Application of traditional Chinese medicine composition in preparation of medicine for urticaria

Abstract

The invention relates to an application of a traditional Chinese medicine composition in preparation of a medicine for treating urticaria, 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 ear scratching and cheek scratching symptoms of urticaria model rats, reduce the blood vessel permeability of ears of the rats and reduce the content of serum IgE and Eotaxin, and has a good treatment effect on urticaria.

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 preparing a medicine for urticaria. Background Art

[0002] Urticaria is a disease caused by an allergic reaction, where the immune system misidentifies harmless substances as harmful threats to the human body, resulting in an incorrect overreaction and obvious symptoms in the human body, which has a significant impact on the patient's physical, psychological and economic conditions.

[0003] The main clinical symptoms of urticaria are wheals, erythema, angioedema, and repeated attacks of itching. It often starts with skin itching, followed by the appearance of wheals, which are bright red or pale, skin-colored, and a few patients have edematous erythema. The size and shape of the wheals vary, and the onset time is uncertain. The wheals gradually spread and merge into pieces. Due to the edema of the dermal papillae, the epidermal hair follicle openings can be seen to be sunken downward. The wheals last for several minutes to several hours, and a few can be extended to several days before disappearing without leaving any traces. The rash occurs repeatedly in batches, and is more common in those who develop it in the evening. The wheals are often generalized or localized. Sometimes combined with angioedema, occasionally bullae form on the surface of the wheals. Some patients may be accompanied by nausea, vomiting, headache, head swelling, abdominal pain, diarrhea, and severe patients may also have systemic symptoms such as chest tightness, discomfort, pale complexion, accelerated heart rate, weak pulse, decreased blood pressure, and shortness of breath. In view of the above problems, the field of traditional Chinese medicine should actively participate in the prevention and treatment of urticaria and develop appropriate 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 urticaria, wherein the Chinese medicine composition is prepared from cooked aconite root, dried ginger, roasted licorice root, 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 urticaria includes significantly improving the ear-scratching symptoms of urticaria model rats, reducing the permeability of rat ear blood vessels, and reducing serum IgE and Eotaxin levels.

[0006] Specifically, the urticaria can be chronic urticaria.

[0007] 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.

[0008] 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.

[0009] 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.

[0010] 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.

[0011] 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.

[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 urticaria, an oral solution can be used. Severe patients are given one dose per day, divided into 2 to 3 oral or nasogastric administrations, once every 6 to 8 hours; critical patients are given two doses per day, divided into two oral or nasogastric administrations 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 present invention can significantly improve the ear-scratching symptoms of urticaria model rats, reduce the permeability of rat ear blood vessels, and reduce serum IgE and Eotaxin content, indicating that the traditional Chinese medicine composition has a certain therapeutic effect on ovalbumin-induced chronic urticaria in rats. 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 urticaria. 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 Therapeutic effect of Chinese medicine composition on chronic urticaria model induced by ovalbumin sensitization in rats

[0025] 1. Experimental Materials

[0026] 1.1 Animals

[0027] 60 SD rats, SPF grade, weighing 160-180 g, male, were purchased from Sibeifu (Beijing) Biotechnology Co., Ltd.

[0028] Breeding environment: room temperature 20-26℃, relative humidity controlled at 40-70%, separate cages, with no more than 5 animals in each cage.

[0029] 1.2 Drugs and reagents

[0030] The Chinese medicine composition prepared in Example 1, Jiangsu Kangyuan Pharmaceutical Co., Ltd.; levocetirizine hydrochloride tablets (Suzhou Dongrui Pharmaceutical Co., Ltd., national medicine standard H20060333, batch number 221006); ovalbumin (Shanghai Biotech Co., Ltd., batch number 20210309); aluminum hydroxide (Shanghai Bioengineering Co., Ltd., batch number A510023); Evans blue dye (Nanjing Odofoni Biotechnology Co., Ltd., batch number E2129); sodium chloride injection (Shijiazhuang Siyao Co., Ltd., batch number: 2203193205); rat immunoglobulin E (IgE) ELISA Kit (Thermo Fisher, batch number 228921-003); rat eosinophil chemotactic factor (Eotaxin) ELISA Kit (Thermo Fisher, batch number 239322-002).

[0031] 1.3 Instruments

[0032] Electronic balance (Sartorius Scientific Instruments, model: BS224S); body weight scale (Shanghai Xiangchuan Electronic Scale Co., Ltd., model: ACS-SC-DA); low-temperature centrifuge (Eppendorf, Germany, model: 5804R); microplate reader (MeiGu Molecular, USA, model: Flexstation3).

[0033] 2. Dosage design

[0034] The daily dosage of the Chinese medicine composition is 100g of crude drug / day. According to the body surface area conversion method, the equivalent dose for rats is 100g of crude drug / 60kg*6.2=10.33g of crude drug / kg. According to the 1 / 2:1:2 dosing method, the low dose is set to 5.17g of crude drug / kg, the medium dose is set to 10.33g of crude drug / kg, and the high dose is set to 20.67g of crude drug / kg. The drug is administered by gavage, with a gavage volume of 1mL / 100g, once a day.

[0035] The daily dosage of levocetirizine hydrochloride is 5 mg / day. According to the body surface area conversion method, the equivalent dose for rats is 5 mg / 60 kg*12.3=0.52 mg / kg.

[0036] 3. Experimental Methods

[0037] 3.1 Animal modeling and drug administration

[0038] SD rats were adaptively fed for 3 days and allowed to eat feed and water freely. They were randomly divided into a normal control group, a model control group, a levocetirizine hydrochloride control group, and a high-, medium-, and low-dose group of the Chinese medicine composition according to their body weight, with 10 rats in each group.

[0039] SD rats were given an initial immunization on day 1 by ip injection of 1 mg / mL aluminum hydroxide suspension containing ovalbumin (aluminum hydroxide was prepared into a suspension with a concentration of 10 mg / mL using 0.9% saline injection, and then 1 mg ovalbumin and 1 mL aluminum hydroxide suspension were mixed in proportion for later use). The rats were immunized again on day 10, and the appearance of regular papules on the ears and back of the rats was observed, which was considered to be a successful preparation of the urticaria model.

[0040] Each group of rats was administrated once a day starting from the 6th day for 7 consecutive days.

[0041] 3.2 Detection indicators

[0042] 3.2.1 Behavioral Observation

[0043] After the second immunization, the itching condition of rats in each group was observed and recorded within 30 minutes. The rats were placed alone in a quiet environment, and the number of times the rats scratched their ears within 30 minutes was counted.

[0044] 3.2.2 Ear skin vascular permeability

[0045] After the last administration, 0.1% histamine phosphate was injected into the back skin and ears of rats and 1% Evans blue was injected into the tail vein 30 minutes later. The rats were anesthetized and killed, and all ears were collected and immersed in acetone-saline (7:3) solution for 24 hours. The absorbance (A) value of the supernatant was measured at 610 nm using an enzyme reader. The larger the A value, the higher the permeability of the skin blood vessels.

[0046] 3.2.3 Serum IgE and Eotaxin Levels

[0047] Blood was collected from the orbits of rats in each group and allowed to stand for 2 hours. The blood was then centrifuged at 3000 rpm for 10 minutes to obtain serum. The levels of IgE and Eotaxin in the serum were detected by ELISA according to the instructions of the kit.

[0048] 4. Statistical methods

[0049] SPSS 19.0 software was used to analyze the data of each group, and the measurement data were expressed as mean ± standard deviation. The inter-group comparison was performed using the student's t test, and P < 0.05 indicated statistically significant differences.

[0050] 5. Experimental Results

[0051] 5.1 Behavioral Observation

[0052] After the first immunization, rats in each group showed no abnormal behavior. After the second immunization, compared with the normal control group, rats in the model control group had more ear scratching, easy startling, and restlessness behaviors, and the number of ear scratching of rats increased (P < 0.01). Compared with the model control group, rats in the medium and high dose groups of the Chinese medicine composition had less ear scratching and restlessness behaviors, and the number of ear scratching was significantly reduced (P < 0.05, P < 0.01), and the higher the dose of the Chinese medicine composition, the more obvious the improvement of the above symptoms; the number of ear scratching in the levocetirizine control group was significantly reduced (P < 0.01). See Table 1.

[0053] Table 1: Effects on scratching behavior of urticaria model rats

[0054]

[0055] Note: Compared with the normal control group, ## P<0.01; compared with the model control group, *P<0.05, **P<0.01.

[0056] 5.2 Ear skin vascular permeability

[0057] Compared with the normal control group, the back and ear skin tissues of rats in the model control group were blue-stained, and the permeability of the ear blood vessels of rats was significantly increased (P < 0.05). Compared with the model control group, the permeability of the ear blood vessels of rats in the medium and high dose groups of the Chinese medicine combination group was reduced (P < 0.05, P < 0.01), and there was a certain dose-effect relationship; the permeability of the ear blood vessels of rats in the levocetirizine control group was significantly reduced (P < 0.01). See Table 2.

[0058] Table 2: Effects on ear vascular permeability in urticaria model rats

[0059]

[0060]

[0061] Note: Compared with the normal control group, ## P<0.01; compared with the model control group, **P<0.01.

[0062] 5.3 Serum IgE and Eotaxin Levels

[0063] Compared with the normal control group, the serum IgE and Eotaxin levels of the rats in the model control group were increased (P < 0.01); compared with the model control group, the serum IgE levels of the rats in the medium and high dose groups of the Chinese medicine composition were significantly reduced (P < 0.05, P < 0.01), and the Eotaxin levels were significantly reduced (P < 0.01); the serum IgE and Eotaxin levels of the rats in the levocetirizine group were significantly reduced (P < 0.01). See Table 3.

[0064] Table 3: Effects on serum IgE and Eotaxin levels in urticaria model rats

[0065]

[0066] Note: Compared with the normal control group, ## P<0.01; compared with the model control group, *P<0.05, **P<0.01.

[0067] 6. Experimental conclusion

[0068] This study replicated the rat chronic urticaria model and found that the rats had ear scratching, cheek scratching, irritability and other phenomena, the rat ear skin vascular permeability increased, serum IgE and Eotaxin and other inflammatory mediators also increased significantly, improving the model success. The Chinese medicine composition 10.33, 20.67g crude drug / kg can significantly alleviate the symptoms of ear scratching in rats, reduce the permeability of rat ear vessels, serum IgE and Eotaxin inflammatory factor release, indicating that the Chinese medicine composition has a certain therapeutic effect on ovalbumin-induced chronic urticaria in rats.

[0069] 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 the preparation of a drug for urticaria, 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 4, 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 adjuvants 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 prepare a decoction, and reducing the pressure to concentrate the decoction filtrate to obtain a clear paste, and crushing it.

10. The use according to any one of claims 1 to 4, wherein the urticaria is chronic urticaria.

Images