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

• Main Authors: Chiang-Chi Hsu, 徐強啟
• Other Authors: Bor-Jinn Shieh
• Format: Others
• Language: zh-TW
• Published: 2006
• Online Access: http://ndltd.ncl.edu.tw/handle/42269787161011340554

碩士 === 中原大學 === 化學研究所 === 94 === 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.