非明膠膠囊的研究; Studies on Non-gelatin Capsules

中國醫藥大學機構典藏 China Medical University Repository, Taiwan > 藥學院 > 藥物化學研究所 > 博碩士論文 > Item 310903500/898

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题名:	非明膠膠囊的研究;Studies on Non-gelatin Capsules
作者:	李健源;Chien-Yuan Lee
贡献者:	中國醫藥大學：藥物化學研究所博士班
关键词:	聚合物膠囊;熱熔法;沾膠法;polymer;capsule;heat-melting method
日期:	2006-07-03
上传时间:	2009-08-13 09:37:11 (UTC+8)
摘要:	近年來已有很多研究者嘗試以聚合物為材料取代明膠(Gelatin)，作為製備膠囊的材料。這種非明膠膠囊具有提供素食人口使用及安定之優點。本研究係利用熱熔法，將Polyethylene oxide (PEO) 或 Hydroxypropyl cellulose (HPC)等材料置於加熱過的模具底模凹洞內；用模杵擠壓成形。成品可符合膠囊品質均一的要求。為測試非明膠膠囊充填藥物後的效果，體外試驗利用藥典模擬胃及腸的緩衝液及添加不同鹽類下，評估不同材質膠囊殼的吸水情形。並利用Propranolol hydrochloride或Theophylline anhydrous為模式藥，添加lactose 或microcrystalline cellulose為賦形劑之配方測試藥物的溶離率。結果顯示 Propranolol hydrochloride因溶解度比theophylline anhydrous高，因此從膠囊裡釋出後的藥物溶離釋放速率也較快。此外，藥物的釋放也較不受賦形劑的影響。藥物釋放的速率也隨著所使用的HPC的平均分子量增加而減緩。添加無機鹽類的人工胃液或人工腸液緩衝溶離液，會明顯的減緩所有HPC膠囊殼之吸水速率及藥物的釋放；但對Gelatin或PEO所製成的膠囊之影響較不顯著。進一步的體內評估，選擇紐西蘭兔進行藥物動力學探討，以theophylline anhydrous為模式藥的非明膠膠囊配方在口服之後，所獲的藥物動力學參數，顯示所有膠囊的血中濃度曲線下面積(AUC0-∞)與半衰期(T1/2)在統計上並沒有明顯的差距。體外溶離50 %所需時間及體內藥動學參數的體內/體外相關性。此外，Hydroxypropyl methylcellulose (HPMC)以沾膠法，所作成的膠囊，也明顯的受溶離緩衝液鹽類的影響。其他於體內外藥物釋放評估的結果顯示，與明膠膠囊並沒有明顯的差異。 Recent years, many scientists attempt to use polymers as materials for instead of gelatin to prepare capsules. The non-gelatin capsules showed more stable were than gelatin capsules and accept for vegetarians. In this study, hard capsule shells were made by a heat-melting method, which involved heating Polyethylene oxide (PEO) or Hydroxypropyl cellulose (HPC) powder into a mold, followed by inserting a suitable size of pestle in a mold to coat the melted shell materials (HPC or PEO) onto the pestle, and formed the capsule shells. The water uptake and dissolution test of various non-gelatin capsule shells were evaluated in either simulated gastric fluid or intestinal fluid buffer media that added one of inorganic salts including lithium chloride, sodium chloride, potassium chloride, calcium chloride or aluminum chloride. Propranolol hydrochloride and theophylline were selected as the model drugs for drug release studies. It was found Propranolol hydrochloride released from various capsules was faster than that of theophylline due to the higher solubility of the former. There were no significantly different in the release rate from the formulation containing either microcrystalline cellulose or lactose as diluents. Moreover, release rate was decreased with increasing molecular weight grades of HPC used as shell materials. Inorganic salt showed having marked influence on the dissolution rate, and that decreased with increasing concentration of salt in dissolution medium. The drug release from HPC capsules was greater affected by electrolytes than that from gelatin and PEO capsules. In vivo studies were conducted in rabbits with novel capsules and compared with gelatin capsules. It was found that the pharmacokinetic parameters included AUC0-∞ and T1/2 has showed no significantly difference among various capsules, all containing theophylline formulation. The correlation between TD50 in vitro and several parameters in vivo were established. HPMC capsule were also prepared, and its in vivo-in vitro test shows no significantly difference from the gelatin capsule.
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