CN111514214B

CN111514214B - Traditional Chinese medicine composition and application

Info

Publication number: CN111514214B
Application number: CN202010355198.0A
Authority: CN
Inventors: 卢张伟; 李海云
Original assignee: Nanjing Xinkangli Pharmaceutical Technology Co ltd
Current assignee: Nanjing Xinkangli Pharmaceutical Technology Co ltd
Priority date: 2020-04-29
Filing date: 2020-04-29
Publication date: 2022-03-29
Anticipated expiration: 2040-04-29
Also published as: CN111514214A

Abstract

The invention provides a traditional Chinese medicine composition which comprises extracts of coptis chinensis, myrrh, dandelion and Chinese violet and peppermint oil. The invention comprehensively utilizes the pharmacological actions of various medicinal materials, combines the medicinal materials to play a synergistic interaction effect, obviously improves the treatment effect of single or a plurality of the medicinal materials, can be matched with a substrate which is moisturizing and non-irritant to prepare the compound traditional Chinese medicine ointment, and can pertinently treat and relieve skin diseases caused by tumor targeted medicaments.

Description

Traditional Chinese medicine composition and application

Technical Field

The invention belongs to the field of pharmaceutical preparations, and particularly relates to a traditional Chinese medicine composition and application thereof.

Background

With the continuous emergence of anti-tumor molecular targeted therapeutic drugs and the expansion of indications, more and more tumor patients can select the drugs to reduce the adverse reactions of chemotherapy and improve the quality of life. However, targeting anti-tumor drugs often cause more adverse reactions to the skin, wherein the symptoms such as pimple, pustule, macula, urticaria, pruritus, dry and chapped skin, edema, skin ulceration, delayed skin wound healing and the like are common (Zhang Meihua. Chinese medicine Abstract, 2016,33(6): 710-.

Although the existing medicines for treating the rash have more varieties and can achieve the purpose of preventing or relieving symptoms to a certain extent, the medicines mainly focus on antiallergic drugs, hormones, antibiotics and the like, such as the antiallergic drugs diphenhydramine, promethazine, cetirizine and the like, and hormone products such as prednisone, hydrocortisone, dexamethasone and the like, but the medicines are easy to generate drug resistance or certain intolerable adverse reactions after long-term use. Meanwhile, the adverse reactions of the skin are easy to relapse after treatment, and the adverse reactions need to be taken all the time, so that great pain is brought to patients, and the economic burden of families of the patients is correspondingly increased.

The traditional Chinese medicine is one of the Chinese medicine treasure, and shows good clinical effect in the aspect of treating or relieving skin diseases. Although no traditional Chinese medicine, traditional Chinese medicine compound or traditional Chinese medicine preparation specially aiming at adverse skin reactions caused by targeted tumor treatment medicines exists at present, some traditional Chinese medicine preparations aiming at common skin diseases gradually enter clinical treatment of skin diseases, and new traditional Chinese medicine treatment prescriptions and modern preparations are developed according to the formation mechanism and clinical symptoms of the skin diseases (CN1268367C, CN103520390B, CN1157203C, CN107213397A and the like).

Therefore, the traditional Chinese medicine preparation which has obvious curative effect, easy preparation and simple components and is pertinently used for treating common adverse skin reactions caused by the targeted tumor treatment medicine has extremely strong clinical practical value and urgency, and is not only favorable for reducing the pain of chemotherapy patients, but also favorable for reducing the economic burden caused by long-term administration.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for clinically treating and relieving common skin adverse reactions, particularly skin adverse reactions caused by tumor-targeted drugs, and aims to fill up the blank of traditional Chinese medicine products in the field of treatment of skin disease adverse reactions caused by tumor-targeted drugs, so that the medication safety of patients is improved, the medication pain is reduced, the medication cost is reduced, and the life quality of the patients is improved.

In order to achieve the above purpose, the invention provides the following technical scheme:

a Chinese medicinal composition comprises extracts of Coptidis rhizoma, Myrrha, herba Taraxaci, herba Violae, and oleum Menthae Dementholatum.

Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight:

0.5 to 2.5 parts of coptis chinensis extract,

1-5 parts of myrrh extract

1-4 parts of dandelion extract

1-8 parts of Chinese violet extract

0.1-1 part of mint oil.

The extracts of the coptis chinensis, the myrrh, the dandelion and the Chinese violet are dry powder of a solution obtained by decocting the medicinal materials with water. Preferably, the Coptidis rhizoma extract is dried powder (preferably spray dried) of medicinal liquid obtained by decocting Coptidis rhizoma with 10 times of water (preferably 2 hr); the Myrrha extract is dried powder (preferably spray dried) of medicinal liquid obtained by decocting Myrrha with 10 times of water (preferably for 2 hr); the herba Taraxaci extract is dried powder (preferably spray dried) of medicinal liquid obtained by decocting herba Taraxaci with 10 times of water (preferably 2 hr); the herba Violae extract is dried powder (preferably spray-dried) of decoction obtained by decocting herba Violae with 10 times of water (preferably for 2 hr).

The traditional Chinese medicine composition is a skin external preparation, such as a solution, an ointment, an oil, a cream, a lotion, a paste, a tincture, a gel or a powder. Preferably an ointment.

Furthermore, the ointment also comprises 50-300 parts by weight of glycerol and 5-50 parts by weight of sodium carboxymethyl cellulose.

Can be prepared by the following method (weighing/measuring the corresponding components according to the prescription of the medicine):

(1) weighing a certain amount of sodium carboxymethylcellulose, dissolving in pure water overnight for swelling;

(2) weighing pure water, and heating to dissolve extracts of Coptidis rhizoma, Myrrha, herba Taraxaci, and herba Violae;

(3) mixing the sodium carboxymethylcellulose obtained in the step (1) with the aqueous solution obtained in the step (2);

(4) weighing a certain amount of glycerol, adding the glycerol into the mixed solution obtained in the step (3), and stirring;

(5) and (4) measuring an ethanol solution to dissolve the peppermint oil, adding the peppermint oil into the system obtained in the step (4), and continuously stirring to uniformly mix the peppermint oil and the system to obtain the ointment preparation.

The ointment disclosed by the invention is semisolid at room temperature, and has good fluidity and good needle penetration.

The invention also aims to provide application of the traditional Chinese medicine composition in preparing medicines for treating the rash and the skin complications or secondary symptoms thereof. Preferably, the skin rash and the skin complications or secondary symptoms thereof are adverse skin reactions caused by the treatment of tumor-targeted drugs, and include pimples, pustules, maculas, urticaria, pruritus, dry and chapped skin, edema, skin ulceration, delayed skin wound healing and the like.

Compared with the prior art, the invention has the following advantages and beneficial effects:

(1) the invention comprehensively utilizes the effects of the coptis, the dandelion and the Chinese violet for clearing heat and drying dampness, purging fire, removing toxin and treating sore, combines the effects of the myrrh for activating blood and relieving pain, and eliminating swelling and promoting granulation, and combines the pain relieving and itching relieving effects of the peppermint oil, thereby exerting the synergistic effect and obviously improving the treatment effect of single or a plurality of medicines. Can be mixed with moisturizing and non-irritating matrix to make into compound Chinese medicinal ointment. The invention has the effects of removing rash, diminishing inflammation, removing necrotic tissue, promoting granulation, astringing and healing, and inhibiting scar hyperplasia.

(2) The compound traditional Chinese medicine ointment prepared by the invention can be used for pertinently treating and relieving skin diseases caused by tumor targeted drugs, and is expected to become the first compound traditional Chinese medicine preparation for treating the skin diseases.

(3) The invention has the advantages of cheap and easily obtained raw materials, pure nature, safety, harmlessness, no need of adding antibiotics and preservatives, less components, simple preparation process, controllable cost and easy industrial production.

In conclusion, the compound traditional Chinese medicine ointment has important clinical application and development values.

Detailed Description

The invention will be further explained and illustrated with reference to specific examples, which are given for illustrative purposes only and are not intended to limit the scope of the invention in any way.

Example 1

The coptis extract is 10: the water extract with the specification of 1 is obtained after spray drying; the myrrh extract is myrrh 10: the water extract with the specification of 1 is obtained after spray drying; the dandelion extract is dandelion 10: the water extract with the specification of 1 is obtained after spray drying; the herba violae extract is herba violae 10: the water extract with the specification of 1 is obtained after spray drying.

Prescription 1:

sodium carboxymethylcellulose	20g
		Coptidis rhizoma extract	0.5g
Myrrha extract	1g
		Dandelion extract	1g
Herba Violae extract	1g
		Mint oil	0.1g
Glycerol	100g

(1) Weighing sodium carboxymethylcellulose in a prescription amount, dissolving in 400mL of pure water overnight for swelling;

(2) weighing 250mL of pure water, and heating to dissolve extract freeze-dried powder of coptis chinensis, myrrh, dandelion and Chinese violet;

(3) mixing the sodium carboxymethylcellulose obtained in the step (1) with the aqueous solution of the medicine obtained in the step (2);

(4) weighing 100g of glycerol, adding the glycerol into the mixed solution in the step (3), and stirring;

(5) and (3) measuring 10mL of ethanol solution, dissolving 0.1g of peppermint oil, adding the dissolved peppermint oil into the system obtained in the step (4), adding pure water to a constant volume of 1000mL, continuously stirring to uniformly mix the mixture, and performing irradiation disinfection to obtain the preparation.

Example 2

Prescription 2:

sodium carboxymethylcellulose	20g
		Coptidis rhizoma extract	2.5g
Myrrha extract	5g
		Dandelion extract	4g
Herba Violae extract	8g
		Mint oil	0.1g
Glycerol	100g

The preparation of the invention is prepared by weighing the traditional Chinese medicine extracts and the matrix material in the formula 2 according to the preparation process of the embodiment 1.

Example 3

Prescription 3:

sodium carboxymethylcellulose	20g
		Coptidis rhizoma extract	1g
Myrrha extract	2.5g
		Dandelion extract	2g
Herba Violae extract	4g
		Mint oil	0.1g
Glycerol	100g

The preparation of the present invention was prepared by the preparation method of example 1 by weighing each of the herbal extracts and the matrix material of formula 3.

Example 4

The traditional Chinese medicine ointment prepared in the embodiments 1, 2 and 3 of the invention is used for treating drug eruptions and skin ulceration symptoms of sorafenib treatment patients, 4 cases of the ointment are treated, and 1 case of the ointment is contained in each group. 4 drug eruption patients with no drug relief served as blank controls. The standard of curative effect is as follows: (1) and (3) excellent: after the medicine is applied for 3 days, the drug eruption begins to disappear, and the ulcerated wound surface is healed after 8 days; (2) good: after the medicine is applied for 5 days, the drug eruption begins to disappear, and the ulcerated wound surface is healed after 2 weeks; (3) and (4) invalidation: after the medicine is applied for 2 weeks, the medicine eruption does not disappear, and after 2 weeks, the fester wound surface does not heal. The treatment results are shown in table 1 below.

TABLE 1

Example 5

Based on the prescription 3, one of the Chinese medicinal components is reduced, the Chinese medicinal extracts and the matrix material are weighed according to the corresponding prescription in the following table, and the ointment preparation with each prescription is prepared according to the preparation method of the embodiment 1.

	Prescription 4	Prescription 5	Prescription 6	Prescription 7	Prescription 8
						Sodium carboxymethylcellulose	20g	20g	20g	20g	20g
Coptidis rhizoma extract	/	1g	1g	1g	1g
						Myrrha extract	2.5g	/	2.5g	2.5g	2.5g
Dandelion extract	2g	2g	/	2g	2g
						Herba Violae extract	4g	4g	4g	/	4g
Mint oil	0.1g	0.1g	0.1g	0.1g	/
						Glycerol	100g	100g	100g	100g	100g

Example 6

The traditional Chinese medicine ointment prepared by the prescription 3-8 is considered to treat or relieve the drug eruptions and skin ulceration symptoms of patients treated by the targeted antitumor drugs, 5 cases of the ointment are used in each group, and the patients without drug treatment or drug eruptions are used as a blank control group. The therapeutic effect criteria were set and determined as in example 4. The therapeutic effect is shown in table 2. As can be seen from the data in table 2, the therapeutic or palliative effect of the Chinese medicinal composition (formula 3) is the best, and the removal of any Chinese medicine in the formula can affect the effect. Wherein, the treatment groups lack the extracts of the coptis and the dandelion all have ineffective cases, the treatment group lack the extract of the myrrh has the worst effect, the number of the ineffective cases is 3, and the total effective rate is only 40 percent. The comparison result shows that the components of the traditional Chinese medicine composition have synergistic and synergistic effects, can obviously relieve or treat drug eruptions, and has the best treatment effect.

TABLE 2 preliminary Effect analysis of Compound Chinese medicinal ointment

Claims

1. A traditional Chinese medicine composition is characterized by comprising the following medicines in parts by weight:

0.5-2.5 parts of coptis extract

1-5 parts of myrrh extract

1-4 parts of dandelion extract

1-8 parts of Chinese violet extract

0.1 to 1 part of mint oil,

2. The Chinese medicinal composition of claim 1, wherein the Chinese medicinal composition is an external preparation for skin.

3. The Chinese medicinal composition according to claim 2, wherein the skin external preparation is selected from a solution, an ointment, an oil, a cream, a lotion, a paste, a tincture, a gel or a powder.

4. The Chinese medicinal composition according to claim 3, wherein the skin external preparation is an ointment, and further comprises glycerin and sodium carboxymethyl cellulose.

5. The traditional Chinese medicine composition according to claim 4, wherein the glycerol is 50-300 parts by weight, and the sodium carboxymethyl cellulose is 5-50 parts by weight.

6. The use of the Chinese medicinal composition according to any one of claims 1 to 5 in the preparation of a medicament for treating skin rash and its skin complications or secondary symptoms, which are adverse skin reactions caused by a tumor-targeted medicament.

7. The use according to claim 6, characterized in that said skin rash and its cutaneous complications or secondary symptoms comprise pimples, pustules, maculas, urticaria, pruritus, dry and chapped skin, oedema, skin ulceration, delayed healing of skin wounds.