TWI409076B - Medical herb composition for increasing inflammation, swell and pain, method for manufacturing medical herb abstract, application for the same - Google Patents

Medical herb composition for increasing inflammation, swell and pain, method for manufacturing medical herb abstract, application for the same Download PDF

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TWI409076B
TWI409076B TW98129069A TW98129069A TWI409076B TW I409076 B TWI409076 B TW I409076B TW 98129069 A TW98129069 A TW 98129069A TW 98129069 A TW98129069 A TW 98129069A TW I409076 B TWI409076 B TW I409076B
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extract
medicinal material
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chinese herbal
organic solvent
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TW201106960A (en
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Tian Shung Wu
Tai Ting Chou
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Uni President Biotech Co Ltd
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Abstract

A medical herb composition for increasing inflammation, swell and pain includes first and herb materials. The first herb material includes Bletillae Rhizoma, Cinnamomi Cortex, Angelicae Dahuricae Radix, Angelicae sinensis Radix, Paeoniae Radix, Notopterygii Rhizoma Et Radix, Linderae Radix, Glycyrrhizae Radix, Angelicae pubescentis Radix, and Rheiradix Et Rhizoma. The second herb material is selected from one, two or three of the group consisting of Zingiber officinale, Qlibanum and Myrrha. Additional material (Zingiber officinale, Qlibanum and Myrrha) of the medical herb composition of the present invention can increase curative effect. In addition, the present invention discloses the process for manufacturing abstract. For example, the first and herb materials and an organic solvent are put into a vessel, is heated and extracted, is filtered during heating. Then, the extracted filtrate is concentrated to an extract. Compared with the conventional prescription, the relative steps of the process for manufacturing abstract of the medical herb composition of the present invention have no disadvantage of the conventional prescription.

Description

用於消炎消腫止痛之中草藥組成物、製備方法及其應用Medicinal composition for anti-inflammatory, swelling and pain relief, preparation method and application thereof

本發明係有關於一種用於消炎消腫止痛之中草藥組成物,更特別有關於一種用於消炎消腫止痛之中草藥萃取物、製備方法及其應用。The invention relates to a herbal composition for anti-inflammatory, swelling and analgesic, and more particularly to an herbal extract for anti-inflammatory, swelling and analgesic, a preparation method and application thereof.

由於現代人的生活越來越緊張、忙碌,並且沒有太多時間運動,再加上長期的站著或坐著的結果。因此,現代人常常有許多文明病,例如神經或筋骨發炎、肌肉酸痛等症狀。若疏於治療,則造成惡性循環、氣血不順。Because modern people's lives are getting more and more intense, busy, and there is not much time for exercise, plus the result of standing or sitting for a long time. Therefore, modern people often have many civilized diseases, such as inflammation of the nerves or muscles, muscle soreness and other symptoms. If it is neglected, it will cause a vicious circle and qi and blood.

自古以來,中國人應用中草藥於疾病治療已有幾千年經驗,一直都以固本抗邪的方式治療外來的疾病,並解決內在的發炎或酸痛問題,而使中草藥得以延續至今。Since ancient times, Chinese people have used Chinese herbal medicine for thousands of years of experience in the treatment of diseases. They have been treating foreign diseases in a way that is solid and resistant to evil, and have solved the problem of internal inflammation or soreness, so that Chinese herbal medicine can continue to this day.

目前,中草藥業者為了迎合現代人的方便需求,紛紛研發出中草藥貼布。該中草藥貼布具有外用治療方便性,只須針對身體酸痛或不適的位置予以貼敷在皮膚上,藉由該中草藥貼布的成分滲入於人體皮膚內,慢慢將藥效予以發揮出來。At present, Chinese herbal medicine manufacturers have developed Chinese herbal medicine patches in order to meet the convenience needs of modern people. The Chinese herbal patch has the convenience of external treatment, and is only applied to the skin at a position where the body is sore or uncomfortable, and the ingredients of the Chinese herbal patch are infiltrated into the human skin, and the effect is gradually exerted.

萬應膏自古以來都被用於治療身體酸痛及不適等症狀,因此在功效上已被長期認可,其配方組成為中草藥之川烏、木鱉子、草烏、生地黃、白蘞、白芨、肉桂、白芷、當歸、赤芍、羌活、苦參、烏藥、甘草、獨活、元參、大黃等17種藥材。然而,其中部分藥材,例如川烏、木鱉子及草烏目前已被證實具有毒性及皮膚刺激性,因此使用後容易造成皮膚不適,如下表1所示。Wanying cream has been used to treat body aches and discomforts since ancient times, so it has been recognized for a long time. Its formula is composed of Chuanwu, Muzizi, Caowu, Rehmannia, Radix, Radix Paeoniae Alba. 17 kinds of medicinal herbs such as cinnamon, white peony, angelica, red peony, medlar, sophora, black medicinal herbs, licorice, solo, yuan ginseng and rhubarb. However, some of the medicinal materials, such as Chuanwu, Muxizi and Caowu, have been proven to be toxic and skin irritating, so they are prone to skin discomfort after use, as shown in Table 1 below.

此外,古方萬應膏多以麻油進行藥材成分萃取,容易因溫度過高破壞藥材內的成分,或有效成分萃取不完整,品質管制不易以及成型時加入大量氧化鋅而造成重金屬殘留的問題等。In addition, Gufang Wanying Ointment uses sesame oil to extract medicinal ingredients, which is easy to destroy the ingredients in the medicinal materials due to excessive temperature, or the extraction of active ingredients is not complete, the quality control is not easy, and the problem of heavy metal residue is caused by adding a large amount of zinc oxide during molding.

因此,需要提供一種用於消炎消腫止痛之中草藥組成物,能夠解決前述的問題。Therefore, it is necessary to provide a herbal composition for anti-inflammatory, swelling, and analgesic, which can solve the aforementioned problems.

本發明提供一種用於消炎消腫止痛之中草藥組成物,包含一第一類藥材及一第二類藥材。該第一類藥材包含白芨、肉桂、白芷、當歸、芍藥、羌活、烏藥、甘草、獨活、大黃。該第二類藥材係選自薑、乳香及沒藥所構成之群組中的一者、二者或三者。The invention provides a herbal composition for anti-inflammatory, swelling and analgesic, comprising a first medicinal material and a second medicinal material. The first type of medicinal materials include white peony, cinnamon, white peony, angelica, peony, scorpion, black medicinal herb, licorice, solitary, and rhubarb. The second type of medicinal material is selected from one, two or three of the group consisting of ginger, frankincense and myrrh.

本發明之用於消炎消腫止痛之中草藥組成物並未包含川烏、木鱉子、草烏、生地黃、白蘞、苦參及元參。因此,本發明之用於消炎消腫止痛之中草藥組成物完全不同於萬應膏固有配方。再者,由於川烏、木鱉子及草烏已被證實具有毒性及皮膚刺激性,因此本發明之中草藥組成物不會有萬應膏固有配方之缺點。另外,相較於萬應膏固有配方,本發明之中草藥組成物更包含了添加藥材(薑、乳香及沒藥),以增加其療效。The herbal composition for anti-inflammatory, swelling and pain relief of the present invention does not include Chuanwu, Muzizi, Caowu, Rehmannia, Radix Paeoniae Alba, Sophora flavescens and Yuanshen. Therefore, the herbal composition for anti-inflammatory, swelling, and analgesic of the present invention is completely different from the inherent formulation of Wanying Cream. Furthermore, since Chuanwu, Muxizi and Caowula have been confirmed to be toxic and skin irritating, the herbal composition of the present invention does not have the disadvantages of the inherent formulation of Wanying Cream. In addition, compared with the inherent formulation of Wanying Cream, the herbal composition of the present invention further comprises an added medicinal material (ginger, frankincense and myrrh) to increase its therapeutic effect.

本發明選擇對皮膚及人體無刺激、過敏性之有效中草藥之處方組成;特殊之萃取、製備方法及以動物試驗法驗證本發明之消炎消腫止痛之功效,有別於一般傳統之萬應膏及市售之中藥貼布,下文將配合所附圖示,作詳細說明。The invention selects the effective Chinese herbal medicine which has no irritation and allergic effect on the skin and the human body; the special extraction, preparation method and the animal test method verify the anti-inflammatory swelling and pain relief effect of the invention, which is different from the general traditional Wanying cream And the commercially available traditional Chinese medicine patch, which will be described in detail below with the accompanying drawings.

本發明提供一種用於消炎消腫止痛之中草藥組成物,其包含一第一類藥材及一第二類藥材。該第一類藥材,包含白芨、肉桂、白芷、當歸、芍藥(例如赤芍)、羌活、烏藥、甘草、獨活、大黃,其中該第一類藥材為基礎藥材。該第二類藥材,其選自薑、乳香及沒藥所構成之群組中的一者、二者或三者,其中該第二類藥材為添加藥材。詳細而言,本發明之中草藥組成物包含下表2之7種排列組合的藥材。The invention provides a herbal composition for anti-inflammatory, swelling and analgesic, which comprises a first medicinal material and a second medicinal material. The first type of medicinal material comprises white peony, cinnamon, white peony, angelica, peony (such as red peony), medlar, black medicinal herb, licorice, lycorrhea, rhubarb, wherein the first medicinal material is a basic medicinal material. The second type of medicinal material is selected from one, two or three of the group consisting of ginger, frankincense and myrrh, wherein the second medicinal material is an added medicinal material. In detail, the herbal composition of the present invention comprises seven kinds of medicinal materials arranged in combination in Table 2 below.

當該第二類藥材選自薑、乳香及沒藥所構成之群組中的一者時,則該中草藥組成物包含11味藥材,每一味藥材之重量百分比為9.09%±5%之範圍內。當該第二類藥材選自薑、乳香及沒藥所構成之群組中的二者時,則該中草藥組成物包含12味藥材,每一味藥材之重量百分比為8.33%±5%之範圍內。當該第二類藥材選自薑、乳香及沒藥所構成之群組中的三者時,則該中草藥組成物包含13味藥材,每一味藥材之重量百分比為7.69%±5%之範圍內。When the second type of medicinal material is selected from the group consisting of ginger, frankincense and myrrh, the Chinese herbal medicine composition comprises 11 medicinal materials, and the weight percentage of each medicinal material is in the range of 9.09%±5%. . When the second type of medicinal material is selected from the group consisting of ginger, frankincense and myrrh, the Chinese herbal medicine composition comprises 12 medicinal materials, and the weight percentage of each medicinal material is in the range of 8.33%±5%. . When the second type of medicinal material is selected from the group consisting of ginger, frankincense and myrrh, the Chinese herbal medicine composition comprises 13 medicinal materials, and the weight percentage of each medicinal material is within the range of 7.69%±5%. .

本發明之第一類藥材為基礎藥材,而該第二類藥材為添加藥材。表2之7種排列組合的藥材,皆可達成本發明之療效。本發明僅以第7種組合:中草藥組成物包含有13味藥材(亦即白芨、肉桂、白芷、當歸、芍藥、羌活、烏藥、甘草、獨活、大黃、薑、乳香及沒藥)為實施例說明如後,而其餘6種組合亦可以用類似方式實施,不再贅述。The first type of medicinal material of the present invention is a basic medicinal material, and the second medicinal material is an added medicinal material. The medicinal materials of the seven kinds of arrangement and combination in Table 2 can reach the therapeutic effect of the invention. The invention only uses the seventh combination: the Chinese herbal medicine composition contains 13 herbs (ie, white peony, cinnamon, white peony, angelica, peony, medlar, black medicinal herb, licorice, lycox, rhubarb, ginger, frankincense and myrrh) The following is a description of the embodiments, and the other six combinations can also be implemented in a similar manner, and will not be described again.

本發明之一實施例之用於消炎消腫止痛之中草藥組成物的配方與萬應膏的固有配方之比較,如下表3。A comparison of the formulation of the anti-inflammatory, anti-inflammatory and analgesic herbal composition of the present invention with the intrinsic formula of the Wanying cream is shown in Table 3 below.

本發明之用於消炎消腫止痛之中草藥組成物並未包含川烏、木鱉子、草烏、生地黃、白蘞、苦參及元參。因此,本發明之用於消炎消腫止痛之中草藥組成物完全不同於萬應膏固有配方。再者,由於川烏、木鱉子及草烏已被證實具有毒性及皮膚刺激性,因此本發明之中草藥組成物不會有萬應膏固有配方之缺點。另外,相較於萬應膏固有配方,本發明之中草藥組成物更包含了添加藥材(薑、乳香及沒藥),以增加其療效。The herbal composition for anti-inflammatory, swelling and pain relief of the present invention does not include Chuanwu, Muzizi, Caowu, Rehmannia, Radix Paeoniae Alba, Sophora flavescens and Yuanshen. Therefore, the herbal composition for anti-inflammatory, swelling, and analgesic of the present invention is completely different from the inherent formulation of Wanying Cream. Furthermore, since Chuanwu, Muxizi and Caowula have been confirmed to be toxic and skin irritating, the herbal composition of the present invention does not have the disadvantages of the inherent formulation of Wanying Cream. In addition, compared with the inherent formulation of Wanying Cream, the herbal composition of the present invention further comprises an added medicinal material (ginger, frankincense and myrrh) to increase its therapeutic effect.

根據本發明之用於消炎消腫止痛之中草藥組成物,其藥材的文獻功效,如下表4。According to the present invention, the documentary efficacy of the medicinal material for the anti-inflammatory, swelling and analgesic herbal composition is as shown in Table 4 below.

本發明之中草藥萃取物,其可藉由本發明之第一實施例之製備方法所製得。參考第1圖,該第一實施例之製備方法包含下列步驟:在步驟100中,提供一第一類藥材及一第二類藥材,其中該第一類藥材包含白芨、肉桂、白芷、當歸、芍藥(例如赤芍、白芍)、羌活、烏藥、甘草、獨活、大黃,該第一類藥材為基礎藥材,且該第二類藥材選自薑(例如乾薑、生薑)、乳香及沒藥,該第二類藥材為添加藥材。在步驟102中,加入一有機溶劑(例如甲醇、乙醇或丙酮、甲基乙基酮、煤油(石油醚)及己烷等),並將該第一及第二類藥材與該有機溶劑置入一第一容器(亦即萃取桶)內,使該第一及第二類藥材與該有機溶劑之重量百分比為1:N,以形成一混合液,其中N介於3與12之間的數值。較佳地,N為8。在步驟104中,加熱該混合液至一預定溫度並萃取一預定時間,以進行萃取,其中該預定溫度介於30℃與100℃之間。當該有機溶劑為乙醇(亦即酒精)時,較佳地該預定溫度介於乙醇之沸點加減5℃的範圍內。該預定時間介於1與6小時之間。在步驟106中,趁熱過濾該混合液,取萃取之濾液至一第二容器(亦即量杯)。在步驟108中,將萃取之濾液濃縮至含水量10%~40%、該有機溶劑含量3%~30%之浸膏。較佳地,將萃取之濾液濃縮至含水量10%~20%、有機溶劑含量5%~10%之浸膏。該浸膏為中間產品,可方便運送及販賣,以進行後續最終產品。在步驟110中,將萃取之殘渣自該容器移除。The herbal extract of the present invention can be obtained by the production method of the first embodiment of the present invention. Referring to FIG. 1, the preparation method of the first embodiment comprises the following steps: In step 100, a first type of medicinal material and a second medicinal material are provided, wherein the first medicinal material comprises white peony, cinnamon, white peony, angelica, Peony (eg, red peony, white peony), medlar, black medicinal herb, licorice, lycoxual, rhubarb, the first medicinal material is the basic medicinal material, and the second medicinal material is selected from ginger (eg dried ginger, ginger), Frankincense and myrrh, the second type of medicine is added herbs. In step 102, an organic solvent (such as methanol, ethanol or acetone, methyl ethyl ketone, kerosene (petroleum ether), hexane, etc.) is added, and the first and second medicinal materials are placed in the organic solvent. In a first container (ie, an extraction barrel), the weight percentage of the first and second types of medicinal materials and the organic solvent is 1:N to form a mixed solution, wherein N is between 3 and 12 . Preferably, N is 8. In step 104, the mixture is heated to a predetermined temperature and extracted for a predetermined time to perform extraction, wherein the predetermined temperature is between 30 ° C and 100 ° C. When the organic solvent is ethanol (i.e., alcohol), it is preferred that the predetermined temperature is in the range of 5 ° C of the boiling point of the ethanol. The predetermined time is between 1 and 6 hours. In step 106, the mixture is filtered while hot, and the extracted filtrate is taken to a second container (i.e., a measuring cup). In step 108, the extracted filtrate is concentrated to an extract having a water content of 10% to 40% and an organic solvent content of 3% to 30%. Preferably, the extracted filtrate is concentrated to an extract having a water content of 10% to 20% and an organic solvent content of 5% to 10%. The extract is an intermediate product that can be easily shipped and sold for subsequent final products. In step 110, the extracted residue is removed from the container.

本發明之中草藥萃取物,其亦可藉由本發明之第二實施例之製備方法所製得。參考第2圖,該第二實施例之製備方法包含下列步驟:在步驟200中,提供一第一類藥材及一第二類藥材,其中該第一類藥材包含白芨、肉桂、白芷、當歸、芍藥、羌活、烏藥、甘草、獨活、大黃,該第一類藥材為基礎藥材,且該第二類藥材選自薑、乳香及沒藥,該第二類藥材為添加藥材。在步驟202中,加入一有機溶劑,並將該第一及第二類藥材與該有機溶劑置入一第一容器(亦即萃取桶)內,使該第一及第二類藥材與該有機溶劑之重量百分比為1:N,以形成一第一混合液,其中N介於3與12之間的數值。較佳地,N為8。在步驟204中,加熱該第一混合液至一第一預定溫度並萃取一第一預定時間,以進行第1次萃取,其中該第一預定溫度介於30℃與100℃之間。當該有機溶劑為乙醇時,較佳地該第一預定溫度介於乙醇之沸點加減5℃的範圍內。該第一預定時間介於1與6小時之間。在步驟206中,趁熱過濾該第一混合液,取第1次萃取之濾液至一第二容器(亦即量杯)。在步驟208中,保留第1次萃取之殘渣。在步驟210中,重新添加該有機溶劑,使該藥材與該有機溶劑之重量百分比回到1:N,以形成一第二混合液,其中N介於3與12之間的數值。較佳地,N為8。在步驟212中,加熱該第二混合液至一第二預定溫度並萃取一第二預定時間,以進行第2次萃取,其中該第二預定溫度介於30℃與100℃之間。當該有機溶劑為乙醇時,較佳地該第二預定溫度介於乙醇之沸點加減5℃的範圍內。該第二預定時間介於1與6小時之間。在步驟214中,趁熱過濾該第二混合液,取第2次萃取之濾液。在步驟216中,混合第一次萃取之濾液與第二次萃取之濾液。在步驟218中,將該混合濾液濃縮至含水量10%~40%、該有機溶劑含量3%~30%之浸膏。較佳地,將混合濾液濃縮至含水量10%~20%、有機溶劑含量5%~10%之浸膏。該浸膏為中間產品,可方便運送及販賣,以進行後續最終產品。在步驟220中,將第2次萃取之殘渣自該容器移除。The herbal extract of the present invention can also be obtained by the production method of the second embodiment of the present invention. Referring to FIG. 2, the preparation method of the second embodiment comprises the following steps: In step 200, a first type of medicine and a second type of medicine are provided, wherein the first type of medicine comprises white peony, cinnamon, white peony, angelica, The first type of medicinal material is selected from the group consisting of ginger, frankincense and myrrh, and the second type of medicinal material is added medicinal material. In step 202, an organic solvent is added, and the first and second types of medicinal materials and the organic solvent are placed in a first container (ie, an extraction barrel) to make the first and second medicinal materials and the organic The weight percentage of solvent is 1:N to form a first mixture, where N is between 3 and 12. Preferably, N is 8. In step 204, the first mixed liquid is heated to a first predetermined temperature and extracted for a first predetermined time to perform a first extraction, wherein the first predetermined temperature is between 30 ° C and 100 ° C. When the organic solvent is ethanol, preferably the first predetermined temperature is in the range of 5 ° C of the boiling point of the ethanol. The first predetermined time is between 1 and 6 hours. In step 206, the first mixture is filtered while hot, and the first extracted filtrate is taken to a second container (i.e., a measuring cup). In step 208, the residue of the first extraction is retained. In step 210, the organic solvent is re-added, and the weight percentage of the medicinal material and the organic solvent is returned to 1:N to form a second mixed solution, wherein N is between 3 and 12. Preferably, N is 8. In step 212, the second mixed liquid is heated to a second predetermined temperature and extracted for a second predetermined time to perform a second extraction, wherein the second predetermined temperature is between 30 ° C and 100 ° C. When the organic solvent is ethanol, preferably the second predetermined temperature is in the range of 5 ° C of the boiling point of the ethanol. The second predetermined time is between 1 and 6 hours. In step 214, the second mixture is filtered while hot, and the second extracted filtrate is taken. In step 216, the first extracted filtrate and the second extracted filtrate are mixed. In step 218, the mixed filtrate is concentrated to an extract having a water content of 10% to 40% and an organic solvent content of 3% to 30%. Preferably, the mixed filtrate is concentrated to an extract having a water content of 10% to 20% and an organic solvent content of 5% to 10%. The extract is an intermediate product that can be easily shipped and sold for subsequent final products. In step 220, the residue from the second extraction is removed from the container.

參考第3圖,本發明之中草藥萃取物可應用於中草藥貼布300。該中草藥貼布300包含一膠帯層310及一中草藥藥劑層320。該中草藥藥劑層320配置於該膠帯層310上。在本實施例中,該中草藥藥劑層包含一稀釋劑及本發明之中草藥萃取物的浸膏。該中草藥萃取物的浸膏(中間產品)摻入該稀釋劑中,如此以形成該中草藥藥劑層(最終產品)。該稀釋劑包含乙醇、水及水性黏膠。該中草藥貼布300具有中草藥萃取物之含量為50~3500mg/14g(每片中草藥貼布)。Referring to Fig. 3, the herbal extract of the present invention can be applied to a Chinese herbal patch 300. The herbal patch 300 comprises a capsule layer 310 and a herbal medicine layer 320. The herbal medicine layer 320 is disposed on the capsule layer 310. In this embodiment, the herbal medicine layer comprises a diluent and an extract of the herbal extract of the present invention. The extract of the Chinese herbal extract (intermediate product) is incorporated into the diluent so as to form the herbal medicine layer (final product). The diluent comprises ethanol, water and an aqueous binder. The Chinese herbal patch 300 has a Chinese herbal extract content of 50 to 3500 mg/14 g (each herbal patch).

參考第4圖,本發明之中草藥萃取物可應用於中草藥噴劑。在本實施例中,該中草藥噴劑400包含一稀釋劑及本發明之中草藥萃取物的浸膏。該中草藥萃取物的浸膏(中間產品)摻入該稀釋劑中,如此以形成該中草藥噴劑(最終產品)。該稀釋劑包含乙醇、多醇類、水。該中草藥噴劑400具有中草藥萃取物之含量為10~500mg/g。在另一實施例中,該中草藥噴劑不須包含濃縮後的浸膏(中間產品),而是包含濃縮前的萃取濾液(亦為中間產品),如此減少濃縮步驟,可降低製程時間及成本。Referring to Figure 4, the herbal extract of the present invention can be applied to a Chinese herbal spray. In this embodiment, the herbal spray 400 comprises a diluent and an extract of the herbal extract of the present invention. The extract of the Chinese herbal extract (intermediate product) is incorporated into the diluent so as to form the herbal spray (final product). The diluent comprises ethanol, polyols, water. The Chinese herbal medicine spray 400 has a Chinese herbal medicine extract content of 10 to 500 mg/g. In another embodiment, the Chinese herbal medicine spray does not need to contain the concentrated extract (intermediate product), but includes the extraction filtrate (also an intermediate product) before concentration, thus reducing the concentration step, thereby reducing the process time and cost. .

參考第5圖,本發明之在本實施例中,中草藥萃取物可應用於中草藥藥膏500,藥膏又可分為油膏、水性凝膠及乳膏。該中草藥藥膏500包含一稀釋劑及本發明之中草藥萃取物的浸膏。該中草藥萃取物的浸膏(中間產品)摻入該稀釋劑中,如此以形成該中草藥藥膏(最終產品)。該稀釋劑中油膏包含凡士林、白蠟油、非離子界面活性劑;水性凝膠則包含乙醇、水及非離子界面活性劑;乳膏則包含油脂、蠟及乳化劑。該中草藥藥膏500具有中藥萃取物之含量均為10~500mg/g。Referring to Fig. 5, in the present embodiment, the Chinese herbal medicine extract can be applied to the Chinese herbal medicine cream 500, and the ointment can be further divided into an ointment, a water-based gel and a cream. The herbal ointment 500 comprises a diluent and an extract of the herbal extract of the present invention. The extract of the Chinese herbal extract (intermediate product) is incorporated into the diluent so as to form the herbal ointment (final product). The diluent contains ointment, white wax oil and nonionic surfactant; the aqueous gel contains ethanol, water and nonionic surfactant; the cream contains grease, wax and emulsifier. The Chinese herbal medicine ointment 500 has a Chinese herbal medicine extract content of 10 to 500 mg/g.

再者,本發明之中草藥萃取物亦可應用於內服製劑,而內服製劑又可分為散劑、丸劑及錠劑。在本實施例中,該內服製劑包含一稀釋劑及本發明之中草藥萃取物的浸膏。該中草藥萃取物的浸膏(中間產品)摻入該稀釋劑中,如此以形成該內服製劑(最終產品)。散劑及丸劑之稀釋劑包含澱粉及糖類(如糖或蜂蜜);錠劑之稀釋劑則包含結晶性纖維素為主。該內服製劑具有中藥萃取物之含量為3~250mg/g。Furthermore, the herbal extract of the present invention can also be applied to an internal preparation, and the internal preparation can be further divided into a powder, a pill and a lozenge. In this embodiment, the internal preparation comprises a diluent and an extract of the herbal extract of the present invention. The extract of the Chinese herbal extract (intermediate product) is incorporated into the diluent so as to form the internal preparation (final product). The diluent of the powder and the pill contains starch and sugar (such as sugar or honey); the diluent of the tablet contains crystalline cellulose. The internal preparation has a content of a traditional Chinese medicine extract of 3 to 250 mg/g.

另外,上述中草藥萃取物包含下列9種主要指標成分:芍藥苷(Paeoniflorin)、阿魏酸(Ferulic acid)、桂皮醛(Cinnamaldehyde)、甘草甜苷(Glycyrrhizin)、大黃酸(Rhein)、歐前胡素(Imperatorin)、蛇床子素(Osthol)、異歐前胡素(Isoimperatorin)以及生薑酚(Gingerol),其中每1g萃取物內所含之指標成分的含量分別為:芍藥苷(Paeoniflorin)4.466~1.488mg、阿魏酸(Ferulic acid)0.382~0.127mg、桂皮醛(Cinnamaldehyde)2.159~0.720mg、甘草甜苷(Glycyrrhizin)9.677~3.226mg、大黃酸(Rhein)1.013~0.338mg、歐前胡素(Imperatorin)0.727~0.242mg、蛇床子素(Osthol)1.389~0.463mg、異歐前胡素(Isoimperatorin)0.709~0.236mg以及生薑酚(Gingerol)0.144~0.432mg。In addition, the above-mentioned herbal extract contains the following nine main indicator components: Paeoniflorin, Ferulic acid, Cinnamaldehyde, Glycyrrhizin, Rhein, and Eucalyptus. Imperatorin, Osthol, Isoimperatorin, and Gingerol, in which the content of the indicator components per 1 g of extract is: Paeoniflorin 4.466~1.488mg, ferulic acid (0.33~0.127mg), Cinnamaldehyde 2.19~0.720mg, Glycyrrhizin 9.767~3.226mg, Rhein 1.013~0.338mg, Europe Imperatorin 0.727~0.242mg, Osthol 1.389~0.463mg, Isoimperatorin 0.709~0.236mg and Gingerol 0.144~0.432mg.

本發明之實驗例及數據:Experimental examples and data of the present invention:

A.各藥材萃取浸膏對於動物皮膚刺激性試驗:A. Extracting extracts of various medicinal materials for animal skin irritation test:

萬應膏的固有配方及本發明之中草藥組成物配方的各藥材與95%乙醇以1:8的重量比於廻流萃取裝置以80℃萃取3小時,重複2次,收集2次萃取液過濾後,以減壓濃縮機濃縮成浸膏。分別取25μl浸膏以及陽性和陰性對照品給藥於已剔除背毛之動物皮膚,經過24小時刺激後,觀察紀錄貼後24、48及78小時皮膚之反應,依皮膚刺激性計分系統評分法(如下表5)及皮膚刺激性指標(Primary Dermal Irritation Index)(如下表6),用以評估其皮膚的刺激程度(如下表7)。The intrinsic formula of Wanying paste and the medicinal materials of the herbal composition of the present invention and 95% ethanol were extracted by a turbulent flow extraction device at a weight ratio of 1:8 at 80 ° C for 3 hours, repeated twice, and two times of extract filtration were collected. Thereafter, it was concentrated into a extract by a vacuum condenser. 25 μl of the extract and positive and negative controls were administered to the skin of the animal with the back hair removed. After 24 hours of stimulation, the skin reaction was observed at 24, 48 and 78 hours after the recording, and scored according to the skin irritation scoring system. The method (Table 5 below) and the Primary Dermal Irritation Index (Table 6 below) were used to assess the degree of skin irritation (Table 7 below).

表7Table 7 皮膚的刺激程度Skin irritation

表7可得知,本發明之中草藥組成物配方的部分藥材雖然具有弱刺激性,但是本發明之浸膏不具有刺激性。然而,萬應膏卻具有中度刺激性。As can be seen from Table 7, although some of the medicinal materials of the herbal composition of the present invention have weak irritation, the extract of the present invention is not irritating. However, Wan Ying cream is moderately irritating.

B.本發明之中草藥組成物配方的藥材較佳萃取條件:B. The preferred extraction conditions of the herbal composition of the present invention are:

本發明之中草藥組成物配方中13種藥材以等比例或各種比例混合後,在不同條件下(溫度、有機溶劑)進行萃取及濃縮,經適當稀釋後進行高效液相層析法(HPLC)試驗,並計算出(芍藥、當歸、肉桂、甘草、大黃、白芷、獨活、羌活)指標成分的含量,比較不同條件的藥材萃取結果,篩選出最佳的藥材萃取條件,如下表8。In the herbal composition of the present invention, 13 kinds of medicinal materials are mixed in equal proportion or in various proportions, and then extracted and concentrated under different conditions (temperature, organic solvent), and subjected to high performance liquid chromatography (HPLC) test after appropriate dilution. And calculate the content of the index components (peony, angelica, cinnamon, licorice, rhubarb, white peony, singular, scorpion), compare the extraction results of different medicinal materials, and select the best medicinal material extraction conditions, as shown in Table 8 below.

結果如下表9:以高效液相層析法(HPIC)計算出不同條件下,每1g複方藥材的萃取液內所含的指標成分平均含量(n=3次),單位為mg,由下表9可以看出95%~50%乙醇或溫度越高可萃取出較多的指標成分。The results are as follows: Table 9: High-performance liquid chromatography (HPIC) calculated under the different conditions, the average content of the index components contained in the extract of each 1g compound medicinal material (n = 3 times), the unit is mg, from the following table 9 It can be seen that 95%~50% ethanol or higher temperature can extract more index components.

C.本發明之中草藥組成物配方之各藥材的高效液相層析法(HPLC)分析圖譜:C. High performance liquid chromatography (HPLC) analysis of each medicinal material of the herbal composition of the present invention:

各藥材取1g並添加95%乙醇8g於廻流萃取裝置以80℃萃取3小時,重複2次,收集2次萃取液過濾後,以減壓濃縮機濃縮成浸膏,以甲醇(MeOH)定量至150.0ml作為檢液,取10μl的檢液以高效液相層析法(HPLC)進行成分分析並建立指紋圖譜,如下表10。1 g of each medicinal material and 8 g of 95% ethanol were added to the turbulent flow extraction apparatus for extraction at 80 ° C for 3 hours, repeated twice, and the extract was collected twice, filtered, and concentrated into a extract by a vacuum concentrator, and quantified by methanol (MeOH). To 150.0 ml as a test solution, 10 μl of the test solution was subjected to high performance liquid chromatography (HPLC) for component analysis and fingerprinting was established as shown in Table 10 below.

D.本發明之中草藥組成物配方的高效液相層析法(HPLC)分析圖譜:D. High performance liquid chromatography (HPLC) analysis of the formulation of the herbal composition of the present invention:

本發明之中草藥組成物配方各藥材取1g混合後為13g,並添加95%乙醇104g於廻流萃取裝置以80℃萃取3小時,取濾液,殘渣再依上步驟重複1次,收集2次萃取液過濾後,以減壓濃縮機濃縮成浸膏,以甲醇(MeOH)定量至150.0ml作為檢液,取10μl的檢液以高效液相層析法(HPLC)進行成分分析並建立指紋圖譜,如下表11。The herbal composition of the present invention is prepared by mixing 1 g of each medicinal material with 13 g, and adding 104 g of 95% ethanol to the turbulent flow extraction device for extraction at 80 ° C for 3 hours, taking the filtrate, and repeating the residue according to the above procedure, collecting 2 times of extraction. After filtering the liquid, it was concentrated into an extract by a vacuum concentrator, and the mixture was quantified to 150.0 ml with methanol (MeOH) as a test solution, and 10 μl of the test solution was subjected to high performance liquid chromatography (HPLC) for component analysis and fingerprinting. See Table 11 below.

E.本發明之藥材成分浸膏透皮試驗:E. Transdermal test of the medicinal ingredient extract of the present invention:

試驗動物為Wistar(威斯達)大白鼠(重量約250g)。試驗期間,飼料飲水均採任食。試驗樣品為中草藥組成物配方萃取濃縮浸膏。老鼠先行頸椎斷離犧牲,再以電動剃毛器剃除腹部毛髮,取下腹部皮膚。取下皮膚,內部以生理食鹽水濕潤後,夾在直式Transdermal Franz Cell System(經皮吸收系統)的Donor cell(蓋帽區)與Receptor cell(本體區)間,測試樣品分別溶於適當溶劑中,並置於Donor cell內。Receptor cell充滿生理鹽水(含20% PEG400,聚乙二醇400)於37℃恆溫與500rpm固定速度攪拌下進行皮膚的穿透試驗,並於3、6、12、24、36及72小時採樣,針對中草藥貼布之指標成分,將樣本注入高效液相層析法(HPLC)中進行含量測定。The test animals were Wistar rats (weight about 250 g). During the test, the feed water was taken. The test sample is a concentrated extraction extract of a Chinese herbal medicine composition. The mouse was sacrificed before the cervical spine was broken, and the abdominal hair was shaved with an electric shaver to remove the abdominal skin. The skin was removed and the inside was moistened with physiological saline and sandwiched between a Donor cell and a Receptor cell of a transdermal Franz Cell System. The test samples were dissolved in a suitable solvent. And placed in the Donor cell. The Receptor cell was filled with physiological saline (containing 20% PEG400, polyethylene glycol 400) at a constant temperature of 37 ° C and a fixed speed stirring at 500 rpm for skin penetration test, and samples were taken at 3, 6, 12, 24, 36 and 72 hours. For the indicator components of the Chinese herbal patch, the sample was injected into high performance liquid chromatography (HPLC) for content determination.

結果為高效液相層析法(HPLC)可偵測到的透皮成分為當歸、芍藥、肉桂等藥材之成分,且包含有上述三種藥材之指標成分,如下表12。As a result, the transdermal components detectable by high performance liquid chromatography (HPLC) are components of medicinal materials such as angelica, peony, and cinnamon, and include the index components of the above three medicinal materials, as shown in Table 12 below.

F.本發明之中草藥貼布的鎮痛實驗:F. Analgesic experiment of the herbal patch of the invention:

一、醋酸扭體法:First, acetic acid writhing method:

原理:若以化學物質刺激動物,如:acetic acid(醋酸),bradykinin(緩激肽),K+ ,等腹腔注射刺激腹膜或接觸及皮膚引起刺激化學敏感型接受體引發疼痛反應,表現腹部收縮內陷,後肢伸展,身體扭曲或蠕行等扭體表現。Principle: If chemical substances are used to stimulate animals, such as: acetic acid (acetic acid), bradykinin (bradykinin), K + , etc., intraperitoneal injections stimulate the peritoneum or contact and skin cause stimulation of chemically sensitive receptors to trigger pain response, showing abdominal contraction A writhing manifestation such as invagination, hind limb extension, body twisting or creeping.

試驗動動為ICR小白鼠(公;6-8週齡)。試驗期間,飼料飲水均採任食。並於試驗前,禁食24小時。試驗共分為3組,分別為負控制組(不含任何藥物之藥貼布)、正控制組(市售Indomethacin(引朵美洒辛)& Diclofenac sodium(雙氯芬酸鈉)藥貼布)及實驗組(實驗用4種不同劑量之藥貼布),每組12隻。The test was initiated by ICR mice (male; 6-8 weeks old). During the test, the feed water was taken. And fasted for 24 hours before the test. The trials were divided into three groups, the negative control group (without any drug patch), the positive control group (commercially available Indomethacin & Diclofenac sodium) and the experiment. Group (4 different doses of drug patch for the experiment), 12 in each group.

小白鼠稱重編號,然後四肢固定於平板並進行腹部剃毛後,將藥貼布(2×3cm)貼於小白鼠的腹部上。3小時後去除藥貼布(或不去除藥貼布),以0.6%醋酸溶液進行腹腔注射(i.p.,20mL/kg)。觀察10分鐘內,小白鼠的扭曲(writhing)次數,並紀錄其扭曲平均值(writhing mean),如下表13。The mice were weighed and numbered, and then the limbs were fixed on the flat plate and shaved in the abdomen, and the patch (2 x 3 cm) was attached to the abdomen of the mouse. After 3 hours, the drug patch was removed (or the drug patch was not removed) and intraperitoneally injected (i.p., 20 mL/kg) with 0.6% acetic acid solution. Observe the number of twistings of the mouse within 10 minutes and record the wringing mean, as shown in Table 13 below.

結果為本發明之中草藥貼布的扭曲平均值小於負控制組(不含任何藥物之藥貼布)的扭曲平均值,因此本發明之中草藥貼布確實具有鎮痛之療效。As a result, the twisted average value of the herbal patch of the present invention is smaller than the twisted average of the negative control group (the drug patch without any drug), and therefore the herbal patch of the present invention does have an analgesic effect.

二、福馬林(formalin)試驗法:Second, formalin (formalin) test method:

原理:皮下注射稀釋過之福馬林於大鼠、鼷鼠可觀察到中樞及周邊神經系統之兩相之疼痛反應,此種福馬林舔足實驗最早是由Dubuisson和Dennis 1977年提出,其對許多類鎮痛藥物的篩選是一有效且可靠的模型,當由皮下注入福馬林於人類皮膚,4-5分鐘會引起強烈且尖銳的灼熱感,接下來30-60分鐘則有持續的疼痛感,若表現於鼷鼠則因足掌受到注入的福馬林(formalin)刺激引起疼痛而有舔足或頓足的行為表現,最初注入的福馬林(formalin)於0-5分造成的痛反應(initial pain)所花費的舔足時間稱之為前期(early phase),主要是因直接刺激痛覺反應接受體造成substance P(P物質),bradykinin(緩激肽)釋出而有痛反應;而於15-40分鐘所花費的舔足時間則稱之為後期,主要是因發炎反應造成一些化學傳遞物(chemical mediators),如histamine(組織胺)、serotonin(血清素)、prostaglandin(前列腺素)及kinin(激肽)等,由受損組織細胞釋放出引起。簡言之。以福馬林誘發小白鼠造成疼痛而有舔腳的行為反應,可對發炎性及非發炎性疼痛的鎮痛藥物活性及作用機理作一有效的評估。另外,以福馬林誘導產生的痛反應,其濃度大小佔很重要因素,當於0.02~0.2%時僅誘導出前期舔足反應,以光學顯微鏡作組織鑑定,其改變微小;而於1%或更高之福馬林濃度時可誘導出前期及後期舔足反應,若注入福馬林5%,30分鐘後在組織鑑定上可發現有急生發炎反應,顆粒球破壞及腫脹均可見。Principle: Subcutaneous injection of diluted formalin in rats, moles can observe the pain response of the two phases of the central and peripheral nervous system. This type of Fumalin foot test was first proposed by Dubuisson and Dennis in 1977, which is many The screening of analgesic drugs is an effective and reliable model. When subcutaneously injected into the human skin by subcutaneous injection, it will cause a strong and sharp burning sensation in 4-5 minutes, and there will be continuous pain in the next 30-60 minutes. It is manifested in the behavior of the moles caused by the injection of the formalin stimulation and the lameness or foot-up behavior. The initial injection of formalin caused a painful reaction at 0-5 points. The lame time spent is called the early phase, mainly due to the direct stimulation of the pain response receptor causing substance P (substance P), bradykinin (bradykinin) release and painful response; The amount of lameness spent in 40 minutes is called late, mainly due to inflammatory reactions that cause chemical mediators such as histamine, serotonin, prostaglandin, and kinin. Kinin), etc., caused by the release of damaged tissue cells. In short. The effect of the analgesic drug activity and mechanism of action of inflammatory and non-inflammatory pain can be effectively evaluated by the effect of formalin-induced pain and crappy behavior in mice. In addition, the concentration of pain induced by formalin is an important factor. When it is 0.02~0.2%, only the pre-clam foot reaction is induced, and the tissue is identified by light microscopy. The change is small; Higher levels of formalin can induce pre- and late lameness reactions. If flumarin is injected 5%, acute inflammatory reaction can be found in tissue identification after 30 minutes, and particle ball destruction and swelling can be seen.

試驗動物為ICR小白鼠(公;6-8週齡)。試驗期間,飼料飲水均採任食。並於試驗前,禁食24小時。試驗共分為3組,分別為負控制組(不含任何藥物之藥貼布)、正控制組[市售Indomethacin(引朵美洒辛)& Diclofenac sodium(雙氯芬酸鈉)藥貼布]及實驗組(實驗用4種不同劑量之中草藥貼布),每組12隻。The test animals were ICR mice (male; 6-8 weeks old). During the test, the feed water was taken. And fasted for 24 hours before the test. The trial was divided into three groups, the negative control group (drug patch without any drug), the positive control group [commercially available Indomethacin & Diclofenac sodium drug patch] and experiment Group (4 different doses of herbal patch) for each group, 12 in each group.

小白鼠稱重編號,將藥貼布(2×3cm)再剪成四等份,貼於小白鼠的腳背上,再以透氣膠帶纏繞固定,3小時後去除藥貼布,以當天配製的1%福馬林(formalin)溶液行皮下注射20μl於腳背,計算0-5分鐘及15-40分鐘期間內小鼠之舔足時間,如下表14。The mouse was weighed and numbered. The medicine patch (2×3cm) was cut into four equal parts and attached to the instep of the mouse. Then it was wrapped with air-permeable tape. After 3 hours, the medicine patch was removed and the day was prepared. The % formalin solution was subcutaneously injected with 20 μl on the instep, and the lameness time of the mice during 0-5 minutes and 15-40 minutes was calculated as shown in Table 14 below.

結果為本發明之中草藥貼布的舔足時間小於負控制組(不含任何藥物之藥貼布)的舔足時間,因此本發明之中草藥貼布確實具有鎮痛之療效。As a result, the lameness time of the herbal patch of the present invention is less than the lameness time of the negative control group (the drug patch without any drug), and therefore the herbal patch of the present invention does have an analgesic effect.

G.本發明之中草藥貼布消炎消腫實驗:G. The anti-inflammatory and swelling test of the herbal patch of the invention:

原理:γ-carrageenin注入足蹠所引起之浮腫是雙相性反應,注射γ-carrageenin後,在不同時間有不同物質釋放而引起發炎腫脹,即0-1.5小時或20分鐘至1小時內(first phase)histamine(組織胺),serotonin(血清素),PAF(platelet activating factor)(血小板活化因子)會游離出來;1.5-2.5小時(second phase),kinin(激肽)類物質會釋放,2.5小時之後(third phase),prostaglandin(前列腺素)及leukotriens(白三烯素)會釋放出而造成發炎腫脹。Principle: The edema caused by γ-carrageenin injection into the ankle is a biphasic reaction. After injection of γ-carrageenin, different substances are released at different times to cause inflammation and swelling, ie 0-1.5 hours or 20 minutes to 1 hour (first phase )histamine (histamine), serotonin (serotonin), PAF (platelet activating factor) (platelet activating factor) will be released; 1.5-2.5 hours (second phase), kinin (kinin) substances will be released, after 2.5 hours (third phase), prostaglandin (prostaglandin) and leukotriens (leucotriene) are released to cause inflammation and swelling.

試驗動動為SD大白鼠(公;6-8週齡)。試驗期間,飼料飲水均採任食。並於試驗前,禁食24小時。試驗共分為3組,分別為負控制組(不含任何藥物之藥貼布)、正控制組[市售Indomethacin(引朵美洒辛)& Diclofenac sodium(雙氯芬酸鈉)藥貼布]及實驗組(實驗用4種不同劑量之藥貼布),每組8隻。The test was performed in SD rats (male; 6-8 weeks old). During the test, the feed water was taken. And fasted for 24 hours before the test. The trial was divided into three groups, the negative control group (drug patch without any drug), the positive control group [commercially available Indomethacin & Diclofenac sodium drug patch] and experiment Group (4 different doses of drug patch for the experiment), 8 in each group.

將大白鼠稱重編號,並於大白鼠的足蹠以簽字筆,劃一「劃量線」。以腫脹測定儀(Plethysmometer)先測量其足蹠之體積。先穿自製(不同規格)束腹彈性繃帶以避免老鼠咬掉中草藥貼布。各組老鼠經皮下注射0.1ml的Carrageenan(鹿角菜膠)(10mg/ml in saline)於足蹠。正控制組及實驗組貼中草藥貼布(2×3cm)於足蹠,並以透氣膠帶纏繞固定,以腫脹測定儀量0、2、4、6和24小時等(不同時間測定後需再更新中草藥貼布)之腫脹百分比,觀察各時間點之消腫情形並劃出實驗組與對照組之腫脹曲線是否有生物統計的差別,如下表15。The rats were weighed and numbered, and the "white line" was drawn with a signature pen on the ankles of the rats. The volume of the ankle was measured first with a Plethysmometer. Wear a self-made (different size) corset elastic bandage to prevent the mouse from biting off the Chinese herbal patch. Each group of mice was injected subcutaneously with 0.1 ml of Carrageenan (carrageenan) (10 mg/ml in saline) in the athlete's foot. Positive control group and experimental group paste Chinese herbal patch (2 × 3cm) on the ankle, and wrapped with breathable tape, with the amount of swelling tester 0, 2, 4, 6 and 24 hours, etc. (required to be updated after different time measurement) Percentage of swelling of Chinese herbal patch), observe the swelling at each time point and draw out whether there is a biometric difference between the swelling curve of the experimental group and the control group, as shown in Table 15 below.

結果為本發明之中草藥貼布的浮腫百分比小於負控制組(不含任何藥物之藥貼布)的浮腫百分比,因此本發明之中草藥貼布確實具有消炎消腫之療效。As a result, the percentage of edema of the herbal patch of the present invention is less than the percentage of edema of the negative control group (the drug patch without any drug), and therefore the herbal patch of the present invention does have the effect of reducing inflammation and swelling.

雖然本發明已以前述實施例揭示,然其並非用以限定本發明,任何本發明所屬技術領域中具有通常知識者,在不脫離本發明之精神和範圍內,當可作各種之更動與修改。因此本發明之保護範圍當視後附之申請專利範圍所界定者為準。The present invention has been disclosed in the foregoing embodiments, and is not intended to limit the present invention. Any of the ordinary skill in the art to which the invention pertains can be modified and modified without departing from the spirit and scope of the invention. . Therefore, the scope of the invention is defined by the scope of the appended claims.

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第1圖:為本發明之第一實施例之製備方法之流程圖。Fig. 1 is a flow chart showing the preparation method of the first embodiment of the present invention.

第2圖:為本發明之第二實施例之製備方法之流程圖。Fig. 2 is a flow chart showing the preparation method of the second embodiment of the present invention.

第3圖:為具有本發明之中草藥貼布之立體示意圖。Fig. 3 is a perspective view showing the herbal patch of the present invention.

第4圖:為具有本發明之中草藥噴劑之剖面示意圖。Fig. 4 is a schematic cross-sectional view showing the herbal spray of the present invention.

第5圖:為具有本發明之中草藥藥膏之立體示意圖。Fig. 5 is a perspective view showing the herbal ointment of the present invention.

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Claims (24)

一種中草藥組成物,包含:一第一類藥材,包含白芨、肉桂、白芷、當歸、芍藥、羌活、烏藥、甘草、獨活、大黃,且該第一類藥材實質上未包含有川烏、木鱉子及草烏;以及一第二類藥材,其選自薑、乳香及沒藥所構成之群組中的一者,其中上述11味藥材中的每一味藥材之重量百分比為9.09%±5%之範圍內。 A Chinese herbal medicine composition comprising: a first type of medicinal material, comprising white peony, cinnamon, white peony, angelica, peony, medlar, black medicinal herb, licorice, lycorrhea, rhubarb, and the first medicinal material substantially does not contain Chuanwu, a medicinal material selected from the group consisting of ginger, frankincense, and myrrh, wherein the weight percentage of each of the above 11 herbs is 9.09% ± Within 5%. 一種中草藥組成物,包含:一第一類藥材,包含白芨、肉桂、白芷、當歸、芍藥、羌活、烏藥、甘草、獨活、大黃,且該第一類藥材實質上未包含有川烏、木鱉子及草烏;以及一第二類藥材,其選自薑、乳香及沒藥所構成之群組中的二者,其中上述12味藥材中的每一味藥材之重量百分比為8.33%±5%之範圍內。 A Chinese herbal medicine composition comprising: a first type of medicinal material, comprising white peony, cinnamon, white peony, angelica, peony, medlar, black medicinal herb, licorice, lycorrhea, rhubarb, and the first medicinal material substantially does not contain Chuanwu, a medicinal material selected from the group consisting of ginger, frankincense, and myrrh, wherein the weight percentage of each of the above 12 herbs is 8.33% ± Within 5%. 一種中草藥組成物,包含:一第一類藥材,包含白芨、肉桂、白芷、當歸、芍藥、羌活、烏藥、甘草、獨活、大黃,且該第 一類藥材實質上未包含有川烏、木鱉子及草烏;以及一第二類藥材,包含薑、乳香及沒藥,其中上述13味藥材中的每一味藥材之重量百分比為7.69%±5%之範圍內。 A Chinese herbal medicine composition comprising: a first type of medicinal material comprising white peony, cinnamon, white peony, angelica, peony, medlar, black medicinal herb, licorice, lycox, rhubarb, and the One type of medicinal material does not substantially contain Chuanwu, Muxizi and Caowu; and a second type of medicinal material containing ginger, frankincense and myrrh, wherein the weight percentage of each of the above 13 medicinal materials is 7.69%±5% Within the scope. 一種中草藥萃取物,其藉由下列步驟所製得:提供一第一類藥材及一第二類藥材,其中該第一類藥材包含白芨、肉桂、白芷、當歸、芍藥、羌活、烏藥、甘草、獨活、大黃,該第一類藥材為基礎藥材且實質上未包含有川烏、木鱉子及草烏,該第二類藥材選自薑、乳香及沒藥所構成之群組中的一者、二者或三者,該第二類藥材為添加藥材;將該第一及第二類藥材與一有機溶劑置入一容器內,使該第一及第二類藥材與該有機溶劑之重量百分比為1:N,以形成一第一混合液,其中N為介於3與12之間的數值;加熱該第一混合液至30℃與100℃之間並萃取1至6小時,以進行第1次萃取;以及趁熱過濾該第一混合液,取第1次萃取之濾液。 A Chinese herbal medicine extract obtained by the following steps: providing a first medicinal material and a second medicinal material, wherein the first medicinal material comprises white peony, cinnamon, white peony, angelica, peony, peony, black medicinal herb, licorice The first type of medicinal material is a basic medicinal material and substantially does not include Chuanwu, Muxizi and Caowu. The second medicinal material is selected from the group consisting of ginger, frankincense and myrrh. In one, two or three, the second type of medicinal material is an added medicinal material; the first and second medicinal materials and an organic solvent are placed in a container to make the first and second medicinal materials and the organic solvent The weight percentage is 1:N to form a first mixed liquid, wherein N is a value between 3 and 12; heating the first mixed liquid to between 30 ° C and 100 ° C and extracting for 1 to 6 hours, The first extraction is carried out; and the first mixed liquid is filtered while hot, and the filtrate of the first extraction is taken. 依申請專利範圍第4項之中草藥萃取物,另包含下列步驟: 將第一次萃取之濾液濃縮至含水量10%~40%、該有機溶劑含量3%~30%之浸膏。 According to the fourth patent application of the patent scope, the following steps are included: The filtrate extracted for the first time is concentrated to an extract having a water content of 10% to 40% and an organic solvent content of 3% to 30%. 依申請專利範圍第5項之中草藥萃取物,其另藉由下列步驟所製得:保留第1次萃取之殘渣;重新添加該有機溶劑,使該藥材與該有機溶劑之重量百分比回到1:N,以形成一第二混合液,其中N介於3與12之間的數值;加熱該第二混合液至30℃與100℃之間並萃取1至6小時,以進行第2次萃取;以及趁熱過濾該第二混合液,取第2次萃取之濾液。 According to the fifth patent of the patent application scope, the herbal extract is obtained by the following steps: retaining the residue of the first extraction; re-adding the organic solvent to return the weight percentage of the medicinal material to the organic solvent back to 1: N, to form a second mixture, wherein N is between 3 and 12; heating the second mixture to between 30 ° C and 100 ° C and extracting for 1 to 6 hours for the second extraction; The second mixture was filtered while hot, and the filtrate from the second extraction was taken. 依申請專利範圍第6項之中草藥萃取物,其另藉由下列步驟所製得:混合第一次萃取之濾液與第二次萃取之濾液,並將該混合濾液濃縮至含水量10%~40%、該有機溶劑含量3%~30%之浸膏。 According to the sixth patent of the patent application scope, the herbal extract is obtained by the following steps: mixing the first extraction filtrate with the second extraction filtrate, and concentrating the mixed filtrate to a water content of 10%~40 %, the organic solvent content of 3% to 30% of the extract. 依申請專利範圍第4項之中草藥萃取物,其中該有機溶劑係選自甲醇、乙醇、丙酮、甲基乙基酮、煤油(石油醚)及己烷所構成之群組中至少一者。 The herbal extract according to item 4 of the patent application scope, wherein the organic solvent is at least one selected from the group consisting of methanol, ethanol, acetone, methyl ethyl ketone, kerosene (petroleum ether) and hexane. 依申請專利範圍第4項之中草藥萃取物,其中該有機溶劑係為乙醇,且該第一混合液係加熱至乙醇之沸點加減5℃的範圍內。 According to the fourth aspect of the patent application, the organic solvent is ethanol, and the first mixed liquid is heated to a boiling point of ethanol of 5 ° C. 依申請專利範圍第6項之中草藥萃取物,其中該有機溶劑係為乙醇,且該第一及第二混合液係加熱至乙醇之沸點加減5℃的範圍內。 According to the sixth aspect of the patent application, the organic solvent is ethanol, and the first and second mixed liquids are heated to a boiling point of ethanol of 5 ° C. 依申請專利範圍第4項之中草藥萃取物,其中N為8。 According to the fourth patent application of the patent scope, the N is 8. 依申請專利範圍第4項之中草藥萃取物,其中係包含有下列9種指標成分:芍藥苷(Paeoniflorin)、阿魏酸(Ferulic acid)、桂皮醛(Cinnamaldehyde)、甘草甜苷(Glycyrrhizin)、大黄酸(Rhein)、歐前胡素(Imperatorin)、蛇床子素(Osthol)、異歐前胡素(Isoimperatorin)以及生薑酚(Gingerol)。 According to the fourth patent application of the patent scope, the following nine indicators are included: Paeoniflorin, Ferulic acid, Cinnamaldehyde, Glycyrrhizin, Rhubarb Acid (Rhein), Imperatorin, Osthol, Isoimperatorin, and Gingerol. 依申請專利範圍第12項之中草藥萃取物,其中每1 g萃取物內所含之指標成分的含量分別為:芍藥苷(Paeoniflorin)4.466~1.488mg、阿魏酸(Ferulic acid)0.382~0.127mg、桂皮醛(Cinnamaldehyde)2.159~0.720mg、甘草甜苷(Glycyrrhizin)9.677~3.226mg、大黄酸(Rhein)1.013~0.338mg、歐前胡素(Imperatorin)0.727~0.242mg、蛇床子素(Osthol)1.389~0.463mg、異歐前胡素(Isoimperatorin)0.709~0.236mg以及生薑酚(Gingerol)0.144~0.432mg。 According to the 12th Chinese herbal medicine extract of the patent application scope, the content of the index components contained in each 1 g of extract is: Paeoniflorin 4.466~1.488mg, Ferulic acid 0.382~0.127mg , Cinnamaldehyde 2.159~0.720mg, Glycyrrhizin 9.677~3.226mg, Rhein 1.013~0.338mg, Imperatorin 0.727~0.242mg, Osthol 1.389~0.463mg, Isoimperatorin 0.709~0.236mg and Gingerol 0.144~0.432mg. 一種中草藥貼布,包含: 一膠帶層;以及一中草藥藥劑層,配置於該膠帶層上,其中該中草藥藥劑層包含如申請專利範圍第5或7項所述之浸膏。 A Chinese herbal patch containing: a layer of tape; and a layer of herbal medicine disposed on the layer of tape, wherein the layer of herbal medicine comprises the extract of claim 5 or 7. 依申請專利範圍第14項之中草藥貼布,其中該中草藥藥劑層另包含有以乙醇、水及水性粘膠所組成的一稀釋劑,且該浸膏摻入該稀釋劑中。 According to the patent application scope of claim 14, the herbal medicine layer further comprises a diluent composed of ethanol, water and an aqueous adhesive, and the extract is incorporated into the diluent. 依申請專利範圍第15項之中草藥貼布,其中該中草藥貼布具有中草藥萃取物之含量為50~3500mg/14g。 According to the 15th item of the patent application, the Chinese herbal patch has a Chinese herbal extract content of 50~3500mg/14g. 一種中草藥噴劑,包含如申請專利範圍第4項所述之萃取濾液。 A Chinese herbal medicine spray comprising the extracted filtrate as described in claim 4 of the patent application. 一種中草藥噴劑,包含如申請專利範圍第5項所述之浸膏。 A Chinese herbal medicine spray comprising the extract as described in claim 5 of the patent application. 一種中草藥藥膏,包含如申請專利範圍第5或7項所述之浸膏。 A Chinese herbal ointment comprising the extract as described in claim 5 or 7. 依申請專利範圍第19項之中草藥藥膏,另包含:一稀釋劑,其中該浸膏摻入該稀釋劑中,該稀釋劑包含有乙醇、水及水性粘膠。 According to claim 19, the herbal ointment further comprises: a diluent, wherein the extract is incorporated into the diluent, the diluent comprising ethanol, water and an aqueous viscose. 依申請專利範圍第20項之中草藥藥膏,其中該中草藥藥膏為油膏、水性凝膠及乳膏之其中一者。 According to the 20th item of the patent application, the Chinese herbal ointment is one of an ointment, a water gel and a cream. 一種內服製劑,包含如申請專利範圍第5或7 項所述之浸膏。 An internal preparation comprising, as claimed in claim 5 or 7 The extract described in the item. 依申請專利範圍第22項之內服製劑,另包含:一稀釋劑,其中該浸膏摻入該稀釋劑中,該稀釋劑包含有乙醇、水及水性粘膠。 According to the internal preparation of claim 22, the method further comprises: a diluent, wherein the extract is incorporated into the diluent, the diluent comprising ethanol, water and an aqueous viscose. 依申請專利範圍第23項之內服製劑,其中該內服製劑為散劑、丸劑及錠劑之其中一者。 Oral preparation according to item 23 of the patent application scope, wherein the internal preparation is one of a powder, a pill and a lozenge.
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