TWI756638B - Use of preparing a pharmaceutical composition for external use to treat itching or allergic symptoms and preparation method of the pharmaceutical composition for external use - Google Patents

Use of preparing a pharmaceutical composition for external use to treat itching or allergic symptoms and preparation method of the pharmaceutical composition for external use Download PDF

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TWI756638B
TWI756638B TW109105887A TW109105887A TWI756638B TW I756638 B TWI756638 B TW I756638B TW 109105887 A TW109105887 A TW 109105887A TW 109105887 A TW109105887 A TW 109105887A TW I756638 B TWI756638 B TW I756638B
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TW202131943A (en
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呂秉勳
張貴珠
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欣綠智國際企業有限公司
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Abstract

本發明揭露一種製備外用醫藥組合物以治療搔癢或過敏症狀的用途,其特徵在於:該外用醫藥組合物係具有土茯苓、荊芥、防風、地膚子、白鮮皮、黃柏、川芎、當歸、何首烏、白芷、百部、苦參、白芨和月見草油。如此一來,透過具有上述成分之外用醫藥組合物,就能夠於塗抹在傷口或是病症發生處後,產生抗發炎、活血滋潤、與修復皮膚之功效。 The present invention discloses an application for preparing a medicinal composition for external use to treat itching or allergic symptoms, characterized in that the medicinal composition for external use comprises tuckahoe, nepeta, fangfeng, kochia, white fresh skin, phellodendri, chuanxiong, angelica, He Shou Wu, Angelica, Bai Bu, Sophora Radix, Bletilla striata and Evening Primrose Oil. In this way, the external pharmaceutical composition with the above-mentioned ingredients can produce anti-inflammatory, blood-activating and moisturizing, and skin-repairing effects after being applied to the wound or the place where the disease occurs.

Description

製備外用醫藥組合物以治療搔癢或過敏症狀的用途及外 用醫藥組合物之製備方法 Use and external use of preparing a pharmaceutical composition for external use to treat itching or allergic symptoms Preparation method of pharmaceutical composition

本發明係屬於醫藥品之領域,尤其是一種用途為塗抹在皮膚上可以治療搔癢或過敏症狀的醫藥組合物及其製備方法。 The present invention belongs to the field of pharmaceuticals, in particular to a pharmaceutical composition which can be applied on the skin to treat itching or allergic symptoms and a preparation method thereof.

按,尿毒性搔癢症(uremic pruritus)是末期腎臟病(ESRD)病患常見並感到困擾的一種症狀,其病生理機轉尚未被完全了解,且症狀雖能經過治療後減輕卻非常難以根除。尿毒搔癢症的盛行率在成年透析病患的盛行率逐年變異相當大,有些研究認為透析效率的增加可能降低盛行率,以解釋其盛行率由1980和1993年的50及90%,到後續研究報告顯示的22~57%;另一項大型研究(the Dialysis Outcomes and Practice Patterns Study[DOPPS])則顯示成人透析病患的尿毒搔癢症盛行率為42%。 According to press, uremic pruritus is a common and troublesome symptom in patients with end-stage renal disease (ESRD). The prevalence of pruritus varies considerably from year to year in adult dialysis patients, and some studies suggest that an increase in dialysis efficiency may reduce the prevalence, explaining that the prevalence increased from 50% and 90% in 1980 and 1993 to subsequent studies. The report showed 22-57%; another large study (the Dialysis Outcomes and Practice Patterns Study [DOPPS]) showed that the prevalence of uremic scrapie in adult dialysis patients was 42%.

尿毒搔癢症最好發的部位在背部,但手臂、頭部及腹部也可能出現,也有許多病人為全身性的搔癢,發生的頻率從每日數分鐘到幾乎沒有間斷的持續性搔癢、過敏不等。常見的特徵還有夜間惡化,進而影響睡眠品質,這種情況在較嚴重的尿毒搔癢病患身上出現,甚至會使病人產生疲倦及憂鬱的情形;而高溫(特別是大量出汗的情況)及壓力也會加重搔癢的症狀。另外有些病患於透析時搔癢的情況會加重,有些則是減輕。 Uremic pruritus is best seen on the back, but it may also occur on the arms, head, and abdomen. Many patients also suffer from generalized pruritus. The frequency of occurrence ranges from a few minutes a day to almost uninterrupted persistent itching, allergic reactions. Wait. Common features are worsening at night, which affects sleep quality. This situation occurs in patients with more severe uric pruritus, and even makes the patient feel tired and depressed; high temperature (especially in the case of profuse sweating) and Stress can also exacerbate itching symptoms. In addition, some patients experience increased itching during dialysis, while others decrease.

並且,尿毒搔癢症的病患皮膚容易乾燥,會出現鱗狀表現或表皮龜裂,因為反覆搔抓產生顯著的皮膚變化,如表皮剝落(excoriations)、單純性苔 癬(lichen simplex)、結節性癢疹(pruritus nodularis)、角化性丘疹(keratotic papules)毛囊性皮膚角化症(follicular hyperkeratosis)及後天穿透性皮膚病(Acquired perforating dermatosis,APD)。 Moreover, patients with pruritus are prone to dry skin, scaly manifestations or epidermal cracking, as repeated scratching produces significant skin changes, such as excoriations, simple moss Ringworm (lichen simplex), pruritus nodularis (pruritus nodularis), keratotic papules (keratotic papules), follicular hyperkeratosis (follicular hyperkeratosis) and acquired perforating dermatosis (Acquired perforating dermatosis, APD).

由於搔癢的症狀在透析病人非常常見,因此除非有一致且有說服力的證據顯示病患的搔癢是源自其他原因的情況,否則臨床上會先假設病患的搔癢是來自於尿毒搔癢。臨床診斷上可以參考的特徵包含有:開始透析時伴隨搔癢發生、症狀持續不間斷、顯著的鈣磷鎂離子、副甲狀腺素、血清尿素氮的濃度升高。 Because itching is very common in dialysis patients, unless there is consistent and convincing evidence that the patient's itching is from other causes, it is clinically assumed that the patient's itching is from uremic itching. Features that can be referred to in clinical diagnosis include: pruritus at the start of dialysis, persistent symptoms, markedly elevated concentrations of calcium, phosphorus, and magnesium ions, parathyroid hormone, and serum urea nitrogen.

又,由於對於尿毒搔癢症的病生理機制尚未全部研究透徹,故目前仍然無法找到最有效的治療方式,對於患有嚴重搔癢症的患者,儘管達到了最佳的Kt/V目標,搔癢仍無法改善。尿毒搔癢症的治療方式尚有使用口服抗組織胺藥和gabapentin、外用潤膚劑或局部鎮痛劑、紫外線B(UVB)光療法和腎移植。然而臨床上有許多頑固性尿毒搔癢症的患者接受以上的治療方式後並無顯著療效,且等待腎臟移植並不容易。目前較廣泛治療尿毒搔癢的外用治療方法如下: In addition, because the pathophysiological mechanism of uremic pruritus has not been fully studied, it is still not possible to find the most effective treatment method. improve. Pruritus is treated with oral antihistamines and gabapentin, topical emollients or topical analgesics, ultraviolet B (UVB) phototherapy, and kidney transplantation. However, there are many patients with refractory uremic pruritus who have received the above treatment methods and have no significant effect, and it is not easy to wait for kidney transplantation. At present, the most widely used topical treatments for uremic itching are as follows:

1.潤膚劑(emollients)是尿毒搔癢的首選外用治療,針對理學檢查可見乾燥症病徵的患者更建議使用。 1. Emollients are the preferred topical treatment for uric itching, and are recommended for patients with xerosis symptoms on physical examination.

2.局部止痛劑(如pramoxine)可緩解搔癢。在一家製藥公司贊助的隨機試驗中,其中包括28例血液透析患者,比較每日兩次使用pramoxine與僅使用潤膚劑,發現使用pramoxine的患者搔癢改善較為明顯(分別為61和12%)。Pramoxine在這次試驗中被證明是安全和方便的。建議使用於已規律使用潤膚劑仍持續有搔癢出現的病患。 2. Topical pain relievers (such as pramoxine) can relieve itching. In a randomized trial sponsored by a pharmaceutical company that included 28 hemodialysis patients comparing twice-daily use of pramoxine with emollients alone, it was found that those who used pramoxine had greater improvement in itching (61 and 12 percent, respectively). Pramoxine proved safe and convenient in this trial. Recommended for patients with persistent itching despite regular use of emollients.

3.精油(essential oils),以增加角質層含水量。在一個為期2週、隨機、安慰劑為控制組的研究,將病患分為兩組,一組使用2.2%次亞麻油酸(γ-lynolenic acid)乳膏一天三次,另一組使用安慰劑乳膏一天三次,結果發現使用次亞麻油酸乳膏較安慰劑組能有效降低搔癢的症狀。 3. Essential oils (essential oils) to increase the water content of the stratum corneum. In a 2-week, randomized, placebo-controlled study, patients were divided into two groups, one group received a 2.2% gamma-lynolenic acid cream three times a day, and the other group received a placebo The cream was applied three times a day, and it was found that the use of the linoleic acid cream was more effective in reducing itching symptoms than the placebo group.

然而,仍有許多患者使用以上西醫的外用治療雖然對於搔癢的情況有一時的改善,但長久下來搔癢的強況還是無法得到較好的控制,況且上述之治療方式無法有效修復皮膚上已產生之傷口,導致傷口修復緩慢,同時又因搔癢的緣故使得傷口更難癒合,因此是否有別於傳統西醫的治療方式便成為醫學界需要思考並研究的目標。 However, there are still many patients who use the above topical treatment of Western medicine to improve itching temporarily, but the severe itching cannot be well controlled for a long time. Moreover, the above-mentioned treatment methods cannot effectively repair the itchiness that has occurred on the skin. Wounds cause slow wound healing, and at the same time, itching makes wounds more difficult to heal. Therefore, whether the treatment method is different from traditional Western medicine has become a goal that the medical community needs to think about and study.

有鑑於此,本發明人感其未臻完善而竭其心智苦心研究,並憑其從事該項產業多年之累積經驗,進而提供一種製備外用醫藥組合物以治療搔癢或過敏症狀的用途及外用醫藥組合物之製備方法,以期可以改善上述習知技術之缺失。 In view of this, the inventors feel that they are not perfect and exhausted their painstaking research, and relying on their accumulated experience in the industry for many years, and then provide a preparation of a pharmaceutical composition for external use to treat itching or allergic symptoms. Use and external medicine The preparation method of the composition is expected to improve the above-mentioned deficiencies of the prior art.

本發明之一目的,旨在提供一種製備外用醫藥組合物以治療搔癢或過敏症狀的用途及外用醫藥組合物之製備方法,以純天然漢方草本之成分製作成外用醫藥組合物,而達到保濕止癢,也可以助於傷口修復。 One object of the present invention is to provide a method for preparing a medicinal composition for external use to treat itching or allergic symptoms and a method for preparing the medicinal composition for external use. , can also aid in wound repair.

於是,本發明揭露一種製備外用醫藥組合物以治療搔癢或過敏症狀的用途,其特徵在於:該外用醫藥組合物係具有土茯苓、荊芥、防風、地膚子、白鮮皮、黃柏、川芎、當歸、何首烏、白芷、百部、苦參、白芨和月見草油。 Therefore, the present invention discloses a method for preparing a medicinal composition for external use to treat itching or allergic symptoms, characterized in that: the medicinal composition for external use comprises tuckahoe, nepeta, fenfeng, kochi, white fresh skin, phellodendron, chuanxiong, Angelica, Polygonum, Angelica, Baibu, Sophora Radix, Bletilla striata and Evening Primrose Oil.

較佳者,土茯苓係為13個重量份,荊芥係為10個重量份,防風係為5個重量份,地膚子係為5個重量份,白鮮皮係為5個重量份,黃柏係為5個重量份,川芎係為5個重量份,當歸係為5個重量份,何首烏係為5個重量份,白芷係為5個重量份,百部係為5個重量份,苦參係為5個重量份,而白芨係為5個重量份。 Preferably, 13 parts by weight of Poria cocos, 10 parts by weight of Nepeta, 5 parts by weight of windproof, 5 parts by weight of Kochia, 5 parts by weight of white fresh skin, 5 parts by weight of Cortex Phellodendri 5 parts by weight of Radix Chuanxiong, 5 parts by weight of Angelica sinensis, 5 parts by weight of Polygonum multiflorum, 5 parts by weight of Angelica Radix, 5 parts by weight of Baibu Department, 5 parts by weight of Sophora flavescens It is 5 parts by weight, and the Bletilla striata is 5 parts by weight.

較佳者,該外用醫藥組合物之施用方式係選自以下族群之一或其組合:精油、乳液、乳霜、溶液、懸浮液或油膏。 Preferably, the administration mode of the external pharmaceutical composition is selected from one of the following groups or a combination thereof: essential oil, lotion, cream, solution, suspension or ointment.

較佳者,搔癢或過敏症狀係指尿毒性搔癢症所引起之表皮剝落(excoriations)、單純性苔癬(lichen simplex)、結節性癢疹(pruritus nodularis)、角化性丘疹(keratotic papules)毛囊性皮膚角化症(follicular hyperkeratosis)及後天穿透性皮膚病(Acquired perforating dermatosis,APD)或灰指甲。 Preferably, pruritus or allergic symptoms refer to excoriations, lichen simplex, pruritus nodularis, keratotic papules and hair follicles caused by uremic pruritus Follicular hyperkeratosis (follicular hyperkeratosis) and acquired penetrating dermatosis (Acquired perforating dermatosis, APD) or onychomycosis.

此外,本發明又揭露一種用於治療搔癢或過敏症狀的外用醫藥組合物之製備方法,其步驟包含:取13個重量份的土茯苓、10個重量份的荊芥、5個重量份的防風、5個重量份的地膚子、5個重量份的白鮮皮、5個重量份的黃柏、5個重量份的川芎、5個重量份的當歸、5個重量份的何首烏、5個重量份的白芷、5個重量份的百部、5個重量份的苦參以及5個重量份的白芨;將上述成分加入月見草油後,加熱沸騰後維持90~100度煮2小時;及油萃後再過濾雜質後即可得出該外用醫藥組合物。 In addition, the present invention discloses a preparation method of a pharmaceutical composition for external use for treating itching or allergic symptoms. 5 parts by weight of Kochia seeds, 5 parts by weight of white fresh skin, 5 parts by weight of Cork, 5 parts by weight of Chuanxiong, 5 parts by weight of Angelica sinensis, 5 parts by weight of Polygonum multiflorum, 5 parts by weight Radix Angelicae Dahuricae, 5 parts by weight of 100 parts, 5 parts by weight of Sophora flavescens and 5 parts by weight of Bletilla striata; after adding the above ingredients into evening primrose oil, keep boiling at 90~100 degrees and cook for 2 hours; and after the oil extraction The external pharmaceutical composition can be obtained after filtering the impurities again.

在某些實施例中,該外用醫藥組合物係再加入精製乳油木果脂300公克與精製蜂蠟140公克後賦型,即可形成油膏劑型之該外用醫藥組合物。 In some embodiments, the pharmaceutical composition for external use is formed by adding 300 grams of refined shea butter and 140 grams of refined beeswax to form the pharmaceutical composition for external use in the form of an ointment.

在某些實施例中,該外用醫藥組合物係再加入精製乳油木果脂與橄欖乳化蠟,且精製乳油木果脂和橄欖乳化蠟的重量比係為15比4,加熱至熔解 後再加入純水,且該外用醫藥組合物與純水的體積比係為10比31,持續攪拌即可形成乳霜型之該外用醫藥組合物。 In certain embodiments, the pharmaceutical composition for external use is further added with refined shea butter and olive emulsifying wax, and the weight ratio of refined shea butter and olive emulsifying wax is 15:4, heated to melt Then pure water is added, and the volume ratio of the external medicinal composition to pure water is 10 to 31, and the external medicinal composition of cream type can be formed by continuous stirring.

在某些實施例中,該外用醫藥組合物係再加入精製乳油木果脂與橄欖乳化蠟,且精製乳油木果脂和橄欖乳化蠟的重量比係為5比2,加熱至熔解後再加入純水,且該外用醫藥組合物與純水的體積比係為5比19,持續攪拌即可形成乳液型之該外用醫藥組合物。 In certain embodiments, the pharmaceutical composition for external use is further added with refined shea butter and olive emulsifying wax, and the weight ratio of refined shea butter and olive emulsifying wax is 5 to 2, heated to melting and then added Pure water, and the volume ratio of the pharmaceutical composition for external use to pure water is 5 to 19, and continuous stirring can form the pharmaceutical composition for external use in an emulsion type.

較佳者,所加入之月見草油的容量係為1100毫升。 Preferably, the volume of the evening primrose oil added is 1100 ml.

如此一來,透過上述之製備方法以及所製出之外用醫藥組合物,就能夠於塗抹在傷口或是病症發生處後,產生抗發炎、活血滋潤、與修復皮膚之功效,而且這樣透過完全由純天然漢方草本所組成之醫藥組合物,可以在傷口或搔癢處停留更久,更利於傷口的修復及提升止癢的效果,同時又因天然草本的關係,所以就算是長時間停留在傷口處亦不會對皮膚產生其他不良變化,如過敏等,相較於傳統西藥化合物的治療方式又是溫和許多,表示本發明之實用性及創新性。 In this way, through the above-mentioned preparation method and the prepared pharmaceutical composition for external use, after being applied to the wound or the place where the disease occurs, the effects of anti-inflammatory, invigorating blood and moisturizing, and skin repair can be produced. The medicinal composition composed of pure natural Kampo herbs can stay on the wound or itching for a longer time, which is more conducive to the repair of the wound and enhances the effect of relieving itching. It also does not cause other adverse changes to the skin, such as allergies, and is much milder than traditional western medicine compounds, which shows the practicability and innovation of the present invention.

第1圖,為本發明第一實施例之治療前後的搔癢量表示意圖。 Fig. 1 is a schematic diagram of the itching scale before and after treatment according to the first embodiment of the present invention.

第2圖,為本發明第一實施例之治療前後的皮損改善狀況圖。 Fig. 2 is a graph showing the improvement of skin lesions before and after treatment according to the first embodiment of the present invention.

第3圖,為本發明第二實施例之治療前後的搔癢量表示意圖。 FIG. 3 is a schematic diagram of the itching scale before and after treatment according to the second embodiment of the present invention.

第4圖,為本發明第二實施例之治療前後的皮損改善狀況圖。 Fig. 4 is a graph showing the improvement of skin lesions before and after treatment according to the second embodiment of the present invention.

第5圖,為本發明第三實施例之治療前後的灰指甲改善狀況圖。 Fig. 5 is a graph showing the improvement of onychomycosis before and after treatment according to the third embodiment of the present invention.

為使本領域具有通常知識者能清楚了解本發明之內容,謹以下列說明搭配圖式,敬請參閱。 In order to enable those skilled in the art to clearly understand the content of the present invention, please refer to the following descriptions and drawings.

以下係提出不同的實施例,以供展現本發明所提供之外用醫藥組合物的實際功效,而本發明之外用醫藥組合物係具有土茯苓、荊芥、防風、地膚子、白鮮皮、黃柏、川芎、當歸、何首烏、白芷、百部、苦參以及白芨,且在這些實施例中所使用之該外用醫藥組合物之製備方法為取13個重量份的土茯苓、10個重量份的荊芥、5個重量份的防風、5個重量份的地膚子、5個重量份的白鮮皮、5個重量份的黃柏、5個重量份的川芎、5個重量份的當歸、5個重量份的何首烏、5個重量份的白芷、5個重量份的百部、5個重量份的苦參以及5個重量份的白芨,並且將上述成分加入頂級月見草油1100毫升後,加熱沸騰後維持90~100度煮2小時,接著油萃後再過濾雜質即可得出該外用醫藥組合物,此時該外用醫藥組合物係以精油的方式呈現,而這些實施例中則以油膏劑型的方式進行,因此會再對精油型之該外用醫藥組合物進行加工,亦即該外用醫藥組合物再加入純天然精製乳油木果脂300公克與純天然的精製蜂蠟140公克後賦型,即可形成膏狀的該外用醫藥組合物,並根據病患的情況而取適量塗抹於患部。 The following are different examples to demonstrate the actual efficacy of the pharmaceutical composition for external use provided by the present invention. , Chuanxiong, Angelica, Polygonum multiflorum, Angelica dahurica, Baibu, Sophora flavescens and Bletilla striata, and the preparation method of the medicinal composition for external use used in these examples is to take 13 parts by weight of Tuckahoe, 10 parts by weight of Nepeta , 5 parts by weight of windproof, 5 parts by weight of Kochia seeds, 5 parts by weight of white fresh skin, 5 parts by weight of Treats, 5 parts by weight of Chuanxiong, 5 parts by weight of Angelica sinensis, 5 parts by weight of 5 parts by weight of Polygonum multiflorum, 5 parts by weight of Angelica dahurica, 5 parts by weight of Bai Bu Bu, 5 parts by weight of Sophora flavescens and 5 parts by weight of Bletilla striata, and after adding the above-mentioned ingredients to 1100 ml of top evening primrose oil, heated and boiled to maintain 90~100 degree boiled for 2 hours, then filter the impurities after oil extraction to obtain the external medicinal composition, at this time the external medicinal composition is presented in the form of essential oil, and in these embodiments, in the form of an ointment dosage form. Therefore, the external medicinal composition of the essential oil type will be processed again, that is, the external medicinal composition will be shaped after adding 300 grams of pure natural refined shea butter and 140 grams of pure natural refined beeswax. The pharmaceutical composition for external use is formed into a paste, and an appropriate amount is applied to the affected part according to the condition of the patient.

此外,該外用醫藥組合物亦可以乳液、乳霜、溶液或懸浮液之方式呈現,而乳霜型之該外用醫藥組合物的作法係在該外用醫藥組合物中加入精製乳油木果脂與橄欖乳化蠟,且精製乳油木果脂和橄欖乳化蠟的重量比係為15比4,加熱至熔解後再加入純水,且該外用醫藥組合物與純水的體積比係為10比31,持續攪拌即可形成乳霜型之該外用醫藥組合物。乳液型之該外用醫藥組合物的作法則是在該外用醫藥組合物中加入精製乳油木果脂與橄欖乳化蠟,且精製乳油木果脂和橄欖乳化蠟的重量比係為5比2,加熱至熔解後再加入純水,且 該外用醫藥組合物與純水的體積比係為5比19,持續攪拌即可形成乳液型之該外用醫藥組合物。 In addition, the pharmaceutical composition for external use can also be presented in the form of emulsion, cream, solution or suspension, and the pharmaceutical composition for external use in the form of cream is to add refined shea butter and olive to the pharmaceutical composition for external use Emulsifying wax, and the weight ratio of refined shea butter and olive emulsifying wax is 15 to 4, and pure water is added after being heated to melting, and the volume ratio of this external pharmaceutical composition to pure water is 10 to 31, continuing The external pharmaceutical composition in cream form can be formed by stirring. The practice of this external medicinal composition of emulsion type is to add refined shea butter and olive emulsifying wax in this external medicinal composition, and the weight ratio of refined shea butter and olive emulsifying wax is 5 to 2, heating After melting, pure water is added, and The volume ratio of the external pharmaceutical composition to pure water is 5 to 19, and the external pharmaceutical composition of emulsion type can be formed by continuous stirring.

第一實施例 first embodiment

請參閱第1圖和第2圖,其係為本發明第一實施例之治療前後的搔癢量表示意圖和治療前後的皮損改善狀況圖。如圖所示,本實施例之病患已經過血液透析10年,搔癢9年,經常搔抓至流血,身上的衣物總是血跡斑斑,身上滿是尿毒痘與抓痕,如第2圖中20181121之示意,半夜搔抓失眠,也影響了枕邊人,9年來四處求醫,嘗試過多種治療皆無效。當蕭先生第一次來就診時對其做搔癢量表的評估,如第1圖左側20181017所示,屬於非常嚴重的等級。而在接受該外用醫藥組合物之塗抹治療後,搔癢程度大減,睡眠品質也大幅改善,就如第1圖中曲線持續向右下移動所示,皮膚傷口改善並收口,就如第2圖中20181121和20190419兩組的照片對照所示,亦可看出圖中詳細記錄了皮損的改善狀況。從上述可知,該外用醫藥組合物確實對搔癢程度、傷口及病症具有足夠的修復力及抑制力,相較於傳統的治療法來說,亦確實具有先前技術所未有的功效。 Please refer to Fig. 1 and Fig. 2, which are schematic diagrams of the itching scale before and after treatment and a graph of the improvement of skin lesions before and after treatment according to the first embodiment of the present invention. As shown in the figure, the patient in this example has been on hemodialysis for 10 years, and has been itching for 9 years. He often scratches until he bleeds. His clothes are always stained with blood, and his body is full of uremia and scratches, as shown in Figure 2. As indicated by 20181121, scratching and insomnia in the middle of the night also affected the person beside the bed. For the past 9 years, I have sought medical treatment everywhere, and I have tried various treatments to no avail. When Mr. Xiao first came to see the doctor, he was evaluated on the itch scale, as shown in 20181017 on the left side of Figure 1, which belonged to a very serious level. After receiving the smear treatment of the external pharmaceutical composition, the degree of itching was greatly reduced, and the sleep quality was also greatly improved, as shown by the continuous downward movement of the curve in Figure 1, the skin wound was improved and closed, as shown in Figure 2 In the comparison of the photos of the two groups of 20181121 and 20190419, it can also be seen that the improvement of the skin lesions is recorded in detail in the picture. From the above, it can be seen that the external pharmaceutical composition has sufficient repairing and inhibiting powers on itching, wounds and diseases, and compared with traditional treatment methods, it also has an effect that is unprecedented in the prior art.

第二實施例 Second Embodiment

請參閱第3圖和第4圖,其係為本發明第二實施例之治療前後的搔癢量表示意圖和治療前後的皮損改善狀況圖。如圖所示,本實施例之病患則是經過腹膜透析6年,搔癢2年,當李先生第一次來就診時對其做搔癢量表的評估,屬於非常嚴重的等級,如第3圖左側20181205所示,其搔癢嚴重影響病患之睡眠,且手臂上有大面積的皮膚穿透瘡,如第4圖最左側20191205之示意,傷口除了搔癢之外,長期以來無法收口,時常需要以刀片割傷口流出黑血才得以止癢。但是,在接受該外用醫藥組合物之塗抹治療後,搔癢程度大減,就如第3圖中曲 線雖有震盪但依舊持續向右下移動所示,而且皮膚傷口亦有顯著改善並收口,就如第4圖中20191205、20190102、20190128至20190325這4個時間段所分別拍攝的照片相互對照所示,亦可看出圖中詳細記錄了皮損的改善狀況。 Please refer to Fig. 3 and Fig. 4, which are schematic diagrams of the itching scale before and after treatment and a graph of improvement of skin lesions before and after treatment according to the second embodiment of the present invention. As shown in the figure, the patient in this example has been through peritoneal dialysis for 6 years and has had itching for 2 years. When Mr. Li first came to see the doctor, he was evaluated by the pruritus scale, which belonged to a very serious level, such as the third grade. As shown in 20181205 on the left side of the picture, the itching seriously affects the patient's sleep, and there are large areas of skin penetrating sores on the arms, as shown in 20191205 on the far left of the fourth picture, the wound cannot be closed for a long time except for itching, and it is often necessary to The itching was relieved only by cutting the wound with a knife and bleeding black. However, after receiving the smearing treatment of the external pharmaceutical composition, the degree of itching was greatly reduced, as shown in the curve in Figure 3. Although the line oscillates, it still continues to move downward to the right, and the skin wound has also been significantly improved and closed, as shown in Figure 4. It can also be seen that the improvement of the skin lesions is recorded in detail in the figure.

第三實施例 Third Embodiment

請參閱第5圖,其係為本發明第三實施例之治療前後的灰指甲改善狀況圖。該外用醫藥組合物除了可以治療搔癢、過敏及修復傷口之外,亦可以用來治療灰指甲,如第5圖所示,本實施例之病患的灰指甲(甲癬)指甲色黃濁、增厚且易脆碎裂,40年以來皆無法完全治癒(如20190505所示),然而使用該外用醫藥組合物塗抹治療兩個月後,指甲的黃濁與增厚狀況已明顯改善,碎裂指甲亦有顯著地改善,就如20190505至20190714,這4個時間段所分別拍攝的照片相互對照所示。 Please refer to FIG. 5 , which is a graph showing the improvement of onychomycosis before and after treatment according to the third embodiment of the present invention. In addition to treating itching, allergies and repairing wounds, the pharmaceutical composition for external use can also be used to treat onychomycosis. As shown in Figure 5, the onychomycosis (onychomycosis) of the patient in this example is yellow in color, Thickened and easily brittle and fragmented, it has not been completely cured for 40 years (as shown in 20190505). However, after applying the topical pharmaceutical composition for two months, the turbidity and thickening of the nails have been significantly improved, and the nails are fragmented. Nails also improved significantly, as shown in the comparison of photos taken in these four time periods from 20190505 to 20190714.

綜上所述,透過本發明所提供之該外用醫藥組合物以及其製備方法,只要將該外用醫藥組合物塗抹患部就確實可以達到修復傷口,同時又能止癢脫敏之功效,而且由於是純天然漢方草本之成分所製成,因此不會如西醫的藥物一般,可能會對患者的身體造成損害,因此在用藥上亦能較為放心。此外,本發明所使用之各個成分雖為中醫中會使用之藥材,但本發明更著重於這些藥材之成分配比以及其所能達到之功效用途,而且,在這樣的成分配比下,本發明提供之該外用醫藥組合物所能達到的功效是最佳的,而且又將中藥的成分(藥材)和西方的輔助成分(月見草油)結合後,以不同之方式呈現(乳液、乳霜、精油、藥膏等),進而做出結合中西醫之產品,與傳統的西藥用化合物治療完全不同,且功效又大幅增強,展現出本發明之實用性及創新性。 To sum up, through the medicinal composition for external use provided by the present invention and the preparation method thereof, as long as the medicinal composition for external use is applied to the affected part, the wound repair can be achieved, and the effects of relieving itching and desensitization can be achieved at the same time. It is made of natural Kampo herbal ingredients, so it will not cause damage to the patient's body like Western medicine, so you can feel more at ease in medication. In addition, although the various components used in the present invention are medicinal materials that can be used in traditional Chinese medicine, the present invention focuses more on the composition ratio of these medicinal materials and the efficacy and use that can be achieved. The efficacy that the external medicinal composition provided by the invention can achieve is the best, and after combining the ingredients of traditional Chinese medicine (medicinal materials) and the auxiliary ingredients of the West (evening primrose oil), it is presented in different ways (emulsion, cream, Essential oils, ointments, etc.), and then make a product that combines traditional Chinese and Western medicine, which is completely different from the traditional Western medicine compound treatment, and the effect is greatly enhanced, showing the practicability and innovation of the present invention.

惟,以上所述者,僅為本發明之較佳實施例而已,並非用以限定本發明實施之範圍;故在不脫離本發明之精神與範圍下所作之均等變化與修飾,皆應涵蓋於本發明之專利範圍內。 However, the above descriptions are only preferred embodiments of the present invention, and are not intended to limit the scope of implementation of the present invention; therefore, equivalent changes and modifications made without departing from the spirit and scope of the present invention should be included in the within the scope of the patent of the present invention.

Claims (8)

一種製備外用醫藥組合物以治療搔癢或過敏症狀的用途,其特徵在於:該外用醫藥組合物係具有土茯苓、荊芥、防風、地膚子、白鮮皮、黃柏、川芎、當歸、何首烏、白芷、百部、苦參以及白芨和月見草油;其中,搔癢或過敏症狀係指尿毒性搔癢症所引起之表皮剝落(excoriations)、單純性苔癬(lichen simplex)、結節性癢疹(pruritus nodularis)、角化性丘疹(keratotic papules)毛囊性皮膚角化症(follicular hyperkeratosis)及後天穿透性皮膚病(Acquired perforating dermatosis,APD)。 An application for preparing a medicinal composition for external use to treat itching or allergic symptoms, characterized in that: the medicinal composition for external use is composed of Tuckahoe, Nepeta, Fangfeng, Kochia, Baixianpi, Phellodendri, Chuanxiong, Angelica, Polygonum Radix, Angelica Radix et Rhizoma , Bai Bu, Sophora flavescens, Bletilla striata and Evening Primrose oil; among them, pruritus or allergic symptoms refers to excoriations, lichen simplex, pruritus nodularis caused by uremic prurigo , keratotic papules (keratotic papules) follicular hyperkeratosis (follicular hyperkeratosis) and acquired penetrating dermatosis (Acquired perforating dermatosis, APD). 如申請專利範圍第1項所述之用途,其中,土茯苓係為13個重量份,荊芥係為10個重量份,防風係為5個重量份,地膚子係為5個重量份,白鮮皮係為5個重量份,黃柏係為5個重量份,川芎係為5個重量份,當歸係為5個重量份,何首烏係為5個重量份,白芷係為5個重量份,百部係為5個重量份,苦參係為5個重量份,而白芨係為5個重量份。 The use as described in item 1 of the scope of application for patent application, wherein, 13 parts by weight of tuckahoe, 10 parts by weight of nepeta, 5 parts by weight of windproof, 5 parts by weight of Kochia 5 parts by weight of fresh skin, 5 parts by weight of Cork, 5 parts by weight of Chuanxiong, 5 parts by weight of Angelica, 5 parts by weight of Polygonum multiflorum, 5 parts by weight of Angelica The part is 5 parts by weight, the Sophora flavescens is 5 parts by weight, and the Bletilla striata is 5 parts by weight. 如申請專利範圍第2項所述之用途,其中,該外用醫藥組合物之施用方式係選自以下族群之一或其組合:精油、乳液、乳霜、溶液、懸浮液或油膏。 The use according to item 2 of the claimed scope, wherein the administration mode of the external pharmaceutical composition is selected from one of the following groups or a combination thereof: essential oil, lotion, cream, solution, suspension or ointment. 一種用於治療搔癢或過敏症狀的外用醫藥組合物之製備方法,其步驟包含:取13個重量份的土茯苓、10個重量份的荊芥、5個重量份的防風、5個重量份的地膚子、5個重量份的白鮮皮、5個重量份的黃柏、5個重量份的川 芎、5個重量份的當歸、5個重量份的何首烏、5個重量份的白芷、5個重量份的百部、5個重量份的苦參以及5個重量份的白芨;將上述成分加入月見草油後,加熱沸騰後維持90~100度煮2小時;及油萃後再過濾雜質後即可得出該外用醫藥組合物;其中,搔癢或過敏症狀係指尿毒性搔癢症所引起之表皮剝落(excoriations)、單純性苔癬(lichen simplex)、結節性癢疹(pruritus nodularis)、角化性丘疹(keratotic papules)毛囊性皮膚角化症(follicular hyperkeratosis)及後天穿透性皮膚病(Acquired perforating dermatosis,APD)。 A preparation method of a pharmaceutical composition for external use for treating itching or allergic symptoms, the steps comprising: taking 13 parts by weight of Tuckahoe, 10 parts by weight of Nepeta, 5 parts by weight of windproof, 5 parts by weight of ground Fructus, 5 parts by weight of fresh white skin, 5 parts by weight of Cork, 5 parts by weight of Sichuan Xiong, 5 parts by weight of Angelica sinensis, 5 parts by weight of Polygonum multiflorum, 5 parts by weight of Angelica Radix, 5 parts by weight of Baizhi, 5 parts by weight of Sophora flavescens and 5 parts by weight of Bletilla striata; adding the above components After the evening primrose oil is heated and boiled, it is maintained at 90 to 100 degrees and boiled for 2 hours; and after the oil is extracted and the impurities are filtered, the pharmaceutical composition for external use can be obtained; wherein, itching or allergic symptoms refer to the epidermis caused by uric pruritus Excoriations, lichen simplex, pruritus nodularis, keratotic papules, follicular hyperkeratosis, and acquired penetrating dermatosis perforating dermatosis, APD). 如申請專利範圍第4項所述之製備方法,其中,所加入之月見草油的容量係為1100毫升。 The preparation method as described in item 4 of the scope of the application, wherein the added volume of evening primrose oil is 1100 ml. 如申請專利範圍第5項所述之製備方法,其中,該外用醫藥組合物係再加入精製乳油木果脂300公克與精製蜂蠟140公克後賦型,即可形成油膏劑型之該外用醫藥組合物。 The preparation method as described in item 5 of the scope of the application, wherein the external medicinal composition is formed by adding 300 grams of refined shea butter and 140 grams of refined beeswax to form the external medicinal combination in the form of an ointment. thing. 如申請專利範圍第5項所述之製備方法,其中,該外用醫藥組合物係再加入精製乳油木果脂與橄欖乳化蠟,且精製乳油木果脂和橄欖乳化蠟的重量比係為15比4,加熱至熔解後再加入純水,且該外用醫藥組合物與純水的體積比係為10比31,持續攪拌即可形成乳霜型之該外用醫藥組合物。 The preparation method as described in item 5 of the scope of the application, wherein the external medicinal composition is further added with refined shea butter and olive emulsified wax, and the weight ratio of refined shea butter and olive emulsified wax is 15:1 4. After heating to melting, pure water is added, and the volume ratio of the external medicinal composition to pure water is 10:31, and the external medicinal composition of cream type can be formed by continuous stirring. 如申請專利範圍第5項所述之製備方法,其中,該外用醫藥組合物係再加入精製乳油木果脂與橄欖乳化蠟,且精製乳油木果脂和橄欖乳化蠟的重量比係為5比2,加熱至熔解後再加入純水,且該外用醫藥組合物與純水的體積比係為5比19,持續攪拌即可形成乳液型之該外用醫藥組合物。 The preparation method as described in item 5 of the scope of the application, wherein the pharmaceutical composition for external use is further added with refined shea butter and olive emulsifying wax, and the weight ratio of refined shea butter and olive emulsifying wax is 5:5 2. After heating to melting, pure water is added, and the volume ratio of the external pharmaceutical composition to pure water is 5:19, and the external pharmaceutical composition of emulsion type can be formed by continuous stirring.
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