青光眼藥物之分析方法及其安定性受容器影響之探討。

An Investigation of Analysis Methods on the Glaucoma Drug and Its Stability Affected by the Containers.

徐強啟(Chiang-Chi Hsu)

指導教授 ： 謝博進

中原大學/理學院/化學研究所/碩士(2006年)

https://doi.org/10.6840/cycu200600768

摘要

對於青光眼患者所開立的處方物多以Timolol來降低患者眼壓；而現今治療青光眼最新藥物為Latanoprost。是一種前列腺素 F2α的衍生物，藉由增加眼房水液之流出量來減少眼壓。
本研究乃將具有合併治療法的處方，其結合減少房水生成的Timolol成分與增加房水由葡萄膜鞏膜通路排出的Latanoprost成分，進行分析方法的確效及容器安定性試驗之探討。
分析方法確效之執行乃參照US pharmacopoeia含量分析方法確效之指標及衛生署制定分析方法確效指導手冊之規定，進行本分析方法對於處方成分Latanoprost含量分析準確性及專一性。
容器安定性試驗，乃採用歐盟藥品評估法規中的ICH Q1A（R2）（Stability Testing Guidelines：Stability Testing of New Drug Substances and Products）規範進行安定性試驗，以評估各眼藥水容器供應商所提供的無菌LDPE材質容器，於5℃±3℃（2~8℃）�
25℃±2℃60％±5％RH條件下執行180天的安定性。
研究Latanoprost成分的退化曲線，推定其有效期間並判定最佳安定性之眼藥水容器供應商，以確保藥品具有效性及安全性。
Latanoprost安定性除受外在環境因素：溫度、濕度等影響外，容器充填材質及容器吸附明確的對其安定性為主要影響因素。
近代容器供應商之無菌LDPE材質容器，對Latanoprost具有最佳的安定性。

關鍵字

安定性分析 ； 分析方法確效 ； 青光眼

並列摘要

Timolol is an effective ocular hypotensive agent to patients with glaucoma. The latest treatment of glaucoma is Latanoprost. Latanoprost, a prostaglandin F2α analogue, is a selective prostanoid FP receptor agonist, which exerts its function by increasing the uveoscleral outflow to reduce ocular hypertension.
This study applies the prescription that provides the combination treatment, which reduces the aqueous humor by using Timolol and increases the aqueous humor from uveoscleral outflow by using Latanoprost. Therefore, the study applies Analysis Method Validation and Container Stability to experiment the research.
The execution of Analysis Method Validation consults the standard of Assay of analysis Method Validation produced by US pharmacopoeia and the guideline booklet of Analysis Method Validation produced by The Department of Health. This study is using the Analysis Method Validation to experiment the accuracy and specificity of the quantity container of Latanoprost.
The experiment of Container Stability applies the standard of ICH Q1A（R2）（Stability Testing Guidelines：Stability Testing of New Drug Substances and Products）produced by The European Agency for the Evaluation of Medicinal to test its stability. The purpose to test its stability is to estimate the sterilized Low Density Polyethylene （LDPE） containers, which are provided by eye drops of container suppliers, can be stable within 5℃±3℃（2~8℃）� 25℃±2℃60％±5％RH (Relative Humidity) under 180 days.
Within the study, we experiment the degenerating curve of Latanoprost to infer its term of validity and to judge which eye drops of container supplier that possesses the best stability in order to make sure that the medicine has both validity and stability.
Besides the external environment factors, such as temperature, humidity, the stability of Latanoprost will be mainly affected by the material and the absorption of the containers. Lately, the material of sterilized Low Density Polyethylene （LDPE） containers, provided by eye drops of container suppliers, provides the most stable condition to Latanoprost.

並列關鍵字

Latanoprost ； Glaucoma ； Timolol

參考文獻

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