干燥、喷雾干燥及冷冻干燥对六味地黄提取物物理性质与粉体学性质的差异。结果六味地黄喷雾干燥所得浸膏粉的黏性较小,所得粉粒较细小、圆整,且压缩度、抗张强度、吸湿速率及平衡吸湿量均比真空干燥的大。冷冻干燥所得浸膏粉的比表面积、孔容均比真空干燥的大。结论干燥方式及原理的不同导致了干燥产物物理性质与粉体学性质的差异,应根据不同制备的需求选择不同的制备工艺。     

猴头菌-地龙生物转化物干浸膏粉吸湿性考察

摘 要 目的：通过对干浸膏粉进行吸湿性研究,确定猴头菌 地龙（HD）生物转化物制剂成型工艺的相对湿度条件及对应相对湿度条件下制剂操作的最长时间。方法: 配制不同湿度环境的溶液,测定HD生物转化物干浸膏粉样品在不同湿度环境溶液中的吸湿速度及计算HD干浸膏粉临界相对湿度（CRH）。建立吸湿速度的数学模型并绘制吸湿百分率随相对湿度变化的曲线,求吸湿速度参数和吸湿百分率达到5%时对应的相对湿度及时间,用解析几何及直线回归法计算CRH,从而确定生产、贮存过程中空气湿度的控制范围及操作条件。结果: 在25℃, RH为66.0%、80.8%、88.2%、99.0%的条件下,HD干浸膏粉暴露空气中7.088,3.953,2.892,0.661 h吸湿百分率则达到5%;计算得吸湿百分率达到5%时对应的相对湿度是50.84%,最短时间是9.937 h。HD生物转化物干浸膏粉CRH为68.12%。结论:HD生物转化物干浸膏粉制剂环境的相对湿度控制在50.84%以下,操作时间不超过9.937 h;或相对湿度控制在68.12%以下,操作时间不超过6.810 h。该条件下才能保证HD干浸膏粉吸湿率控制在5%以下,不影响制剂的制备。     

灵芝多糖制粒工艺对吸湿性和流动性的影响研究

摘要：目的:考察灵芝多糖不同制粒工艺对其吸湿性和流动性的影响。方法:在灵芝多糖喷雾干燥工艺及处方初筛的基础上,应用极端顶点设计试验筛选干法制粒主辅料的最优处方及配比,采用正交设计对干法制粒工艺参数优化,并研究其对灵芝多糖吸湿性和流动性的影响。结果:喷雾干燥工艺得到的颗粒压缩度为32.36%,休止角为33.8°,24 h吸湿率为11.46%,未能很好地解决其流动性和吸湿性,经过干法制粒得到的灵芝多糖固体化颗粒能够改善其吸湿性及流动性。通过混料设计筛选最优处方为辛烯基琥珀酸淀粉钠与灵芝多糖1∶1,其最佳工艺参数为进料速度15 Hz,滚轮速度20 Hz,滚轮压力0.5 MPa,整粒速度15 Hz时,该工艺下收率相对高。在此条件下,灵芝多糖固体化颗粒24 h吸湿率为7.10%,24 h临界相对湿度为77.35%,休止角为30.1°,流动性良好。结论:经过干法制粒得到的灵芝多糖固体化颗粒能够显著改善其吸湿性及流动性。     

喷雾干燥法改善中药浸膏吸湿性的研究

目的:利用喷雾干燥法改善中药浸膏的吸湿性和流动性,最大限度地改善喷雾干燥的黏壁现象,为中药工业现代化提供合理的相对湿度环境及生产条件。方法:以正交试验法筛选最佳辅料配方以及最佳工艺条件,并考察浸膏干粉的吸湿性和流动性因素。结果:向溶液中加入3%微粉硅胶、7%β-环糊精,可以极大地降低浸膏粉的吸湿性。最佳工艺为浸膏比重1.10g.mL-1、进风温度170℃、雾化压力0.5Mpa、进料速度400mL.h-1;最佳处方的临界相对湿度为64%。结论:本研究结果可以改善传统干燥中药方法时间长、浸膏易吸湿等问题。     

复方番泻叶微丸赋形剂的选择

目的选择复方番泻叶喷雾干燥粉末微丸成型工艺的赋形剂.方法考察粉体的吸湿性、休止角,微丸的外观质量及溶散时限等因素.结果微晶纤维素可改善该粉体的性质,增加制剂的成型性能.结论微晶纤维素作为该工艺的赋形剂较为适宜.     

干燥方式对大血藤提取物粉体学性质的影响

目的考察不同干燥方式对大血藤提取物的粉体学性质的影响,并初步筛选适宜的粉体表面改性剂。方法考察了真空干燥、喷雾干燥两种方法对大血藤提取物的粉体学性质的影响,并通过粉体表面改性技术,初步筛选了改性剂。结果喷雾干燥法所制的大血藤浸膏粉粒径小而均匀,圆整性好,吸湿性及流动性略逊于真空干燥制品,大血藤浸膏粉经过微晶纤维素改性后流动性、吸湿性及成形性得到明显改善。结论干燥方式的不同导致了干燥产物粉体学性质的差异,通过粉体表面改性技术可以改善中药提取物的粉体学性质。     

正交试验法优选胃乐舒颗粒喷雾干燥工艺

目的：研究胃乐舒颗粒最佳喷雾干燥工艺,为其质量稳定提供保证.方法：以延胡索乙素含量、干粉收率、含水率为考察指标,采用正交试验方法主要考察进风温度、浸膏比重、供液速度三个因素对干燥效果影响.结果：优选的最佳干燥工艺条件为进风温度145℃、浸膏比重1.10、供液速度25 ml·rmin-.结论：优选的最佳工艺条件合理、重复性好、稳定可靠,可做为胃乐舒颗粒的干燥条件,为其制剂的干燥工艺改进提供依据.     

Effect of Spray Drying and Subsequent Processing Conditions on Residual Moisture Content and Physical/Biochemical Stability of Protein Inhalation Powders

Purpose. To understand the effect of spray drying and powder processing environments on the residual moisture content and aerosol performance of inhalation protein powders. Also, the long-term effect of storage conditions on the powder's physical and biochemical stability was presented. Methods. Excipient-free as well as mannitol-formulated powders of a humanized monoclonal antibody (anti-IgE) and recombinant human deoxyribonuclease (rhDNase) were prepared using a Buchi 190 model spray dryer. Residual moisture content and moisture uptake behavior of the powder were measured using thermal gravimetric analysis and gravimetric moisture sorption isotherm, respectively. Protein aggregation, the primary degradation product observed upon storage, was determined by size-exclusion HPLC. Aerosol performance of the dry powders was evaluated after blending with lactose carriers using a multi-stage liquid impinger (MSLI). Results. Spray-dried powders with a moisture level (~ 3%) equivalent to the freeze-dried materials could only be achieved using high-temperature spray-drying conditions, which were not favorable to large-male manufacturing, or subsequent vacuum drying. These dry powders would equilibrate with the subsequent processing and storage environments regardless of the manufacturing condition. As long as the relative humidity of air during processing and storage was lower than 50%, powders maintained their aerosol performance (fine particle fraction). However, powders stored under drier conditions exhibited better long-term protein biochemical stability. Conclusions. Manufacturing, powder processing, and storage environments affected powder's residual moisture level in a reversible fashion. Therefore, the storage condition determined powder's overall stability, but residual moisture had a greater impact on protein chemical stability than on powder physical stability.     

Overcoming Poor Tabletability of Bulky Absorption Enhancers by Spray Drying Technology

Absorption enhancers are often a major component of solid oral peptide formulations as compared to the active pharmaceutical ingredient and excipients. This commonly results in poor tabletability that is hard to mitigate in direct compaction by addition of small amounts of excipients. To improve the tabletability of bulky absorption enhancers, the model absorption enhancers, sodium cholate and deoxycholic acid, were co–spray-dried with hydroxypropyl methylcellulose E5, where the percentage of absorption enhancers was not lower than 90% (w/w). The physicochemical properties of the resulting powders were assessed by laser diffraction, scanning electron microscopy, X-ray powder diffraction, thermogravimetric analysis, and differential scanning calorimetry. The powders were compressed into tablets, and the tabletability was evaluated. Co–spray drying with 10% of hydroxypropyl methylcellulose significantly improved the tabletability of the both absorption enhancers. Moreover, it was demonstrated that small particle size and amorphous state rather than high moisture content contributed to the improved tabletability of the spray-dried powders. The study suggests that spray drying technology can be promising to overcome the poor tabletability of oral peptide formulation consisting of large amounts of absorption enhancers.     

金耳多糖浸膏喷雾干燥工艺研究

目的对全耳多糖浸膏的喷雾干燥工艺进行优选。方法采用正交试验法，以含水量为考察指标，对影响喷雾干燥的因素进行考察，确定最佳喷雾干燥工艺。结果喷雾干燥机进风温度和输液泵开裂对试验结果有影响，浸膏相对密度对试验结果无影响。结论金耳多糖浸膏的最佳干燥工艺条件为浸膏相对密度1．04。进口温度180℃，输液泵开裂70％。     

舒肝散结片干燥工艺研究

目的 优选舒肝散结片的干燥工艺.方法 比较减压干燥和喷雾干燥对舒肝散结片的干燥效果,并采用正交试验设计,优选喷雾干燥的条件.结果 进风温度为(190±2)℃,排风温度为(90±2)℃,提取液浓缩至相对密度为1.15～1.20(60℃测定)时喷雾效果最好.结论 喷雾干燥适合作为舒肝散结片的干燥工艺.