TW202131943A - Use of preparing pharmaceutical composition for external use to treat itching or allergic symptoms and preparation method of pharmaceutical composition for external use capable of producing the functions of anti-inflammation and skin repair - Google Patents

Use of preparing pharmaceutical composition for external use to treat itching or allergic symptoms and preparation method of pharmaceutical composition for external use capable of producing the functions of anti-inflammation and skin repair Download PDF

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TW202131943A
TW202131943A TW109105887A TW109105887A TW202131943A TW 202131943 A TW202131943 A TW 202131943A TW 109105887 A TW109105887 A TW 109105887A TW 109105887 A TW109105887 A TW 109105887A TW 202131943 A TW202131943 A TW 202131943A
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TWI756638B (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

The present invention discloses a use of preparing pharmaceutical composition for external use to treat itching or allergic symptoms, which is characterized in that: the pharmaceutical composition for external use includes smilax glabra, schizonepetae herba, saposhnikovia divaricata, kochia scoparia, dictamnus dasycarpus, phellodendron chinense, ligusticum chuanxiong, angelica sinensis, polygonum multiflorum, angelica dahurica, baibu, sophora flavescens, bletilla striata and evening primrose oil. In this way, with the pharmaceutical composition for external use with the aforementioned ingredients, it is able to produce functions of anti-inflammation, blood invigoration and nourishment, and skin repairs 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 of preparing external pharmaceutical composition to treat itching or allergic symptoms and preparation method of external 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 invention belongs to the field of medicines, and in particular is a medicinal composition that is applied to 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 statistics, uremic pruritus (uremic pruritus) is a common and distressing symptom in patients with end-stage renal disease (ESRD). Its pathophysiology has not been fully understood, and although the symptoms can be relieved after treatment, it is very difficult to eradicate. The prevalence rate of uremia pruritus in adult dialysis patients varies considerably from year to year. Some studies suggest that the increase in dialysis efficiency may reduce the prevalence rate to explain its prevalence rate from 50 and 90% in 1980 and 1993 to follow-up studies. The report shows 22~57%; another large study (the Dialysis Outcomes and Practice Patterns Study [DOPPS]) shows that the prevalence rate of uremia in adult dialysis patients is 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。Uremia pruritus is most commonly found on the back, but arms, head and abdomen may also occur. There are also many patients with systemic pruritus. The frequency of occurrence ranges from a few minutes a day to almost uninterrupted persistent pruritus and allergies. Wait. Common features include deterioration at night, which affects the quality of sleep. This condition occurs in patients with more severe uremia and scrapie, and can even make the patient tired and depressed; and high temperature (especially in the case of a lot of sweating) and Stress can also aggravate the symptoms of itching. In addition, some patients experience increased itching during dialysis, while others are lessened.

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)。In addition, patients with uremic pruritus are prone to dry skin, scaly appearance or epidermal cracking, because repeated scratching produces significant skin changes, such as epidermal exfoliation (excoriations), simple lichen simplex (lichen simplex), nodularity Pruritus nodularis, keratotic papules, follicular hyperkeratosis and 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 the symptoms of itching are very common in dialysis patients, unless there is consistent and convincing evidence that the patient's itching is due to other causes, clinically, it will be assumed that the patient's itching is from uremic itching. The characteristics that can be referred to in clinical diagnosis include: the occurrence of itching at the beginning of dialysis, the continuous uninterrupted symptoms, and the significant increase in the concentration 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: 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。 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。 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。In addition, since the pathophysiology of uremia pruritus has not been fully studied, the most effective treatment is still not available. For patients with severe pruritus, even though the optimal Kt/V target is reached, pruritus is still not available. improve. Uremia and pruritus are treated with oral antihistamines and gabapentin, topical emollients or local analgesics, ultraviolet B (UVB) phototherapy, and kidney transplantation. However, there are many patients with intractable uremia and pruritus in the clinic, after receiving the above treatment methods, there is no significant effect, and it is not easy to wait for a kidney transplant. At present, the more widely used external treatment methods for the treatment of uremia and itching are as follows: 1. Emollients (emollients) are the first choice for topical treatment of uremia and itching, and it is more recommended for patients with symptoms of sjogren on physical examination. 2. Local analgesics (such as pramoxine) can relieve itching. In a randomized trial sponsored by a pharmaceutical company, which included 28 hemodialysis patients, comparing the use of pramoxine twice a day with the emollient alone, it was found that patients who used pramoxine improved significantly (61 and 12%, respectively). Pramoxine proved to be safe and convenient in this trial. It is recommended for patients who have been using emollients regularly and still have persistent itching. 3. 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 was treated with 2.2% linoleic acid (γ-lynolenic acid) cream three times a day, and the other group was treated with placebo The cream was used three times a day, and it was found that the use of sublinoleic acid cream was more effective in reducing the symptoms of itching 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-mentioned external treatments of Western medicine to improve the itching situation for a while, but the intensity of itching can not be better controlled for a long time, and the above-mentioned treatment methods cannot effectively repair the existing skin. Wounds cause slow wound repair, and at the same time, itching makes it more difficult to heal wounds. Therefore, whether the treatment 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 inventor feels that he is not perfect and exhausts his mental and painstaking research, and based on his accumulated experience in this industry for many years, he provides a pharmaceutical composition for external use to treat itching or allergic symptoms and external medicine. The preparation method of the composition is expected to improve the deficiency of the above-mentioned conventional technology.

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 purpose of the present invention is to provide a method for preparing a pharmaceutical composition for external use to treat itching or allergic symptoms and a method for preparing the pharmaceutical composition for external use, which is made into a pharmaceutical composition for external use with pure natural Chinese herbal ingredients to achieve moisturizing and antipruritic , Can also help 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 use for preparing a pharmaceutical composition for external use to treat itching or allergic symptoms, which is characterized in that the pharmaceutical composition for external use has Smilax glabra, Nepeta, Parsnip, Kochia scoparia, white fresh bark, Phellodendron chinense, Ligusticum chuanxiong, Angelica, Polygonum multiflorum, Angelica dahurica, Baibu, Sophora flavescens, 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, Smilax glabra is 13 parts by weight, Nepeta is 10 parts by weight, Parsnip is 5 parts by weight, Kochia scoparia is 5 parts by weight, Baixian peel is 5 parts by weight, Phellodendron It is 5 parts by weight, Ligusticum chuanxiong is 5 parts by weight, Angelica is 5 parts by weight, Polygonum is 5 parts by weight, Angelica dahurica is 5 parts by weight, Stemone is 5 parts by weight, Sophora flavescens The line is 5 parts by weight, and the Bletilla line 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 application mode of the external pharmaceutical composition is selected from one or a combination of the following groups: essential oils, emulsions, creams, solutions, suspensions or ointments.

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, itching or allergic symptoms refer to the hair follicles caused by uremic pruritus (excoriations), lichen simplex (lichen simplex), pruritus nodularis (pruritus nodularis), and keratotic papules (keratotic papules). Follicular hyperkeratosis (follicular hyperkeratosis) and 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 also discloses a method for preparing a pharmaceutical composition for external use for treating itching or allergic symptoms. The method comprises the following steps: taking 13 parts by weight of Smilax glabra, 10 parts by weight of Nepeta, 5 parts by weight of parsnip, 5 parts by weight of Kochia scoparia, 5 parts by weight of white fresh peel, 5 parts by weight of cork, 5 parts by weight of Ligusticum chuanxiong, 5 parts by weight of Angelica, 5 parts by weight of Polygonum multiflorum, 5 parts by weight Angelica dahurica, 5 parts by weight of Stemona, 5 parts by weight of Sophora flavescens, and 5 parts by weight of Bletilla; Add the above ingredients into evening primrose oil, heat and boil at 90~100 degrees for 2 hours; and after oil extraction After filtering impurities, the external pharmaceutical composition can be obtained.

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 external pharmaceutical composition is formed by adding 300 grams of refined shea butter and 140 grams of refined beeswax to form the external pharmaceutical composition in an ointment form.

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 some 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 to olive emulsifying wax is 15 to 4. The composition is heated to melt before adding Pure water, and the volume ratio of the external pharmaceutical composition to pure water is 10 to 31, and continuous stirring can form the cream-type external pharmaceutical composition.

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 some embodiments, the pharmaceutical composition for external use is further added with refined shea butter and olive emulsified wax, and the weight ratio of refined shea butter to olive emulsified wax is 5 to 2, which is heated to melt before adding Pure water, and the volume ratio of the external pharmaceutical composition to pure water is 5 to 19, and the external pharmaceutical composition of the emulsion type can be formed by continuous stirring.

較佳者,所加入之月見草油的容量係為1100毫升。Preferably, the volume of 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 external pharmaceutical composition, after being applied to the wound or the place where the disease occurs, it can produce anti-inflammatory, invigorating blood and nourishing, and repairing skin effects. 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 the improvement of anti-itching effect. At the same time, due to the relationship of natural herbs, it can stay on the wound for a long time. It will not cause other undesirable changes to the skin, such as allergies. Compared with the traditional western medicine compound, the treatment method is much milder, indicating the practicality and innovation 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 with ordinary knowledge in the field to clearly understand the content of the present invention, please refer to the following description 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 show the actual effect of the external pharmaceutical composition provided by the present invention, and the external pharmaceutical composition of the present invention has Smilax chinensis, Nepeta, Parsnip, Kochia scoparia, fresh bark, Phellodendron amurense , Ligusticum chuanxiong, Angelica, Polygonum multiflorum, Angelica dahurica, Stemone, Sophora flavescens, and Bletilla striata, and the preparation method of the topical pharmaceutical composition used in these examples is to take 13 parts by weight of Smilax glabra and 10 parts by weight of Nepeta , 5 parts by weight of parsnip, 5 parts by weight of Kochia scoparia, 5 parts by weight of white fresh peel, 5 parts by weight of cork, 5 parts by weight of Ligusticum chuanxiong, 5 parts by weight of Angelica, 5 parts by weight Parts of Polygonum multiflorum, 5 parts by weight of Angelica dahurica, 5 parts by weight of Stemona, 5 parts by weight of Sophora flavescens, and 5 parts by weight of Bletilla striata, and after adding the above ingredients to 1100 ml of top evening primrose oil, it is maintained after heating and boiling Boil at 90 to 100 degrees for 2 hours, then extract the oil and filter impurities to obtain the pharmaceutical composition for external use. At this time, the pharmaceutical composition for external use is presented in the form of essential oils. In these examples, it is in the form of ointment. Therefore, the topical pharmaceutical composition of essential oil type will be processed again, that is, the topical pharmaceutical composition will be shaped by adding 300 grams of pure natural refined shea butter and 140 grams of pure natural refined beeswax. The external pharmaceutical composition is formed into a paste, and an appropriate amount is applied to the affected area 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 method for the pharmaceutical composition for external use of the cream type is to add refined shea butter and olive to the pharmaceutical composition for external use. Emulsified wax, and the weight ratio of refined shea butter and olive emulsified wax is 15 to 4. After heating to melt, add pure water, and the volume ratio of the external pharmaceutical composition to pure water is 10 to 31, continuing The external pharmaceutical composition of cream type can be formed by stirring. The method for the external pharmaceutical composition of the emulsion type is to add refined shea butter and olive emulsifying wax to the external pharmaceutical composition, and the weight ratio of refined shea butter to 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 the emulsion type can be formed by continuous stirring.

第一實施例The 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 Figures 1 and 2, which are schematic diagrams of the itching scale before and after treatment and diagrams 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, has itchy for 9 years, often scratches until bleeding, the clothes on his body are always bloody, and his body is covered with uremic acne and scratches, as shown in Figure 2. According to 20181121, scratching and insomnia in the middle of the night also affected the person next to the pillow. In the past 9 years, I have sought medical treatment and tried a variety of treatments to no avail. When Mr. Xiao came to the doctor for the first time, he was evaluated by the Itching Scale. As shown in 20181017 on the left side of the first figure, it belongs to a very serious level. After receiving the application of the pharmaceutical composition for external use, the degree of itching was greatly reduced, and the quality of sleep was also greatly improved, as shown by the continuous downward movement of the curve in the first figure, the skin wound improved and closed, as shown in the second figure. As shown 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 figure. It can be seen from the above that the external pharmaceutical composition does have sufficient repair power and inhibitory power for the degree of itching, wounds and diseases, and it does have an effect that is not available in the prior art compared with the traditional treatment method.

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 Figures 3 and 4, which are schematic diagrams of the pruritus scale before and after treatment and diagrams of the 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 undergone peritoneal dialysis for 6 years and has itching for 2 years. When Mr. Li came to see the doctor for the first time, he was evaluated on the Itching Scale, which is a very serious grade, such as the third As shown in 20181205 on the left side of the picture, its itching seriously affects the patient’s sleep, and there are large areas of skin penetrating sores on the arm. As shown in the leftmost side of picture 4, 20191205, the wound has been unable to close the mouth for a long time except for itching, and it is often necessary Cut the wound with a blade to stop the itching with black blood flowing out. However, after receiving the application of the pharmaceutical composition for external use, the degree of itching was greatly reduced, as shown in the curve in Figure 3, although the curve oscillated but continued to move to the lower right, and the skin wound was also significantly improved and closed. As shown in the comparison of the photos taken in the four time periods of 20191205, 20190102, 20190128 to 20190325 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The 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 Figure 5, which is a diagram showing the improvement of onychomycosis before and after treatment in the third embodiment of the present invention. In addition to treating itching, allergies and repairing wounds, the external pharmaceutical composition can also be used to treat onychomycosis. Thickened and brittle and chipped, it has not been completely cured for 40 years (as shown in 20190505). However, after two months of treatment with the topical pharmaceutical composition, the yellowing and thickening of the nails have been significantly improved, and the nails have been chipped. The nails have also been significantly improved, as shown by the comparison of the photos taken in the 4 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。In summary, through the external pharmaceutical composition provided by the present invention and the preparation method thereof, as long as the external pharmaceutical composition is applied to the affected part, the wound can be repaired and the effect of relieving itching and desensitization can be achieved, and because it is pure It is made of natural Kampo herbal ingredients, so it is not as good as western medicine, and may cause damage to the patient's body, so it can be more assured in medicine. In addition, although the ingredients used in the present invention are medicinal materials that will be used in Chinese medicine, the present invention focuses more on the composition ratio of these medicinal materials and the functions and uses they can achieve. Moreover, under such a composition ratio, the present invention The efficacy of the external pharmaceutical composition provided by the invention is the best, and it combines the components of traditional Chinese medicine (medicinal materials) with western auxiliary components (evening primrose oil) and presents them in different ways (lotions, creams, Essential oils, ointments, etc.), and then make products that combine Chinese and Western medicine, which are completely different from traditional Western medicine compound treatments, and their efficacy is greatly enhanced, demonstrating 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 are only the preferred embodiments of the present invention, and are not used to limit the scope of implementation of the present invention; therefore, equal changes and modifications made without departing from the spirit and scope of the present invention should be covered in Within the scope of the patent 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。 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。 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。 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。 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。Figure 1 is a schematic diagram of the pruritus scale before and after treatment in the first embodiment of the present invention. Figure 2 is a diagram showing the improvement of skin lesions before and after treatment in the first embodiment of the present invention. Figure 3 is a schematic diagram of the pruritus scale before and after treatment in the second embodiment of the present invention. Figure 4 is a diagram showing the improvement of skin lesions before and after treatment in the second embodiment of the present invention. Figure 5 is a diagram showing the improvement of onychomycosis before and after treatment in the third embodiment of the present invention.

Claims (9)

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。An application for preparing a pharmaceutical composition for external use to treat itching or allergic symptoms, which is characterized in: The pharmaceutical composition for external use contains Smilax glabra, Nepeta, Parsnip, Kochia scoparia, White fresh peel, Phellodendron amurense, Ligusticum chuanxiong, Angelica, Polygonum multiflorum, Angelica dahurica, Stemona, Sophora flavescens, Bletilla striata and evening primrose oil. 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。As described in item 1 of the scope of the patent application, among them, Smilax glabra is 13 parts by weight, Nepeta is 10 parts by weight, windproof is 5 parts by weight, Kochia scoparia is 5 parts by weight, white Fresh peel is 5 parts by weight, Phellodendron is 5 parts by weight, Chuanxiong is 5 parts by weight, Angelica is 5 parts by weight, Polygonum is 5 parts by weight, Angelica dahurica is 5 parts by weight, 100 The part system is 5 parts by weight, the Sophora flavescens system is 5 parts by weight, and the Bletilla striata system 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 scope of patent application, wherein the application mode of the external pharmaceutical composition is selected from one or a combination of the following groups: essential oils, emulsions, creams, solutions, suspensions or ointments. 如申請專利範圍第3項所述之用途,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)或灰指甲。As described in item 3 of the scope of patent application, wherein, itching or allergic symptoms refer to exfoliation (excoriations), lichen simplex (lichen simplex), and pruritus nodularis (pruritus nodularis) caused by uremic pruritus , Keratotic papules (keratotic papules) follicular hyperkeratosis (follicular hyperkeratosis) and acquired perforating dermatosis (APD) or onychomycosis. 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。A method for preparing a pharmaceutical composition for external use for the treatment of itching or allergic symptoms, the steps of which include: Take 13 parts by weight of Smilax glabra, 10 parts by weight of Nepeta, 5 parts by weight of parsnips, 5 parts by weight of Kochia scoparia, 5 parts by weight of white fresh peel, 5 parts by weight of Phellodendron chinense, 5 parts by weight Parts by weight of Ligusticum chuanxiong, 5 parts by weight of Angelica, 5 parts by weight of Polygonum multiflorum, 5 parts by weight of Angelica dahurica, 5 parts by weight of Stemona, 5 parts by weight of Sophora flavescens, and 5 parts by weight of Bletilla striata; After adding the above ingredients to the evening primrose oil, heat it to boil and keep it at 90~100 degrees for 2 hours; and After the oil is extracted and the impurities are filtered, the pharmaceutical composition for external use can be obtained. 如申請專利範圍第5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 described in item 5 of the scope of patent application, wherein the volume of the evening primrose oil added is 1100 ml. 如申請專利範圍第6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。According to the preparation method described in item 6 of the scope of patent application, the external pharmaceutical composition is formulated by adding 300 grams of refined shea butter and 140 grams of refined beeswax to form the external pharmaceutical composition in ointment form Things. 如申請專利範圍第6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 6 of the scope of patent application, wherein the pharmaceutical composition for external use is further added with refined shea butter and olive emulsified wax, and the weight ratio of refined shea butter to olive emulsified wax is 15% 4. After heating to dissolve, add pure water, and the volume ratio of the external pharmaceutical composition to pure water is 10 to 31, and continuous stirring can form the external pharmaceutical composition of cream type. 如申請專利範圍第6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 described in item 6 of the scope of patent application, wherein the external pharmaceutical composition is further added with refined shea butter and olive emulsified wax, and the weight ratio of refined shea butter to olive emulsified wax is 5 parts 2. After heating to dissolve, add pure water, and the volume ratio of the external pharmaceutical composition to pure water is 5 to 19. Continuous stirring can form the external pharmaceutical composition of emulsion type.
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