Traditional Chinese medicine composition for preventing and treating seborrheic dermatitis

Abstract

The present invention discloses a traditional Chinese medicine composition for preventing and treating seborrheic dermatitis, which is prepared from the following raw materials by weight: 3-5 parts of speranskia tuberculata; 3-5 parts of raw oriental arborvitae twig; 3-5 parts of processed fleece-flower root; 1-2 parts of Chinese prickly ash; 3-5 parts of lightyellow sophora root; 1-2 parts of peppermint; 1-2 parts of polygonatum odoratum; 2-3 parts of processed stemona root. The traditional Chinese medicine composition of the present invention can effectively remove or reduce scalp scales, relieve scalp itching, and promote hair growth.

Description

Technical Field

[0001] The present invention relates to a traditional Chinese medicine composition for preventing and treating seborrheic dermatitis. Background Art

[0002] Seborrheic dermatitis is a clinically common and frequently-occurring skin disease. It is caused by hyperfunction of the sebaceous gland secretion, resulting in excessive sebum secretion. It is mainly manifested as excessive sebum on the scalp, shiny and greasy, increased scales, accompanied by itching. Both men and women can be affected, and the prevalence rate is relatively high in young and middle-aged people. It is related to diet, mood, and work and rest time, and is prone to recurrence. A number of epidemiological studies have shown that in tropical and subtropical regions, among middle school students aged 12 - 20, the prevalence rate of seborrheic dermatitis reaches about 10%.

[0003] Clinically, selenium disulfide lotion or ketoconazole lotion can be used to wash the hair, and some patients have certain effects. Selenium disulfide lotion has the effects of removing oil and antifungal, but it is irritating, and side effects such as contact dermatitis, dry and dull hair or scalp, and hair discoloration may occur after use; ketoconazole is a broad-spectrum antifungal drug, and repeated use is prone to drug resistance and loss of efficacy. For patients with severe symptoms, oral tretinoin, roxithromycin, minocycline, etc. can be taken, all of which have certain curative effects. However, seborrheic dermatitis is prone to recurrence, lasting for several years or even decades. Long-term and repeated use of tretinoin or antibiotic drugs will all produce certain side effects. Summary of the Invention

[0004] In view of the above deficiencies of the prior art, according to the embodiments of the present invention, it is desired to provide a traditional Chinese medicine composition for preventing and treating seborrheic dermatitis that is convenient to use and has few side effects.

[0005] According to an embodiment, a traditional Chinese medicine composition for preventing and treating seborrheic dermatitis provided by the present invention is prepared from the following raw materials in parts by weight: 3 - 5 parts of speranskia tuberculata; 3 - 5 parts of fresh oriental arborvitae twig; 3 - 5 parts of prepared fleece-flower root; 1 - 2 parts of Chinese prickly ash; 3 - 5 parts of lightyellow sophora root; 1 - 2 parts of wild mint; 1 - 2 parts of fragrant solomonseal rhizome; 2 - 3 parts of prepared stemona root.

[0006] According to an embodiment, in the above-mentioned traditional Chinese medicine composition for preventing and treating seborrheic dermatitis of the present invention, the parts by weight of the raw materials are preferably: 3 parts of speranskia tuberculata; 3 parts of fresh oriental arborvitae twig; 3 parts of prepared fleece-flower root; 1 part of Chinese prickly ash; 3 parts of lightyellow sophora root; 1 part of wild mint; 1 part of fragrant solomonseal rhizome; 2 parts of prepared stemona root.

[0007] In the traditional Chinese medicine composition for preventing and treating seborrheic dermatitis of the present invention, speranskia tuberculata: dispels wind and dampness, relaxes tendons and activates collaterals, promotes blood circulation to relieve pain, detoxifies and resolves rash; fresh oriental arborvitae twig: cools blood, stops bleeding, dispels wind and dampness, scatters swelling and toxin; prepared fleece-flower root: supplements the liver and kidney, benefits essence and blood, blackens hair, strengthens tendons and bones, reduces turbidity and lipid; Chinese prickly ash: warms the middle-jiao to dispel cold, eliminates dampness, relieves pain, kills insects, and relieves fishy smell toxicity; lightyellow sophora root: clears heat and dries dampness, kills insects, and promotes diuresis; wild mint: disperses wind-heat, clears the head, and penetrates rash; fragrant solomonseal rhizome: nourishes yin and moistens dryness, generates fluid and quenches thirst; stemona root: moistens the lungs to lower qi and relieve cough, and kills insects.

[0008] The traditional Chinese medicine composition for preventing and treating seborrheic dermatitis of the present invention can be prepared into a pharmaceutically acceptable dosage form according to conventional methods.

[0009] The preparation of the granule of the traditional Chinese medicine composition for preventing and treating seborrheic dermatitis of the present invention can adopt the conventional methods in the art, without any special features, and generally includes the following steps:

[0010] (1) Water decoction extraction: Weigh the raw materials according to parts by weight, decoct with water twice. For the first time, add 8 times the amount of water, put in all the decoction pieces except mint, and boil for 1 hour (add mint at the 40th minute), for the second time, add 6 times the amount of water, and boil for 1 hour. Combine the decoction liquids and concentrate, controlling the concentration temperature: 70 - 90°C, vacuum degree: -0.03 MPa to -0.07 MPa, steam pressure: 0.03 MPa to 0.06 MPa.

[0011] (2) Spray drying: Set the inlet air temperature at (135 - 165)°C and the outlet air temperature at (90 - 110)°C, and add an appropriate amount of dextrin for adjustment.

[0012] (3) Dry granulation: Obtain qualified granules, and then pack them with a granule automatic packaging machine.

[0013] The usage method of the granule of the traditional Chinese medicine composition for preventing and treating seborrheic dermatitis of the present invention: Put the granule into the shampoo, let it stand still, and wait until it is completely dissolved, then it can be used according to the normal hair washing method.

[0014] Subsequent examples will prove that the traditional Chinese medicine composition of the present invention can effectively remove or reduce scalp scales, relieve scalp itching, and promote hair growth. Specific embodiments

[0015] The following combines specific embodiments to further elaborate the present invention. These embodiments should be understood as only for illustrating the present invention and not for limiting the protection scope of the present invention. After reading the content recorded in the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent changes and modifications also fall within the scope defined by the claims of the present invention.

[0016] Example 1

[0017] Weigh 30 g of speranskia tuberculata, 30 g of fresh oriental arborvitae twig, 30 g of prepared fleece-flower root, 10 g of Chinese prickly ash, 30 g of lightyellow sophora root, 10 g of mint, 10 g of polygonatum odoratum, and 20 g of prepared stemona root, decoct with water twice. For the first time, add 8 times the amount of water, put in all the decoction pieces except mint, and boil for 1 hour (add mint at the 40th minute), for the second time, add 6 times the amount of water, and boil for 1 hour. Combine the decoction liquids and concentrate, controlling the concentration temperature: 70 - 90°C, vacuum degree: -0.03 MPa to -0.07 MPa, steam pressure: 0.03 MPa to 0.06 MPa.

[0018] Spray drying: Set the inlet air temperature at 135 - 165°C and the outlet air temperature at 90 - 110°C, and adjust by adding an appropriate amount of dextrin.

[0019] Dry granulation: Obtain qualified granules, and pack them into bags with an automatic granule packaging machine, 14 grams per bag.

[0020] Usage method: Add one bag of anti-dandruff, anti-itching and hair growth granules to 100 ml of shampoo matrix to make an anti-dandruff, anti-itching and hair growth shampoo. Let it stand for 10 hours until completely dissolved, and then it can be used according to the normal shampoo method.

[0021] Test example - Clinical data

[0022] 1.1 General information

[0023] Collect 64 outpatients from the Dermatology Clinic of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from March 2021 to December 2021. Inclusion criteria: Patients who meet the Western medicine diagnostic criteria for seborrheic dermatitis and some of the traditional Chinese medicine syndrome diagnostic criteria belonging to the wind-heat syndrome or blood-deficiency and wind-dryness syndrome. Aged 12 - 75 years old, gender is not limited. See Table 1.

[0024] Table 1. Case distribution

[0025]

[0026] Number of included cases: 64, Number of completed cases: 60, Number of dropped cases: 2, Dropout rate: 3.13%

[0027] Number of excluded cases: 0, Exclusion rate: 0.0

[0028] 1.2 Diagnostic criteria

[0029] (1) Western medicine diagnostic criteria: Refer to the clinical manifestations of dry seborrhea in "Chinese Clinical Dermatology":

[0030] ① Diffuse, grayish-white, greasy, bran-like scales on the head;

[0031] ② Often accompanied by itching;

[0032] ③ Showing a chronic course.

[0033] (2) Traditional Chinese medicine syndrome diagnostic criteria: Those belonging to the wind-heat and blood-dryness syndrome (refer to the second edition of "Practical Traditional Chinese Surgery"), accompanied by scalp erythema, some of which can fuse into large patches, with itching aggravated by heat, scalp scales being greasy or dry, dry stools, red tongue with thin coating, and rapid pulse.

[0034] 1.3 Treatment plan.

[0035] (1) Test drug

[0036] Test medicine: 1 pack of the anti-dandruff, anti-itching and hair-growing granules prepared in Example 1 was added to 1 bottle of 100 ml shampoo matrix, and left standing for 10 hours. After complete dissolution, it can be used for hair washing.

[0037] Control medicine: Selenium disulfide lotion (Jiangsu Tianhe Disano Pharmaceutical Co., Ltd., approval number of national drug standard H10800003).

[0038] (2) Medication method

[0039] Take an appropriate amount of the anti-dandruff, anti-itching and hair-growing shampoo, apply it to the wet hair and scalp, and gently knead until foamy. After 3 - 5 minutes, rinse it with warm water. If necessary, it can be repeated once. Wash hair once every 3 days.

[0040] Observe once at 0, 7, and 14 days respectively. 14 days is one treatment course. The observation time is one treatment course.

[0041] 1.4 Efficacy evaluation indicators.

[0042] (1) Main efficacy indicators: Improvement of scalp scales, improvement of itching;

[0043] (2) Secondary efficacy indicators: Improvement of the color of scalp erythema and the area of skin lesions.

[0044] (3) Comprehensive efficacy determination

[0045] Improvement rate = (total score before treatment - total score after treatment) / total score before treatment × 100%

[0046] Among them, the total score is defined as: the sum of the scores of scalp scales, itching, the color of scalp erythema, and the area of skin lesions. It is formulated according to the standards specified in the "Guiding Principles for Clinical Research of New Chinese Medicines" of the Ministry of Health:

[0047] Cure: Improvement rate ≥ 95%;

[0048] Marked effect: 70% ≤ improvement rate < 95%;

[0049] Effective: 30% ≤ improvement rate < 70%;

[0050] Ineffective: Improvement rate < 30%

[0051] Total effective rate = cure rate + marked effect rate + effective rate

[0052] (4) Main efficacy indicators: Improvement of the scores of scalp scales and itching;

[0053] (5) Secondary efficacy indicators: Improvement of the scores of the color of scalp erythema and the area of skin lesions.

[0054] (6) Description of statistical analysis methods: Descriptive statistical analysis. Qualitative indicators or ordinal indicators are described by frequency tables, percentages, or constituent ratios; quantitative indicators are described by means, standard deviations, or medians, lower quartiles (Q1), and upper quartiles (Q3). For the comparability analysis between two groups, chi-square test, Fisher's exact probability method, and Wilcoxon rank sum test are used for qualitative data. For quantitative data that conforms to the normal distribution, t-test is used (perform homogeneity of variance test between groups, with 0.05 as the test level. When the variances are unequal, the Satterthwaite method is used for corrected t-test), and for data that does not conform to the normal distribution, Wilcoxon rank sum test is used. For ordinal data, Wilcoxon rank sum test is used. For the comparison of the two groups of main efficacy indicators, CMH χ2 test corrected for the center is used, and for secondary efficacy indicators, non-parametric test methods are used. In addition to general statistical analysis methods for the comparison of the incidence rates of adverse reactions in the two groups, the cases of normal before treatment and abnormal after treatment are mainly described. Hypothesis testing uniformly uses two-sided tests, and the test statistic and its corresponding P-value are given, with the significance level α taken as 0.05.

[0055] 2. Treatment results.

[0056] 2.1 Comparison of scalp symptoms after treatment in the two groups.

[0057] The two groups were respectively externally applied with the anti-dandruff, antipruritic, and hair-growing shampoo prepared in Example 1 and selenium disulfide lotion for hair washing. After two weeks, the scalp scales in both groups were reduced compared with those before treatment (P < 0.05), and there was no statistical difference between the two groups (P > 0.05); the itching degree in both groups was alleviated compared with that before treatment (P < 0.05), and the experimental group was superior to the control group (P < 0.05); for the erythema color, the experimental group became significantly lighter or disappeared compared with the treatment period (P < 0.05), and there was no statistical difference in the control group compared with that before treatment (P > 0.05); the skin lesion area in both groups was reduced compared with that before treatment (P < 0.05), and the experimental group was superior to the control group (P < 0.05). See Table 2 for details.

[0058] Table 2. Comparison of scalp symptoms after treatment in the two groups

[0059]

[0060] Note: * P < 0.05 compared with before treatment; ▲ P < 0.05 compared with the control group

[0061] 2.2 Determination of comprehensive efficacy.

[0062] The comparison of the comprehensive efficacy after treatment in the two groups showed that the markedly effective rate of the treatment group was 75%, and that of the control group was 53.3%. The treatment group was significantly superior to the control group (P < 0.05). See Table 3 for details.

[0063] Table 3. Comparison of clinical efficacy of patients in the two groups (cases · %)

[0064]

[0065] Note: *P < 0.05 compared with the control group.

Claims

1. An external-use traditional Chinese medicine composition for preventing and treating seborrheic dermatitis, characterized in that, It is made from the following raw medicinal materials in parts by weight: 3 - 5 parts of Speranskia tuberculata; 3 - 5 parts of fresh Platycladus orientalis; 3 - 5 parts of processed Polygonum multiflorum; 1 - 2 parts of Chinese prickly ash; 3 - 5 parts of Sophora flavescens; 1 - 2 parts of Mentha haplocalyx; 1 - 2 parts of Polygonatum odoratum; 2 - 3 parts of processed Stemona sessilifolia.

2. The external-use traditional Chinese medicine composition for preventing and treating seborrheic dermatitis according to claim 1, characterized in that, The parts by weight of the raw medicinal materials are respectively: 3 parts of Speranskia tuberculata; 3 parts of fresh Platycladus orientalis; 3 parts of processed Polygonum multiflorum; 1 part of Chinese prickly ash; 3 parts of Sophora flavescens; 1 part of Mentha haplocalyx; 1 part of Polygonatum odoratum; 2 parts of processed Stemona sessilifolia.

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