共查询到16条相似文献,搜索用时 156 毫秒
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均匀设计和回归分析优化安神宁软胶囊的制备工艺 总被引:2,自引:1,他引:1
目的 研究安神宁软胶囊的最佳制备工艺. 方法 采用均匀实验设计和多元逐步回归分析,以内容物混悬液的沉降体积比和流动性评价为指标,考察药物与分散介质的比例、助悬剂的用量和润湿剂的用量对内容物稳定性的影响;以软胶囊崩解时限和加速试验条件下的崩解时限二者的综合评分为指标,考察明胶-甘油、明胶-纯化水比例以及熔胶温度对囊皮溶解性能的影响. 结果 安神宁软胶囊内容物处方为:药物干粉与大豆油比例为1:1.5,助悬剂蜂蜡用量为内容物质量分数的4%,润湿剂大豆磷脂用量为内容物质量分数的2% . 软胶囊囊皮处方为明胶:甘油:水=1:0.5:1 (以质量比计算). 结论 均匀设计和回归模型可以对实验 结果 进行高精度预测,优化了安神宁软胶囊的制备工艺. 相似文献
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目的:研究红景天软胶囊的最佳处方工艺。方法:采用单因素试验,以沉降体积比和流动性为指标筛选红景天软胶囊填充物处方,以遮光度、感官效果和崩解时限等指标对囊壳处方进行筛选,确定红景天软胶囊处方工艺。结果:红景天软胶囊处方中红景天提取物为20%,大豆油为基质,加入蜂蜡5%和磷脂2%为最佳,囊壳以明胶-甘油-水-焦糖色(1:0.4:0.8:0.025)为囊材制成的红景天软胶囊最佳。结论:本处方工艺稳定,操作简便,符合红景天软胶囊生产工艺及质量控制方面的要求。 相似文献
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均匀实验设计优选软胶囊胶皮处方 总被引:2,自引:0,他引:2
目的考察不同因素对软胶囊胶皮溶解性能的影响。方法以柠檬黄为指示剂,改变因素的水平,测定胶皮溶解速率,用均匀设计优化胶皮处方。考察明胶与甘油质量的比例、聚乙醇400(PEG400)的量、二氧化钛的量对胶皮溶解速率的影响规律,优化出胶皮处方。结果明胶与甘油之比、PEG400的用量两个因素对结果影响最大。明胶与甘油之比为1∶0.847,PEG400的用量为明胶的5.862%时,胶皮有最大溶解速率(4.548)。结论该方法简单、实用,有助于对胶皮处方的进一步研究。 相似文献
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目的研究健脑软胶囊的最佳成型工艺。方法采用单因素试验法确定健脑软胶囊成型的基质和囊材。以流动性、切断性和沉降体积比为指标,对软胶囊内容物的处方进行筛选。结果以大豆油为基质,内容物配比以每1 000粒软胶囊中加入超临界提取物173 g、浸膏粉171 g、蜂蜡25 g、棕榈油15 g、大豆卵磷脂15 g为最佳,并以明胶-甘油-水(2∶1∶2)为囊材制成软胶囊。结论本工艺稳定,操作简便,对产品大生产有指导意义。 相似文献
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目的:探讨提高麻黄软胶囊稳定性的方法.方法:明胶与羟丙基甲基纤维素(HPMC)复配作为软胶囊的囊壳材料,减少明胶交联反应.采用中心复合试验设计,优选复配胶的处方和工艺,测定复配胶的凝胶性质,并进行复配胶软胶囊的稳定性考察.结果:复配胶处方确定为明胶(冻力180 g)、明胶(冻力240 g)、HPMC、甘油、水用量比为49∶26∶25∶30∶200,复配软胶囊胶凝时间5.72 min,崩解时限4.6 min,加速90 d的崩解时限11.2 min,加速90 d的累积溶出百分率86.6%.结论:明胶-HPMC复配可以提高麻黄软胶囊的稳定性. 相似文献
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目的研制坎地沙坦酯自微乳软胶囊,并对其溶出度进行评价。方法制备坎地沙坦酯自微乳软胶囊,并按药典方法考察自微乳软胶囊与普通胶囊在三种不同溶出介质(水、0.1mol/L盐酸和pH6.8的缓冲溶液)中的溶出度。结果坎地沙坦酯自微乳释药系统处方为乙酸乙酯:聚氧乙烯氢化蓖麻油RH40:聚乙二醇400为9∶14∶7。坎地沙坦酯自微乳受溶出介质的影响小,且溶出速率高于普通胶囊。结论自微乳软胶囊能显著提高坎地沙坦酯的体外溶出。 相似文献
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Two strengths of BMS-309403 capsules were developed from a common stock granulation. Dissolution testing of the capsules was conducted utilizing the USP apparatus 2 (paddle) with a neutral pH dissolution medium. Unexpectedly, the lower-strength capsules exhibited slower dissolution than the higher-strength capsules filled with the same stock granulation. Higher variability was also observed for the lower-strength capsules. This was found to be mainly caused by a low fill weight in a relatively large size hard gelatin capsule shell. Instead of bursting open, some gelatin capsule shells softened and collapsed onto the granulation, which delayed the release of the active drug. The problem was aggravated by the use of coil sinkers which hindered the medium flow around the capsules. Switching from the gelatin capsule shells to the HPMC (hydroxypropyl methylcellulose) shells reversed the dissolution rate ranking between the two capsule strengths. However, both dissolved at a slower rate initially than the gelatin capsules due to the inherent dissolution rate of the HPMC shells at pH 6.8. Notably, the HPMC shells did not occlude the granulation as observed with the gelatin shells. The study demonstrated that the dissolution of capsule formulations in neutral pH media was significantly affected by the fill weight, sinker design, and capsule shell type. Careful selection of these parameters is essential to objectively evaluate the in vitro drug release. 相似文献
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Zdravka Misic Katharina Muffler Georg Sydow Martin Kuentz 《Journal of pharmaceutical sciences》2012,101(12):4516-4528
For decades, gelatin has been used in the rotary die process as a shell‐forming material of soft capsules because of its unique physicochemical properties. However, with respect to the encapsulation of comparatively hydrophilic lipid‐based formulations, gelatin has one considerable drawback: Immediately after production, the capsule shell contains a large amount of water (up to 35%). There is the potential for water to migrate from the capsule shell into the formulation, which will lead to a decrease in drug solubility and, in turn, the potential for drug crystallization. The present study introduces a novel capsule material that was obtained from extrusion. The starch‐based polyvinyl alcohol thermoplastic capsules (S‐PVA‐C) mainly comprised a blend of starch and PVA. Gelatin and the novel material were used to encapsulate a hydrophilic lipid‐based system of fenofibrate. Considerable water migration was observed from the soft gelatin shell to the hydrophilic formulation during drying and drug crystallization resulted in soft gelatin capsules. In contrast, S‐PVA‐C displayed no substantial water exchange or drug crystallization upon storage. The thermoplastic capsule material further exhibited more surface roughness and higher resistance to mechanical deformation compared with gelatin. In conclusion, S‐PVA‐C provided a robust drug product following encapsulation of a rather hydrophilic lipid‐based formulation. 相似文献
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《Pharmaceutical development and technology》2013,18(4):379-383
Two strengths of BMS‐309403 capsules were developed from a common stock granulation. Dissolution testing of the capsules was conducted utilizing the USP apparatus 2 (paddle) with a neutral pH dissolution medium. Unexpectedly, the lower‐strength capsules exhibited slower dissolution than the higher‐strength capsules filled with the same stock granulation. Higher variability was also observed for the lower‐strength capsules. This was found to be mainly caused by a low fill weight in a relatively large size hard gelatin capsule shell. Instead of bursting open, some gelatin capsule shells softened and collapsed onto the granulation, which delayed the release of the active drug. The problem was aggravated by the use of coil sinkers which hindered the medium flow around the capsules. Switching from the gelatin capsule shells to the HPMC (hydroxypropyl methylcellulose) shells reversed the dissolution rate ranking between the two capsule strengths. However, both dissolved at a slower rate initially than the gelatin capsules due to the inherent dissolution rate of the HPMC shells at pH 6.8. Notably, the HPMC shells did not occlude the granulation as observed with the gelatin shells. The study demonstrated that the dissolution of capsule formulations in neutral pH media was significantly affected by the fill weight, sinker design, and capsule shell type. Careful selection of these parameters is essential to objectively evaluate the in vitro drug release. 相似文献
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目的:考察中药麻黄软胶囊的溶出稳定性及影响因素,探讨中药软胶囊溶出迟缓机制。方法:采用加速试验,评价麻黄软胶囊的溶出稳定性;以平衡溶胀量和ε-氨基酸残基含量为指标,评价明胶囊壳的交联程度;应用红外光谱和醛类专属反应,鉴定麻黄提取物中醛类成分,并测定其含量。结果:在加速试验条件下(40℃,75%相对湿度),放置30天后,明胶囊壳的平衡溶胀量和ε-氨基酸残基含量均显著下降(P〈0.01),其交联度显著增加(P〈0.01);放置60天后,麻黄软胶囊溶出度显著下降(P〈0.01)。环境因素(高温/高湿)、溶媒介质(聚乙二醇)和药物成分(麻黄提取物)均可导致明胶交联度显著提高(P〈0.01),其中麻黄提取物的作用明显大于另两种影响因素。麻黄提取物中醛质量分数达约1.6%。结论:麻黄软胶囊溶出迟缓与囊壳明胶发生交联反应有关,而麻黄提取物中醛类成分是促进软胶囊发生交联反应、导致其溶出迟缓的主要原因。 相似文献
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Crosslinking studies in gelatin capsules treated with formaldehyde and in capsules exposed to elevated temperature and humidity 总被引:3,自引:0,他引:3
Incomplete in vitro capsule shell dissolution and subsequent drug release problems have recently received attention. A modified USP dissolution method was used to follow capsule shell dissolution, and a 2,4,6-trinitrobenzenesulfonic acid (TNBS) assay was used to follow loss of epsilon-amino groups to study this shell dissolution problem postulated to be due to gelatin crosslinking. The dissolution problems were simulated using hard gelatin capsule (HGC) shells previously treated with formaldehyde to crosslink the gelatin. These methods were also used to study the effect of uncrosslinked HGC stored under stressed conditions (37 degrees C and 81% RH) with or without the presence of soft gelatin capsule shells (SGC). A 120 ppm formaldehyde treatment reduced gelatin shell dissolution to 8% within 45 min in water at 37 degrees C. A 200 ppm treatment reduced gelatin epsilon-amino groups to 83% of the original uncrosslinked value. The results also support earlier reports of non-amino group crosslinking by formaldehyde in gelatin. Under stressed conditions, HGC stored alone showed little change over 21 weeks. However, by 12 to 14 weeks, the HGC exposed to SGC showed a 23% decrease in shell dissolution and an 8% decrease in the number of epsilon-amino groups. These effects on the stressed HGC are ascribed to a volatile agent from SGC shells, most likely formaldehyde, that crosslinked nearby HGC shells. This report also includes a summary of the literature on agents that reduce gelatin and capsule shell dissolution and the possible mechanisms of this not-so-simple problem. 相似文献