Scalp micro-ecological balance composite acid ointment based on multi-acid synergistic targeting delivery and preparation method thereof

Abstract

The invention relates to the technical field of scalp inflammation treatment, in particular to scalp micro-ecological balance composite acid ointment based on multi-acid synergistic targeted delivery and a preparation method thereof. Comprising the following components in parts by weight: 1.5 to 2.5 parts of supramolecular coated salicylic acid, 2.0 to 3.0 parts of nano crystallized azelaic acid, 3.0 to 5.0 parts of tartaric acid, 0.2 to 0.3 part of tretinoin, 1.5 to 2.5 parts of amphiphilic lactobionic acid derivative, 1.5 to 2.5 parts of pegylated pyruvic acid, 1.6 to 4.2 parts of traditional Chinese medicine extract and 82.0 to 90.0 parts of external basic agent. The composite acid prepared by mixing the supramolecular coated salicylic acid, the tartaric acid and the nano-crystallized azelaic acid is externally used for treating the scalp seborrheic dermatitis, so that the skin irritation caused by independently using the supramolecular coated salicylic acid, the tartaric acid and the nano-crystallized azelaic acid is reduced, and meanwhile, the scalp seborrheic dermatitis is treated; wherein the traditional Chinese medicine extract has small irritation to scalp, has synergistic interaction and supplementation with the compound acid, can effectively balance grease secretion of sebaceous gland and reduce seborrheic dermatitis, and has good prevention and treatment effects on seborrheic dermatitis.

Description

Technical Field

[0001] This application relates to the technical field of scalp inflammation treatment, and in particular to a scalp microecological balance compound acid ointment based on multi-acid synergistic targeted delivery and its preparation method. Background Art

[0002] Scalp seborrheic dermatitis (SSD) is a chronic scalp inflammatory disease, mainly manifested as greasy scalp, increased scales, accompanied by repeated scalp itching, erythema, inflammatory papules, etc. Sebaceous glands secrete vigorously in young and middle-aged people, and the disease shows a younger trend. It is one of the important inducements of androgenetic alopecia. If not treated in time, as the condition develops and evolves, the hair gradually becomes thinner and sparser, eventually leading to hair loss, bringing psychological burden and social pressure to patients. The cause of this disease is not yet clear, and several main factors related to the onset are known: colonization of Malassezia, excessive sebum secretion, genetic susceptibility, and immune factors.

[0003] For scalp seborrheic dermatitis, the current clinical treatment methods are relatively single, mostly using topical antifungal drugs and glucocorticoid ointments externally to relieve symptoms, but long-term application will produce adverse reactions such as telangiectasia, epidermal atrophy, and pigmentation, and the treatment effect is not good, so there is room for improvement. Summary of the Invention

[0004] This application provides a scalp microecological balance compound acid ointment based on multi-acid synergistic targeted delivery and its preparation method to improve the following technical problems:

[0005] For scalp seborrheic dermatitis, the current clinical treatment methods are relatively single, mostly using topical antifungal drugs and glucocorticoid ointments externally to relieve symptoms, but long-term application will produce adverse reactions such as telangiectasia, epidermal atrophy, and pigmentation, and the treatment effect is not good.

[0006] In the first aspect, this application provides a scalp microecological balance compound acid ointment based on multi-acid synergistic targeted delivery, adopting the following technical scheme:

[0007] A scalp microecological balance compound acid ointment based on multi-acid synergistic targeted delivery, comprising the following components in parts by weight:

[0008]

[0009] Among them, the molecular weight of the traditional Chinese medicine extract is between 100 - 5000 kDa.

[0010] In a feasible technical solution of this application, the traditional Chinese medicine extract is a single component or a compound of multiple components among the following materials: Flos Chrysanthemi Indici extract, Sophora flavescens extract, Phellodendron amurense extract, or ginsenoside.

[0011] In an implementable technical solution of the present application, the traditional Chinese medicine extract comprises the following components in parts by weight:

[0012]

[0013] In an implementable technical solution of the present application, it comprises the following components in parts by weight:

[0014]

[0015]

[0016] In an implementable technical solution of the present application, the external base agent is a single component or a compound of multiple components among the following materials: beeswax, mineral oil, petrolatum.

[0017] In an implementable technical solution of the present application, the fruit acid is lipophilic mandelic acid.

[0018] Among them, mandelic acid, also known as amygdalic acid, is a lipophilic fruit acid with strong antibacterial effects, which is beneficial to effectively control the colonization problem of Malassezia scalp caused by scalp seborrheic dermatitis.

[0019] In a second aspect, the present application provides a method for preparing a scalp microecological balance compound acid ointment based on multi-acid synergistic targeted delivery, adopting the following technical solution:

[0020] A method for preparing a scalp microecological balance compound acid ointment based on multi-acid synergistic targeted delivery, comprising the following steps:

[0021] (1) Compound acid emulsification: Take 1.5 - 2.5 parts of supramolecular encapsulated salicylic acid, 2.0 - 3.0 parts of nanocrystalline azelaic acid, 3.0 - 5.0 parts of fruit acid, 0.2 - 0.3 parts of retinoic acid, 1.5 - 2.5 parts of amphiphilic lactobionic acid derivative, 1.5 - 2.5 parts of polyethylene glycolated pyruvic acid, and 75.0 - 85.0 parts of external base agent, put them into the first vacuum emulsifying pot to obtain a first mixture, heat the first mixture to 80 - 85 °C and stir to make it fully mixed evenly to obtain a first paste, and keep it warm for 15 - 25 minutes;

[0022] (2) Traditional Chinese medicine ingredient emulsification: Take 1.0 - 2.0 parts of sunflower extract, 0.2 - 0.8 parts of sophora flavescens extract, 0.3 - 0.7 parts of phellodendron amurense extract, 0.1 - 0.7 parts of ginsenoside, and 10.0 - 20.0 parts of external base agent, put them into the second vacuum emulsifying pot to obtain a second mixture, heat the second mixture to 42 - 45 °C and stir to make it fully mixed evenly to obtain a second paste, and keep it warm for 15 - 25 minutes;

[0023] (3) Paste mixture: Cool the first paste to 42 - 45 °C in the first vacuum emulsifying pan, then add the second paste, and then keep warm and stir for 8 - 12 minutes until fully and evenly mixed;

[0024] (4) Cooling and stirring: After cooling to 39 - 40 °C, keep warm and stir for 8 - 12 minutes, and then cool to 35 °C - 38 °C, and then let it stand to obtain the scalp microecological balance compound acid ointment as described above.

[0025] In summary, the working principle and beneficial technical effects of this application are as follows:

[0026] Scalp seborrheic dermatitis can bring many problems such as excessive sebum secretion, scalp microecological disorder, lack of hair follicle nutrition, and scalp oxidative stress disorder. The scalp microecological balance compound acid ointment of this application starts from the mechanism of scalp oiliness and seborrheic alopecia, and the composite functional components improve excessive sebum secretion, scalp microecological disorder, lack of hair follicle nutrition, and scalp oxidative stress disorder in a targeted manner according to the mechanism and in gradients. While controlling scalp inflammation, it can also reduce the secretion of scalp oil, regulate the scalp microecological environment, strengthen the barrier function of the scalp, thereby inhibiting the colonization and reproduction of Malassezia, and is convenient and fast to use without obvious adverse reactions. Description of the Drawings

[0027] In order to more clearly illustrate the technical solutions in the embodiments of this application, the following will briefly introduce the drawings required for description in the embodiments. Obviously, the drawings in the following description are only some embodiments of this application. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0028] Figure 1 It is a comparison of dermoscopies before and after treatment in the compound acid ointment treatment group in the embodiments of this application.

[0029] Figure 2 It is a comparison of dermoscopies before and after treatment in the conventional compound acid essence treatment group in the embodiments of this application.

[0030] Figure 3 It is a comparison of dermoscopies before and after treatment in the drug treatment group in the embodiments of this application.

[0031] Figure 4 It is a process flow chart of the manufacturing method of the scalp microecological balance compound acid ointment in the embodiments of this application. Detailed Embodiments

[0032] In order to make the technical problems, technical solutions, and beneficial effects to be solved by this application clearer, the following further details this application in combination with the drawings and embodiments. It should be understood that the specific embodiments described here are only used to explain this application and are not used to limit this application.

[0033] It should be noted that when an element is referred to as "fixed to" or "disposed on" another element, it can be directly on the other element or indirectly on the other element. When an element is referred to as "connected to" another element, it can be directly connected to the other element or indirectly connected to the other element.

[0034] It should be understood that the orientation or positional relationship indicated by terms such as "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present application.

[0035] In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include one or more of such features. In the description of the present application, the meaning of "a plurality" is two or more, unless otherwise specifically defined.

[0036] The following will further elaborate on the present application in conjunction with the attached Figures 1 - 4 for a more detailed description of the present application.

[0037] The embodiments of the present application disclose a scalp microecological balance compound acid ointment based on polyacid synergistic targeted delivery. Referring to Figures 1 - 3 , the scalp microecological balance compound acid ointment adopts the following technical solutions:

[0038] A scalp microecological balance compound acid ointment based on polyacid synergistic targeted delivery, comprising the following components in parts by weight:

[0039]

[0040] Wherein the external base agent is a single component or a compound of multiple components selected from the following materials: beeswax, mineral oil, petrolatum. In this embodiment, the external base agent is preferably white petrolatum.

[0041] Moreover, the fruit acid is preferably lipophilic mandelic acid. Mandelic acid, also known as amygdalic acid, is a lipophilic fruit acid with strong antibacterial effects, which is beneficial to effectively control the colonization problem of Malassezia scalp in scalp seborrheic dermatitis.

[0042] Please refer to Figure 4, the embodiment of the present application also provides a method for preparing the scalp microecological balance compound acid ointment based on multi-acid synergistic targeted delivery as described above, including the following steps:

[0043] (1) Compound acid emulsification: Take 1.5 - 2.5 parts of supramolecular encapsulated salicylic acid, 2.0 - 3.0 parts of nanocrystalline azelaic acid, 3.0 - 5.0 parts of fruit acid, 0.2 - 0.3 parts of tretinoin, 1.5 - 2.5 parts of amphiphilic lactobionic acid derivative, 1.5 - 2.5 parts of polyethylene glycolated pyruvic acid, and 75.0 - 85.0 parts of external base agent, put them into the first vacuum emulsifying pot to obtain a first mixture, heat the first mixture to 80 - 85 °C and stir to make it fully mixed evenly to obtain a first paste, and keep it warm for 15 - 25 minutes;

[0044] (2) Traditional Chinese medicine ingredient emulsification: Take 1.0 - 2.0 parts of sunflower extract, 0.2 - 0.8 parts of sophora flavescens extract, 0.3 - 0.7 parts of phellodendron amurense extract, 0.1 - 0.7 parts of ginsenoside, and 10.0 - 20.0 parts of external base agent, put them into the second vacuum emulsifying pot to obtain a second mixture, heat the second mixture to 42 - 45 °C and stir to make it fully mixed evenly to obtain a second paste, and keep it warm for 15 - 25 minutes;

[0045] (3) Paste mixing: Cool the first paste to 42 - 45 °C through the first vacuum emulsifying pot, then add the second paste, and then keep it warm and stir for 8 - 12 minutes until fully mixed evenly;

[0046] (4) Cooling and stirring: After cooling to 39 - 40 °C, keep it warm and stir for 8 - 12 minutes, then cool to 35 °C - 38 °C, and let it stand to obtain the scalp microecological balance compound acid ointment based on multi-acid synergistic targeted delivery.

[0047] The working principle and beneficial technical effects of the present application are as follows:

[0048] Scalp seborrheic dermatitis will bring many problems such as excessive oil secretion, scalp microecological disorder, lack of hair follicle nutrition, and scalp oxidative stress disorder;

[0049] Regarding the problem of excessive sebum secretion: It is improved by the compounding of supramolecularly encapsulated salicylic acid and sunflower extract. Supramolecularly encapsulated salicylic acid is lipophilic and can penetrate along the sebaceous gland unit, thereby dissolving cutin, improving hyperkeratosis of hair follicles, cleaning the excess sebum in scalp pores, and inhibiting the excessive secretion of sebum. It is commonly used in the treatment of seborrheic dermatitis. Moreover, supramolecularly encapsulated salicylic acid has an inhibitory effect on Malassezia and Staphylococcus epidermidis that are abnormally colonized in patients with seborrheic dermatitis. It can be further combined with sunflower extract. The aromatic compounds in sunflower extract can kill bacteria and fungi, prevent them from causing infections, and have strong antibacterial and antifungal activities, which can effectively inhibit the growth of bacteria and fungi. Among them, the sustained-release time of supramolecularly encapsulated salicylic acid is greater than 8 hours, and the pH value is between 3.8 and 4.2, so as to be beneficial to the regulation of the stratum corneum to be acidic for a long time.

[0050] The compounding of nanocrystalline azelaic acid, fruit acid, tretinoin, etc. also has good oil control effects. The combination of various compound acids can inhibit sebum secretion through different mechanisms. Fruit acid, namely α-hydroxy acid, has a smaller molecular weight and stronger permeability, so fruit acid can penetrate deep into the skin, remove the keratinocytes accumulated on the epidermis, dredge pores, and can also promote the generation of collagen and increase the thickness of the dermis layer of the skin. The amphiphilic lactobionic acid derivative can form a ceramide-like structure, which helps to repair the scalp barrier. Polyethyleneglycolated pyruvic acid can regulate the TLR2 / NF-kB pathway, thus helping the scalp to regulate and enhance immunity.

[0051] Regarding the problem of scalp microecological disorders: Nanocrystalline azelaic acid is an excellent microecological improver, and the particle size of nanocrystalline azelaic acid is between 50 and 80 nm, supplemented with fruit acid, tretinoin, etc. to promote microecological renewal. Nanocrystalline azelaic acid can inhibit the growth and reproduction of Propionibacterium acnes and Staphylococcus epidermidis, especially can inhibit Malassezia, and reduce the EC50 to 0.8 μg / mL, reducing sebum secretion. Nanocrystalline azelaic acid derived from wheat binds to glycine, the smallest of the twenty amino acids in the human body (glycine is also rich in natural moisturizing factors), which can help improve the scalp microecology and rebuild the scalp skin barrier.

[0052] Regarding the problem of lack of hair follicle nutrition: Excessive sebum secretion and free fatty acids can stimulate the hair follicle orifice to produce more desquamation and block the hair follicle orifice, resulting in excessive sebum retention. Coupled with the repeated stimulation of free fatty acids, the hair follicle eventually expands and ruptures, and the contents are released into the surrounding tissues to produce an inflammatory reaction, which further leads to the lack of hair follicle nutrition and blood supply. The compounded compound acid helps to remove the accumulation of sebum, thereby releasing the hair follicle blockage and improving hair follicle nutrition and blood supply. On the other hand, if necessary, tretinoin can penetrate deep into the skin and stimulate the growth of epithelial cells, thereby directly supplementing the required nutrients for the hair follicles.

[0053] Regarding the problem of scalp oxidative stress imbalance: Nano-crystallized azelaic acid, supramolecularly encapsulated salicylic acid, fruit acids, retinoic acid, etc. have a compound regulatory effect on oxidative stress, and then improve scalp oxidative stress problems through multiple pathways. Fruit acids have a strong antioxidant effect. In terms of the oxidative stress level index ROS, fruit acids can reduce the ROS level by more than 32% to help improve the problem of scalp oxidative stress imbalance;

[0054] Regarding the problem of inflammatory stimulation: Supramolecularly encapsulated salicylic acid is a common anti-inflammatory ingredient and can participate in regulating the inflammatory response of cells through a wide range of multiple pathways, and is widely used in clinical and skincare. Due to its excellent anti-inflammatory effect, nano-crystallized azelaic acid has great advantages in dealing with skin problems such as rosacea. On the scalp and facial skin, supramolecularly encapsulated salicylic acid and nano-crystallized azelaic acid can further be combined with ingredients such as vitamin B5 to reduce scalp immune response, reduce inflammatory infiltration, delay the destruction and loss of collagen and elastic fibers in the scalp, and slow down the occurrence of scalp aging; Nano-crystallized azelaic acid is a natural organic acid. Compared with other acids, nano-crystallized azelaic acid is milder for sensitive and poorly tolerated skin and is easier to tolerate. Nano-crystallized azelaic acid affects the keratinization process of epidermal cells, making the epidermis and hair keratinize normally, and it can also play an anti-androgen role by blocking the activity of 5α-reductase;

[0055] The scalp microecological balance compound acid ointment of the present application starts from the mechanism of scalp oiliness and seborrheic alopecia, and the compound functional ingredients improve excessive oil secretion, scalp microecological disorders, lack of hair follicle nutrition, scalp oxidative stress imbalance, etc. in a targeted manner according to the mechanism and gradient. While controlling scalp inflammation, it can also reduce the secretion of scalp oil, regulate the scalp microecological environment, strengthen the barrier function of the scalp, thereby inhibiting the colonization and reproduction of Malassezia, and is convenient and fast to use with no obvious adverse reactions.

[0056] Example 1

[0057] The scalp microecological balance compound acid ointment comprises the following components in parts by weight:

[0058]

[0059]

[0060] Example 2

[0061] The scalp microecological balance compound acid ointment comprises the following components in parts by weight:

[0062] Example 3

[0063] The scalp microecological balance compound acid ointment comprises the following components in parts by weight:

[0064]

[0065]

[0066] Example 4

[0067] The scalp microecological balance compound acid ointment comprises the following components in parts by weight:

[0068] Supramolecular encapsulated salicylic acid 2.0 parts

[0069] Example 5

[0070] The scalp microecological balance compound acid ointment comprises the following components in parts by weight:

[0071]

[0072]

[0073] Comparative Example 1

[0074] The scalp microecological balance compound acid ointment comprises the following components in parts by weight:

[0075] Comparative Example 2

[0076] The scalp microecological balance compound acid ointment comprises the following components in parts by weight:

[0077]

[0078]

[0079] Comparative Example 3

[0080] The scalp microecological balance compound acid ointment comprises the following components in parts by weight:

[0081] Comparative Example 4

[0082] The scalp microecological balance compound acid ointment comprises the following components in parts by weight:

[0083]

[0084]

[0085] To verify the therapeutic effect of the scalp microecological balance compound acid ointment in this application on scalp seborrheic dermatitis and observe its clinical efficacy, 90 patients with scalp seborrheic dermatitis were recruited and randomly divided into three groups: the compound acid ointment treatment group, the conventional compound acid essence treatment group, and the drug treatment group. The patients were followed up on the 7th, 14th, 21st, and 28th days respectively.

[0086] In this study experiment, the adhesive scale ten - level scoring (ASFS scoring) was used to evaluate the scalp scale condition; the peak itching numerical rating scale (NRS scoring) was used to evaluate the scalp itching degree of the patients; at the same time, the subjective symptoms of the patients were collected for evaluation and dermoscopy was performed. The results showed that after the external use of the scalp microecological balance compound acid ointment, the ASFS score decreased, the NRS score decreased, the scalp scales were significantly reduced, and the scalp greasiness and itching degree were both significantly alleviated. Moreover, the curative effect of the compound acid ointment treatment group was better than that of the drug treatment group and the conventional compound acid essence treatment group.

[0087] Conclusion: The scalp microecological balance compound acid ointment of this application has a good curative effect in the treatment of scalp seborrheic dermatitis, can significantly reduce the scalp erythema, itching and scales of patients. Especially in improving the scalp itching degree of patients, the scalp microecological balance compound acid ointment treatment shows greater advantages than traditional drug treatment and conventional compound acid essence treatment.

[0088] 1.1 Test subjects

[0089] The subjects of this study were 47 males and 43 females who visited the dermatology department of the hospital from July 2022 to November 2022, with an average age of (27.3 ± 7.3) years and an average disease course of (3.0 ± 1.3) years. They all had clinical manifestations of seborrheic dermatitis to varying degrees, such as scalp erythema, itching, inflammatory papules, scales, etc.

[0090] Inclusion criteria for SSD: ① Meeting the SSD diagnostic criteria in "Chinese Clinical Dermatology" edited by Zhao Bian, and being diagnosed with SSD by two dermatologists at or above the deputy chief physician level; ② Aged 18 - 60 years, gender - unrestricted; ③ Having clinical manifestations such as scalp erythema (inflammatory), itching, inflammatory papules, scales, etc.; ④ Signs such as scalp congestion, blood vessel dilation, scales, etc. can be seen under dermoscopy; ⑤ Not having systematically applied or topically applied drugs for the treatment of SSD within 3 months before enrollment; ⑥ Voluntarily participating and signing the informed consent form.

[0091] Exclusion criteria for SSD: ① Patients allergic to compound acid; ② Having received relevant treatment for scalp seborrheic dermatitis within 3 months; ③ Not accepting the research protocol of this study; ④ Having hyperthyroidism or hypothyroidism, severe malnutrition, endocrine disorders, autoimmune diseases or other major diseases involving organs such as the heart, liver, lungs, and brain; ⑤ Having a history of mental disorders or mental diseases; ⑥ Pregnant or lactating women.

[0092] Termination criteria for the study: ① Poor compliance with the research treatment plan and inability to cooperate with the treatment; ② Occurrence of serious adverse events, complications, and special physiological changes, and inability to continue participating in the trial; ③ Presence of factors affecting the efficacy evaluation; ④ Patients lost to follow-up.

[0093] 1.2 Research protocol

[0094] The above patients were randomly divided into 3 groups, with 30 cases in each group. In the compound acid ointment treatment group, the scalp microecological balance compound acid ointment in Example 1 of this application was evenly applied to the scalp of the test patients, massaged until absorbed, and then washed off after 30 minutes. The treatment was given once a week for 4 consecutive times; in the conventional compound acid essence treatment group, the conventional compound acid essence was evenly applied to the patients' scalps twice a day for a total of 4 weeks. The main components of the conventional compound acid essence were: 2% supramolecular encapsulated salicylic acid and 2% fruit acid; in the drug treatment group: amorolfine ointment + fluticasone propionate ointment were evenly applied to the patients' scalps twice a day for 4 consecutive weeks; follow-up visits were conducted once a week and photos were taken for records, with a total of 4 follow-up visits lasting for 4 weeks. Each group adopted a randomized controlled research method.

[0095] 1.3 Materials and instruments

[0096] Dermoscope: Model CBS - 2026, produced by Wuhan Boshi Electronics Co., Ltd.

[0097] 1.4 Efficacy evaluation criteria

[0098] 1.4.1 Dermoscope detection

[0099] The patients' scalps were detected using a dermoscope before treatment and after 1, 2, 3, and 4 weeks of treatment. Signs such as scalp inflammatory papules, vascular dilation, scales, perifollicular signs, and honeycomb pigmented net were detected. It was done once a week for a total of 5 times.

[0100] 1.4.2 ASFS score (Adhesive Scale Ten - Grade Scoring Method)

[0101] The ASFS score (Adhesive Scale Ten - Grade Scoring Method) was used to evaluate the severity of the patients' scales. Each area was scored from 0 to 10 according to the severity of the scalp scales, where 0 indicates no scales (none), 1 - 2 indicates small powdery gray - white rough scales (a small amount), 3 - 4 indicates small to medium - sized scale flakes (mild), 5 - 6 indicates large and thin scale flakes loosely attached to the scalp (moderate), 7 - 8 indicates large adhesive scale flakes (obvious), and 9 - 10 indicates thick white - to - yellow scales tightly attached to the scalp (severe). Finally, the scores of each area were added up to get the total score (0 - 80 points). The higher the total score, the more severe the dandruff.

[0102] 1.4.3 NRS score (Numeric Rating Scale for Peak Pruritus)

[0103] Subjective symptoms before and after treatment in each group were scored in the form of a questionnaire, and the conditions of scalp greasiness, itching, and scaling were recorded. The NRS score (Peak Pruritus Numerical Rating Scale) is a self-report by the patient to evaluate the itching condition in the past 24 hours. A score of 0 represents no itching, and a score of 10 represents the most severe itching imaginable. The patient rates the most severe itching experienced in the past 24 hours. The higher the score, the more severe the itching.

[0104] 1.5 Efficacy evaluation criteria

[0105] Efficacy index = (mean score before treatment - mean score after treatment) / mean score before treatment × 100%

[0106] Cure: Efficacy index ≥ 90%; Marked effect: Efficacy index 70% - 89%; Effective: Efficacy index 30% - 69%; Ineffective: Efficacy index < 30%; Total effective rate = (number of cured cases + number of markedly effective cases) / total number × 100%.

[0107] 1.6 Statistical methods

[0108] SPSS 25.0 software was used for statistical analysis of the experimental results. Measurement data were expressed as mean ± standard deviation, and one-way analysis of variance was used for between-group comparison. If the difference was statistically significant, the LSD method was further used for pairwise comparison. P < 0.05 indicated that the difference was statistically significant.

[0109] 2 Results

[0110] 2.1 ASFS score (Adhesive Scale of Flakes - Ten - level Score)

[0111] After one - week scalp application of the scalp micro - ecological balance compound acid ointment of the present application, the patients felt that the degree of scaling was significantly reduced (see Table 1). In experimental group one, the scale score decreased from the baseline T0 (4.93 ± 1.71) to (3.45 ± 1.57) (P < 0.05). After four - week treatment, it further decreased to (2.86 ± 1.73) compared with the baseline T0 (P < 0.05).

[0112] Table 1 Comparison of ASFS scores before and after treatment with the scalp micro - ecological balance compound acid ointment of the present application

[0113] Compound Acid Ointment Treatment Group Average Value Number of Cases Standard Deviation Before Treatment 4.9310 30 1.70987 One Week after Treatment 3.4483 30 1.57176 Four Weeks after Treatment 2.8621 30 1.72635

[0114] After one - week scalp application of the conventional compound acid essence, the patients felt that the degree of scaling was reduced (see Table 2). The results showed that the scale score decreased from the baseline T0 (4.86 ± 1.46) to (3.67 ± 0.91) (P < 0.05). After four - week treatment, it further decreased to (3.57 ± 1.29) compared with the baseline T0 (P < 0.05).

[0115] Comparison of ASFS scores before and after treatment with conventional compound acid essence

[0116] Conventional Compound Acid Essence Treatment Group Average Value Number of Cases Standard Deviation Before Treatment 4.8571 30 1.45896 One Week after Treatment 3.6667 30 0.91287 Four Weeks after Treatment 3.5714 30 1.28730

[0117] After one week of treatment with topical scalp application of drugs, the patients felt that the scale symptoms were significantly relieved (see Table 3). The results showed that the scale score decreased from the baseline T0 (4.06 ± 1.12) to (3.19 ± 0.75) (P < 0.05). After four weeks of treatment, it further decreased to (3.00 ± 0.12) compared with the baseline T0 (P < 0.05).

[0118] Table 3 Comparison of ASFS scores before and after drug treatment

[0119]

[0120]

[0121] The improvement of scores before and after treatment in the three groups was compared jointly (Table 4). It can be seen that the three treatment methods all improved the scale degree of the patients to varying degrees. Among them, the improvement degree of the compound acid ointment treatment group of this application was the largest, followed by the topical drug group (P < 0.001).

[0122] Table 4 Comparison of ASFS scores before and after treatment among the three groups

[0123] Group Cured Markedly Effective Effective Ineffective Total Effective Rate Compound Acid Ointment Treatment Group 20 5 5 0 83.3％ Conventional Compound Acid Essence Treatment Group 8 12 6 4 66.7％ Drug Treatment Group 15 8 5 2 76.7％

[0124] 2.2 NRS score (Numeric Rating Scale for Peak Pruritus)

[0125] After one week of treatment with the scalp microecological balance compound acid ointment of this application by scalp application, the patients felt that the itching degree was significantly reduced (see Table 5). In experimental group one, the NRS score decreased from the baseline T0 (6.19 ± 2.11) to (2.86 ± 0.66) (P < 0.05). After four weeks of treatment, it further decreased to (1.52 ± 0.75) compared with the baseline T0 (P < 0.001).

[0126] Table 5 Comparison of NRS scores before and after treatment with the scalp microecological balance compound acid ointment of this application

[0127] Compound Acid Ointment Treatment Group Average Value Number of Cases Standard Deviation Before Treatment 6.1905 30 2.11232 One Week after Treatment 2.8571 30 0.65465 Four Weeks after Treatment 1.5238 30 0.74960

[0128] After one week of treatment with conventional compound acid essence by scalp application, the patients felt that the itching degree was significantly reduced (see Table 6). The results showed that the NRS score decreased from the baseline T0 (3.94 ± 1.29) to (2.44 ± 1.15) (P < 0.05). After four weeks of treatment, it further decreased to (2.00 ± 1.32) compared with the baseline T0 (P < 0.01).

[0129] Comparison of NRS scores before and after treatment with conventional compound acid essence in Table 6

[0130] Conventional Compound Acid Essence Treatment Group Average Value Number of Cases Standard Deviation Before Treatment 3.9375 30 1.28938 One Week after Treatment 2.4375 30 1.15289 Four Weeks after Treatment 2.0000 30 1.32019

[0131] One week after topical drug treatment, the patients felt that the degree of itching was significantly reduced (see Table 7). The results showed that the NRS score decreased from the baseline T0 (5.45 ± 1.62) to (3.31 ± 1.29) (P < 0.05). After four weeks of treatment, it further decreased to (2.24 ± 0.83) compared with the baseline T0 (P < 0.05).

[0132] Comparison of NRS scores before and after drug treatment in Table 7

[0133] Drug Treatment Group Average Value Number of Cases Standard Deviation Before Treatment 5.4483 30 1.61657 One Week after Treatment 3.3103 30 1.28462 Four Weeks after Treatment 2.2414 30 0.83045

[0134] The improvement of scores before and after treatment in the three groups was compared jointly (Table 8). It can be seen that the three groups all improved the degree of scalp itching in patients to varying degrees. Among them, the compound acid ointment treatment group was more effective in improving the scalp itching of patients, followed by the drug treatment group (P < 0.001).

[0135] Comparison of NRS scores before and after treatment among the three groups in Table 8

[0136] Group Cured Markedly Effective Effective Ineffective Total Effective Rate Compound Acid Ointment Treatment Group 25 5 0 0 100％ Conventional Compound Acid Essence Treatment Group 12 8 6 4 66.7％ Drug Treatment Group 15 10 5 0 83.3％

[0137] 2.3 Dermoscopy detection

[0138] There were no significant differences in scalp mirror indexes among the three groups of patients before treatment. Under dermoscopy: capillary dilatation, scalp congestion, inflammatory papules and scales could be seen on the scalp. After treatment, scalp erythema, scalp scales and inflammatory papules in the three groups of patients were significantly reduced. After 4 weeks of treatment in the compound acid ointment treatment group, various scalp inflammations of the patients healed. After 4 weeks of treatment in the conventional compound acid essence treatment group and the drug treatment group, the scalp inflammation symptoms were alleviated to varying degrees, but local scalp skin lesions were prone to recurrence. For details, please refer to Figures 1 - 3 .

[0139] At the same time, in order to compare the effects of Examples 1 to 5 and Comparative Examples 1 to 4, after applying the scalp microecological balance compound acid ointment of Examples 1 to 5 on the scalp for one week, the patients felt that the degree of scales was significantly reduced and the degree of itching was significantly reduced. After applying the scalp microecological balance compound acid ointment of Comparative Examples 1 to 4 on the scalp for one week, the patients felt that the degree of scales was somewhat reduced and the degree of itching was somewhat reduced (see Table 9).

[0140] Table 9 ASFS scores and NRS scores after applying the scalp microecological balance compound acid ointment of Examples 1 to 5 and Comparative Examples 1 to 4 on the scalp for one week

[0141] Number of Cases Average Value of ASFS after Treatment Average Value of NRS after Treatment Example 1 90 3.5483 2.5375 Example 2 90 3.5187 2.5776 Example 3 90 3.5413 2.5975 Example 4 90 3.5284 2.5577 Example 5 90 3.5777 2.5265 Comparative Example 1 90 4.8375 6.5905 Comparative Example 2 90 4.7378 6.4951 Comparative Example 3 90 4.5876 6.2943 Comparative Example 4 90 4.1874 6.8945

[0142] In summary, currently, there are reports on the clinical use of supramolecularly encapsulated salicylic acid to treat seborrheic dermatitis, acne, local keratin hyperplasia, tinea corporis and other diseases. The composite acid configured by supramolecularly encapsulated salicylic acid, fruit acid and nano-crystallized azelaic acid is used to treat facial seborrheic dermatitis and acne with good clinical effects, but there is still no good treatment for scalp seborrheic dermatitis. Therefore, in this study, we explored and prepared a new scalp microecological balance composite acid ointment for the efficacy of scalp seborrheic dermatitis. The study used the scalp microecological balance composite acid ointment of this application to treat scalp seborrheic dermatitis, reducing the skin irritation caused by the use of supramolecularly encapsulated salicylic acid, fruit acid, and nano-crystallized azelaic acid alone, while treating scalp seborrheic dermatitis.

[0143] The results of the study showed that the scalp microecological balance compound acid ointment of the present application can more effectively improve the symptoms of scalp dandruff and scalp itching in patients compared with conventional compound acid essence and topical medication (see Table 1-8). Dermoscopic examination found that after the patients used compound acid scalp treatment, the symptoms of scalp erythema, inflammatory papules and scaling were significantly alleviated (see Figures 1 - 3 ).

[0144] All 30 patients in the compound acid ointment treatment group had no adverse reactions, which shows that the scalp microecological balance compound acid ointment of the present application has a good therapeutic effect on scalp seborrheic dermatitis, and can significantly reduce the patient's scalp erythema, itching and scaling, especially in improving the degree of scalp itching in patients. The scalp microecological balance compound acid ointment scalp treatment of the present application shows greater advantages than traditional drug treatment and conventional compound acid essence topical treatment.

[0145] This application proves that scalp microecological balance compound acid ointment treatment is a safe, simple and effective method for treating scalp seborrheic dermatitis, providing a safer and more effective new method for the treatment of scalp seborrheic dermatitis in the future.

[0146] The above description is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the application should be included in the protection scope of the present application.

Claims

1. A scalp microecological balance composite acid ointment based on multi-acid coordinated targeted delivery, characterized in that: The composition comprises the following components in parts by weight: Wherein, the molecular weight of the traditional Chinese medicine extract is between 100-5000 kDa.

2. The scalp microecological balance composite acid ointment based on multi-acid coordinated targeted delivery according to claim 1, characterized in that: The Chinese medicine extract is a single component or a compound of multiple components of the following materials: sunflower extract, sophora flavescens extract, phellodendron amurense extract or ginsenoside.

3. The scalp microecological balance composite acid ointment based on multi-acid coordinated targeted delivery according to claim 2, characterized in that: The Chinese medicine extract comprises the following components in parts by weight:

4. The scalp microecological balance composite acid ointment based on multi-acid coordinated targeted delivery according to claim 3, characterized in that: The composition comprises the following components in parts by weight:

5. The scalp microecological balance composite acid ointment based on multi-acid coordinated targeted delivery and applicable to the scalp according to claim 1, characterized in that: The external base is a single component of the following materials or a compound of multiple components: beeswax, mineral oil, and vaseline.

6. The scalp microecological balance compound acid ointment according to claim 1, characterized in that: The fruit acid is lipophilic mandelic acid.

7. A method for preparing a scalp microecological balance composite acid ointment based on multi-acid coordinated targeted delivery, characterized in that: The following steps are involved: (1) Composite acid emulsification: 1.5-2.5 parts of supramolecularly encapsulated salicylic acid, 2.0-3.0 parts of nanocrystalline azelaic acid, 3.0-5.0 parts of fruit acid, 0.2-0.3 parts of retinoic acid, 1.5-2.5 parts of amphiphilic lactobionic acid derivatives, 1.5-2.5 parts of polyethylene glycolized pyruvic acid, and 75.0-85.0 parts of a topical base are placed in a first vacuum emulsifying pot to obtain a first mixture, the first mixture is heated to 80-85° C. and stirred to be fully mixed to obtain a first paste, and the mixture is kept warm for 15-25 minutes; (2) Emulsification of Chinese herbal medicine components: 1.0-2.0 parts of golden sunflower extract, 0.2-0.8 parts of sophora flavescens extract, 0.3-0.7 parts of phellodendron amurense extract, 0.1-0.7 parts of ginsenosides, and 10.0-20.0 parts of external base are placed in a second vacuum emulsifying pot to obtain a second mixture, and the second mixture is heated to 42-45° C. and stirred to be fully mixed to obtain a second paste, and the mixture is kept warm for 15-25 minutes; (3) Paste mixing: cool the first paste to 42-45° C. in a first vacuum emulsifying pot, add the second paste, and then keep warm and stir for 8-12 minutes until fully mixed; (4) Cooling and stirring: cooling to 39-40° C. and stirring for 8-12 minutes, then cooling to 35° C. to 38° C. and allowing to stand to obtain the scalp microecological balance composite acid ointment based on multi-acid synergistic targeted delivery as described in any one of claims 1 to 6.

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