200838495 九、發明說明： 【發明所屬之技術領域】 本發明係關於一種中藥之製造方法，詳言之，係關於一 種利用高壓萃取法之濃縮中藥之製造方法。 【先前技術】 近年來，隨著生化科技之進步，濃縮中藥之應用漸為普 及。與傳統中藥劑型一湯、丸、散、膏、丹、酒、露、鍵 等不同的是，現代濃縮中藥之劑型有：濃縮散劑 (Powder)、顆粒（Granuie)、膠囊（Capsule)、錠劑（⑽㈣、 液劑、貼布等。隨著科學化之進展，台灣的中藥廠已強制 執行GMP製程，以獲得高品質之產品。 參考圖1，顯示習知濃縮中藥之製造方法之流程示意 圖。首先，步驟S101係提供一中藥原料。本文所稱之「中 藥原料J係為有原典依據之品名或處方，例如醫宗金鑑、 醫方集解、本草綱目、中國醫學大辭典或太平惠明和劑局 方等’為一般所公認之中藥製劑。 接著，步驟S102係前處理該中藥原料，通常包括外觀性 味鑑定、藥材成分檢驗、洗淨及處方調配等。 接著，步驟S103係加水煎煮萃取。在本步驟中，需加進 大量的水，再以約100。(：之沸騰溫度煎煮該中藥原料，以 萃取出該中藥原料中之指標成分或活性成分，例如：醣 類、芬類及有機酸等。另外，如果以半酒水煎煮該中藥原 料’則可以苹取出酚類及生物碱。 接著，步驟S104係濃縮步驟，其係加熱該步驟sl〇3所得 11779i.doc 200838495 之萃取液，使其水分蒸發以提高其濃度，且得到一濃縮液 (又稱「浸膏」）。 接著’步驟S105係造粒步驟’其係將該濃縮液與一賦型 劑置入一混合造粒機，混合一適當時間以形成顆粒狀。該 賦型劑通常為澱粉。 接著，步驟S106係乾燥步驟，其係將該步驟sl〇5之顆粒 乾燥一適當時間。 瞻接著，步驟S107係製成所需之劑型，例如··散劑、顆 粒、膠囊或錠劑等。最後，步驟s 108係為包裝步驟，即將 步驟S107所製成之劑型包裝成成品出售。 另外，步驟S104所得之濃縮液也可以不經過步驟§1〇5之 造粒步驟，而直接形成液劑，如步驟31〇9所示。之後直接 經由步驟S108包裝成成品出售。 該習知製造方法之缺點在於，該步驟sl〇3需加入大量的 水以進行煎煮萃取。以萃取體積比（中藥原料：水）來看， Φ黃精為1 : 25，胖大海為1 : 55，人參為i : 5〇，黑木耳為 1 : 32 ’紅景天為丨：4〇 ’沙棘為丨：4〇，魔芋為i :⑽。 亦即在該步驟S103中，需加入中藥原料數十倍之水，其不 僅浪費水，而且將如此大量的水加熱至約100。。，也會浪 費大量能源。 口 θ專利第1243680號「去油酸棗仁錠劑之製程」揭示 了利用超臨界流體萃取製程技術，以二氧化碳為第一次萃 祕劑萃取出萃出物，該萃出物包含低揮發性油腊與微量 t酸棗仁4料活性物質。之後，該萃出物再經過精館加 117791.doc 200838495 半水酒或熱水為溶劑，將該萃出物中所含之酸 二：：甘恤物質萃取出纟。此-製程不僅繁複，而且 仍…、、雨要大量的水來進行煎煮。 因此，有必要提供-種創新且具進步性的濃縮中藥之製 造方法，以解決上述問題。 【發明内容】200838495 IX. Description of the Invention: [Technical Field] The present invention relates to a method for producing a traditional Chinese medicine, and more particularly to a method for producing a concentrated Chinese medicine using a high pressure extraction method. [Prior Art] In recent years, with the advancement of biochemical technology, the application of concentrated Chinese medicine has become more and more popular. Different from traditional Chinese medicines, soups, pills, powders, dans, wines, dews, keys, etc., the dosage forms of modern concentrated Chinese medicines are: Powder, Granuie, Capsule, Ingot Agent ((10) (4), liquid agent, patch, etc. With the progress of science, the Chinese medicine factory in Taiwan has enforced the GMP process to obtain high-quality products. Referring to Figure 1, the flow chart of the manufacturing method of the conventional concentrated Chinese medicine is shown. First, step S101 provides a traditional Chinese medicine raw material. The term "Chinese medicine raw material J" is a product name or prescription based on the original code, such as medical medicinal gold, medical prescription, herbal standard, Chinese medical dictionary or Taipinghui. The present invention is generally recognized as a traditional Chinese medicine preparation. Next, the step S102 is pre-treatment of the traditional Chinese medicine raw material, which usually includes the appearance taste identification, the medicine ingredient inspection, the washing and the prescription preparation, etc. Next, the step S103 is to add water to fry. Boil the extraction. In this step, a large amount of water is added, and then the Chinese medicine raw material is boiled at a boiling temperature of about 100 to extract the index component or activity in the raw material of the traditional Chinese medicine. For example, sugar, fennel, organic acid, etc. In addition, if the raw material of the traditional Chinese medicine is cooked in half-baked water, the phenols and alkaloids can be taken out. Next, step S104 is a concentration step, which is to heat the step sl1 The extract of 11779i.doc 200838495 obtained in 〇3 is evaporated to increase the concentration thereof, and a concentrated liquid (also referred to as "extract") is obtained. Next, 'Step S105 is a granulation step' which is An excipient is placed in a mixing granulator and mixed for a suitable period of time to form a granule. The excipient is usually starch. Next, step S106 is a drying step, which is to dry the granule of the step s1〇5. Next, step S107 is prepared into a desired dosage form, such as powder, granules, capsules or lozenges, etc. Finally, step s 108 is a packaging step, that is, the dosage form prepared in step S107 is packaged into a finished product for sale. In addition, the concentrate obtained in the step S104 can also directly form a liquid agent without the granulation step of the step §1〇5, as shown in the step 31〇9, and then directly packaged into a finished product for sale via the step S108. A disadvantage of the manufacturing method is that the step sl3 needs to add a large amount of water for decoction extraction. In terms of the extraction volume ratio (Chinese medicine raw material: water), Φ Huang Jing is 1:25, and the fat sea is 1:55. , ginseng is i: 5〇, black fungus is 1: 32 'Rhodiola is 丨: 4〇' Seabuckthorn is 丨: 4〇, konjac is i: (10). That is, in this step S103, the number of raw materials to be added Ten times the water, which not only wastes water, but also heats such a large amount of water to about 100. It also wastes a lot of energy. The method of "the process of removing oleic acid and jujube tablets" is disclosed in the θ Patent No. 1243680. The fluid extraction process technology extracts the extract with carbon dioxide as the first chelating agent, and the extract contains low volatile oil wax and trace t-jujube 4 active material. After that, the extract is further extracted into the sputum by adding 117791.doc 200838495 semi-aqueous wine or hot water as a solvent. This process is not only complicated, but also..., rain requires a lot of water for boiling. Therefore, it is necessary to provide an innovative and progressive method of manufacturing concentrated Chinese medicine to solve the above problems. [Summary of the Invention]
本發明之主要目的係提供—種中藥之製造方法，包括以 下步驟：⑷提供—中藥原料；⑻以⑴㈣大氣壓之壓 力，溫度3G至1()代萃取該中藥原料，以得到-萃取液； ⑷濃縮該萃取液，以得到一濃縮液：及⑷後處理該濃縮 液’以得到-濃縮中藥。藉此’尸、需添加少量的水作為共 溶劑’即可萃取出大量該中藥原料中之指標成分或活性成 分，因此可節省水的使用。it卜々k，士& ,$ >刃使用此外，本發明不需要加熱至沸 騰即可萃取，因此可以節省大量能源。 【實施方式】 本文所稱之「中藥原料」係為有原典依據之品名或處 方’例如醫宗金鑑、醫方集解、本草綱目'中國醫學大辭 典或太平惠明和劑局方等，為一般所公認之中藥製劑。 參考圖2，顯示本發明濃縮中藥之製造方法之較佳實施 例之流程示意圖。首先，步驟S2〇1係提供一中藥原料。接 著，步驟S202係前處理該令藥原料，通常包括外觀性味鑑 定、藥材成分檢驗、洗淨及處方調配等。較佳地，該前處 理步驟更包括利用均質機將該中藥原料打碎、混合，取4 至200 mesh的中藥原料。 117791.doc 200838495 接著’步驟S203係以2至1000大氣壓之壓力萃取，以得 到一萃取液。在本實施例中，係以超臨界二氧化碳為溶劑 萃取該中藥原料，其壓力係高於72·8大氣壓，較佳地，係 介於72·8至1000大氣壓。其溫度係介於3〇t：至ι〇〇χ：，較 佳地，係介於31.2。(：至8(TC。該二氧化碳之流速約為3至 10公升/分鐘。在本實施例中，同時添加少量的水作為共 溶劑（Co-solvent),所添加之水量約為該中藥原料之i至5 倍。該萃取液包含大量該中藥原料中之指標成分或活性成 分，例如：醣類、苷類及有機酸等。 接著，步驟S204係濃縮步驟，其係加熱或過濾該步驟 S203所得之萃取液，使其水分蒸發以提高其濃度，且得到 一濃縮液。 接著，步驟S205係造粒步驟，其係將該濃縮液與一賦型 劑混合一適當時間後，利用真空、熱風或緩緩喷入一喷霧 乾燥機，以形成顆粒狀。該賦型劑通常為澱粉。在另一實 施例中，該濃縮液可直接利用真空、熱風或緩緩噴入一噴 霧乾燥機（該喷霧乾燥機預先置入該賦型劑），以形成顆粒The main object of the present invention is to provide a method for manufacturing a traditional Chinese medicine, comprising the steps of: (4) providing a raw material of a traditional Chinese medicine; (8) extracting the raw material of the traditional Chinese medicine by a pressure of (1) (iv) atmospheric pressure at a temperature of 3G to 1 () to obtain an extract; (4) The extract is concentrated to obtain a concentrate: and (4) the concentrate is post-treated to obtain a concentrated Chinese medicine. By using the corpse and adding a small amount of water as a co-solvent, a large amount of the index component or the active component in the raw material of the traditional Chinese medicine can be extracted, thereby saving water use. It is also used in the present invention. In addition, the present invention can be extracted without heating to boiling, thereby saving a large amount of energy. [Embodiment] The "Chinese medicine raw materials" referred to in this article are the product names or prescriptions based on the original texts, such as the medical medicinal gold ginseng, the medical prescription, the herbal syllabus, the Chinese medical dictionary or the Taiping Huiming and Pharmacy Bureau. Generally recognized as a Chinese medicine preparation. Referring to Fig. 2, there is shown a schematic flow chart of a preferred embodiment of the method for producing a concentrated Chinese medicine of the present invention. First, step S2〇1 provides a traditional Chinese medicine raw material. Next, in step S202, the drug raw material is pre-treated, and generally includes an appearance taste identification, a drug ingredient inspection, a washing, and a prescription formulation. Preferably, the pre-treatment step further comprises breaking and mixing the raw material of the traditional Chinese medicine with a homogenizer to obtain a traditional Chinese medicine raw material of 4 to 200 mesh. 117791.doc 200838495 Next, the step S203 is extracted at a pressure of 2 to 1000 atm to obtain an extract. In the present embodiment, the raw material of the traditional Chinese medicine is extracted by using supercritical carbon dioxide as a solvent, and the pressure system is higher than 72·8 atm., preferably, it is between 72·8 and 1000 atm. The temperature range is from 3〇t: to ι〇〇χ:, preferably, it is between 31.2. (: to 8 (TC. The flow rate of the carbon dioxide is about 3 to 10 liters/min. In this embodiment, a small amount of water is simultaneously added as a co-solvent, and the amount of water added is about the raw material of the traditional Chinese medicine. i. 5 times. The extract contains a large amount of the index component or the active component in the raw material of the traditional Chinese medicine, for example, a saccharide, a glycoside, an organic acid, etc. Next, step S204 is a concentration step, which is heated or filtered to obtain the step S203. The extract is evaporated to increase its concentration, and a concentrated liquid is obtained. Next, step S205 is a granulation step of mixing the concentrate with an excipient for a suitable period of time, using vacuum, hot air or Slowly sprayed into a spray dryer to form granules. The excipient is usually starch. In another embodiment, the concentrate can be directly sprayed into a spray dryer using vacuum, hot air or slowly. The spray dryer is pre-loaded with the excipient) to form granules
狀。 A 接著，步驟S206係乾燥步驟，其係將該步驟S2〇5之顆粒 乾燥一適當時間。 接著，步驟S207係製成所需之劑型，例如^ 〜如·散劑、顆 粒、膠囊或鍵劑專。最後’步驟S 2 0 8係為包展步驟g將 步驟S207所製成之劑型包裝成成品出售。 另外，步驟S204所得之濃縮液也可以不級讽 卜、^過步驟S205之 117791.doc 200838495 造粒步驟，而直接形成液劑，如步驟§2()9所示。之後直 經由步驟S208包裝成成品出售。 本發明之優點為，該步驟湖只需添加少量的水作為共 溶劑’即可萃取出大量該中藥原料中之指標成分或活料 分’因此可節省水的使用。此外，本發明不需要加熱萃 取，因此可以節省大量能源。 兹以下列實例予以詳細說明本發明，唯並不意味本發明shape. A Next, step S206 is a drying step of drying the particles of the step S2 to 5 for an appropriate period of time. Next, step S207 is prepared into a desired dosage form, such as a powder, a granule, a capsule or a key. Finally, the step S 2 0 8 is to package the dosage form prepared in step S207 into a finished product for sale. Further, the concentrate obtained in the step S204 may be subjected to a granulation step by step 117791.doc 200838495 granulation step, as shown in step § 2 (). Then, it is packaged into a finished product for sale via step S208. An advantage of the present invention is that in this step, a small amount of water is added as a co-solvent to extract a large amount of the index component or the live material component of the raw material of the traditional Chinese medicine, thereby saving water use. Furthermore, the present invention does not require heating extraction, so that a large amount of energy can be saved. The invention is illustrated in detail by the following examples, which are not intended to illustrate
僅偈限於此專實例所揭示之内容。 實例1 ·以枸把子為例 其步驟如下： 1 ·取枸把子500公克均質磨碎。 2·加入1.5倍的水作為共溶劑，且設定溫度壓力為8〇 °C、300大氣壓，以二氧化碳為溶劑，流速為丨至5公 升/分鐘，萃取時間3至4小時，即可得到枸杞子之萃 取液約680克。 3·將上述步驟2之萃取液，於溫度低於6〇〇c之減壓濃縮 機中得約70克之濃縮液。 4.將上述步驟3所得之濃縮液緩緩喷入噴霧乾燥機（該噴 霧乾燥機預先置入一賦型劑），以形成顆粒狀。該賦 型劑係為澱粉。喷完後繼續乾燥3〇分鐘。 5 ·將乾燥後之顆粒以20 mesh及100 mesh篩網篩選，取 20〜100 mesh之顆粒，即得顆粒成品。 6·將步驟5所得之顆粒成品利用打鍵機製成键劑產品。 7.將步驟6所得之錠劑產品包裝。 117791.doc 200838495 實例2 :以當歸為例 其步驟如下： 1. 取當知5 0 0公克均質磨碎。 2. 加入3倍的水作為共溶劑，且設定溫度壓力為6〇它、 400大氣壓，以二氧化碳為溶劑，流速為1至5公升/分 鐘，萃取時間3到4小時，即可得到當歸之萃取液約 1300 克。 • 3·將上述步驟2之萃取液，於溫度低於6CTC之減壓濃縮 機中得約100克之濃縮液。 4.將上述步驟3所得之濃縮液緩緩噴入喷霧乾燥機（該噴 務乾燥機預先置入一賦型劑），以形成顆粒狀。該賦 型劑係為澱粉。喷完後繼續乾燥30分鐘。 5·將乾燥後之顆粒以20 mesh及100 mesh_網篩選，取 20〜1〇〇 mesh之顆粒，即得顆粒成品。 _ 6·將步驟5所得之顆粒成品利用打錠機製成錠劑產品。 • 7·將步驟6所得之旋劑產品包裝。 實例3 :以黃耆為例 其步驟如下： 1·取黃耆500公克均質磨碎。 2·加入1·5倍的水作為共溶劑，且設定溫度壓力為5〇 C、400大氣壓，以二氧化碳為溶劑，流速為公 升/分鐘’萃取時間3到4小時，即可得到黃耆之萃取 液約710克。 3·將上述步驟2之萃取液，於溫度低於6〇它之減壓濃縮 117791.doc -10· 200838495 機中得約7 0克之濃縮液。 4.將上述步驟3所得之濃縮液緩緩噴入噴霧乾燥機（該噴 務乾燥機預先置入一賦型劑），以形成顆粒狀。該賦 型劑係為澱粉。喷完後繼續乾燥30分鐘。 5·將乾燥後之顆粒以2〇 mesh及100 mesh篩網篩選，取 20〜1〇〇 mesh之顆粒，即得顆粒成品。 6·將步驟5所得之顆粒成品利用打錠機製成錠劑產品。 7·將步驟6所得之錠劑產品包裝。 實例4 :以茯苓為例 其步驟如下： 1 ·取伏荟5 0 0公克均質磨碎。 2·加入1.5倍的水作為共溶劑，且設定溫度壓力為5〇 °C、300大氣壓，以二氧化碳為溶劑，流速為1至5公 升/分鐘，萃取時間3到4小時，即可得到茯荟之萃取 液約710克。 3.將上述步驟2之萃取液，於溫度低於6(rc之減壓濃縮 機中得約7 0克之濃縮液。 4·將上述步驟3所得之濃縮液緩緩噴入噴霧乾燥機（該噴 霧乾燥機預先置入一賦型劑），以形成顆粒狀。該賦 型劑係為澱粉。喷完後繼續乾燥30分鐘。 5·將乾燥後之顆粒以2〇 mesh及1〇〇 mesh篩網篩選，取 20〜100 mesh之顆粒，即得顆粒成品。 6·將步驟5所得之顆粒成品利用打錠機製成錠劑產品。 7 ·將步驟6所得之錠劑產品包裝。 117791.doc •11- 200838495 惟上述實施例僅為說明本發明之原理及其功效，而非用 以限制本發明。因此，習於此技術之人士對上述實施例進 行修改及變化仍不脫本發明之精神。本發明之權利範圍應 如後述之申請專利範圍所列。 【圖式簡單說明】 取处刀忠芡流程示意圖；及Only limited to what is disclosed in this specific example. Example 1 • Taking the scorpion as an example The steps are as follows: 1 • The granules were homogenized by grinding 500 gram. 2. Add 1.5 times of water as a co-solvent, set the temperature pressure to 8 ° C, 300 atm, use carbon dioxide as the solvent, the flow rate is 丨 to 5 liters / min, the extraction time is 3 to 4 hours, you can get the scorpion The extract is about 680 grams. 3. The extract of the above step 2 was subjected to a concentrate of about 70 g in a vacuum concentrator having a temperature of less than 6 〇〇c. 4. The concentrate obtained in the above step 3 is slowly sprayed into a spray dryer (the spray dryer is preliminarily placed in an excipient) to form pellets. The excipient is starch. Continue to dry for 3 minutes after spraying. 5 · The dried granules are screened by 20 mesh and 100 mesh sieves, and the granules of 20~100 mesh are taken to obtain the finished granules. 6. The finished pellet obtained in the step 5 is made into a key product by using a keying machine. 7. Pack the lozenge product obtained in step 6. 117791.doc 200838495 Example 2: Taking Angelica as an example The steps are as follows: 1. Take a knowledge of 500 gram homogenization. 2. Add 3 times of water as a co-solvent, set the temperature to 6 〇, 400 atm, use carbon dioxide as solvent, flow rate is 1 to 5 liters / minute, extraction time is 3 to 4 hours, you can get the extract of Angelica The liquid is about 1300 grams. • 3. Add the extract of step 2 above to a concentrate of about 100 grams in a vacuum concentrator at a temperature below 6 CTC. 4. The concentrate obtained in the above step 3 is slowly sprayed into a spray dryer (the spray dryer is preliminarily placed with an excipient) to form a pellet. The excipient is starch. Continue to dry for 30 minutes after spraying. 5. The dried granules are screened by 20 mesh and 100 mesh mesh, and the granules of 20~1 〇〇 mesh are taken to obtain the finished granules. _ 6. The pellet obtained in the step 5 is made into a tablet product by using a tableting machine. • 7. Pack the spinner product from step 6. Example 3: Taking Astragalus as an example The steps are as follows: 1. Take 500 grams of Astragalus homogenate and grind. 2· Add 1.5 times of water as a co-solvent, and set the temperature pressure to 5〇C, 400 atmospheres, using carbon dioxide as the solvent, the flow rate is liters/min, and the extraction time is 3 to 4 hours, then the extract of Astragalus can be obtained. The liquid is about 710 grams. 3. The extract of the above step 2 was concentrated to a concentration of about 70 g in a machine having a temperature of less than 6 Torr and concentrated under reduced pressure of 117791.doc -10·200838495. 4. The concentrate obtained in the above step 3 is slowly sprayed into a spray dryer (the spray dryer is preliminarily placed with an excipient) to form a pellet. The excipient is starch. Continue to dry for 30 minutes after spraying. 5. The dried granules are screened by 2 〇 mesh and 100 mesh sieves, and the granules of 20~1 〇〇 mesh are taken to obtain the finished granules. 6. The finished pellet obtained in the step 5 is made into a tablet product by using a tableting machine. 7. Pack the lozenge product obtained in step 6. Example 4: Taking 茯苓 as an example The steps are as follows: 1 · Take 0.50 g of homogenized grit. 2. Add 1.5 times of water as a co-solvent, set the temperature to 5 ° ° C, 300 atmospheres, use carbon dioxide as the solvent, the flow rate is 1 to 5 liters / minute, the extraction time is 3 to 4 hours, you can get the 茯The extract was about 710 grams. 3. The extract of the above step 2 is obtained in a concentration of less than 6 (rc reduced concentration concentrator of about 70 grams of concentrated liquid. 4. The concentrated liquid obtained in the above step 3 is slowly sprayed into the spray dryer (the The spray dryer is pre-set with a refining agent to form a granule. The excipient is starch. After drying, the drying is continued for 30 minutes. 5. The dried granules are sieved at 2 〇mesh and 1 〇〇mesh. Screen screening, taking 20~100 mesh particles, that is, the finished pellets. 6. The finished pellet obtained in step 5 is made into a tablet product by using a tableting machine. 7 · Packing the tablet product obtained in step 6. 117791.doc The above-mentioned embodiments are merely illustrative of the principles and effects of the present invention, and are not intended to limit the present invention. Therefore, those skilled in the art can make modifications and changes to the above-described embodiments without departing from the spirit of the present invention. The scope of the present invention should be as set forth in the scope of the patent application described below. [Simplified description of the drawing]
圖2顯示本發明濃縮中藥之;生 杉一九 卡之i绝方法之較佳實施例之流 程不意圖。Fig. 2 is a view showing the flow of a preferred embodiment of the concentrated Chinese medicine of the present invention;
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