Application of traditional Chinese medicine composition in preparation of medicine for treating hand-foot-and-mouth disease

Abstract

The invention relates to an application of a traditional Chinese medicine composition in preparation of a medicine for treating hand-foot-and-mouth disease, which is characterized in that the traditional Chinese medicine composition is prepared from prepared monkshood, dried ginger, honey-fried licorice root, honeysuckle, spina gleditsiae, humulus scandens, pogostemon cablin and pericarpium citri reticulatae. The composition can obviously improve the death protection rate of the ICR suckling mouse infected with the hand-foot-mouth virus, prolong the average survival day number and relieve the clinical disease symptom of the virus infected suckling mouse.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, relates to a new use of a traditional Chinese medicine composition, and specifically relates to an application of the traditional Chinese medicine composition in the preparation of a medicine for hand, foot and mouth disease. Background Art

[0002] Hand, foot and mouth disease is a global infectious disease, and the disease has been reported in most parts of the world. There are many viruses that cause hand, foot and mouth disease, mainly coxsackievirus, echovirus and new enterovirus of the genus Enterovirus of the family Picornaviridae. CoxA group 16, 4, 5, 7, 9, 10, CoxB group 2, 5, 13, and EV71 are all common pathogens of hand, foot and mouth disease, and the most common are CoxA16 and EV71.

[0003] Hand, foot and mouth disease is a common infectious disease caused by enterovirus. The main clinical features of this disease are herpes on the hands, feet and mouth, so it is commonly known as hand, foot and mouth disease. Most patients have mild symptoms, but a few patients may develop complications such as myocarditis, pulmonary edema, aseptic encephalitis, meningoencephalitis, etc. Some seriously ill children progress rapidly and are prone to death. It often occurs in infants and young children under the age of 5, so it is often called "childhood hand, foot and mouth disease." In view of the above problems, the field of traditional Chinese medicine should actively intervene in the prevention and treatment of hand, foot and mouth disease and develop symptomatic prescriptions. Summary of the invention

[0004] In order to solve the above technical problems, the present invention provides a use of a Chinese medicine composition in preparing a medicine for hand, foot and mouth disease, wherein the Chinese medicine composition is prepared from cooked aconite, dried ginger, roasted licorice, honeysuckle, Gleditsia sinensis, Ipomoea australis, patchouli and dried tangerine peel. The use may be any method that is beneficial to improving the corresponding symptoms of the patient, including treatment or prevention.

[0005] Specifically, the use for hand, foot and mouth disease includes significantly improving the death protection rate of ICR suckling mice infected with hand, foot and mouth virus, prolonging the average survival days, and alleviating the clinical symptoms of infected suckling mice.

[0006] Further, the Chinese medicine composition comprises: the Chinese medicine composition comprises: 1-50 parts of cooked aconite, 1-50 parts of dried ginger, 1-50 parts of roasted licorice, 1-50 parts of honeysuckle, 1-50 parts of Gleditsia sinensis, 1-50 parts of Ipomoea australis, 1-50 parts of patchouli, and 1-50 parts of dried tangerine peel. The composition of the present invention can be directly ground into powder, or it can be an extract prepared by conventional means in the art. The Chinese medicine used in the composition of the present invention can also be used in the form of direct grinding into powder, extracts, or other processed forms.

[0007] Further, 10-30 parts of cooked aconite, 5-15 parts of dried ginger, 20-30 parts of roasted licorice, 10-20 parts of honeysuckle, 10-30 parts of gleditsia thorns, 20-45 parts of cinnamon bark, 10-15 parts of patchouli, and 5-15 parts of tangerine peel.

[0008] Furthermore, the Chinese medicine composition includes: 10-20 parts of cooked aconite, 10-15 parts of dried ginger, 20-25 parts of roasted licorice, 10-15 parts of honeysuckle, 10-20 parts of Gleditsia sinensis, 20-30 parts of Ipomoea australis, 10-12 parts of patchouli, and 5-10 parts of tangerine peel.

[0009] Furthermore, the Chinese medicine composition includes: 10-12 parts of cooked aconite, 12-15 parts of dried ginger, 20-22 parts of roasted licorice, 10-12 parts of honeysuckle, 10-12 parts of Gleditsia sinensis, 20-22 parts of Ipomoea australis, 10-12 parts of patchouli, and 5-6 parts of tangerine peel.

[0010] Preferably, the Chinese medicine composition comprises: 10 parts of cooked aconite root, 15 parts of dried ginger, 20 parts of roasted licorice root, 10 parts of honeysuckle, 10 parts of Gleditsia sinensis, 20 parts of Ipomoea australis, 10 parts of patchouli, and 5 parts of tangerine peel.

[0011] The present invention also provides a use of any of the above-mentioned traditional Chinese medicine compositions in the preparation of drugs for resisting coxsackievirus.

[0012] In some embodiments, the aforementioned medicine further comprises a medically acceptable carrier and / or excipient. Specifically, the carrier or excipient may be a carrier or excipient commonly used in the art, including fillers, disintegrants, lubricants, suspending agents, adhesives, sweeteners, flavoring agents, preservatives, and substrates, specifically including but not limited to starch, lactose, glucose, sodium carboxymethyl cellulose, ethyl cellulose and methyl cellulose, malt, gelatin, polyols (such as propylene glycol, glycerol, mannitol), compressed tablets, etc., to help improve the stability of the pharmaceutical composition or increase the activity, or produce an acceptable taste or smell in the case of oral administration.

[0013] In some embodiments, the composition can be prepared into granules, tablets, capsules, pills, oral solutions, oral suspensions or oral emulsions using existing traditional Chinese medicine preparation methods, thereby facilitating clinical administration.

[0014] Furthermore, the preparation method of the traditional Chinese medicine composition includes taking cooked aconite, dried ginger, roasted licorice, honeysuckle, Gleditsia sinensis, Ipomoea australis, patchouli, and tangerine peel, adding 8 to 12 times the total mass of water of the raw materials, heating to boiling, keeping slightly boiling for 1 to 2 hours, and obtaining a first decoction and medicinal residues after separation; for the second time, taking the medicinal residues obtained after the first decoction, adding 6 to 10 times the total mass of water of the raw materials, heating to boiling, keeping slightly boiling for 1 to 2 hours, and obtaining a second decoction and medicinal residues after separation; combining the first decoction and the second decoction to prepare a decoction, and decompressing and concentrating the decoction filtrate to obtain a clear paste, and crushing it.

[0015] When the composition of the present invention is used as a drug for treating hand, foot and mouth disease, an oral solution can be used. Severe patients are given one dose per day, divided into 2 to 3 oral doses or nasogastric administration, once every 6 to 8 hours; critical patients are given two doses per day, divided into two oral doses or nasogastric administration in the morning and evening, once every 8 to 12 hours; mild patients are given one dose per day, orally or nasogastric administration. Each dose is 150 to 250 ml.

[0016] When the medicine is in the form of granules or tablets, the dosage is converted into a decoction dose and then taken orally.

[0017] Clinical trials have shown that the pharmaceutical composition of the present invention can significantly reduce the deterioration of patients, especially for severe and critical patients. Moreover, it also has a certain therapeutic effect on severe and critical patients.

[0018] The composition of the invention can significantly improve the death protection rate of ICR suckling mice infected with hand, foot and mouth virus, prolong the average survival days, and alleviate the clinical symptoms of suckling mice infected with the virus. DETAILED DESCRIPTION

[0019] As mentioned above, the present invention aims to provide a use of a Chinese medicine composition in the preparation of a drug for hand, foot and mouth disease. The following will be described in detail in conjunction with the content of a specific experiment.

[0020] The following experiments, if no specific conditions are specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The APIs or excipients, reagents or instruments used, if the manufacturer is not specified, are all conventional products that can be purchased commercially. Unless otherwise specified, all percentages, ratios, proportions or parts are by weight.

[0021] Unless otherwise defined, all professional and scientific terms used herein have the same meanings as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to those described herein can be applied to the present invention.

[0022] Example 1 Preparation of Chinese medicine composition

[0023] Take 10 kg of cooked aconite, 15 kg of dried ginger, 20 kg of roasted licorice, 10 kg of honeysuckle, 10 kg of Gleditsia sinensis, 20 kg of Ipomoea australis, 10 kg of Patchouli, and 5 kg of dried tangerine peel, add 8 times the total mass of water of the raw materials, heat to boiling, keep slightly boiling for 1 hour, and separate to obtain the first decoction and residue; for the second time, take the residue obtained after the first decoction, add 8 times the total mass of water of the raw materials, heat to boiling, keep slightly boiling for 1 hour, and separate to obtain the second decoction and residue; combine the first decoction and the second decoction to obtain a decoction, reduce the pressure on the decoction filtrate and concentrate it to obtain a clear paste, grind it into fine powder to obtain a Chinese medicine composition, add an appropriate amount of maltodextrin, mix well, and granulate to obtain Chinese medicine composition granules.

[0024] Experimental Example 2 In vivo efficacy experiment of Chinese medicine composition against Coxsackievirus A16

[0025] 1. Experimental Materials

[0026] 1.1 Animals

[0027] ICR mice, SPF grade, were used in formal infection experiments. Sucker mice, 13 to 14 days old, were used. Both males and females were used.

[0028] 1.2 Drugs

[0029] The Chinese medicine composition prepared in Example 1 was produced by Jiangsu Kangyuan Pharmaceutical Co., Ltd.; Ribavirin granules were produced by Sichuan Baili Pharmaceutical Co., Ltd., batch number: 230318, specification: 50 mg / bag.

[0030] 2. Experimental Methods

[0031] The suckling mice at 13-14 days old were randomly divided into a normal control group, a virus control group, a ribavirin granule group (100 mg / kg), and a low-, medium-, and high-dose group of the Chinese medicine composition (10.25, 20.5, and 41 g crude drug / kg), with 10 mice in each group.

[0032] CVA16-MA was diluted with PBS (CVA16-MA is a mouse-adapted strain obtained by adaptive passage of the shzh05-1 strain of Coxsackievirus A16 (from the Institute of Pathogenic Biology, Chinese Academy of Medical Sciences) in mice) and 200ul (equivalent to 4000 TCID 50 ) were infected with virus, and the normal control group was intraperitoneally injected with an equal volume of PBS.

[0033] The first dose was given 1 hour after virus infection, and the drug was administered by gavage once a day for 14 consecutive days. The normal control group and the virus control group were gavaged with an equal volume of pure water.

[0034] The mortality protection rate, average survival days, and clinical symptom scores were used as observation indicators, and the mortality and clinical symptoms of the suckling mice were observed for 14 consecutive days. The scoring criteria for clinical symptoms of suckling mice are: 0 points for normal; 1 point for reduced activity; 2 points for arched back and erect hair; 3 points for hind limb weakness; 4 points for hind limb paralysis; and 5 points for death. The calculation method for the mortality protection rate is: mortality protection rate (%) = (mortality rate of the virus control group - mortality rate of the experimental group) / mortality rate of the virus control group * 100%

[0035] 3. Experimental results

[0036] After the CVA16 virus solution was injected intraperitoneally to create a model, all the suckling mice in the virus control group died 12 days after infection, with a mortality rate of 100% and an average survival of 7.6 days. Compared with the virus control group, by the end of the observation, 7 suckling mice in the low-dose group of the Chinese medicine composition died, with a death protection rate of 30%, and an average survival of 9.8 days; 5 suckling mice in the medium-dose group of the Chinese medicine composition died, with a death protection rate of 50%, and an average survival of 11.5 days; 5 suckling mice in the high-dose group of the Chinese medicine composition died, with a death protection rate of 50%, and an average survival of 11.9 days. It shows that the Chinese medicine composition has a certain protective effect on the survival of suckling mice and can prolong the average survival of infected suckling mice. The results are shown in Table 1.

[0037] Table 1 Protective effect of the Chinese medicine composition of the present invention on suckling mice infected with CVA16

[0038]

[0039] After CVA16 virus infected 13-14 day old ICR suckling mice, the suckling mice in the virus control group became ill after 1 day, died on the 4th day, and all died on the 12th day. Compared with the virus control group, the medium and high dose groups of the Chinese medicine composition had a certain protective effect. Although some mice also showed reduced activity after 1 day, the disease process was slower than that of the virus control group, and 5 mice survived, and the mouse disease score was always lower than that of the virus control group during the observation period. The results are shown in Table 2.

[0040] Table 2 Effect of the Chinese medicine composition of the present invention on clinical symptom scores of suckling mice infected with CVA16

[0041]

[0042] The traditional Chinese medicine composition proposed by the invention can significantly reduce the death caused by Coxsackie virus infection in ICR suckling mice, improve the death protection rate, prolong the average survival days, and alleviate the clinical symptoms of suckling mice after infection.

[0043] The above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the embodiments here. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. Use of a Chinese medicine composition in preparing a drug for hand, foot and mouth disease, characterized in that: The traditional Chinese medicine composition is prepared from the following components: 1-50 parts of cooked aconite root, 1-50 parts of dried ginger, 1-50 parts of roasted licorice root, 1-50 parts of honeysuckle, 1-50 parts of Gleditsia sinensis thorns, 1-50 parts of Ipomoea australis, 1-50 parts of patchouli, and 1-50 parts of tangerine peel.

2. The use according to claim 1, characterized in that: The traditional Chinese medicine composition is composed of the following components by weight: 10-20 parts of cooked aconite, 10-15 parts of dried ginger, 20-25 parts of roasted licorice, 10-15 parts of honeysuckle, 10-20 parts of Gleditsia sinensis, 20-30 parts of Ipomoea australis, 10-12 parts of patchouli, and 5-10 parts of tangerine peel.

3. The use according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following components by weight: 10-12 parts of cooked aconite root, 12-15 parts of dried ginger, 20-22 parts of roasted licorice root, 10-12 parts of honeysuckle, 10-12 parts of Gleditsia sinensis thorns, 20-22 parts of Ipomoea australis, 10-12 parts of patchouli, and 5-6 parts of tangerine peel.

4. The use according to claim 1, characterized in that: The traditional Chinese medicine composition consists of the following components: 10 parts of cooked aconite root, 15 parts of dried ginger, 20 parts of roasted licorice root, 10 parts of honeysuckle, 10 parts of Gleditsia sinensis thorns, 20 parts of Ipomoea australis, 10 parts of patchouli, and 5 parts of tangerine peel.

5. The use according to any one of claims 1 to 3, characterized in that: The drug also includes pharmaceutically acceptable excipients or additives medically acceptable excipients.

6. The use according to claim 5, characterized in that The pharmaceutically acceptable excipients or additives include fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, and bases.

7. The application according to claim 6, characterized in that: The dosage form for the drug includes an oral dosage form, an injection dosage form or an external dosage form.

8. The use according to claim 4, characterized in that: The medicine is in the form of granules, tablets, capsules, pills, oral solutions, oral suspensions or oral emulsions.

9. The use according to claims 1-4, characterized in that: The preparation method of the traditional Chinese medicine composition comprises the following steps: taking cooked aconite root, dried ginger, roasted licorice root, honeysuckle, thorn of Gleditsia sinensis, five-clawed dragon, patchouli, and tangerine peel, adding 8 to 12 times of water equivalent to the total mass of the raw materials, heating to boiling, maintaining a slight boiling for 1 to 2 hours, and obtaining a first decoction and medicinal residues after separation; a second time, taking the medicinal residues obtained after the first decoction, adding 6 to 10 times of water equivalent to the total mass of the raw materials, heating to boiling, maintaining a slight boiling for 1 to 2 hours, and obtaining a second decoction and medicinal residues after separation; combining the first decoction and the second decoction to obtain a decoction, and reducing the pressure on the decoction filtrate to concentrate it to obtain a clear paste, and crushing it.

10. Use of a Chinese medicine composition in the preparation of a drug for treating anti-Coxsackie virus, characterized in that: The traditional Chinese medicine composition comprises, by weight, 1-50 parts of cooked aconite root, 1-50 parts of dried ginger, 1-50 parts of roasted licorice root, 1-50 parts of honeysuckle, 1-50 parts of Gleditsia sinensis thorns, 1-50 parts of Ipomoea australis, 1-50 parts of patchouli, and 1-50 parts of tangerine peel.

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