Chrysanthemum scurf-removing pure traditional Chinese medicine lotion as well as preparation method, decoction piece and use method thereof

Abstract

The invention relates to a chrysanthemum-grass anti-dandruff pure traditional Chinese medicine lotion and a preparation method thereof as well as decoction pieces and a use method thereof. The chrysanthemum-grass anti-dandruff pure traditional Chinese medicine lotion is prepared by mixing and decocting wild chrysanthemum, garden balsam stem, cacumen biotae, polygonum multiflorum, radix angelicae, radix sophorae flavescentis and mint in a mass ratio of 20: 30: 30: 30: 15: 15: 15. The preparation method comprises the following steps: soaking the discharged herbal medicines in water, boiling on big fire, decocting on slow fire after boiling, and pouring out the liquid medicine; continuously adding water into medicine residues, boiling with big fire again, decocting with slow fire, and pouring out medicine liquid; and mixing the two liquid medicines together to obtain the chrysanthemum-grass anti-dandruff pure traditional Chinese medicine lotion. The decoction pieces are processed according to the formula of the chrysanthemum and grass anti-dandruff pure traditional Chinese medicine lotion. The use method comprises the following steps: boiling after soaking, pouring out the liquid medicine, adding water again, boiling, and pouring out the liquid medicine. The traditional Chinese medicine composition is used for treating scalp seborrheic dermatitis and is stable in curative effect, not prone to relapse, good in safety, high in patient compliance, more direct and remarkable in curative effect, and the medicine efficacy directly reaches the disease site.

Description

Technical Field

[0001] The present invention relates to a pure Chinese herbal medicine lotion for removing dandruff from chrysanthemum weeds, its preparation method, decoction pieces and its usage method, belonging to the technical field of biomedicine. Background Art

[0002] Seborrheic dermatitis (SD), also known as seborrheic eczema, is a chronic papulosquamous and superficial inflammatory skin disease that occurs in sebum-rich areas. Seborrheic dermatitis of the scalp is clinically characterized by patches of varying sizes, light red or yellowish-red in color, covered with bran-like scales or greasy crusts, accompanied by varying degrees of itching. With the changes in the dietary structure, work pressure, sleep quality, etc. of the modern social population, the incidence rate is gradually increasing, and the recurrence rate is also continuously increasing. Seborrheic dermatitis of the scalp causes great distress to patients' lives due to the scales on the exposed parts, accompanied by hair loss and recurrent itching.

[0003] Research Status at Home and Abroad

[0004] 1. Western Medicine Treatment

[0005] 1.1 Keratolytic Agents

[0006] Including coal tar, salicylic acid, and zinc pyrithione shampoo, etc. Coal tar has the effects of relieving itching and dissolving keratin. Salicylic acid has anti-inflammatory, keratin-conditioning, and antibacterial effects. Coal tar lotion and salicylic acid-containing lotion may cause adverse reactions such as skin dryness and irritant dermatitis. Zinc pyrithione has non-specific keratinization and antifungal properties, but due to the lack of relevant safety and effectiveness data, it should be used with caution in the treatment of infant SD.

[0007] 1.2 Antifungal Treatment

[0008] Current research believes that Malassezia plays an important role in the pathogenesis of SD, so antifungal drug treatment occupies an important position in the treatment of SD. Commonly used drugs include: ketoconazole, sertaconazole, ciclopirox gel, 2.5% selenium sulfide lotion, oral itraconazole, etc. Topical imidazole drugs, such as ketoconazole, clotrimazole, and miconazole, mainly play a role by inhibiting the synthesis of the fungal cell wall. 1% ciclopirox (cream, shampoo, gel) is a broad-spectrum antifungal drug, and its mechanism of action involves inhibiting metal-dependent enzymes with anti-inflammatory activity in fungal cells. There are problems with topical antifungal drugs such as effective early treatment, significant decline in efficacy after long-term use, and recurrence after discontinuation. Oral antifungal drugs require regular monitoring of liver function and cannot cure seborrheic dermatitis, and most patients are reluctant to accept them.

[0009] 1.3 Anti-inflammatory Drugs

[0010] 1.3.1 Glucocorticoid drugs: Topical use of low-potency corticosteroids can effectively clear the symptoms and signs related to SD. They are mainly topical preparations, such as hydrocortisone cream, betamethasone dipropionate lotion, desonide cream, etc. Topical glucocorticoids can be used alone or in combination with antifungal drugs. However, due to their side effects, such as telangiectasia, hirsutism, atrophy, and dermatitis, long-term use is not recommended.

[0011] 1.3.2 Calcineurin inhibitors: They mainly treat SD by inhibiting calcineurin. Calcineurin is a calcium-dependent phosphatase necessary for T-cell activation and the production of pro-inflammatory cytokines. In addition to its anti-inflammatory effect, it may also have antifungal effects against Malassezia furfur and Pityrosporum ovale. They mainly include tacrolimus, pimecrolimus, etc. The main adverse reactions of using 0.1% tacrolimus ointment to treat SD are burning, stinging, itching, etc. at the application site.

[0012] Topical corticosteroids and calcineurin inhibitors should only be used for the disease control of patients with obvious symptoms and moderate to severe conditions. In addition, the current dosage form of calcineurin inhibitors is only ointment, which clinically limits its use on the scalp.

[0013] 1.4 Other drugs

[0014] In addition, there are some new drugs such as hyaluronic acid gel, niacinamide, zinc pyrithione aerosol, etc. However, there are still relatively few relevant literature reports, and their efficacy and adverse reactions still need to be further demonstrated.

[0015] 1.5 Physical therapy

[0016] It includes intense pulse light (IPL), narrow band ultraviolet (NB-UVB), photodynamic therapy (PDT), radiofrequency (RF), etc. Generally speaking, the clinical evidence in physical therapy is still relatively insufficient and still needs further research.

[0017] 2. Traditional Chinese medicine treatment

[0018] 2.1 Internal treatment methods of traditional Chinese medicine

[0019] 2.1.1 The syndrome of blood heat and wind dryness is due to the external attack of wind-heat pathogens, which consumes yin and blood, or the wind-heat pathogens accumulate in the skin, and the skin loses nourishment. The main treatment method is usually to clear heat and moisten dryness. Usually, prescriptions such as Loquat Leaf Decoction for Clearing the Lung or Cooling Blood and Eliminating Wind Powder are used, which clear heat and expel wind and are assisted by prescriptions for nourishing blood and moistening dryness. Fu Chunlei [Fu Chunlei. Clinical Observation on the Treatment of Seborrheic Dermatitis (Exuberant Heat in the Lung and Stomach) with Yinqiao Xiaofeng Decoction [D]. Harbin: Heilongjiang University of Chinese Medicine, 2017.] used Yinqiao Xiaofeng Decoction orally, and the control group was given Licorzinc Granules orally to treat cases of the blood heat and wind dryness type. After 4 weeks of treatment, the total effective rate of the treatment group was 96.88%, and the total effective rate of the control group was 71.88%. Yinqiao Xiaofeng Decoction clears heat and purges fire, dispels wind and relieves itching, and has obvious curative effects on seborrheic dermatitis.

[0020] 2.1.2 The main clinical manifestations of the syndrome of dampness-heat in the spleen and stomach are greasy and exudative skin lesions. The main treatment principle is usually to clear heat and promote diuresis. Jia Ying [Jia Ying, Deng Weifang, Wang Youqiu. Analysis of the Experience in Treating Seborrheic Dermatitis with Traditional Chinese Medicine Internal and External Treatments [J]. Journal of Shanxi University of Chinese Medicine, 2018, 19(1): 58 - 59, 71.] is good at using prescriptions such as Simumiao Powder and Pinellia Decoction for Purging Heart Fire, and can significantly improve the symptoms such as desquamation and greasiness of patients by strengthening the spleen and promoting diuresis. Lin Jiepeng [Lin Jiepeng. Clinical Observation on the Treatment of Seborrheic Dermatitis of the Spleen Deficiency and Dampness-Heat Type with Modified Chushi Weiling Decoction [J]. Practical Clinical Journal of Integrated Traditional Chinese and Western Medicine, 2017, 17(8): 47 - 49.] studied the curative effect of Chushi Weiling Decoction on seborrheic dermatitis of the spleen deficiency and dampness-heat type, and compared the clinical curative effects, improvement of skin rashes, improvement of traditional Chinese medicine syndromes and adverse reactions of two groups of patients with conventional western medicine and traditional Chinese medicine. It was found that Chushi Weiling Decoction has significant curative effects in improving symptoms such as the color of skin rashes, the area of skin rashes, the degree of itching, flushing and slight swelling of skin rashes, and improving the general symptoms of patients.

[0021] 2.1.3 Yin deficiency and blood dryness syndrome Mao Jialin [Mao Jialin. Professor Lu Deming's experience in treating seborrheic dermatitis [J]. Chinese Medicine Education, 1999, (3): 51-53.] believes that the treatment of this disease should focus on nourishing Yin. Wind-heat or damp-heat are both superficial symptoms, while Yin deficiency is the root. Long-term use of heat-clearing and damp-removing, wind-dispelling and other agents will easily damage Yin fluid over time, causing Yin fluid deficiency and skin loss of nutrients. Yin deficiency is also an important reason for relapse in most patients. Therefore, agents such as Trichosanthes, Rubia cordifolia, Lithospermum officinale, and Imperatae cylindrica that nourish Yin and moisturize the skin play a more important role in long-term treatment of difficult-to-heal cases. Jiang Liying [Jiang Liying, Gu Minhua, Chen Huijuan, et al. Clinical study on Zhibai Dihuang Decoction for the treatment of seborrheic dermatitis [J]. Journal of Traditional Chinese Medicine, 2015, 30(6): 898-900.] The study found that Zhibai Dihuang Decoction combined with Chuanbai Zhiyang Lotion has significant efficacy in the treatment of seborrheic dermatitis with Yin deficiency and blood dryness syndrome. The selection of Chinese medicine prescriptions based on syndrome differentiation can not only improve skin symptoms and regulate physical constitution, but also be combined with external preparations to dispel wind and relieve itching locally, directly reach the site of the disease, and are not prone to drug resistance. It treats both the symptoms and the root cause, and has a definite effect. Yang Xiaoxiao [Yang Xiaoxiao. Clinical observation on Qufeng Huanji Pills for the treatment of dry type seborrheic dermatitis of the head and face [D]. Harbin: Heilongjiang Academy of Traditional Chinese Medicine, 2018.] Qufeng Huanji Pills were used to nourish Yin, clear heat and dispel wind to treat seborrheic dermatitis, with a cure rate of 62.5%, an effective rate of 96.88%, and an adverse reaction rate of 3.13%, which was lower than the control group of 6.25%. Seborrheic dermatitis recurs frequently, depleting the Ying Yin, and long-term use of dehumidifying products further leads to Yin deficiency. Therefore, Yin-nourishing products play an important role in the treatment of refractory seborrheic dermatitis.

[0022] Oral Chinese medicine has a certain effect in treating scalp seborrheic dermatitis, but it requires high syndrome differentiation and accurate syndrome differentiation to achieve a good effect. Another part of patients are unwilling to accept oral Chinese medicine treatment because of the bitter taste of oral Chinese medicine or gastrointestinal reactions.

[0023] 2.2 External treatment with traditional Chinese medicine

[0024] Research on external treatment with traditional Chinese medicine is quite popular, with insecticidal and antipruritic treatments as the main treatment methods. Possible mechanisms include inhibiting sebum secretion, reducing free fatty acid content, inhibiting the growth of Pityrosporum, repairing the skin barrier, and improving skin moisture content.

[0025] 2.3 Non-drug TCM external treatment

[0026] Non-drug external treatments such as plum blossom needle pricking, filiform needle acupuncture, fire needle, bloodletting puncture, auricular point pressing pellet, ear acupuncture, etc. have the characteristics of simple operation, low adverse reactions, and low recurrence rate. According to the literature, the effective rate is over 87%. However, there are relatively few high-quality studies on single interventions currently. Traditional Chinese medicine external treatments such as fire needle, bloodletting puncture, catgut embedding, etc. are widely used in the clinical treatment of seborrheic dermatitis, and patients have a high degree of satisfaction. Catgut embedding, auricular points, acupuncture, etc. not only belong to external treatments but also can regulate the internal organs by dredging meridians and regulating yin and yang to treat both the symptoms and the root causes. However, there is a lack of research on single influencing factors currently.

[0027] In summary, the current Western medicine treatment of seborrheic dermatitis mainly uses antifungal drugs, keratolytic agents, anti-inflammatory drugs (topical corticosteroids and calcineurin inhibitors), etc. The short-term curative effect is obvious, but it is easy to relapse repeatedly. The curative effect decreases after long-term use, and the long-term use of hormones by patients becomes a more serious problem for patients. Oral traditional Chinese medicine treatment is limited in clinical application because some patients cannot tolerate the taste of traditional Chinese medicine. Therefore, how to effectively, safely, and conveniently treat scalp seborrheic dermatitis and reduce its recurrence has become an important problem in current treatment.

[0028] The inventor found through retrieval that the patent with the publication number CN 102641382 B, a pharmaceutical composition for treating seborrheic alopecia, discloses sophora flavescens, biota orientalis, wild chrysanthemum, and impatiens balsamina. However, through research, the inventor found that there are still essential differences between it and this patent, as follows:

[0029] Different indications: The main symptoms of seborrheic alopecia are increased scalp oil secretion, and the hair gradually becomes sparse and soft, especially obvious in areas such as the forehead and the top of the head. Some patients may be accompanied by mild scalp itching. Seborrheic dermatitis often presents as greasy or dry scales covering erythema, often accompanied by varying degrees of itching.

[0030] Different populations: Seborrheic alopecia is more common in men and women after puberty, and the onset age is usually between 20 and 50 years old. Male patients are often more severe and common than female patients. Seborrheic dermatitis can occur at any age, including children and adolescents. The incidence rates in both men and women are relatively high.

[0031] Different effects: The chrysanthemum and herb anti-dandruff lotion in this patent application is for seborrheic dermatitis patients. In the formula, angelica dahurica and mint enhance the effects of dispelling wind, removing dandruff, and relieving itching. Polygonum multiflorum nourishes blood, dispels wind, and blackens and conditions the hair to prevent the drugs in the formula from being too warm and dry.

[0032] Different formulas: The formula of this patent is different from the formula of the pharmaceutical composition for treating seborrheic alopecia disclosed in CN 102641382 B, and the drug effects are different, and the synergistic effects between various herbs are different.

[0033] It can be seen that the patent with the publication number CN 102641382 B does not constitute a technical inspiration for the formula and preparation method of this patent application. They belong to significantly different special fields and research directions, and there are obvious pharmacological differences. Summary of the Invention

[0034] In order to solve the above problems, the present invention discloses a pure Chinese herbal medicine lotion for removing dandruff from chrysanthemums and herbs, its preparation method, decoction pieces and usage method. The chrysanthemum and herb dandruff-removing lotion of the present invention is used for treating scalp seborrheic dermatitis, with stable curative effect, not easy to relapse, good safety, high patient compliance, and the medicinal power reaching the affected area directly, and the curative effect is more direct and significant. The specific technical solution is as follows:

[0035] A pure Chinese herbal medicine lotion for removing dandruff from chrysanthemums and herbs is obtained by boiling a mixture of wild chrysanthemum, Impatiens balsamina L., Platycladus orientalis (L.) Franco, Polygonum multiflorum Thunb., Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav., Sophora flavescens Aiton and Mentha haplocalyx Briq. in water. The mass ratio of wild chrysanthemum, Impatiens balsamina L., Platycladus orientalis (L.) Franco, Polygonum multiflorum Thunb., Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav., Sophora flavescens Aiton and Mentha haplocalyx Briq. is: 20:30:30:30:15:15:15.

[0036] Furthermore, every 1000 mL of the pure Chinese herbal medicine lotion for removing dandruff from chrysanthemums and herbs is the medicinal liquid obtained by boiling 20 g of wild chrysanthemum, 30 g of Impatiens balsamina L., 30 g of Platycladus orientalis (L.) Franco, 30 g of Polygonum multiflorum Thunb., 15 g of Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav., 15 g of Sophora flavescens Aiton and 15 g of Mentha haplocalyx Briq.

[0037] Furthermore, the wild chrysanthemum is the dried capitulum of Chrysanthemum indicum L. of the Compositae family;

[0038] The Impatiens balsamina L. is the dried stem of Impatiens balsamina L. of the Balsaminaceae family;

[0039] The Platycladus orientalis (L.) Franco is the dried branch tips and leaves of Platycladus orientalis (L.) Franco of the Cupressaceae family;

[0040] The Polygonum multiflorum Thunb. is the dried tuberous root of Polygonum multiflorum Thunb. of the Polygonaceae family;

[0041] The Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav. is the dried root of Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav. of the Umbelliferae family;

[0042] The Sophora flavescens Aiton is the dried root of Sophora flavescens Aiton of the Leguminosae family;

[0043] The Mentha haplocalyx Briq. is the dried aerial part of Mentha haplocalyx Briq. of the Labiatae family.

[0044] The method for preparing the above-mentioned pure Chinese herbal medicine lotion for removing dandruff from chrysanthemums and herbs includes the following steps:

[0045] Step 1: Weigh wild chrysanthemum, Impatiens balsamina L., Platycladus orientalis (L.) Franco, Polygonum multiflorum Thunb., Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav., Sophora flavescens Aiton and Mentha haplocalyx Briq. according to the weight ratio described in Claim 1, mix them and soak them in normal temperature water;

[0046] Step 2: Place the soaked water obtained in Step 1 together with the medicinal materials on a high fire to boil. After boiling, change to a slow fire and decoct, and then pour out the medicinal liquid;

[0047] Step 3: Continuously add normal temperature water to the medicinal residues after pouring out the medicinal liquid in Step 2, then place it on a high fire and bring to a boil. After boiling, change to a gentle fire and decoct for a while, and then pour out the medicinal liquid;

[0048] Step 4: Mix the medicinal liquids from Step 2 and Step 3 together to obtain the pure traditional Chinese medicine lotion for removing dandruff from chrysanthemum and herb.

[0049] Furthermore, the soaking duration in Step 1 is 30 to 40 minutes.

[0050] Furthermore, the decocting duration on a gentle fire in Step 2 and Step 3 is 10 to 20 minutes.

[0051] Furthermore, the amount of added water for soaking in Step 1 is 8 to 12 times the mass of the medicinal materials.

[0052] Furthermore, the amount of added water in Step 3 is half of the amount of added water in Step 1.

[0053] A pure traditional Chinese medicine lotion slice for removing dandruff from chrysanthemum and herb is prepared by processing the above-mentioned wild chrysanthemum, Impatiens balsamina, Platycladus orientalis, Polygonum multiflorum, Angelica dahurica, Sophora flavescens, and Mentha haplocalyx into slices according to the mass ratio of 20:30:30:30:15:15:15.

[0054] A method for using the above-mentioned pure traditional Chinese medicine lotion slice for removing dandruff from chrysanthemum and herb includes the following steps:

[0055] Step 1: Soak in water: Place the slices in water with a weight 10 to 12 times that of the slices and soak for 30 minutes;

[0056] Step 2: Decoct for the first time: After bringing to a boil, decoct for 1 hour and pour out the medicinal liquid;

[0057] Step 3: Decoct for the second time: Add water half the amount of the added water in Step 1 to the medicinal residues, bring to a boil, decoct for 1 hour, pour out the medicinal liquid, and mix it with the medicinal liquid from the first decoction;

[0058] Step 4: Let it cool for later use.

[0059] The pharmacology of the present invention is as follows:

[0060] In the lotion formula for removing dandruff from chrysanthemum and herb, wild chrysanthemum clears heat and detoxifies, disperses wind-heat, and Impatiens balsamina dispels wind and dampness, promotes blood circulation and dredges collaterals. The two are the monarch drugs together;

[0061] Platycladus orientalis clears heat and cools blood, promotes hair growth and nourishes hair, and Polygonum multiflorum nourishes blood and dispels wind. They are the ministerial drugs together;

[0062] Angelica dahurica relieves exterior syndrome and disperses wind, dries dampness and relieves itching, and Sophora flavescens clears heat and dries dampness, kills insects and relieves itching. The two drugs assist the monarch drugs to dispel wind, dampness and heat pathogens and are the adjuvant drugs;

[0063] Mentha haplocalyx has a fragrant smell to dispel foulness, and has a cool feeling to relieve itching and is the guiding drug.

[0064] All the herbs together have the effects of clearing heat and expelling wind, removing dampness and relieving itching.

[0065] The beneficial effects of the present invention are as follows:

[0066] The chrysanthemum and herb anti-dandruff lotion of the present invention is composed of 7 simple herbs, with a small unit dose, low price, low cost, good curative effect, and is worthy of popularization and use.

[0067] The external washing of traditional Chinese medicine of the present invention is convenient to use, with significantly higher compliance than oral drugs, and the medicinal power directly reaches the affected area, with a more direct and significant curative effect, and is more easily accepted by patients. Description of the Drawings

[0068] Figure 1 It is the water absorption rate curve graph of the chrysanthemum and herb anti-dandruff lotion pieces of the present invention.

[0069] Figure 2 It is the HPLC chromatogram of luteolin in the chrysanthemum and herb anti-dandruff lotion pieces of the present invention.

[0070] Figure 3 It is the HPLC chromatogram of luteolin of the test sample. Detailed Embodiments

[0071] The following further clarifies the present invention in conjunction with specific embodiments. It should be understood that the following specific embodiments are only used to illustrate the present invention and not to limit the scope of the present invention.

[0072] Every 1000 mL of the pure traditional Chinese medicine chrysanthemum and herb anti-dandruff lotion is the medicinal liquid obtained by boiling 20 g of wild chrysanthemum, 30 g of Impatiens balsamina L., 30 g of Platycladus orientalis (L.) Franco, 30 g of Polygonum multiflorum Thunb., 15 g of Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav., 15 g of Sophora flavescens Aiton, and 15 g of Mentha haplocalyx Briq. The specific process is as follows: Take 20 g of wild chrysanthemum, 30 g of Impatiens balsamina L., 30 g of Platycladus orientalis (L.) Franco, 30 g of Polygonum multiflorum Thunb., 15 g of Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav., 15 g of Sophora flavescens Aiton, and 15 g of Mentha haplocalyx Briq. First, soak the herbs for 30 minutes, boil them with high heat, then change to low heat and decoct for another 10 minutes, and pour out the medicinal liquid; repeat this process and decoct for the second time. The two decocted medicinal liquids are mixed together, totaling about 1000 mL.

[0073] The present invention also claims the pure traditional Chinese medicine chrysanthemum and herb anti-dandruff lotion pieces prepared according to the formula ratio of this patent, specifically: The wild chrysanthemum, Impatiens balsamina L., Platycladus orientalis (L.) Franco, Polygonum multiflorum Thunb., Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav., Sophora flavescens Aiton, and Mentha haplocalyx Briq. are processed into pieces according to the mass ratio of 20:30:30:30:15:15:15.

[0074] The present invention also claims the usage method of the pure traditional Chinese medicine chrysanthemum and herb anti-dandruff lotion pieces of this patent, including the following steps:

[0075] Step 1: Soak in water: Soak the pieces in water with a weight 10 - 12 times that of the pieces for 30 minutes.

[0076] Step 2: First decoction: After bringing to a boil, decoct for 1 hour, then pour out the decoction.

[0077] Step 3: Second decoction: Add water equal to half of the water added in Step 1 to the medicinal residues. After bringing to a boil, decoct for 1 hour, then pour out the decoction and mix it with the decoction from the first decoction.

[0078] Step 4: Let it cool for later use.

[0079] For the chrysanthemum and straw anti-dandruff pure traditional Chinese medicine lotion of this patent and each medicinal material in the chrysanthemum and straw anti-dandruff pure traditional Chinese medicine lotion tablets, the material collection parts and specific requirements are as follows:

[0080] Except for Impatiens balsamina Stem, the medicinal flavors in the prescription are all varieties included in the first part of the Chinese Pharmacopoeia (2020 Edition). All the prepared slices in the process research and pilot-scale research are inspected according to the quality marks of the pharmacopoeia, and the origin and basic sources have been preliminarily determined.

[0081] 1. Wild Chrysanthemum Flower This is the dried capitulum of Chrysanthemum indicum L. of the Compositae family. Origin: Hubei.

[0082] It complies with the relevant regulations under "Wild Chrysanthemum Flower" on page 328 of the first part of the Chinese Pharmacopoeia (2020 Edition).

[0083] 2. Impatiens balsamina Stem This is the dried stem of Impatiens balsamina L. of the Balsaminaceae family. Origin: Liaoning.

[0084] It complies with the relevant regulations under "Impatiens balsamina Stem" on page 214 of the Jiangsu Province Traditional Chinese Medicine Prepared Slices Processing Specification (2002 Edition).

[0085] 3. Oriental Arborvitae Twig and Leaf This is the dried twig tips and leaves of Platycladus orientalis (L.) Franco of the Cupressaceae family. Origin: Shanxi.

[0086] It complies with the relevant regulations under "Oriental Arborvitae Twig and Leaf" on page 225 of the first part of the Chinese Pharmacopoeia (2020 Edition).

[0087] 4. Fleeceflower Root This is the dried tuberous root of Polygonum multiflorum Thunb. of the Polygonaceae family. Origin: Sichuan.

[0088] It complies with the relevant regulations under "Fleeceflower Root" on page 183 of the first part of the Chinese Pharmacopoeia (2020 Edition).

[0089] 5. Dahurian Angelica Root This is the dried root of Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. of the Umbelliferae family. Origin: Anhui.

[0090] It complies with the relevant provisions under "Angelicae Dahuricae Radix" on page 109 of Part I of the Chinese Pharmacopoeia (2020 Edition).

[0091] 6. Sophora flavescens This product is the dried root of Sophora flavescens Ait. of the Leguminosae family. Place of origin: Hebei.

[0092] It complies with the relevant provisions under "Sophora flavescens Radix" on page 211 of Part I of the Chinese Pharmacopoeia (2020 Edition).

[0093] 7. Mentha haplocalyx This product is the dried aerial part of Mentha haplocalyx Briq. of the Lamiaceae family. Place of origin: Anhui.

[0094] It complies with the relevant provisions under "Mentha haplocalyx Herba" on page 394 of Part I of the Chinese Pharmacopoeia (2020 Edition).

[0095] The usage method of the pure traditional Chinese medicine lotion for removing dandruff from chrysanthemum and herbs of the present invention is as follows: First, clean and moisten the scalp and hair conventionally, then apply the chrysanthemum and herb dandruff-removing lotion externally on the wetted scalp, massage locally for 5 minutes, leave it for 5 minutes, and then wash it with clean water once every other day.

[0096] The Dermatology Department of Jiangsu Province Hospital of Integrated Traditional Chinese and Western Medicine has achieved satisfactory clinical efficacy in treating seborrheic dermatitis of the scalp and seborrheic alopecia complicated with seborrheic dermatitis with the chrysanthemum and herb dandruff-removing lotion, and no adverse reactions have been found. The retrospective summary is as follows.

[0097] 1. Materials and Methods

[0098] (1) Clinical data were from 147 outpatients with seborrheic dermatitis of the scalp in our hospital from February 2019 to December 2023, including 61 males and 86 females; the youngest age was 3 years old and the oldest was 67 years old, with an average age of 35.10 ± 8.23 years. Diagnostic criteria: Referring to "Clinical Dermatology", seborrheic dermatitis is a chronic papulosquamous and superficial inflammatory skin disease occurring in seborrheic areas. It is prone to occur in seborrheic areas such as the head, face, and trunk, with clinical features of light red or yellowish-red patches of varying sizes, covered with bran-like scales or greasy crusts, accompanied by itching of varying degrees. Inclusion criteria: The skin lesions are on the scalp and meet the diagnosis of "seborrheic dermatitis"; no systemic use of corticosteroid hormones within the past 2 weeks; no history of oral antihistamine drugs within the past 1 week; no history of topical corticosteroid hormone drugs within the past 1 week. Exclusion criteria: Skin lesions accompanied by severe infections or skin diseases mainly characterized by scales such as psoriasis; skin lesions accompanied by breaks or erosions; pregnant or lactating women; those with severe cardiovascular diseases, liver and kidney diseases, or severe immune function deficiencies.

[0099] (2) Treatment method: The patient first wets the scalp with warm water, and then topically applies the Jucao Anti-dandruff Lotion (20 g of wild chrysanthemum, 30 g of Impatiens balsamina stem, 30 g of Platycladus orientalis leaf, 30 g of Polygonum multiflorum, 15 g of Angelica dahurica, 15 g of Sophora flavescens, 15 g of Mentha haplocalyx Briq.) on the wet scalp, massages locally for 5 minutes, stays for 5 minutes, and then washes it with clean water. Wash the hair once every other day, and 4 weeks of continuous treatment is taken as one course. During the treatment, the patient needs to ensure regular living and rest and a light diet.

[0100] (3) Efficacy indicators: Select the largest area of skin lesions as the target skin lesion, record the area of skin lesions, erythema, scales, seborrhea and itching degree, and conduct skin lesion scoring. Area scoring criteria: 0 points: no rash; 1 point: target skin lesion area < 2 cm 2 ; 2 points: target skin lesion area ≥ 2 < 5 cm 2 ; 3 points: target skin lesion area ≥ 5 cm 2 . Erythema scoring criteria: 0 points: none; 1 point: mild, light brown; 2 points: moderate, light red color; 3 points: severe, bright red color. Scales scoring criteria: 0 points: none; 1 point: mild, scattered; 2 points: moderate, relatively dense; 3 points: severe, very dense, fused into patches and countless. Seborrhea scoring criteria: 0 points: none; 1 point: mild, mild oil stain; 2 points: moderate, obvious oil stain, hair with oily luster; 3 points: severe, serious oil stain, visible clusters of roots sticking together. Itching scoring criteria: 0 points: no itching; 1 point: occasional itching, does not affect daily life; 2 points: paroxysmal itching, sometimes mild and sometimes severe; 3 points: severe itching, seriously affecting sleep and work.

[0101] (4) Efficacy judgment criteria: The Nimodipine method is adopted: [(pre-treatment score - post-treatment score) / pre-treatment score] × 100%.

[0102] Reference standard: The efficacy judgment criteria of facial eczema in the "Diagnostic and Therapeutic Criteria for Traditional Chinese Medical Syndromes of Traditional Chinese Medicine Industry Standards of the People's Republic of China". Recovery: The symptom score is reduced by 95%. Marked effect: 95% > symptom score reduction ≥ 70%. Effective: 70% > symptom score reduction ≥ 30%. Ineffective: The symptom score reduction is less than 30%.

[0103] (5) Statistical method: Data analysis is performed using the spss21.0 statistical software for statistical analysis. Measurement data are analyzed by t-test and expressed as mean ± standard deviation ; count data are analyzed by χ 2 -test, and P < 0.05 indicates that the difference is statistically significant.

[0104] 2. Results

[0105] (1) Clinical efficacy

[0106] ① Comparison of symptom scores: The total number of cases was 147. The symptom score before treatment was 9.86 ± 2.34, and after treatment it was 3.89 ± 2.45. There was a significant difference in symptom scores after treatment compared with before treatment, P < 0.05.

[0107] ② Clinical efficacy: The total number of cases was 147. The cure rate was 13.60% (20), the marked effective rate was 30.61% (45), the effective rate was 44.22% (65), and the ineffective rate was 11.56% (17). The total effective rate was 88.44%.

[0108] (2) Adverse reactions Among 147 patients in the past 5 years, no obvious adverse reactions were observed during and after treatment, and no patient terminated treatment due to adverse reactions.

[0109] 3. Summary

[0110] At present, the western medicine treatment of seborrheic dermatitis mainly uses antifungal drugs, keratolytic agents, anti-inflammatory drugs (topical corticosteroids and calcineurin inhibitors), etc. The short-term curative effect is obvious, but it is easy to relapse, and the curative effect decreases after long-term use. The long-term use of hormones by patients has become a more serious problem. The traditional Chinese medicine external washing is convenient to use, and the compliance is significantly higher than that of oral drugs. Moreover, the medicinal power reaches the affected area directly, and the curative effect is more direct and significant, and it is more easily accepted by patients. In the Jucao Anti-dandruff Lotion formula, Flos Chrysanthemi Indicae clears heat and detoxifies, disperses wind and heat; Herba Impatientis penetrates the bones and dispels wind and dampness, promotes blood circulation and dredges collaterals. The two are the monarch drugs together. Cacumen Platycladi clears heat and cools blood, promotes hair growth and nourishes hair; Radix Polygoni Multiflori nourishes blood and dispels wind, and they are the ministerial drugs together. Radix Angelicae Dahuricae dispels wind from the exterior, dries dampness and relieves itching; Sophora flavescens clears heat and dries dampness, kills insects and relieves itching. The two drugs assist the monarch drugs to dispel wind, heat and dampness pathogens, and are the assistant drugs. Mentha haplocalyx has a fragrant smell to dispel foulness, and relieves itching with coolness, and is the guiding drug. The whole formula together exerts the effects of clearing heat and expelling wind, dispelling dampness and relieving itching. This formula has been clinically applied for more than 15 years, with definite curative effect and good safety, and is worthy of further promotion.

[0111] The Jucao Anti-dandruff Lotion of the present invention has been clinically applied for many years, with definite curative effect, not easy to relapse, no adverse reactions observed, good patient compliance, and has been recognized by the majority of patients. It is of great significance for alleviating the pain of the majority of patients and improving the quality of life of patients, and is worthy of further promotion.

[0112] In order to further verify the pharmacology of this patent, the following introduces the pharmacological experiment process of this patent:

[0113] 1 Extraction process research

[0114] 1. Investigation on the water absorption rate of Chinese herbal pieces

[0115] Weigh 1 copy of the cut Chinese herbal medicine for the Chrysanthemum and Straw Herb Anti-dandruff Pure Chinese Herbal Lotion as described in the patent according to the prescription ratio, making a total of 2 portions. Soak them separately in 10 times the amount of water by weight of the cut herbs at room temperature. Filter out the water solution and weigh them every 30 minutes. After weighing, quickly put the cut herbs back into the original water solution for soaking until the weight change of the soaked cut herbs is not obvious. Plot the soaking time on the abscissa and the water absorption rate on the ordinate. The results are shown in Table 1, Figure 1 .

[0116] Table 1 Results of the determination of the water absorption rate of the cut Chinese herbal medicine for the Chrysanthemum and Straw Herb Anti-dandruff Pure Chinese Herbal Lotion (n = 2)

[0117]

[0118] Note: Water absorption rate (%) = (weight after absorption - weight before absorption) ÷ weight before absorption × 100%

[0119] From Table 1 and Figure 1 it can be seen that the increase in the water absorption rate of the cut herbs is small after soaking for 90 minutes, indicating that they are basically soaked through. Since in industrial production, the process from adding water, decocting to boiling for the cut herbs takes about 60 minutes or so, and the soaking temperature is higher than room temperature during the boiling process, it is considered that soaking for 30 minutes is sufficient. For the orthogonal experiment, it is more appropriate to select three levels of soaking time: 0, 30, and 60 minutes. When the cut herbs are completely soaked through, the water absorption is about 2 times the weight of the cut herbs. Since the concentration of the first decoction of the cut herbs is significantly higher than that of the second decoction, in order to achieve a better decocting effect, it is determined that 2 times more water is added for the first decoction than the second decoction.

[0120] 2. Investigation of the number of extraction times

[0121] In this experiment, the extraction rate was used as the investigation index, and the number of extraction times was investigated by the single-factor parallel comparison experiment method.

[0122] (1) Preparation of the extraction solution

[0123] Weigh the cut herbs of the whole formula according to the prescription ratio, add 12 times the amount of water, soak for 30 minutes, decoct for 1 hour, filter to obtain the first decoction liquid; add 6 times the amount of water to the medicinal residues respectively, extract 2 times, each time for 1 hour, filter to obtain the second and third decoction liquids. Measure the volume of each decoction liquid and store them separately for later use. The experiment was carried out in parallel 2 times.

[0124] (2) Determination of the extraction rate

[0125] Precisely measure 25 mL of the first, second, and third decoction liquids respectively, place them in a watch glass, evaporate to dryness in a water bath, place them in an oven, dry at 105 °C for 3 hours, take them out, place them in a desiccator, cool for 30 minutes, quickly weigh them, and calculate the extraction rate. The results are shown in Table 2.

[0126] Table 2 Extraction rates for different numbers of decoctions (n = 2)

[0127]

[0128] As can be seen from Table 2, the sum of the extract yields of the first decoction and the second decoction accounts for about 90.5% of the total extract yield of the three decoctions. The proportion of the third decoction is relatively small. Considering factors such as energy conservation, improving production efficiency, the traditional extraction times of clinical prescriptions, and better extraction effects in industrial production than in the laboratory, it is determined that it is more appropriate to extract 2 times.

[0129] 3. Orthogonal experiment for optimizing the extraction process - experimental scheme design

[0130] Through the investigation of the water absorption rate of the Jucao anti-dandruff lotion and the number of extraction times, it is determined that the number of extraction times is 2. Three levels of soaking time factors, namely 0 min, 30 min, and 60 min, are selected. Using the L9(3 4 ) orthogonal experiment method, with luteolin (the main active ingredient in the monarch drug Flos Chrysanthemi Indici) and the solid yield in the decoction as evaluation indicators, the effects of soaking time (A), water addition amount (B), and extraction time (C) on the extraction effect are investigated, and range analysis and variance analysis are carried out on the experimental results to optimize the most suitable extraction process parameters. The orthogonal experiment factor level table is shown in Table 3.

[0131] Table 3 Orthogonal experiment factor levels of water extraction process

[0132]

[0133] Quality research experiment

[0134] 1. Methods for related inspection items of the lotion were established

[0135] (1) Determination of pH value

[0136] It was determined according to the "Method for Determination of pH Value" in General Rules 0631 of Part IV of the Chinese Pharmacopoeia (2020 Edition).

[0137] (2) Inspection of filling quantity difference

[0138] According to the gravimetric method under the "Method for Inspection of Minimum Filling Quantity" in General Rules 0942 of the Preparation General Rules of Part IV of the Chinese Pharmacopoeia (2020 Edition): Take 5 pilot-scale products of three batches, remove the outer covers and labels, clean and dry the outer walls of the containers by appropriate methods, weigh them accurately respectively, remove the contents, wash and dry the containers with appropriate solvents, and then weigh the empty containers accurately respectively. Calculate the filling quantity of the contents in each container and the average filling quantity. It is required that the average filling quantity shall not be less than the labeled filling quantity, and the filling quantity of each container shall not be less than 93% of the labeled filling quantity.

[0139] (3) Microbiological limit inspection

[0140] Microbial limit test for non-sterile products: Conduct the test according to the microbial limit test (General Principles 1105, Volume IV of the Chinese Pharmacopoeia 2020 Edition) and the control bacteria test method (General Principles 1106, Volume IV of the Chinese Pharmacopoeia 2020 Edition) and the microbial limit standards for non-sterile drugs (General Principles 1107, Volume IV of the Chinese Pharmacopoeia 2020 Edition).

[0141] 2. Establishment of HPLC content determination method for linarin

[0142] An HPLC method for the determination of linarin, the main active ingredient of Flos Chrysanthemi Indici, the monarch drug in the preparation, was established, providing an experimental basis for the optimization of the extraction process and the formulation of quality standards.

[0143] Chromatographic conditions: Chromatographic column: Agilent 5TC-C 18 (250 mm × 4.6 mm, 5 μm); Mobile phase: acetonitrile - 0.1% phosphoric acid water (20:80); Flow rate: 1.0 mL / min; Column temperature: 30 °C; Detection wavelength: 335 nm; Injection volume: 5 μL for test samples and negative control samples, 30 μL for reference substances. Under these chromatographic conditions, linarin and adjacent peaks achieved baseline separation, with a resolution greater than 1.5. The HPLC chromatograms of the patented cut crude drugs and test samples are shown in Figure 2 and 3 .

[0144] Those skilled in the art of this technology can understand that, unless otherwise defined, all terms (including technical terms and scientific terms) used here have the same meaning as the general understanding of those of ordinary skill in the art to which this application belongs. It should also be understood that terms defined in common dictionaries should be understood to have a meaning consistent with their meaning in the context of the prior art, and will not be interpreted with idealized or overly formal meanings unless defined as here.

[0145] Taking the ideal embodiments of the present invention described above as an inspiration, through the above description, relevant staff can completely make various changes and modifications without departing from the technical idea of this invention. The technical scope of this invention is not limited to the content in the specification, and its technical scope must be determined according to the scope of the claims.

Claims

1. A pure traditional Chinese medicine lotion for removing dandruff from chrysanthemum grass, characterized in that, A medicinal liquid obtained by boiling a mixture of wild chrysanthemum, Impatiens balsamina L., Oriental arborvitae leaves, Polygonum multiflorum Thunb., Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav., Sophora flavescens Aiton, and Mentha haplocalyx Briq. in water. The mass ratio of wild chrysanthemum, Impatiens balsamina L., Oriental arborvitae leaves, Polygonum multiflorum Thunb., Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav., Sophora flavescens Aiton, and Mentha haplocalyx Briq. is 20:30:30:30:15:15:

15.

2. The chrysanthemum and wormwood anti-dandruff pure traditional Chinese medicine lotion according to claim 1, wherein For every 1000 mL of the pure traditional Chinese medicine chrysanthemum-herb anti-dandruff lotion, it is a medicinal liquid obtained by boiling 20 g of wild chrysanthemum, 30 g of Impatiens balsamina L., 30 g of Oriental arborvitae leaves, 30 g of Polygonum multiflorum Thunb., 15 g of Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav., 15 g of Sophora flavescens Aiton, and 15 g of Mentha haplocalyx Briq.

3. The chrysanthemum and wormwood anti-dandruff pure traditional Chinese medicine lotion according to claim 1, characterized in that, The wild chrysanthemum is the dried capitulum of Chrysanthemum indicum L. of the Compositae family; The Impatiens balsamina L. is the dried stem of Impatiens balsamina L. of the Balsaminaceae family; The Oriental arborvitae leaves are the dried branch tips and leaves of Platycladus orientalis (L.) Franco of the Cupressaceae family; The Polygonum multiflorum Thunb. is the dried tuberous root of Polygonum multiflorum Thunb. of the Polygonaceae family; The Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav. is the dried root of Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav. of the Umbelliferae family; The Sophora flavescens Aiton is the dried root of Sophora flavescens Aiton of the Leguminosae family; The Mentha haplocalyx Briq. is the dried aerial part of Mentha haplocalyx Briq. of the Labiatae family.

4. A method for preparing the pure traditional Chinese medicine scalp anti-dandruff lotion of Chrysanthemum and Plantain according to any one of claims 1-3, characterized in that, It includes the following steps: Step 1: Weigh wild chrysanthemum, Impatiens balsamina L., Oriental arborvitae leaves, Polygonum multiflorum Thunb., Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav., Sophora flavescens Aiton, and Mentha haplocalyx Briq. according to the weight ratio described in Claim 1, mix them, and soak them in normal-temperature water. Step 2: Place the soaked water obtained in Step 1 together with the medicinal materials on a high fire to boil. After boiling, change to a slow fire and continue to decoct, then pour out the medicinal liquid. Step 3: Add normal-temperature water to the medicinal residues after pouring out the medicinal liquid in Step 2, then place it on a high fire to boil. After boiling, change to a slow fire and continue to decoct, then pour out the medicinal liquid. Step 4: Mix the medicinal liquids from Step 2 and Step 3 together to obtain the pure traditional Chinese medicine chrysanthemum-herb anti-dandruff lotion.

5. The method for preparing the pure Chinese herbal anti-dandruff lotion from chrysanthemum and straw as claimed in claim 4, wherein The soaking duration in Step 1 is 30 - 40 minutes.

6. The method for preparing the pure traditional Chinese medicine lotion for removing dandruff from chrysanthemum and straw as claimed in claim 4, wherein The duration of changing to a slow fire and continuing to decoct in Step 2 and Step 3 is 10 - 20 minutes.

7. The method for preparing the pure Chinese herbal dandruff-removing lotion of chrysanthemum and straw as claimed in claim 4, wherein, The water addition amount for soaking in Step 1 is 8 - 12 times the mass of the medicinal materials.

8. The method for preparing the pure traditional Chinese medicine lotion for removing dandruff from chrysanthemum and straw as claimed in claim 7, wherein The water addition amount in Step 3 is half of the water addition amount in Step 1.

9. A traditional Chinese medicine decoction piece of a chrysanthemum and grass anti-dandruff pure traditional Chinese medicine lotion, characterized in that, Process the wild chrysanthemum, Impatiens balsamina L., Oriental arborvitae leaves, Polygonum multiflorum Thunb., Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav., Sophora flavescens Aiton, and Mentha haplocalyx Briq. described in Claim 1 into cut crude drugs according to the mass ratio of 20:30:30:30:15:15:

15.

10. A method for using the chrysanthemum and wormwood anti-dandruff pure traditional Chinese medicine lotion pieces according to claim 9, characterized in that, It includes the following steps: Step 1: Soak in water: Place the cut crude drugs in water with a weight 10 - 12 times that of the cut crude drugs and soak for 30 minutes. Step 2: First decoction: After bringing to a boil, decoct for 1 h and pour out the medicinal liquid. Step 3: Second decoction: Add water with half of the water addition amount in Step 1 to the medicinal residues, bring to a boil, decoct for 1 h, pour out the medicinal liquid, and mix it with the medicinal liquid from the first decoction. Step 4: Let it cool for later use.

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