TWI828208B - External ointment containing evodiae fructus and manufacturing method thereof - Google Patents
External ointment containing evodiae fructus and manufacturing method thereof Download PDFInfo
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- 238000004519 manufacturing process Methods 0.000 title abstract description 7
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- 239000004006 olive oil Substances 0.000 claims abstract description 30
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- 239000004480 active ingredient Substances 0.000 description 12
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- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 8
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- TXDUTHBFYKGSAH-SFHVURJKSA-N Evodiamine Chemical compound C1=CC=C2N(C)[C@@H]3C(NC=4C5=CC=CC=4)=C5CCN3C(=O)C2=C1 TXDUTHBFYKGSAH-SFHVURJKSA-N 0.000 description 2
- HMXRXBIGGYUEAX-SFHVURJKSA-N Evodiamine Natural products CN1[C@H]2N(CCc3[nH]c4ccccc4c23)C(=O)c5ccccc15 HMXRXBIGGYUEAX-SFHVURJKSA-N 0.000 description 2
- 206010052428 Wound Diseases 0.000 description 2
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- 239000000463 material Substances 0.000 description 2
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- BWMISRWJRUSYEX-SZKNIZGXSA-N terbinafine hydrochloride Chemical compound Cl.C1=CC=C2C(CN(C\C=C\C#CC(C)(C)C)C)=CC=CC2=C1 BWMISRWJRUSYEX-SZKNIZGXSA-N 0.000 description 1
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Abstract
Description
本發明係關於一種含吳茱萸之外用藥膏之製備方法，特別是指一種以科學方法系統化、標準化、簡單化其製程步驟之製備方法。The present invention relates to a preparation method of an ointment containing Evodia Fructus for external use, and in particular, to a preparation method that uses scientific methods to systematize, standardize and simplify its manufacturing steps.
依照先前技術所揭露之含吳茱萸之外用藥膏之製備方法，係：取吳茱萸細粉加入乙醇中，於室溫下攪拌2小時後過濾備用；將前步驟所得藥渣再次加入乙醇中，並反覆實施前述攪拌、過濾步驟；將第一、第二次之濾液混合濃縮並輔以佐劑，即得一含吳茱萸之外用藥膏。According to the preparation method of the external use ointment containing Evodia Fructus disclosed in the previous technology, the following steps are: add the fine powder of Evodia Fructus to ethanol, stir at room temperature for 2 hours, then filter and set aside; add the medicinal residue obtained in the previous step to ethanol again, and repeat the process The aforementioned stirring and filtering steps are followed; the first and second filtrate are mixed and concentrated and supplemented with an adjuvant to obtain an ointment containing Evodia Fructus for external use.
惟就前述之技術手段，仍存在以下缺點：1. 採用經研磨、打碎之吳茱萸藥粉，不經加熱萃取，直接攪拌製成藥膏，然中藥藥材縱使經研磨、打碎，其中的有效成分仍然存在於藥材中，敷用時，經皮吸收療效不佳。2. 採用經研磨、打碎之吳茱萸藥粉進行萃取，萃取過程無法即時確認吳茱萸之萃取效率，須事後透由額外之器材如：分光光度計、高效液相層析儀等，測量萃取前後之有效成分，以比較、確認。3. 採用水、乙醇作為萃取之溶劑者，然吳茱萸之有效成分多屬脂溶性如：吳茱萸內酯、吳茱萸鹼及吳茱萸次鹼等，以前述溶劑進行萃取，萃取效率不佳；且乙醇之沸點低、揮發性高，以之做為溶劑，較不易保留吳茱萸萃取之有效成分。4. 現行技術所載之含吳茱萸之外用藥膏之製備方法往往需經數次萃取過程以及繁複之製程步驟，耗時長久，對於製程所需之相關技術、設備之要求亦較高，製程不易。However, the above-mentioned technical means still have the following shortcomings: 1. The ground and broken Evodia rutaecarpa powder is used, and is directly stirred to make an ointment without heating and extraction. However, even if the Chinese medicinal materials are ground and broken, the active ingredients are still there. It exists in medicinal materials and has poor percutaneous absorption when applied. 2. Use grinded and crushed Evodia elata powder for extraction. The extraction efficiency of Evodia elata cannot be confirmed immediately during the extraction process. Additional equipment must be used afterwards, such as: spectrophotometer, high-performance liquid chromatography, etc., to measure the effectiveness before and after extraction. Ingredients to compare and confirm. 3. Water or ethanol is used as the extraction solvent. However, the active ingredients of Evodia Fructus are mostly fat-soluble, such as: evodiacetone, evodiamine and evodiamine, etc. If the above solvent is used for extraction, the extraction efficiency is not good; and the boiling point of ethanol is Low and high volatility, it is difficult to retain the active ingredients of Evodia Fructus extract when used as a solvent. 4. The preparation method of the topical ointment containing Evodia Fructus as described in the current technology often requires several extraction processes and complicated manufacturing steps, which takes a long time. The requirements for the related technologies and equipment required for the manufacturing process are also high, and the manufacturing process is not easy.
依上所述，現存之含吳茱萸之外用藥膏之製成方法，尚缺乏一以科學方法系統化、標準化、簡易化其製程步驟，於保留藥膏有效成分之同時，並大幅降低製程所需時間及對於技術、設備要求之製備方法。According to the above, the existing methods for making external ointments containing Evodia Fructus still lack a scientific method to systematize, standardize and simplify the process steps, while retaining the active ingredients of the ointment and significantly reducing the time and cost of the process. Preparation methods for technical and equipment requirements.
有鑑於現有技術之缺陷，本發明提供一種以科學方法系統化、標準化、簡易化含吳茱萸之外用藥膏之製備方法，對於現有之製備方法進行去繁化簡。In view of the shortcomings of the prior art, the present invention provides a systematic, standardized and simplified preparation method of an ointment containing Evodia Fructus for external use using a scientific method, thereby eliminating complexity and simplifying the existing preparation method.
為達成上述目的，本發明提供一種含吳茱萸之外用藥膏之製備方法，其包含以下步驟：1. 將未經研磨或打碎的吳茱萸與橄欖油混合後，加熱萃取得到一油萃取液；2. 將該油萃取液進行過濾；3. 將該經過濾的油萃取液趁熱加入蜂蠟中攪拌，至該蜂蠟完全溶解；4. 將該經過濾的油萃取液與蜂蠟之組合物靜置冷卻。In order to achieve the above object, the present invention provides a method for preparing an external ointment containing Evodia Fructus, which includes the following steps: 1. Mix Evodia Fructus that has not been ground or broken and olive oil, and then heat and extract to obtain an oil extract; 2. Filter the oil extract; 3. Add the filtered oil extract to beeswax while it is hot and stir until the beeswax is completely dissolved; 4. Leave the filtered oil extract and beeswax composition to cool.
本發明具有以下有益效果：1. 本發明將未經研磨、打碎之吳茱萸加熱萃取其有效成分，得大幅提升外敷時經皮吸收之效率。2. 本發明採用未經研磨、打碎之吳茱萸，得於加熱萃取過程經由觀察吳茱萸顏色變化，立即確認有效成分之萃取效率。3. 本發明採用橄欖油作為萃取溶劑，成分天然、穩定性高，得大幅提升吳茱萸之脂溶性有效成分之萃取效率。4. 本發明以科學方法系統化、標準化、簡易化其製程步驟，除得有效保留、提高吳茱萸之有效成分、縮短製程所需時間外，更大幅降低製程對於技術、設備之要求，製程容易且不易失敗。The present invention has the following beneficial effects: 1. The present invention heats and extracts the active ingredients of Evodia rutaecarpa without grinding and crushing, which can greatly improve the efficiency of transdermal absorption during external application. 2. The present invention uses Evodia Fructus that has not been ground or broken. The extraction efficiency of the active ingredients can be immediately confirmed by observing the color change of Evodia Fructus during the heating extraction process. 3. The present invention uses olive oil as the extraction solvent, which has natural ingredients and high stability, and can greatly improve the extraction efficiency of the fat-soluble active ingredients of Evodia Fructus. 4. The present invention uses scientific methods to systematize, standardize and simplify the process steps. In addition to effectively retaining and improving the active ingredients of Evodia Evodia and shortening the time required for the process, the present invention also significantly reduces the requirements for technology and equipment in the process. The process is easy and Not easy to fail.
本實施例提供一種含吳茱萸之外用藥膏之製備方法，可使用於製備治療嬰幼兒疾病如：嬰幼兒腸絞痛、腹瀉的藥物；亦可用於製備治療皮膚疾病如：濕疹、手、足汗皰疹、接觸性皮膚炎、異位性皮膚炎、褥瘡、甲癬等疾病的藥物；亦可用於製備治療骨科疾病如：橈骨莖突腱鞘炎疾病、肱骨外上髁炎，或其他肩、肘、腕、膝、踝等部位之肌腱炎等的藥物；亦可用於製備傷口痛癢，癒合不良或滲出液等病症的藥物，如：各類手術後傷口癒合不良。This embodiment provides a method for preparing a topical ointment containing Evodia Fructus, which can be used to prepare medicines for the treatment of infant diseases such as infant colic and diarrhea; and can also be used to prepare drugs for the treatment of skin diseases such as eczema, hand and foot sweating. Medicines for herpes, contact dermatitis, atopic dermatitis, bedsores, onychomycosis and other diseases; can also be used to prepare drugs for the treatment of orthopedic diseases such as: radial styloid tenosynovitis, lateral epicondylitis of the humerus, or other shoulders, elbows, It can be used to treat tendonitis in wrists, knees, ankles and other parts of the body; it can also be used to prepare medicines for wounds that are itchy, poor healing or exudate, such as poor wound healing after various surgeries.
該含吳茱萸之外用藥膏之製備方法，其包含以下步驟：1. 將未經研磨或打碎的吳茱萸，即僅經乾燥的吳茱萸果實與橄欖油混合後，加熱萃取得到一油萃取液；2. 將該油萃取液進行過濾；3. 將該經過濾的油萃取液趁熱加入蜂蠟中攪拌，至該蜂蠟完全溶解；4. 將該經過濾的油萃取液與蜂蠟之組合物靜置冷卻，即得。The preparation method of the ointment containing Evodia Fructus for external use includes the following steps: 1. Mix Evodia Fructus that has not been ground or broken, that is, only dried Evodia Fructus fruits, with olive oil, and then heat and extract to obtain an oil extract; 2. Filter the oil extract; 3. Add the filtered oil extract to beeswax while it is hot and stir until the beeswax is completely dissolved; 4. Leave the filtered oil extract and beeswax composition to cool. That’s it.
根據本發明實施例，較佳的，該吳茱萸、橄欖油及蜂蠟的比例為：吳茱萸300克；橄欖油1,000毫升（ml）；蜂蠟300克。According to the embodiment of the present invention, preferably, the ratio of the Evodia Fructus, olive oil and beeswax is: 300 grams of Evodia Fructus; 1,000 milliliters (ml) of olive oil; and 300 grams of beeswax.
根據本發明實施例，較佳的，更於步驟1另加入黃連，與未經研磨或打碎的吳茱萸，即僅經乾燥的吳茱萸果實及橄欖油一併混合、加熱萃取。更佳的，該吳茱萸、黃連、橄欖油及蜂蠟的比例為：吳茱萸50克；黃連300克；橄欖油1,000毫升；蜂蠟300克。更佳的，該吳茱萸、黃連、橄欖油及蜂蠟的比例亦可為：吳茱萸300克；黃連50克；橄欖油1,000毫升；蜂蠟300克。According to the embodiment of the present invention, preferably, Coptis chinensis is added in step 1, mixed with Evodia rutaecarpa that has not been ground or broken, that is, only dried Evodia rutaecarpa fruits and olive oil, and heated for extraction. More preferably, the proportions of Evodia, Coptis, olive oil and beeswax are: 50 grams of Evodia; 300 grams of Coptis; 1,000 ml of olive oil; and 300 grams of beeswax. More preferably, the ratio of Evodia, Coptis, olive oil and beeswax can also be: 300 grams of Evodia; 50 grams of Coptis; 1,000 ml of olive oil; 300 grams of beeswax.
根據本發明實施例，較佳的，該加熱萃取的方式為加熱橄欖油至沸騰後，再依據吳茱萸及橄欖油總量多寡，持續以文火加熱15至30分鐘，使吳茱萸由褐色轉變為黑色。According to the embodiment of the present invention, preferably, the heating extraction method is to heat the olive oil until it boils, and then continue to heat it over a slow fire for 15 to 30 minutes depending on the total amount of Evodia Fructus and olive oil, so that the Evodia Fructus changes from brown to black.
根據本發明實施例，較佳的，該加熱萃取的方式為於加熱萃取時不攪拌。According to the embodiment of the present invention, preferably, the heated extraction method is performed without stirring during the heated extraction.
本發明提供含吳茱萸之外用藥膏之製備方法之一實施例為：1. 吳茱萸油萃取液之製備：取藥材吳茱萸果實300克，無須研磨或打碎，另取市售之橄欖油1,000毫升，一併加入不鏽鋼鍋中混合，並以瓦斯爐加熱5分鐘至橄欖油沸騰，沸騰後再轉至文火持續加熱30分鐘，加熱過程中不需攪拌前述混合物，經確認鍋內吳茱萸由褐色轉變為黑色後即可熄火，即得吳茱萸油萃取液備用。2. 蜂蠟之製備：取藥材蜂蠟300克，置入另一不鏽鋼鍋備用。3. 含吳茱萸之外用藥膏之製備：將前述吳茱萸油萃取液，趁熱用過濾網過濾，倒入至含該蜂蠟的不鏽鋼鍋中，並同時攪拌鍋內，直至吳茱萸油萃取液完全溶化蜂蠟為止，靜置一段時間冷卻，即得一含吳茱萸之外用藥膏。One example of the method for preparing an ointment containing Evodia for external use provided by the present invention is: 1. Preparation of Evodia Fructus oil extract: Take 300 grams of Evodia Fructus fruit without grinding or breaking it, and take 1,000 ml of commercially available olive oil. Add the mixture to a stainless steel pot and heat it with a gas stove for 5 minutes until the olive oil boils. After boiling, turn to a simmer and continue heating for 30 minutes. There is no need to stir the aforementioned mixture during the heating process. After confirming that the Evodia Evodia in the pot has changed from brown to black Turn off the heat and obtain the Evodia Fructus Fructus oil extract for later use. 2. Preparation of beeswax: Take 300 grams of medicinal beeswax and place it in another stainless steel pot for later use. 3. Preparation of the ointment containing Evodia Fructus for external use: Filter the aforementioned Evodia Fructus oil extract with a filter while it is hot, pour it into a stainless steel pot containing the beeswax, and stir the pot at the same time until the Evodia Fructus oil extract completely dissolves the beeswax. , let it sit for a period of time to cool down, and then you can get an ointment containing Evodia Fructus for external use.
另一實施例為：1. 油萃取液之製備：取藥材吳茱萸果實50克，無須研磨或打碎，另取黃連300克、市售之橄欖油1,000毫升，一併加入不鏽鋼鍋中混合，並以瓦斯爐加熱5分鐘至橄欖油沸騰，沸騰後再轉至文火持續加熱30分鐘，加熱過程中不需攪拌前述混合物，經確認鍋內吳茱萸由褐色轉變為黑色後即可熄火，即得一油萃取液備用。2. 蜂蠟之製備：取藥材蜂蠟300克，置入另一不鏽鋼鍋備用。3. 含吳茱萸之外用藥膏之製備：將前述油萃取液，趁熱用過濾網過濾，倒入至含該蜂蠟的不鏽鋼鍋中，並同時攪拌鍋內，直至前述油萃取液完全溶化蜂蠟為止，靜置一段時間冷卻，即得一含吳茱萸之外用藥膏。Another example is: 1. Preparation of oil extract: Take 50 grams of Evodia Evodia fruit without grinding or breaking it, and take 300 grams of coptis and 1,000 ml of commercially available olive oil. Add them to a stainless steel pot and mix. Heat the olive oil with a gas stove for 5 minutes until the olive oil boils. After boiling, turn to a simmer and continue heating for 30 minutes. There is no need to stir the aforementioned mixture during the heating process. Turn off the heat after confirming that the Evodia evodia in the pot has changed from brown to black, and you will have an oil. Reserve the extract for later use. 2. Preparation of beeswax: Take 300 grams of medicinal beeswax and place it in another stainless steel pot for later use. 3. Preparation of external ointment containing Evodia Fructus: filter the aforementioned oil extract with a filter while it is hot, pour it into a stainless steel pot containing the beeswax, and stir the pot at the same time until the aforementioned oil extract completely dissolves the beeswax. Let it sit for a while to cool down, and you will get an ointment containing Evodia Fructus for external use.
又一實施例為：1. 油萃取液之製備：取藥材吳茱萸果實300克，無須研磨或打碎，另取黃連50克、市售之橄欖油1,000毫升，一併加入不鏽鋼鍋中混合，並以瓦斯爐加熱5分鐘至橄欖油沸騰，沸騰後再轉至文火持續加熱30分鐘，加熱過程中不需攪拌前述混合物，經確認鍋內吳茱萸由褐色轉變為黑色後即可熄火，即得一油萃取液備用。2. 蜂蠟之製備：取藥材蜂蠟300克，置入另一不鏽鋼鍋備用。3. 含吳茱萸之外用藥膏之製備：將前述油萃取液，趁熱用過濾網過濾，倒入至含該蜂蠟的不鏽鋼鍋中，並同時攪拌鍋內，直至前述油萃取液完全溶化蜂蠟為止，靜置一段時間冷卻，即得一含吳茱萸之外用藥膏。Another example is: 1. Preparation of oil extract: Take 300 grams of Evodia Evodia fruit without grinding or breaking it, and take 50 grams of Coptis chinensis and 1,000 ml of commercially available olive oil. Add them to a stainless steel pot and mix. Heat the olive oil with a gas stove for 5 minutes until the olive oil boils. After boiling, turn to a simmer and continue heating for 30 minutes. There is no need to stir the aforementioned mixture during the heating process. Turn off the heat after confirming that the Evodia evodia in the pot has changed from brown to black, and you will have an oil. Reserve the extract for later use. 2. Preparation of beeswax: Take 300 grams of medicinal beeswax and place it in another stainless steel pot for later use. 3. Preparation of external ointment containing Evodia Fructus: filter the aforementioned oil extract with a filter while it is hot, pour it into a stainless steel pot containing the beeswax, and stir the pot at the same time until the aforementioned oil extract completely dissolves the beeswax. Let it sit for a while to cool down, and you will get an ointment containing Evodia Fructus for external use.
前述含吳茱萸之外用藥膏可依據患者年齡、體重、健康狀況、具體病情等因素，決定其使用頻率與次數，並得視情況單獨使用，或與其他口服藥劑、其他治療方式併同使用。The frequency and frequency of use of the aforementioned topical ointment containing Evodia can be determined based on the patient's age, weight, health status, specific illness and other factors, and can be used alone or in combination with other oral medications or other treatments depending on the situation.
本發明採用經乾燥且未經研磨或打碎的吳茱萸果實。吳茱萸（學名 Tetradium ruticarpum，原名 Euodia ruticarpa），為芸香科植物，其藥性辛、苦、熱，具有散寒止痛、疏肝下氣、開鬱止痛的功效，主要用於治療嘔逆吞酸、頭痛、痛經、胃寒疼痛、腳氣水腫、口舌生瘡等病症。 The present invention uses Evodia rutaecarpa fruits that have been dried and not ground or broken. Evodia (scientific name: Tetradium ruticarpum , formerly known as Euodia ruticarpa ) is a plant of the Rutaceae family. Its medicinal properties are acrid, bitter, and hot. It has the effects of dispelling cold and relieving pain, soothing the liver and lowering qi, relieving depression and relieving pain. It is mainly used to treat vomiting, acid swallowing, and headache. , dysmenorrhea, stomach cold pain, athlete's foot edema, mouth and tongue sores and other symptoms.
本發明所採用之黃連（學名： Coptis chinensis），其藥性寒、味苦，具有清熱燥濕，瀉火解毒的功效，主要用於治療濕疹、口瘡、胃腸濕熱等病症。 Coptidis chinensis (scientific name: Coptis chinensis ) used in the present invention has cold properties and bitter taste. It has the effects of clearing away heat and drying dampness, purging fire and detoxifying. It is mainly used to treat eczema, aphtha, gastrointestinal damp-heat and other diseases.
本發明所採用之蜂蠟，其藥性甘、微温，具有收澀，斂瘡，生肌，止痛的功效，外用主要用於治療潰爛不歛，臁瘡糜爛，創傷、燒燙傷等病症。The beeswax used in the present invention has sweet and lukewarm medicinal properties and has the effects of astringent, sore astringent, myogenic and analgesic effects. It is mainly used for external use to treat ulcers, ecthyma, wounds, burns and other diseases.
本發明所採用之橄欖油，其藥性平，味甘酸，具有清熱解毒、退熱消炎、生津除煩的功效，得作為治療皮膚科、骨科發炎性病症之佐劑。The olive oil used in the present invention has mild medicinal properties and a sweet and sour taste. It has the effects of clearing away heat and detoxifying, reducing fever and inflammation, promoting fluid production and relieving troubles, and can be used as an adjuvant in the treatment of dermatological and orthopedic inflammatory diseases.
此外，本發明亦得依據中醫藥物配伍規則，額外加入特定中藥佐劑等，以達成更佳之治療效果及更廣泛之用途。In addition, the present invention can also add specific traditional Chinese medicine adjuvants according to the compatibility rules of traditional Chinese medicine to achieve better therapeutic effects and wider uses.
綜上所述，本發明具有以下的有益效果：1. 本發明將未經研磨、打碎之吳茱萸加熱萃取其有效成分，得大幅提升外敷時經皮吸收之效率。2. 本發明採用未經研磨、打碎之吳茱萸，得於加熱萃取過程經由觀察吳茱萸顏色變化，立即確認有效成分之萃取效率。3. 本發明採用橄欖油作為萃取溶劑，成分天然、穩定性高，得大幅提升吳茱萸之脂溶性有效成分之萃取效率。4. 本發明以科學方法系統化、標準化、簡易化其製程步驟，除得有效保留、提高吳茱萸之有效成分、縮短製程所需時間外，更大幅降低製程對於技術、設備之要求，製程容易且不易失敗。To sum up, the present invention has the following beneficial effects: 1. The present invention heats and extracts the active ingredients of Evodia rutaecarpa without grinding and crushing, which can greatly improve the efficiency of transdermal absorption during external application. 2. The present invention uses Evodia Fructus that has not been ground or broken. The extraction efficiency of the active ingredients can be immediately confirmed by observing the color change of Evodia Fructus during the heating extraction process. 3. The present invention uses olive oil as the extraction solvent, which has natural ingredients and high stability, and can greatly improve the extraction efficiency of the fat-soluble active ingredients of Evodia Fructus. 4. The present invention uses scientific methods to systematize, standardize and simplify the process steps. In addition to effectively retaining and improving the active ingredients of Evodia Evodia and shortening the time required for the process, the present invention also significantly reduces the requirements for technology and equipment in the process. The process is easy and Not easy to fail.
以上所述僅為本發明之較佳可行實施例，非因此侷限本發明之專利權保護範圍，故舉凡運用本發明說明書內容所為之等效技術變化，均應認為包含於本發明之權利保護範圍內，併予陳明。The above descriptions are only the best possible embodiments of the present invention, and do not limit the scope of patent protection of the present invention. Therefore, any equivalent technical changes made by applying the contents of the specification of the present invention should be considered to be included in the scope of patent protection of the present invention. Inside, and make it clear.
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| CN114224951A (en) * | 2021-12-31 | 2022-03-25 | 北京盈科瑞创新医药股份有限公司 | Industrial preparation method of total alkaloids in coptis and evodia composition |
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