中草藥微膠囊造粒技術及品質改善之評估

江伯源
中興大學
傳統中(草)藥製程包括選材、清洗、飲品加工、炮製，再進行不同劑型之製備，丸、散、膏、丹為主要產品形式，熬煮(萃取)、濃縮及造粒處理是重要製備過程，如何確保其品質、藥效並防止吸潮、變味(色)、外型潰散等不良問題發生，另如何利用現代化製程及劑型改良技術，使中藥精緻化及藥效提昇是重要研究課題。造粒技術是現代科學中藥中之重要粒體加工過程，更是中(草)藥走向配方化、調理化過程中必須掌握的核心技術；微膠囊(microencapsuelation)技術是一種利用成膜材料把液體或固體包覆形成小粒子的技術，近年常被應用於食品、西藥及各式化工材料工業上，常供包埋、增黏、抗吸濕、溶解及釋放粒子等，相關微膠囊造粒技術應用於中(草)藥造粒及劑型開發則較少投入研究及生產；本年度(98)衛生署中醫藥委員會“推動傳統藥材生產技術研發類”委託研究計畫研究重要項目—研究重點2-1：“中藥現代化製程及劑型改良技術對品質影響之研究”將利用現代化製藥科技提高藥品效能，使中藥精緻化作研究重點。本研究計畫以麻黃湯(單方及複方)為藥材，使用食品可食用之材料(海藻酸鈉、澱粉)，利用物理微膠囊造粒技術—膠體凝固—液中硬化造粒，進行單層包覆及多層釋放粒子，達到中(草)藥製劑研發及品質改善之效果。其可直接攝取至人體，減少化學反應造立法對人體安全性之風險，有助確效及品直安定性。本計畫“中(草)藥微膠囊造粒技術及品質改善之評估”將研究項目分為四項主題進行：(一)中藥萃取液及最適條件探討：以麻黃湯為實驗藥材，利用RSM(反應曲面實驗)探討固、液比、萃取溫度、時間對藥效成份之萃取評估；以作為微膠囊造粒之蕊心素材。(2)中藥微膠囊造粒技術之評估：利用同軸微膠囊生產器(nicso)探討萃取液及微細化生藥粉末，進行造粒機制及評估殼膜物質、包覆率及釋放性。(3)造粒、包覆品質評估及改善：探討粒徑大小、包覆率、安定性(乳化物微粒子膜安定性)，pH及溫度穩定性、釋放率及利用掃瞄式電子顯微鏡(SEM)觀察及微粒子構造、安定性及釋放性。(4)微膠囊粒子確效評估：利用液相層析儀分析麻黃湯之指標成份Ephedrine、pseudphedrine、Amygdalin、cinnamic acid及glycyrrhizin等成份。
關鍵字：中草藥、微膠囊、造粒、釋放粒子
 
Research on the effects of modern processes and product type refinement technology on the quality of Chinese herbal medicine

Po-Yuan Chiang
National Chung Hsing university
The manufacturing processes of traditional Chinese (herbal) medicine include selection, washing, food processing, and packaging. After these processes, different product types such as pills, powder, and cream are manufactured by long-term cooking (extraction), concentration, and granulization. The processes of maintaining the quality and curative effect; the prevention of moisture absorption, flavor (color) deterioration, loosening of the outer appearance; and the usage of modern processes and product type refinement technology to refine the medicine and enhance the curative effect, are important research topics. Granulization technology is not only an important processing step in the modern science of herbal medicine, but an important core technology that is required to be mastered for the formulation and seasoning of Chinese (herbal) medicine. Microencapsulation technology is a type of technology that uses film-made materials to coat the liquid or solid target into small granules. In recent years, it is often used in food, western medicines and various chemical engineering materials. It is often used for coating, to increase viscosity; prevent moisture absorption; and release particles. There are not many researches and production of related microencapsulation granulization technology in the granulization of Chinese (herbal) medicine and development of product type. This year, the “advancement of traditional medicinal material technology and research “of the Committee on Chinese Medicine and Pharmacy, Department of Health, assigned this research plan—research point 2-1: The use of modern medicine-processing technology in the “Research on the effects of modern processes and product type refinement technology on the quality of Chinese herbal medicine”, to enhance the effectiveness and refinement of the herbal medicine, is an important research topic. This research project is based on Ma-huang soup (single and compound prescriptions), using edible material (sodium alginate, starch) and physical microencapsulation technology—colloid coagulation—solidification of the liquid for single-layer coating and multi-layer particle release, for a brand new production and quality improvement of Chinese (herbal) medicine. It can be directly absorbed by humans, so that the risk of chemical reaction can be decreased during microencapsulation as mentioned above. It is also helpful for efficiency and quality stability.The research item of this research plan, “Estimation of microencapsulation granulization technology and quality improvement”, is divided into four main topics: (1) Examination of liquid herbal medicinal extract and the most appropriate conditions: Ma-huang soup is used as the raw material in this study. RSM is used to examine the effects of the ratio of solid to liquid; extracting temperatures and time, on the extracting estimation of curative effect compositions; which are used as the core ingredients of microencapsulation granulization. (2) Estimation of the microencapsulation granulization technology of Chinese herbal medicine: This study uses a microencapsulation machine (nicso) to examine the extracting liquid and minute raw medicine powder, carry out the granulization mechanism and estimate the cast membrane material, coating rate and release. (3) Estimation and improvement of granulization and coating quality: This examines the particle size; coating rate; stability (emulsified micro-granule membrane stability); pH and stability of the temperatures; release rate; the use of SEM observations and the structure; stability and release of micro-granule structure. (4) Estimation of the determined efficiency of microencapsulation of granules: This uses liquid chromatography to analyze the index composition of Ma-huang soup, such as epherdrine, pseudphedrine, amygdalin, cinnamic acid, glycyrrhizin, etc.
關鍵字：Chinese herbal medicine, microencapsulation, granulization, release particle