Application of combined medicine in preparation of medicine for treating drug rash

Abstract

The invention belongs to the technical field of medicine for medicine rash, and provides application of a combined medicine in preparation of medicine for treating medicine rash. The combined medicine comprises the following components: an antihistamine medicine and a Chinese patent medicine, the components are prepared together or separately for compatible use, simultaneous use or separate use. The combined medicine adopts a medicine combining traditional Chinese medicine and western medicine, has obvious treatment and relieving effects on the medicine rash when being used for preparing the medicine for treating the medicine rash, and particularly can obviously shorten the treatment cycle of mild medicine rash, improve the treatment effect and relieve the side effects of the medicine.

Description

Technical Field

[0001] The invention belongs to the technical field of drug eruption medication, and in particular relates to the application of a combination drug in the preparation of a drug for treating drug eruption. Background Art

[0002] Drug rash, also known as drug dermatitis, is an inflammatory reaction of the skin and mucous membranes caused by drugs that enter the human body through oral, external or injection routes. It is not caused by pathogens and is an allergic disease. It is not contagious. Drug rash is divided into mild drug rash and severe drug rash. Patients with mild drug rash often show symptoms of itchy skin and erythema; patients with severe drug rash may have systemic organ involvement, poisoning reactions, and even life-threatening.

[0003] In recent years, the incidence of drug eruption has been increasing year by year, with an incidence rate of about 1-3%. It occurs in all age groups, with no gender or seasonal differences, and with certain regional differences. In addition to drug factors, drug eruption is caused by individual factors. Individual factors refer to inherited allergic constitutions and certain enzyme defects that are prone to drug eruption, while drug factors refer to the more common drugs that are prone to drug eruption in clinical practice, such as antibiotics, antipyretic and analgesic drugs, drugs for the treatment of mental illness, serum preparations, certain drugs for the treatment of metabolic diseases, drugs for the treatment of gout, anti-thyroid drugs, biological agents, etc.

[0004] The incidence of drug rash is high, so timely intervention and control of drug rash is particularly important. At present, the methods used to treat mild drug rash include: giving more antihistamine drugs, vitamin C or calcium supplements, and taking small doses of oral glucocorticoids when necessary. The treatment cycle is usually 2-3 weeks.

[0005] Currently, the treatment of drug rash generally has a long treatment cycle, and long-term use of glucocorticoids has many side effects, such as causing metabolic disorders in the body, neuropsychiatric abnormalities, aggravating infections, and increasing the risk of pancreatitis; and most antihistamines have more obvious side effects such as drowsiness and dry mouth. Summary of the invention

[0006] In view of the above-mentioned deficiencies in the prior art, the purpose of the present invention is to provide an application of a combination drug in the preparation of a drug for treating drug rash. The combination drug adopts the combination of Chinese and Western medicine, and has obvious therapeutic and alleviating effects on drug rash when used in the preparation of a drug for treating drug rash, especially it can significantly shorten the treatment period of mild drug rash, improve the treatment effect and reduce the side effects of the drug.

[0007] In order to achieve the above object, the solution adopted by the present invention is:

[0008] A combination drug for treating drug eruptions, the components of which include an antihistamine and a Chinese patent medicine; the components are prepared together or separately for combined use, simultaneous use or separate use.

[0009] Furthermore, in a preferred embodiment of the present invention, the antihistamines include azelastine hydrochloride tablets and olopatadine hydrochloride preparations, and the Chinese patent medicine includes Lysimachia chinensis granules.

[0010] Furthermore, in a preferred embodiment of the present invention, the ratio of each component is: azelastine hydrochloride tablets: olopatadine hydrochloride preparation: Lysimachia chinensis granules: 0.5-1.5 mg: 2-3 mg: 10 g.

[0011] Furthermore, in a preferred embodiment of the present invention, the Chinese patent medicine also includes Huoxiang Zhengqi Liquid.

[0012] Furthermore, in a preferred embodiment of the present invention, the ratio of each component is: azelastine hydrochloride tablets: olopatadine hydrochloride preparation: Lysimachia chinensis granules: Huoxiang Zhengqi liquid: 0.5-1.5 mg: 2-3 mg: 10 g: 20 ml.

[0013] Furthermore, in a preferred embodiment of the present invention, drug rash includes mild drug rash.

[0014] Furthermore, in a preferred embodiment of the present invention, mild drug eruptions include exanthematous drug eruptions, erythema multiforme drug eruptions, fixed drug eruptions, urticarial drug eruptions, acne drug eruptions, and purpuric drug eruptions.

[0015] Furthermore, in a preferred embodiment of the present invention, the dosage form of olopatadine hydrochloride preparation includes tablets and capsules.

[0016] The beneficial effects of the use of a combination drug provided by the present invention in the preparation of a drug for treating drug eruption are:

[0017] The combined drug provided by the present invention combines the antihistamines azelastine hydrochloride tablets and olopatadine hydrochloride preparation with the Chinese patent medicines Lysimachia granules and Huoxiang Zhengqi liquid, and the Chinese and Western medicines are used together to achieve a synergistic effect. When used to prepare a drug for treating drug eruption, the treatment cycle of mild drug eruption can be significantly shortened, the treatment effect can be improved, and the side effects of the drug can be reduced.

[0018] Among them, azelastine hydrochloride tablets are H1 receptor antagonists that can prevent the synthesis and release of certain chemicals in allergic reactions, thereby exerting an anti-allergic effect. Compared with general antihistamines, azelastine hydrochloride tablets have strong antihistamine pharmacological activity. At the same time, they also have the effect of comprehensive anti-inflammatory mediators and are used to treat allergic rhinitis, acute and chronic urticaria. Some patients may experience mild drowsiness, dry mouth, and fatigue after taking the drug.

[0019] Olopatadine hydrochloride is a new second-generation antihistamine drug with antihistamine, anti-inflammatory, anti-neurotransmitter, and mast cell membrane stabilization effects. It has high selectivity, strong affinity, and rapid onset of action. It is mainly used clinically to treat urticaria, eczema, rash, psoriasis, erythema multiforme and other itchy skin diseases. Common adverse reactions after taking Olopatadine hydrochloride tablets are a certain degree of drowsiness and dry mouth.

[0020] The main ingredient of the herb is herb, which has the effects of clearing away dampness and heat, relieving stranguria and reducing swelling. It is commonly used for hot stranguria, sand stranguria, painful urination, jaundice and red urine, carbuncle, snake bites, liver and gallstones, and urinary stones.

[0021] Huoxiang Zhengqi Liquid has the effects of warming and dispersing wind-cold, dispelling exterior pathogens and promoting lung function. It can regulate the circulation of qi and blood in the human body, and has the effects of relaxing muscles and tendons, activating collaterals, and promoting lung function. It also has the effects of strengthening the spleen and stomach, digesting food and eliminating dampness, as well as has obvious effects of calming the liver and gallbladder, clearing away heat and detoxifying. It also has the effects of calming the mind and soothing nerves.

[0022] In the overall technical scheme of the present application, for the first time, the Centella asiatica granules and the Huoxiang Zhengqi liquid are used in combination with antihistamines. Within the specific scope of use of the present application, the Centella asiatica granules can exert their excretion-promoting effect to improve the rapid metabolism of the human body, and at the same time, combined with the heat-clearing, detoxifying, relieving exterior symptoms and regulating qi effects of the Huoxiang Zhengqi liquid, it is beneficial to the rapid effects of the active ingredients of azelastine hydrochloride and olopatadine hydrochloride on the human body; in addition, azelastine hydrochloride, olopatadine hydrochloride, Centella asiatica granules and the Huoxiang Zhengqi liquid are used in combination at a certain dose to prepare a drug rash drug, and it is found that compared with the use of a single antihistamine in the preparation of a drug rash drug, the therapeutic effect can be significantly improved and side effects such as drowsiness and dry mouth can be reduced. DETAILED DESCRIPTION

[0023] In order to make the purpose, technical scheme and advantages of the embodiments of the present invention clearer, the technical scheme in the embodiments of the present invention will be described clearly and completely below. If the specific conditions are not specified in the embodiments, they are carried out according to conventional conditions or conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments used is not specified, they are all conventional products that can be purchased commercially.

[0024] The following is a specific description of the use of a combination drug provided in an embodiment of the present invention in the preparation of a drug for treating drug eruption.

[0025] The features and performance of the present invention are further described in detail below in conjunction with the embodiments.

[0026] Example 1

[0027] 1. Clinical data

[0028] 1.1 General information: A total of 240 cases of mild drug eruptions (including exanthematous drug eruptions, erythema multiforme drug eruptions, fixed drug eruptions, urticarial drug eruptions, acne drug eruptions, and purpuric drug eruptions) were clinically observed and treated. All patients were from the outpatient and inpatient departments of the Dermatology Department of Chengdu Second People's Hospital, including 139 males and 101 females with an average age of 38.12 years.

[0029] 1.2 Diagnostic criteria are as follows:

[0030] 1.2.1 TCM Diagnostic Criteria The fifth and sixth editions of the textbook "Chinese Medicine Surgery":

[0031] 1.2.2 Western medicine diagnostic standards "Modern Dermatology" edited by Yang Guoliang, published in 1996, page 418.

[0032] 1.3 Criteria for determining efficacy:

[0033] Clinical cure: Skin lesions completely subsided, systemic symptoms disappeared, and liver and kidney indicators returned to normal;

[0034] Markedly effective: skin lesions subsided by ≥60%, and most systemic symptoms subsided;

[0035] Improvement: Skin lesions disappear by ≥40%, and systemic symptoms gradually subside;

[0036] Ineffective: Systemic symptoms were not significantly alleviated or aggravated;

[0037] Cure rate = number of clinically cured cases / total number of cases × 100%.

[0038] 2. Treatment methods

[0039] 2.1 Case grouping: The above 240 cases were randomly divided into combination medication group 1, combination medication group 2, control group 1, control group 2, control group 3, control group 4, control group 5 and control group 6, 30 people / group; treatment course: 8 days, the efficacy was evaluated every 2 days, and the final efficacy was evaluated after 8 days of medication.

[0040] Combination drug group 1: Take azelastine hydrochloride tablets 1 hour before breakfast and before going to bed, 0.5-1.5 mg / time, 2 times / day, a total of 2 mg / day; take olopatadine hydrochloride preparations in the morning and evening, 2-3 mg / time, 2 times / day, a total of 5 mg / day; take Centella asiatica granules in the morning and afternoon, 10 g / time, 2 times / day;

[0041] Combination drug group 2: Take azelastine hydrochloride tablets 1 hour before breakfast and before bedtime, 0.5-1.5 mg / time, 2 times / day, for a total of 2 mg / day; take olopatadine hydrochloride preparations in the morning and evening, 2-3 mg / time, 2 times / day, for a total of 5 mg / day; take Centella asiatica granules in the morning and afternoon, 10 g / time, 2 times / day; take Huoxiang Zhengqi liquid in the morning and afternoon, 20 ml / time, 2 times / day.

[0042] Control group 1: Take azelastine hydrochloride tablets 1 hour before breakfast and before going to bed, 0.5-1.5 mg / time, 2 times / day, a total of 2 mg / day; take olopatadine hydrochloride preparations in the morning and evening, 2-3 mg / time, 2 times / day, a total of 5 mg / day;

[0043] Control group 2: Take azelastine hydrochloride tablets 1 hour before breakfast and before going to bed, 0.5-1.5 mg / time, 2 times / day, a total of 2 mg / day; take olopatadine hydrochloride preparations in the morning and evening, 2-3 mg / time, 2 times / day, a total of 5 mg / day; take Huoxiang Zhengqi liquid in the morning and afternoon, 20 ml / time, 2 times / day;

[0044] Control group 3: Take azelastine hydrochloride tablets 1 hour before breakfast and before going to bed, 2 mg / time, 2 times / day, a total of 4 mg / day;

[0045] Control group 4: Take olopatadine hydrochloride in the morning and evening, 5 mg / time, 2 times / day, a total of 10 mg / day;

[0046] Control group 5: Take azelastine hydrochloride tablets 1 hour before breakfast and before going to bed, 2 mg / time, 2 times / day, a total of 4 mg / day; take Qianqiancao granules in the morning and afternoon, 10 g / time, 2 times / day; take Huoxiang Zhengqi liquid in the morning and afternoon, 20 ml / time, 2 times / day;

[0047] Control group 6: Take olopatadine hydrochloride preparation in the morning and evening, 5 mg / time, 2 times / day, a total of 10 mg / day; take Qianqiancao granules in the morning and afternoon, 10 g / time, 2 times / day; take Huoxiangzhengqi liquid in the morning and afternoon, 20 ml / time, 2 times / day;

[0048] 3. Treatment results:

[0049] (1) The treatment status of patients in the combination drug groups 1-2 and the control groups 1-6 after 4 days of medication was statistically analyzed. The results are shown in Table 1:

[0050] (2) The cure rates of patients in the combination drug groups 1-2 and the control groups 1-6 were calculated 2 days, 4 days, 6 days and 8 days after medication. The results are shown in Table 2:

[0051] (3) The adverse reactions of patients in the combination medication groups 1-2 and control groups 1-6 within 4 days of medication were observed. The results are shown in Table 3:

[0052] Among them, the cure rate and adverse reaction incidence are counted to one decimal place:

[0053] Table 1

[0054] Group Number of cases Clinical recovery Significant effect Improvement invalid Cure rate / % Combination medication group 1 30 30 0 0 0 100％ Combination medication group 2 30 30 0 0 0 100％ Control group 1 30 25 2 3 0 83.3％ Control group 2 30 26 3 1 0 86.7％ Control group 3 30 12 4 14 0 40％ Control group 4 30 11 7 12 0 36.7％ Control group 5 30 24 3 7 0 80％ Control group 6 30 23 6 4 0 76.7％

[0055] Table 2

[0056]

[0057] Table 3

[0058]

[0059]

[0060] Clinical experiments showed that the cure rate of combination medication group 1 could reach 90% after 2 days of medication, and the patient could be completely cured after 4 days of medication. The cure rate of combination medication group 2 could reach 96.7% after 2 days of medication, and the patient could be completely cured after 4 days of medication. There were statistically significant differences between combination medication groups 1-2 and control groups 1-6 (P<0.05). The clinical cure rate of combination medication groups 1-2 was significantly higher than that of control groups 1-6, especially significantly higher than that of control groups 3 and 4. This indicates that the combination medication provided in the present application is used to prepare drug rash drugs. It is found that compared with the use of a single antihistamine drug in the preparation of drug rash drugs, the treatment period of mild drug rash can be significantly shortened and the treatment effect can be improved.

[0061] The data in Table 3 show that the combined use of drugs for preparing drug rash drugs can also significantly reduce the side effects of antihistamine drugs. Specific embodiment 1

[0063] Yang, male, 32 years old, came to the hospital for treatment on February 10, 2024. He had the following symptoms when he visited the hospital: his limbs, body and face were accompanied by scattered, mostly pin-cap to millet-sized, bright red, slightly edematous macules, papules and maculopapular rashes. The clinical diagnosis was acute exanthematous drug eruption.

[0064] Since February 11, 2024, take azelastine hydrochloride tablets 1 hour before breakfast and before bedtime, 0.5-1.5 mg / time, 2 times / day, for a total of 2 mg / day; take olopatadine hydrochloride preparations in the morning and evening, 2-3 mg / time, 2 times / day, for a total of 5 mg / day; take Centella asiatica granules in the morning and afternoon, 10 g / time, 2 times / day; take Huoxiang Zhengqi Liquid in the morning and afternoon, 20 ml / time, 2 times / day. After taking the medicine for 1 day, the skin lesions were significantly subsided and healed after 2 days. There was no recurrence during the six-month follow-up. Specific embodiment 2

[0066] Li, female, 35 years old, came to the hospital for treatment on December 21, 2023. She had the following symptoms when she came to the hospital: a large number of edematous bright red or purple-red spots with clear boundaries, round and oval shapes, and varying sizes all over the body. The skin lesions around the anus and vulva were accompanied by erosion and exudation. The clinical diagnosis was fixed drug eruption.

[0067] Since December 22, 2023, take azelastine hydrochloride tablets 1 hour before breakfast and before bedtime, 0.5-1.5 mg / time, 2 times / day, for a total of 2 mg / day; take olopatadine hydrochloride preparations in the morning and evening, 2-3 mg / time, 2 times / day, for a total of 5 mg / day; take Centella asiatica granules in the morning and afternoon, 10 g / time, 2 times / day; take Huoxiang Zhengqi Liquid in the morning and afternoon, 20 ml / time, 2 times / day. After taking the medicine for 2 days, the skin lesions were significantly subsided and healed after 3 days. There was no recurrence during the six-month follow-up. Specific embodiment 3

[0069] Huang, female, 32 years old, came to the hospital for treatment on January 4, 2024. She had the following symptoms when she came to the hospital: dark red edematous macules and papulovesicles appeared in the intertriginous areas such as the neck, armpits, and groin, accompanied by petechiae, blisters and exudate in the center. The clinical diagnosis was erythema multiforme drug eruption.

[0070] Since January 5, 2024, take azelastine hydrochloride tablets 1 hour before breakfast and before bedtime, 0.5-1.5 mg / time, 2 times / day, for a total of 2 mg / day; take olopatadine hydrochloride preparations in the morning and evening, 2-3 mg / time, 2 times / day, for a total of 5 mg / day; take Centella asiatica granules in the morning and afternoon, 10 g / time, 2 times / day; take Huoxiang Zhengqi Liquid in the morning and afternoon, 20 ml / time, 2 times / day. After taking the medicine for 2 days, the skin lesions were significantly subsided and healed after 2 days. There was no recurrence during the six-month follow-up. Specific embodiment 4

[0072] Mr. Xia, male, 38 years old, came to the hospital for treatment on September 7, 2023. He had the following symptoms when he visited the hospital: pale and bright red rash appeared all over the body, including wheals and edematous plaques of varying sizes and irregular shapes. The clinical diagnosis was urticaria-type drug rash.

[0073] Since September 8, 2023, take azelastine hydrochloride tablets 1 hour before breakfast and before bedtime, 0.5-1.5 mg / time, 2 times / day, for a total of 2 mg / day; take olopatadine hydrochloride preparations in the morning and evening, 2-3 mg / time, 2 times / day, for a total of 5 mg / day; take Centella asiatica granules in the morning and afternoon, 10 g / time, 2 times / day; take Huoxiang Zhengqi Liquid in the morning and afternoon, 20 ml / time, 2 times / day. After taking the medicine for 1 day, the skin lesions were significantly subsided and healed after 3 days. There was no recurrence during the six-month follow-up. Specific embodiment 5

[0075] Mr. Gao, male, 41 years old, came to the hospital for treatment on March 15, 2024. He had the following symptoms when he came to the hospital: dense follicular papules and small pustules appeared on his face, neck, chest and back, and the clinical diagnosis was acne-type drug eruption.

[0076] Since March 16, 2024, take azelastine hydrochloride tablets 1 hour before breakfast and before bedtime, 0.5-1.5 mg / time, 2 times / day, for a total of 2 mg / day; take olopatadine hydrochloride preparations in the morning and evening, 2-3 mg / time, 2 times / day, for a total of 5 mg / day; take Centella asiatica granules in the morning and afternoon, 10 g / time, 2 times / day; take Huoxiang Zhengqi Liquid in the morning and afternoon, 20 ml / time, 2 times / day. After taking the medicine for 1 day, the skin lesions were significantly subsided and healed after 3 days. There was no recurrence during the six-month follow-up. Specific embodiment 6

[0078] Mr. Wang, male, 37 years old, came to the hospital for treatment on November 8, 2023. He had the following symptoms when he came to the hospital: his lower limbs had paprika-like spots that did not fade when pressed, accompanied by mild itching. The clinical diagnosis was purpuric drug eruption.

[0079] Since November 9, 2023, take azelastine hydrochloride tablets 1 hour before breakfast and before bedtime, 0.5-1.5 mg / time, 2 times / day, for a total of 2 mg / day; take olopatadine hydrochloride preparations in the morning and evening, 2-3 mg / time, 2 times / day, for a total of 5 mg / day; take Centella asiatica granules in the morning and afternoon, 10 g / time, 2 times / day; take Huoxiang Zhengqi Liquid in the morning and afternoon, 20 ml / time, 2 times / day. After taking the medicine for 3 days, the skin lesions were significantly subsided and healed after 4 days. There was no recurrence during the six-month follow-up.

[0080] In summary, the use of the combination drug provided by the present invention in the preparation of a drug for treating drug rash, the combination drug adopts the combination of Chinese and Western medicine, and has obvious effects on the treatment and relief of drug rash when used in the preparation of a drug for treating drug rash, especially can significantly shorten the treatment period of mild drug rash, improve the treatment effect and reduce the side effects of the drug.

[0081] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. Use of a combination drug in the preparation of a drug for treating drug eruption, characterized in that: The components of the combined drug include antihistamines and Chinese patent medicines; the components are prepared together or separately for combined use, simultaneous use or separate use.

2. The use of the combination drug according to claim 1 in the preparation of a drug for treating drug eruption, characterized in that: The antihistamines include azelastine hydrochloride tablets and olopatadine hydrochloride preparations, and the Chinese patent medicine includes Lysimachia chinensis granules.

3. Use of the combination drug according to claim 2 in the preparation of a drug for treating drug eruption, characterized in that: The proportions of the ingredients are as follows: the azelastine hydrochloride tablets: the olopatadine hydrochloride preparation: the Lysimachia sibiricum granules: 0.5-1.5 mg: 2-3 mg: 10 g.

4. The use of the combination drug according to claim 2 in the preparation of a drug for treating drug eruption, characterized in that: The Chinese patent medicine also includes Huoxiang Zhengqi Liquid.

5. Use of the combination drug according to claim 4 in the preparation of a drug for treating drug eruption, characterized in that: The proportions of the ingredients are as follows: the azelastine hydrochloride tablets: the olopatadine hydrochloride preparation: the Lysimachia chinensis granules: the Huoxiang Zhengqi liquid: 0.5-1.5 mg: 2-3 mg: 10 g: 20 ml.

6. Use of the combination drug according to claim 1 in the preparation of a drug for treating drug eruption, characterized in that: The drug rash includes mild drug rash.

7. Use of the combination drug according to claim 6 in the preparation of a drug for treating drug eruption, characterized in that: The mild drug eruption includes exanthematous drug eruption, erythema multiforme drug eruption, fixed drug eruption, urticaria drug eruption, acne drug eruption, and purpura drug eruption.

8. Use of the combination drug according to claim 2 in the preparation of a drug for treating drug eruption, characterized in that: The dosage form of the olopatadine hydrochloride preparation includes tablets and capsules.

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