External use Chinese medicinal compound ointment for treating hand-foot syndrome and preparation method thereof

Abstract

The present invention discloses a traditional Chinese medicine compound ointment for external use for treating hand-foot syndrome and a preparation method thereof. The ointment comprises the following ingredients in parts by weight: 1-15 parts of frankincense, 1-15 parts of myrrh, 1-30 parts of viola yedoensis, 1-30 parts of bletilla striata, 1-30 parts of coptis chinensis, 1-20 parts of knotweed, 1-15 parts of lithospermum officinale, 1-40 parts of notoginseng stem and leaf extract, 1-15 parts of notoginseng total saponins, 1-10 parts of baicalein, 1-10 parts of baicalin, 1-15 parts of emodin, 1-70 parts of vaseline, 1-15 parts of β-sitosterol, 1-5 parts of zinc oxide powder, 1-5 parts of talc, 1-2 parts of lanolin, 1-2 parts of sodium stearate, and 1-20 parts of ethanol. The external-use Chinese medicinal compound ointment of the present invention can effectively treat hand-foot syndrome, has good effect, quick effect and low cost, and the adverse symptoms related to hand-foot syndrome are significantly alleviated after the patient uses it.

Description

Technical Field

[0001] The present invention relates to the technical field of Chinese medicine compositions, and in particular to an external-use Chinese medicine compound ointment for treating hand-foot syndrome and a preparation method thereof. Background Art

[0002] Hand-foot syndrome (HFS) is a common clinical adverse reaction caused by chemotherapy drugs or biological targeted drugs. Drugs that cause HFS include capecitabine, liposomal doxorubicin, vinorelbine, sunitinib, and sorafenib. The clinical manifestations of HFS are progressive skin lesions on the hands and feet, initially on the palms and soles, followed by increased redness and swelling of the hands and feet, accompanied by pain, which can affect daily life. In severe cases, blisters, moist desquamation, and skin ulcers may occur, making it impossible for patients to walk or grasp objects. This can affect the treatment efficacy and quality of life of cancer patients and cause significant pain. Among patients receiving oral capecitabine chemotherapy, 20%-50% are forced to reduce their capecitabine dosage or even discontinue treatment due to unbearable HFS.

[0003] Current treatments for hand-foot syndrome include:

[0004] (1) Western medicine treatments mainly include vitamin B6, vitamin E, COX-2 inhibitors, topical vaseline, etc. However, the effects of the above drugs in treating hand-foot syndrome are poor and the efficacy is unstable.

[0005] (2) Traditional Chinese Medicine treatments include internal Chinese medicine, external Chinese medicine treatments (immersion, wet compresses, topical ointments), a combination of internal and external Chinese medicine, and acupuncture. Among these, external Chinese medicine treatments for hand-foot syndrome have certain advantages. It allows the drug to be directly absorbed through the skin and reach the affected area, reducing the burden on the digestive tract. This makes it particularly suitable for patients with significant digestive tract reactions to chemotherapy.

[0006] Topical Chinese medicine treatments include soaking the herbs and applying ointments. These are cumbersome and time-consuming, and their effectiveness is short-lived. Currently, there are two ointments on the market for treating hand-foot syndrome: MEBO and Jingwanhong. However, the inventors have found that the effectiveness of these two ointments still falls short of the therapeutic needs of patients.

[0007] Therefore, the present invention utilizes the mutual complementation of multiple action mechanisms of different traditional Chinese medicines to provide an external-use traditional Chinese medicine compound ointment for treating hand-foot syndrome and a preparation method thereof. Summary of the Invention

[0008] The present invention aims to overcome the deficiencies of the prior art by providing a topical Chinese herbal compound ointment for treating hand-foot syndrome and a preparation method thereof. The topical Chinese herbal compound ointment of the present invention is effective in treating hand-foot syndrome with good efficacy, rapid results, and low cost. After use, patients experience significant alleviation of symptoms associated with hand-foot syndrome, including lighter coloration of the hands and feet, whitening of nails, improved numbness, disappearance of dryness and cracking, reduced numbness, reduced redness, swelling, and pain, lessened blisters or ulcers, and smoother, more oily skin.

[0009] In order to achieve the above-mentioned purpose, the present invention adopts the following technical solutions:

[0010] Disclosed is an external-use traditional Chinese medicine compound ointment for treating hand-foot syndrome. The ointment comprises the following ingredients in parts by weight: 1-15 parts of frankincense, 1-15 parts of myrrh, 1-30 parts of viola yedoensis, 1-30 parts of bletilla striata, 1-30 parts of coptis chinensis, 1-20 parts of polygonum cuspidatum, 1-15 parts of lithospermum officinale, 1-40 parts of notoginseng stem and leaf extract, 1-15 parts of notoginseng total saponins, 1-10 parts of baicalein, 1-10 parts of baicalin, 1-15 parts of emodin, 1-70 parts of vaseline, 1-15 parts of beta-sitosterol, 1-5 parts of zinc oxide powder, 1-5 parts of talc, 1-2 parts of lanolin, 1-2 parts of sodium stearate, and 1-20 parts of ethanol.

[0011] Preferably, the ointment is composed of the following ingredients in parts by weight: 5-10 parts of frankincense, 5-10 parts of myrrh, 15-20 parts of viola yedoensis, 15-20 parts of bletilla striata, 10-15 parts of coptis chinensis, 5-10 parts of knotweed, 5-10 parts of lithospermum officinale, 20-25 parts of notoginseng stem and leaf extract, 2-6 parts of notoginseng total saponins, 1-5 parts of baicalein, 3-6 parts of baicalin, 12-15 parts of emodin, 50-65 parts of vaseline, 5-12 parts of β-sitosterol, 1-2 parts of zinc oxide powder, 3-5 parts of talc, 1-2 parts of lanolin, 1-2 parts of sodium stearate, and 10-20 parts of ethanol.

[0012] More preferably, the ointment is composed of the following ingredients in parts by weight: 10 parts of frankincense, 8 parts of myrrh, 15 parts of viola yedoensis, 20 parts of bletilla striata, 10 parts of coptis chinensis, 6 parts of knotweed, 8 parts of lithospermum officinale, 20 parts of notoginseng stem and leaf extract, 4 parts of notoginseng total saponins, 2 parts of baicalein, 6 parts of baicalin, 12 parts of emodin, 50 parts of vaseline, 10 parts of β-sitosterol, 1 part of zinc oxide powder, 3 parts of talc, 2 parts of lanolin, 1 part of sodium stearate, and 15 parts of ethanol.

[0013] The ingredients of the topical Chinese herbal compound ointment for treating hand-foot syndrome can be divided into three parts. Frankincense, myrrh, Viola yedoensis, Bletilla striata, Coptis chinensis, Polygonum cuspidatum, and Lithospermum officinale constitute the first part, which is a single Chinese herbal medicine. Extracts of the stems and leaves of Panax notoginseng, total saponins of Panax notoginseng, baicalein, baicalin, and emodin constitute the second part, which is a unit Chinese herbal extract. Vaseline, β-sitosterol, zinc oxide powder, talc, lanolin, sodium stearate, and ethanol constitute the third part, which is a medicated dressing.

[0014] The present invention also provides a method for preparing the above-mentioned external-use Chinese medicine compound ointment, comprising the following steps:

[0015] (1) Mix frankincense, myrrh, Viola yedoensis, Bletilla striata, Coptis chinensis, Polygonum cuspidatum and Lithospermum officinale and boil into a paste;

[0016] (2) Dispersing the extract of chrysanthemum notoginseng stems and leaves, total saponins of Panax notoginseng, baicalein, baicalin and emodin in ethanol and mixing them, then boiling them over low heat to evaporate the ethanol, and then adding vaseline, lanolin and sodium stearate to boil them into a paste for later use;

[0017] (3) adding the paste obtained in step (1) and step (2) to vaseline, further adding β-sitosterol, zinc oxide powder, talc and ethanol to mix, heating the mixture until it becomes a viscous fluid, and then packaging it into sterilized plastic medicine boxes, and waiting for the ointment to solidify to obtain the traditional Chinese medicine compound ointment.

[0018] The present invention has the following technical features:

[0019] 1. In view of the characteristics of hand-foot syndrome, this prescription is mainly composed of traditional Chinese medicines that can promote blood circulation, remove blood stasis, detoxify, resist inflammation, and promote tissue regeneration. It is combined with low-level and high-efficiency traditional Chinese medicine monomers or extracts, and auxiliary materials with astringent and antioxidant effects to enhance the efficacy and reduce costs.

[0020] 2. This ointment has been sterilized at high temperature, is easy to store and use, has a long drug penetration time, and has a definite therapeutic effect.

[0021] 3. The ingredients of the ointment are easy to obtain and simple to make, and can be made at home. DETAILED DESCRIPTION

[0022] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions of the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only a portion of the embodiments of the present invention, not all of them. Based on the described embodiments of the present invention, all other embodiments derived by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0023] Unless otherwise defined, technical or scientific terms used in the present disclosure shall have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs.

[0024] Example 1

[0025] Disclosed is an external-use traditional Chinese medicine compound ointment for treating hand-foot syndrome. The ointment is composed of the following ingredients in parts by weight: 10 parts of frankincense, 8 parts of myrrh, 15 parts of viola yedoensis, 20 parts of bletilla striata, 10 parts of coptis chinensis, 6 parts of polygonum cuspidatum, 8 parts of lithospermum officinale, 20 parts of notoginseng stem and leaf extract, 4 parts of notoginseng total saponins, 2 parts of baicalein, 6 parts of baicalin, 12 parts of emodin, 50 parts of vaseline, 10 parts of beta-sitosterol, 1 part of zinc oxide powder, 3 parts of talc, 2 parts of lanolin, 1 part of sodium stearate, and 15 parts of ethanol.

[0026] The preparation method of the ointment comprises the following steps:

[0027] (1) Mix frankincense, myrrh, violet yedoensis, white hyacinth, coptis root, knotweed and lithospermum erythrorhizon and boil into a viscous, semi-fluid paste. Place in a metal bucket and set aside.

[0028] (2) Place the extract of chrysanthemum notoginseng stems and leaves, total saponins of Panax notoginseng, baicalein, baicalin and emodin in a metal container filled with ethanol liquid, simmer over low heat to evaporate the ethanol, then add vaseline, lanolin and sodium stearate, and simmer into a paste for later use;

[0029] (3) Place a larger metal container on fire, melt the vaseline first, then add the paste obtained in steps (1) and (2) to the vaseline, further add β-sitosterol, zinc oxide powder, talcum powder and ethanol, mix, heat until the properties become a viscous fluid, and then divide into sterilized plastic medicine boxes. After the ointment solidifies, place it in a refrigerator for refrigeration or freezing. This Chinese medicine compound ointment is dark brown.

[0030] Example 2

[0031] Disclosed is an external-use traditional Chinese medicine compound ointment for treating hand-foot syndrome. The ointment is composed of the following ingredients in parts by weight: 15 parts of frankincense, 5 parts of myrrh, 20 parts of viola yedoensis, 15 parts of bletilla striata, 30 parts of coptis chinensis, 15 parts of polygonum cuspidatum, 5 parts of lithospermum officinale, 30 parts of notoginseng stem and leaf extract, 10 parts of notoginseng total saponins, 2 parts of baicalein, 5 parts of baicalin, 12 parts of emodin, 15 parts of vaseline, 8 parts of beta-sitosterol, 3 parts of zinc oxide powder, 2 parts of talc, 1 part of lanolin, 1 part of sodium stearate, and 15 parts of ethanol.

[0032] The preparation method of the ointment comprises the following steps:

[0033] (1) Mix frankincense, myrrh, violet yedoensis, white hyacinth, coptis root, knotweed and lithospermum erythrorhizon and boil into a viscous, semi-fluid paste. Place in a metal bucket and set aside.

[0034] (2) Place the extract of chrysanthemum notoginseng stems and leaves, total saponins of Panax notoginseng, baicalein, baicalin and emodin in a metal container filled with ethanol liquid, simmer over low heat to evaporate the ethanol, then add vaseline, lanolin and sodium stearate, and simmer into a paste for later use;

[0035] (3) Place a larger metal container on fire, melt the vaseline first, then add the paste obtained in steps (1) and (2) to the vaseline, further add β-sitosterol, zinc oxide powder, talcum powder and ethanol, mix, heat until the properties become a viscous fluid, and then divide into high-temperature sterilized plastic medicine boxes. After the ointment solidifies, place it in a refrigerator for refrigeration or freezing. This Chinese medicine compound ointment is dark brown.

[0036] Example 3

[0037] Disclosed is an external-use traditional Chinese medicine compound ointment for treating hand-foot syndrome. The ointment is composed of the following ingredients in parts by weight: 12 parts of frankincense, 5 parts of myrrh, 15 parts of viola yedoensis, 20 parts of bletilla striata, 5 parts of coptis chinensis, 10 parts of polygonum cuspidatum, 5 parts of lithospermum officinale, 40 parts of notoginseng stem and leaf extract, 10 parts of notoginseng total saponins, 2 parts of baicalein, 10 parts of baicalin, 8 parts of emodin, 25 parts of vaseline, 5 parts of beta-sitosterol, 1 part of zinc oxide powder, 5 parts of talc, 2 parts of lanolin, 1 part of sodium stearate, and 10 parts of ethanol.

[0038] The preparation method of the ointment comprises the following steps:

[0039] (4) Mix frankincense, myrrh, violet yedoensis, white hyacinth, coptis root, knotweed and lithospermum officinale and boil them into a thick, semi-fluid paste. Place it in a metal bucket and set aside.

[0040] (5) Place the extract of chrysanthemum notoginseng stems and leaves, total saponins of Panax notoginseng, baicalein, baicalin, and emodin into a metal container filled with ethanol liquid, simmer over low heat to evaporate the ethanol, then add vaseline, lanolin, and sodium stearate, and simmer into a paste for later use;

[0041] (6) Place a larger metal container on fire, melt the vaseline first, then add the paste obtained in steps (1) and (2) to the vaseline, further add β-sitosterol, zinc oxide powder, talcum powder and ethanol, mix, heat until the properties become a viscous fluid, and then divide into high-temperature sterilized plastic medicine boxes. After the ointment solidifies, place it in a refrigerator for refrigeration or freezing. This Chinese medicine compound ointment is dark brown.

[0042] The efficacy of the external Chinese medicinal compound ointment of the present invention for treating hand-foot syndrome is tested. The grading standard of hand-foot syndrome is as follows:

[0043] Grade I: Characterized by any of the following: numbness / dysesthesia / paresthesia of the hands and / or feet, painless swelling or erythema, hyperpigmentation, and / or discomfort that does not interfere with normal activities.

[0044] Grade II: Painful erythema, hyperpigmentation, and swelling of the hands and / or feet and / or discomfort that interferes with the patient's daily activities.

[0045] Grade III: Moist desquamation, ulcers, blisters, hyperpigmentation or severe pain and / or discomfort on the hands and / or feet that prevents the patient from working or performing daily activities. Or the pain is intense and there is loss of skin function.

[0046] A total of 47 patients were selected for the efficacy trial. According to the above grading standards, the 47 breast cancer patients with hand-foot syndrome who were treated with this ointment were classified as Grade I (32 cases), Grade II (13 cases), and Grade III (2 cases). The ointment should be applied once daily, morning and evening. The affected area should be cleaned and dried before use. After use, the remaining ointment should be refrigerated. The efficacy was evaluated after one month of application. In fact, many patients achieved effective results within half a month of using the ointment.

[0047] The degree of clinical symptom relief was used as the efficacy evaluation index. The efficacy evaluation criteria were as follows: markedly effective (significantly relieved clinical symptoms and a reduction of toxicity by one or more grades); effectively effective (partially relieved clinical symptoms and a decrease in toxicity, but not meeting the criteria for markedly effective); and ineffective (unrelieved clinical symptoms or worsening of symptoms). Results: Among 47 patients with hand-foot syndrome, 36 showed marked effectiveness, 11 showed effectiveness, and 0 showed ineffectiveness. The details are shown in Table 1.

[0048] Table 1 Clinical efficacy results of the external use Chinese medicine compound ointment of the present invention

[0049]

[0050] The above clinical treatment results show that the external Chinese medicine compound ointment of the present invention can effectively treat hand-foot syndrome, and the effect is short. After patients used the ointment for one month, the hand-foot syndrome-related symptoms of 76.6% of the patients were significantly relieved, especially for patients with hand-foot syndrome grade III, a good treatment effect was also achieved.

[0051] The above embodiments are only intended to help understand the method of the present invention and its core concept. It should be noted that, without departing from the principles of the present invention, a number of improvements and modifications may be made to the present invention by those skilled in the art, and such improvements and modifications also fall within the scope of protection of the claims of the present invention.

Claims

1. A Chinese medicinal compound ointment for external use for treating hand-foot syndrome, characterized in that: The ointment is composed of the following ingredients in parts by weight: 1-15 parts of frankincense, 1-15 parts of myrrh, 1-30 parts of viola yedoensis, 1-30 parts of bletilla striata, 1-30 parts of coptis chinensis, 1-20 parts of polygonum cuspidatum, 1-15 parts of lithospermum officinale, 1-40 parts of notoginseng stem and leaf extract, 1-15 parts of notoginseng total saponins, 1-10 parts of baicalein, 1-10 parts of baicalin, 1-15 parts of emodin, 1-70 parts of vaseline, 1-15 parts of beta-sitosterol, 1-5 parts of zinc oxide powder, 1-5 parts of talc, 1-2 parts of lanolin, 1-2 parts of sodium stearate, and 1-20 parts of ethanol.

2. The external-use Chinese medicinal compound ointment for treating hand-foot syndrome according to claim 1, characterized in that: The ointment is composed of the following ingredients in parts by weight: 5-10 parts of frankincense, 5-10 parts of myrrh, 15-20 parts of viola yedoensis, 15-20 parts of bletilla striata, 10-15 parts of coptis chinensis, 5-10 parts of knotweed, 5-10 parts of lithospermum officinale, 20-25 parts of notoginseng stem and leaf extract, 2-6 parts of notoginseng total saponins, 1-5 parts of baicalein, 3-6 parts of baicalin, 12-15 parts of emodin, 50-65 parts of vaseline, 5-12 parts of beta-sitosterol, 1-2 parts of zinc oxide powder, 3-5 parts of talc, 1-2 parts of lanolin, 1-2 parts of sodium stearate, and 10-20 parts of ethanol.

3. The external-use Chinese medicinal compound ointment for treating hand-foot syndrome according to claim 1, characterized in that: The ointment is composed of the following ingredients in parts by weight: 10 parts of frankincense, 8 parts of myrrh, 15 parts of viola yedoensis, 20 parts of bletilla striata, 10 parts of coptis chinensis, 6 parts of knotweed, 8 parts of lithospermum officinale, 20 parts of notoginseng stem and leaf extract, 4 parts of notoginseng total saponins, 2 parts of baicalein, 6 parts of baicalin, 12 parts of emodin, 50 parts of vaseline, 10 parts of β-sitosterol, 1 part of zinc oxide powder, 3 parts of talc, 2 parts of lanolin, 1 part of sodium stearate, and 15 parts of ethanol.

4. A method for preparing the external-use Chinese medicinal compound ointment for treating hand-foot syndrome according to any one of claims 1 to 3, characterized in that: The steps include: (1) Mix frankincense, myrrh, Viola yedoensis, Bletilla striata, Coptis chinensis, Polygonum cuspidatum and Lithospermum officinale and boil into a paste; (2) Dispersing the extract of chrysanthemum notoginseng stems and leaves, total saponins of Panax notoginseng, baicalein, baicalin and emodin in ethanol and mixing them, then boiling them over low heat to evaporate the ethanol, and then adding vaseline, lanolin and sodium stearate to boil them into a paste for later use; (3) adding the paste obtained in step (1) and step (2) to vaseline, further adding β-sitosterol, zinc oxide powder, talcum powder and ethanol to mix, heating the mixture until it becomes a viscous fluid, and then packaging it, and waiting for the ointment to solidify to obtain the traditional Chinese medicine compound ointment.

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