正交实验法优选补肾健骨颗粒的制备工艺

目的：优选补肾健骨颗粒的最佳制备工艺。方法：以补肾健骨颗粒中熊果酸的含量及浸膏得率为双重指标，采用正交试验法优选制备工艺。结果：山萸肉、女贞子粉碎成粗粉，用12倍量75％的乙醇为溶媒加热回流提取3次，每次45min，熊果酸的含量最高。其余药材饮片用12倍量水加热回流提取2次，每次60min，浸膏得率最高。结论：经正交设计优化的补肾健骨颗粒的制备工艺可行。     

正交试验法优选保龄洋参含片制粒工艺

目的研究保龄洋参含片制粒最佳生产工艺。方法采用L9(33)正交设计法实验,以生产效率、颗粒水分、颗粒的成品率为指标筛选出最佳制备工艺参数。结果优化制粒的工艺条件,确定一步制粒的最佳工艺参数,从而提高颗粒的成品率。结论正交试验确定的工艺参数用于生产。     

健脾化湿颗粒的制备工艺研究

目的:研究健脾化湿颗粒的制备工艺。方法:以干膏得率和芍药苷得率作为评价指标,采用L9(34)正交试验法优选健脾化湿颗粒的提取工艺;以颗粒吸湿性和成型性为指标,对干法制粒的工艺进行研究。结果:最佳提取工艺为:加10倍水,回流提取2次,每次2h;干压法制备得到的颗粒吸湿性和成型性好。结论:优选的健脾化湿颗粒工艺稳定可行,可应用于工业化生产。     

舒肝健脾颗粒的制备工艺研究

目的探索研究舒肝健脾颗粒的制备工艺。方法以提取法对中药进行提取,并以干膏得率和芍药苷得率作为评价指标,采用L^9（3^4）正交试验法优选舒肝健脾颗粒的提取工艺;以颗粒吸湿性和成型性为指标,对干法制粒的工艺进行研究。结果研究结果发现舒肝健脾颗粒最佳提取工艺为：加10倍水,回流提取2次,每次1．5h;干压法制备得到的颗粒吸湿性和成型性好。结论舒肝健脾颗粒可以通过中药复方的提取,并经过造粒来进行稳定的生产。     

干法制粒在降糖颗粒制备中的应用

目的采用干法制粒工艺制备降糖颗粒,解决颗粒溶化性差的问题。方法以制粒收率为考察指标,采用正交试验方法优选出干法制粒工艺条件。结果干法制粒最佳工艺条件为液扎辊压力9500kPa、转速10r／min、物料传送速度35r／min。结论采用干法制粒制备降糖颗粒的工艺合理可行。     

祛风除痹颗粒制备工艺的实验研究

目的优选祛风除痹颗粒的最佳制备工艺。方法水提取工艺以干膏得率和芍药苷含量为考察指标,采用正交设计法对其提取工艺条件进行优选。确定了制粒方法。结果水提最佳工艺条件：加8倍量水,煎煮3次,每次1h。以干浸膏法制粒,干膏和辅料比为3：7。结论优选出的制备工艺科学合理,适合工业化生产。     

湿法制粒工艺参数对颗粒成型性的影响

目的通过对中药制粒过程中影响因素的考察为中药物料的制粒工艺设计提供参考。方法选取不同类型的中药物料,以颗粒得率和颗粒的粒径分布等为考察指标,对影响制粒结果较为显著的物料的吸湿性、润湿剂、干燥温度、辅料等因素进行试验分析。结果三七粉平衡吸湿量为12.905%,吸湿性最小,在60%的乙醇浓度下颗粒得率和20~60目的颗粒所占的比例较大,干燥温度、辅料等对其影响较小。其他含中药浸膏的粉末平衡吸湿量达到20%以上,黏性大,需要用80%的乙醇、干燥温度>50℃的条件下才能较好地制粒,加入适宜的辅料能显著提高颗粒得率,其中祛白复方浸膏粉加入预胶化淀粉后颗粒得率>80%。结论各类型中药粉末湿法制粒中物料性质、制备条件、辅料等过程参数对颗粒成型性有显著的影响。     

正交设计法优化枣仁神安片干法制粒工艺研究

目的采用干法制粒工艺制备枣仁神安片,研究干法制粒的最佳工艺条件。方法采用L9(34)正交试验,以颗粒得率和颗粒脆碎度为评价指标,考察轧轮压力、轧轮转速、浸膏粉含水、物料传送速度的影响,优化干法制粒最佳工艺参数。结果最佳工艺参数为轧轮压力1.5 MPa,轧轮转速12 r.min 1,物料传送速度50 r.min 1,浸膏粉含水量不得超过6%。结论上述工艺稳定可靠,可应用于枣仁神安片的生产。     

正交试验优化银翘败毒片的干法制粒工艺

目的:优化银翘败毒片干法制粒的工艺条件。方法:以制粒难易程度和崩解时限等为考察指标,对银翘败毒片中辅料微晶纤维素和可压性淀粉的配比、用量及喷干粉的含水量进行筛选;以颗粒得率和休止角为指标,采用L9(34)正交试验对干法制粒工艺中压轮压力、转速及送料速度等条件进行优化并进行验证试验。结果:微晶纤维素与可压性淀粉的比例为7∶3(m/m),二者与(喷干粉+包合物)的混合比例为1∶5;控制喷干粉含水量在1%~2%之间。干法制粒最优工艺参数为压轮压力3.5 MPa、压轮转速4 r/min、送料速度10 r/min。验证试验中颗粒平均得率为69.2%,平均休止角为31.5°,绿原酸转移率达92%以上,且各指标RSD均在2.53%以下(n=3)。结论:按优化辅料处方和工艺制备的颗粒各项指标均具有较好的重现性和可行性,且工艺稳定,适合工业生产。     

正交试验法优选抗早颗粒提取及成型工艺

目的 优选抗早颗粒的提取及成型工艺。方法 以盐酸小檗碱含量和干膏得率的综合评分为评价指标,考察提取时间、提取次数、加水量,采用 L₉(3⁴)正交试验法优选水提工艺;以颗粒得率和水分为评价指标,考察雾化压力、喷雾速率、物料温度,采用L₉(3⁴)正交试验优选流化床制粒工艺。结果 提取次数对水提工艺影响显著,最佳水提工艺为加 8 倍量水,提取 2 次,每次 40 min。雾化压力和喷雾速率对流化床制粒工艺的颗粒得率影响显著,最佳成型工艺为喷雾速率 20 r / min,雾化压力 0. 14 MPa,物料温度55 ℃。结论 该优选工艺稳定性好,可用于抗早颗粒的工业化生产。     

正交法优化苦黄颗粒一步制粒工艺

目的：探索苦黄颗粒的最佳制剂工艺。方法：根据苦黄颗粒的物料特点，结合正交法优选调整流化制粒的工艺，筛选出制剂的最佳生产条件。结果：选用正交法，以CB（C2H6O）为0．75，在风温θ〈85℃时，以4Hz流速流化制粒3h。结论：最优制粒工艺方案（A3B2C2D3）较为合理，并且制粒时休止角α=37．40（°）时，颗粒的流动性最佳。     

Wet granulation as innovative and fast method to prepare controlled release granules based on an ion-exchange resin

The goal of this work was to evaluate the suitability of wet granulation as an innovative and fast method for the preparation of granules containing a drug-resin complex (resinate), having cholestyramine as resin and potassium diclofenac (KD) as drug. Resinate and granules were prepared directly by steam granulation in high shear mixer (method A), using two different amount of resin (granules 1 and 2). For comparison granules 1 were also prepared by conventional batch method followed by steam granulation (method B). All granules showed quite irregular shape, main size fractions between 75 and 500 microm, good flowability and uniform KD distribution. Granules 1A exhibited controlled release profiles at pH 7.4, while granules 2A showed a burst effect due to KD free crystals. FT-IR studies confirmed the complete complexation between resin and KD during the granulation process with method A for granules 1. Finally, the dissolution test of granules 1A in different media revealed a controlled drug release in 12 h, providing the utility of this system for enteric drug delivery. Granules 1B evidenced similar characteristics to those of granules 1A; the drawback of the multistep procedure was related to the long processing time.     

黄麦颗粒制备工艺研究

摘 要 目的： 研究黄麦颗粒的制备工艺,确定最佳工艺条件。方法: 采用单因素筛选法和正交设计法,进行提取工艺和成型工艺优选。结果:最佳工艺为处方量的7味药材,加8倍量水,煎煮2 h,提取3次,合并水提液,减压浓缩、干燥成干浸膏。干膏粉与适量糊精混合均匀后,加40%乙醇湿法制粒,干燥后整粒,即得。结论: 所选工艺科学、合理、稳定,适合工业化生产。     

金樱子醇提颗粒处方工艺研究

目的：筛选金樱子醇提取物颗粒剂的制备工艺.方法：通过综合评分法确定颗粒剂的最佳辅料比,设计L9（34）正交试验,以粒度为评价指标确立处方工艺,并在此基础上考察了临界相对湿度.结果：该颗粒剂采用湿法制粒,最佳处方组成为稠膏-乳糖-可溶性淀粉-10％淀粉浆（5∶12∶3∶0.6）.结论：该颗粒成型性好,相对临界湿度符合生产要求.     

小儿氨酚黄那敏颗粒制备工艺研究

目的：研究湿法制粒法制备小儿氨酚黄那敏颗粒的影响因素及制备工艺.方法：采用正交试验设计,使用高效液相色谱法（HPLC）同时测定对乙酰氨基酚和马来酸氯苯那敏的含量均匀度,并通过综合评分优选制备工艺.结果：最佳制备工艺为：物料过100目筛,采用三维混合方式混合20 min,马来酸氯苯那敏以黏合剂方式加入,所制备的颗粒符合质量要求.结论：本研究所得最佳制备工艺操作简便,对乙酰氨基酚和马来酸氯苯那敏的含量均匀度较高,工艺稳定性较好.     

通脉散瘀颗粒的制备工艺及质量控制

目的:优选通脉散瘀颗粒的适宜辅料,并考察其质量,为质量控制提供参考.方法:湿法制粒,以平衡吸湿率为主要考察指标,优选出辅料微晶纤维素(MCC);对制成的颗粒进行质量检查,以HPLC法测定通脉散瘀颗粒中丹参素、原儿茶醛、丹酚酸B的含量.结果:MCC的平衡吸湿率最低;通脉散瘀颗粒中丹参素、原儿茶醛、丹酚酸B平均含量分别为2.26、0.71、0.17 mg·g-1.结论:制备的通脉散瘀颗粒可去湿防潮,成分可控,质量控制方法简便可行.     

The effect of the amount of binder liquid on the granulation mechanisms and structure of microcrystalline cellulose granules prepared by high shear granulation

The structure of granules changes during the high shear granulation process. The purpose of this research was to investigate the effect of the amount of binder liquid on the structure of the granules and the structural changes which occur during the granulation process, using microcrystalline cellulose (MCC) and water as the model system. The structure is the result of the granulation mechanism; therefore, conclusions can be drawn about the latter by studying the former. X-ray microtomography and scanning electron microscopy (SEM) were applied in order to visualise the densification process of granules, which were first freeze dried in order to preserve their structure. Variations in their porosity were quantified by applying image analysis to the tomography results. In order to link the granule mechanical properties to their structural differences, a micromanipulation technique was used to measure granule resistance to deformation. MCC granules granulated with 100% (w/w) water showed increased densification with time, as expected; detailed examination showed that densification is more pronounced in the core of the granule; whereas the outer part remained more porous. Increased densification reduces deformability, so that granules become more resistant to breakage. The lower deformability of the densified granules in the final stages of granulation might result in establishment of equilibrium between attrition and growth, without substantial gross breakage. On the other hand, when more water was used (125%, w/w), densification was hardly observed; the porosity of the granule core was still high even after prolonged granulation times. This may be explained by the fact that higher water content increases the ease of deformation of granules. This increased deformability led to significant granule breakage even during the final phases of the granulation process. Therefore, for these granules a final equilibrium between breakage and coalescence might be established. This also explains why more granules produced with 125% granulation liquid were composed of fragments of irregular shape.

Our results establish the link between the granulation behaviour of MCC in the latter stages and the material structure of these granules, which is determined by their liquid content. The process conditions (amount of liquid) to be chosen depend largely on the final purpose for which the granular material is produced.     

辛白鼻渊颗粒喷雾制粒工艺优选

目的优选辛白鼻渊颗粒喷雾制粒的最佳工艺。方法采用正交试验法,以喷雾干燥后药粉产量为考察指标优选工艺条件,并进行验证试验和成品质量考察。结果最佳工艺参数为进风温度90℃,喷液转速6 r/min,风机频率45 Hz;薄层鉴别结果显示,供试品溶液色谱中,在与黄芩苷和栀子苷对照品溶液色谱相应位置上显相同颜色的斑点;成品颗粒的主要成分、流动性、粒度、水分、干燥失重和溶化性检查均符合2015年版《中国药典(四部)》规定。结论优选制备工艺所制得的颗粒质量稳定,产品收率高,适宜于工业化生产。     

扶肾颗粒制备工艺研究

目的:优选扶肾颗粒制备工艺。方法:以干膏率和淫羊藿苷含量作为考察指标,采用正交试验法优化扶肾颗粒的提取工艺和醇沉精制工艺,以吸湿百分率为指标考察颗粒辅料。结果:最佳制备工艺条件加10倍水,煎煮3次,每次2h;最佳醇沉浓度是60%;最佳制粒工艺条件为:药材提取物-糊精以1:2的比例湿法制粒。结论:优选项的制备工艺合理,有效成分提取率较好。