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作者(中文):陳柏全
作者(外文):Chen, Po-Chuan
論文名稱(中文):以六標準差方法改善藥廠錠劑產品之溶出率與崩解時間
論文名稱(外文):Applying Six Sigma Approach to Improve Dissolution and Disintegration Time of Tablet Product in a Pharmaceutical Company
指導教授(中文):吳建瑋
指導教授(外文):Wu, Chien-Wei
口試委員(中文):王姿惠
劉時玟
口試委員(外文):Wang, Zih-Huei
Liu, Shih-Wen
學位類別:碩士
校院名稱:國立清華大學
系所名稱:工業工程與工程管理學系碩士在職專班
學號:104036534
出版年(民國):109
畢業學年度:108
語文別:中文
論文頁數:44
中文關鍵詞:六標準差營養補充品錠劑崩解時間溶出率藥廠
外文關鍵詞:Six SigmaDietary SupplementTabletsDisintegration TimeDissolutionPharmaceutical Company
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營養保健品又名保健食品、健康食品,是用來補充人體需要的營養素的一種產品,它主要的功能是維持健康或預防疾病的發生。現代人因為缺乏運動,以及飲食不均衡的問題,容易導致營養素攝取不足,營養補充品這種產品將食物中的營養素萃取出來方便服用,也就成為社會大眾補充營養素的一種簡單方便的手段。其中膠囊或錠狀型式的營養保健品方便控制服用量以及便於攜帶,所以也最為消費者所接受。

個案製藥公司擁有全球領先的營養保健品牌,主力產品為錠劑型營養補充品,產品深受消費者信賴,其中Product X鈣質補充錠更在台灣的市佔率極高,每年供應超過三百萬錠的產品給台灣市場的消費者。因為市場上營養補充品競爭者日益繁多,也為因應消費者和衛生署食品安全法規對營養保健品的品質要求不斷提高,消費營養保健品也需要持續更新,個案公司的鈣質補充錠自2001年上市以來,即持續進行產品改良,維持市場競爭力。

本次研究為個案公司於2017年開發的新型鈣質補充錠處方,在開發過程中發現其錠劑溶解效果不符預期的問題,其背後原因複雜,故本研究透過六標準差系統性的思考及問題解決步驟來進行改善。在本研究中,在定義步驟將顧客之聲轉換成可以衡量的物理量後,沿著DMAIC的步驟,實務經驗搭配實驗測試的方式,完成處方改善,並有效將崩解時間改善了約3.369分鐘,相對於原本處方平均5.889分鐘的崩解時間表現,時間縮短了57.2%。此改善也使新處方產品符合工廠規格,成功上市,維持個案公司的Product X產品競爭力,並且產量連年成長,保持穩定的市佔率與品牌形象。
Dietary Supplement, or so called health food or health functional food, is a product that’s used to supplement the nutrients that human needs on a daily basis. It is used to keep people healthy or prevent illness because of insufficient nutrients. Nowadays, people are often lack of exercise or not having enough nutrients, including Vitamins and Minerals, from their daily diet. Dietary Supplement tablets/capsules, which are products that combined necessary nutrients extracted from food and is easier to take, are then becoming popular and they are admired by the consumers.

Product X is the famous Calcium supplement tablets product in Taiwan markets which owns a big portion of market share. This product was launched since 2001, over three million tablets were supplied to the consumers in Taiwan markets. However, as the TFDA regulations are becoming stricter, and there are more competitors joining this market, the Product X is continuously being updated since product first launched in 2001 by the company to meet market demand and to keep this product competitive to other competitors.

The aim of this study is to solve the tablet dissolution/ disintegration time issue for a pharmaceutical company by applying Six Sigma approach. By applying Six Sigma’s DMAIC steps, together with practical experience and experimental results, the disintegration time has been shorted by 57.2% (from 5.889 to 3.369 minutes), and the new product was launched successfully.
摘要
Abstract
誌謝
目錄
表目錄
圖目錄
第1章 緒論...............1
第2章 文獻回顧...........4
第3章 研究方法...........9
第4章 研究結果..........16
第5章 結論與建議........42
參考文獻................43
中文文獻:
李亮諭 (2018),運用六標準差改善按壓手機螢幕雜音之研究,清華大學工業工程與工程管理學系,碩士論文。

蘇朝墩 (2009),六標準差,新北市:前程文化事業有限公司。

英文文獻:
Abbes, N., Sejri, N., Chaabouni, Y. and Cheikhrouhou, M. (2018). Application of Six Sigma in Clothing SMEs: A Case Study. 2018 IOP Conference Series: Materials Science and Engineering. 460(012009), 1-9.
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Christiansen, Ó. (2011). Rethinking ‘Quality’ by Classic Grounded Theory. International Journal of Quality and Service Sciences. 3(2), 199–210.
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Uzunović, A. and Vranić, E. (2007). Effect of Magnesium Stearate Concentration on Dissolution Properties of Ranitidine Hydrochloride Coated Tablets. Bosnian Journal of Basic Medical Sciences. 7(3), 279-283.
USP <701> Disintegration (2020). The United States Pharmacopeia, 43th Edition. The United States Pharmacopeial Convention.
USP<1225>Validation of Compendial Methods (2020). The United States Pharmacopeia, 43th Edition. The United States Pharmacopeial Convention.
Wooluru, Y., Swamy, D.R., and Nagesh, P. (2014). The Process Capability Analysis-A Tool for Process Performance Measures and Metrics: A Case Study. International Journal for Quality Research. 8(3), 399-416.
Yousaf, A.M., Naheed, F., Shahzad, Y., Hussain, T., and Mahmood, T. (2019). Influence of Sodium Starch Glycolate, Croscarmellose Sodium and Crospovidone on Disintegration and Dissolution of Stevia Loaded Tablets. Polimery w Medycynie. 49(1),19-26.
Zhang, M., Wang, W., Goh, T.N., and He, Z. (2015). Comprehensive Six Sigma Application: A Case Study. Production Planning & Control. 26(3), 219-234.

參考網址:
SIPOC (Suppliers, Inputs, Process, Outputs, Customers) Diagram (2016). American Society for Quality, Service Quality Division. [Retrieved 2020/06/27]. http://asqservicequality.org/glossary/sipocsuppliersinputsprocessoutputscustomersdiagram/

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