Six-ingredient barge-eliminating traditional Chinese medicine composition as well as traditional Chinese medicine preparation and application thereof

Abstract

The invention provides a six-ingredient barge-eliminating traditional Chinese medicine composition and a traditional Chinese medicine preparation and application thereof, and the six-ingredient barge-eliminating traditional Chinese medicine composition comprises the following components in parts by weight: 8-12 parts of peach kernel, 7-11 parts of safflower, 4-8 parts of salvia miltiorrhiza, 4-8 parts of rhizoma cyperi, 13-17 parts of angelica dahurica and 13-17 parts of vernonia anthelmintica. According to the formula, peach kernels for promoting blood circulation, removing blood stasis and removing heat in blood are taken as monarch drugs, safflower and salvia miltiorrhiza are taken as ministerial drugs for promoting blood circulation and removing blood stasis of peach kernels, rhizoma cyperi, radix angelicae and vernonia anthelmintica are taken as adjuvant drugs, and all the drugs are combined to achieve the effects of promoting blood circulation, removing blood stasis, dispelling wind and removing cold. The traditional Chinese medicine composition has the advantages of clear edge with hyperpigmentation, irregular shape accompanied by fullness or pain in chest and hypochondrium, purple and dark tongue or stasis spots and astringent pulse, and has a good curative effect on treating leucoderma.

Description

Technical Field

[0001] The invention relates to the technical field of drug preparation, and in particular to a six-flavor Chinese medicine composition and a Chinese medicine preparation and application thereof. Background Art

[0002] Vitiligo is a common acquired depigmentation skin and mucous membrane disease, which is typically manifested by white spots of varying sizes and shapes with clear or unclear boundaries, which can be localized or diffuse throughout the body. According to the consensus of modern Chinese medicine, vitiligo corresponds to the disease of "white spot wind". According to scholars, "white place", "white no play", "dragon lick", "white spot", "vitiligo", "white spot wind", "white fixed", "white spot wind" and so on have all appeared as vitiligo disease names. Western medicine mainly treats vitiligo with hormone therapy, ultraviolet radiation therapy, laser therapy, etc., and its means are limited, especially hormone therapy has obvious adverse reactions. Patients suffer less pain during treatment with traditional Chinese medicine, internal treatment does not cause much damage to the liver and kidneys, external treatment (including acupuncture, tincture, etc.) is simple and inexpensive, and traditional Chinese medicine can significantly improve the accompanying symptoms of patients through syndrome differentiation and treatment, and improve the quality of life of patients, so traditional Chinese medicine plays an important role in the treatment of vitiligo. Vitiligo is a chronic skin disease that is relatively difficult to treat. Although the patient's life is not threatened by it, the white spots occurring on exposed parts of the skin will cause inferiority complex and mental anxiety in patients due to their loss of beauty, thereby reducing the patient's quality of life. At present, there is a lack of effective drugs for the treatment of vitiligo in the market. Traditional Chinese medicine has a theoretical basis and clinical application value in harmonizing blood and removing wind, soothing the liver and relieving depression, promoting blood circulation and removing blood stasis, and clearing away heat and dampness. Therefore, the use of medical differentiation theory to treat vitiligo and improve the efficacy is a problem that needs to be solved at present. Summary of the invention

[0003] In view of this, the purpose of the present invention is to propose a six-flavor Chinese medicine composition and its Chinese medicine preparation and application to solve the above problems.

[0004] The technical solution of the present invention is achieved in this way:

[0005] A six-flavor Chinese medicine composition for eliminating parasites comprises the following components by weight: 8-12 parts of peach kernel, 7-11 parts of safflower, 4-8 parts of salvia miltiorrhiza, 4-8 parts of cyperus rotundus, 13-17 parts of angelica dahurica and 13-17 parts of vernonia anthelmintic.

[0006] A further solution is that the following components are included by weight: 8-10 parts of peach kernel, 8-10 parts of safflower, 5-7 parts of salvia miltiorrhiza, 5-7 parts of cyperus rotundus, 14-16 parts of angelica dahurica and 14-16 parts of vernonia anthelmintic.

[0007] A further solution is to include the following components by weight: 9 parts of peach kernel, 9 parts of safflower, 6 parts of salvia miltiorrhiza, 6 parts of cyperus rotundus, 15 parts of angelica dahurica and 15 parts of vernonia anthelmintic.

[0008] A further solution is that the peach kernels include stewed peach kernels.

[0009] In one aspect, the present invention provides a Liuwei Xiaobo Chinese medicine preparation, comprising the above-mentioned Liuwei Xiaobo Chinese medicine composition and pharmaceutically acceptable excipients.

[0010] A further solution is that the Liuwei Xiaobo Chinese medicine preparation includes one of capsules, pills and tablets.

[0011] In one embodiment of the present invention, the formula and preparation method of Liuwei Xiaobo Capsule are preferably as follows:

[0012] On the other hand, the present invention provides the use of the above-mentioned Liuwei Xiaobo Chinese medicine composition in the preparation of a drug for treating vitiligo.

[0013] A further solution is the use of the Liuwei Xiaobo Chinese medicine composition in the preparation of a medicine for treating vitiligo caused by qi stagnation and blood stasis, and wind evil spreading to the skin.

[0014] The legal standards for the anthelmintic Vernonia in the prescription are included in the Uyghur Medicine Volume of the Drug Standards of the People's Republic of China, and the legal standards for the remaining medicinal ingredients are all from the 2020 edition of the Chinese Pharmacopoeia, as follows:

[0015] 1. Peach Kernel

[0016] This product is the dried mature seeds of Prunus persica (L.) Batsch, a plant of the Rosaceae family. The fruits are harvested after they are ripe, the pulp and shell are removed, the seeds are taken out, and then dried in the sun.

[0017] To stew peach kernels, take clean peach kernels and peel them according to the stewing method (General Rule 0213). Crush them before use.

[0018] This product should comply with the relevant provisions under Peach Kernel in Part I of the 2020 Edition of the Chinese Pharmacopoeia.

[0019] 2. Safflower

[0020] This product is the dried flower of Carthamus tinctorius L., a plant of the Asteraceae family. The flowers are picked when they turn from yellow to red in summer and dried in the shade or in the sun.

[0021] This product should comply with the relevant provisions under Safflower in Part I of the 2020 edition of the Chinese Pharmacopoeia.

[0022] 3. Salvia miltiorrhiza

[0023] This product is the dried root and rhizome of Salvia miltiorrhiza Bge., a plant of the Lamiaceae family. It is dug in spring and autumn, desilted, and dried.

[0024] This product should comply with the relevant provisions under Salvia miltiorrhiza in Part I of the 2020 edition of the Chinese Pharmacopoeia.

[0025] 4. Cyperus rotundus

[0026] This product is the dried rhizome of Cyperus rotundus L., a plant of the Cyperaceae family. It is dug up in autumn, the hair is burned off, and it is briefly boiled in boiling water or steamed thoroughly before being dried in the sun, or directly dried in the sun after being burned.

[0027] This product should comply with the relevant provisions of the 2020 edition of the Chinese Pharmacopoeia under the item of Cyperus rotundus.

[0028] 5. Angelica dahurica

[0029] This product is the dried root of Angelica dahurica (Fisch.ex Hoffm.) Benth.et Hook.f. of the Umbelliferae family. It is dug up when the leaves turn yellow in summer and autumn, the fibrous roots and mud are removed, and it is dried in the sun or at a low temperature.

[0030] This product should comply with the relevant provisions under Angelica dahurica in Part I of the 2020 edition of the Chinese Pharmacopoeia.

[0031] 6. Vernonia

[0032] This product is the mature fruit of Vernonia anthelmintica Willd., a plant of the Asteraceae family. The fruit is harvested in late autumn and sun-dried.

[0033] This product should comply with the relevant provisions of the "Uyghur Medicine Volume of the Drug Standards of the People's Republic of China" under the item of anthelmintic Vernonia.

[0034] The medicinal materials selected in the prescription do not contain any medicinal ingredients marked as "extremely toxic or highly toxic" in legal standards or any medicinal ingredients proven to have clear toxicity by modern toxicology, nor do they contain any of the 18 anti-incompatibility or 19 anti-compatibility contraindications.

[0035] The whole prescription can activate blood circulation, dissipate blood stasis, dispel wind and eliminate phlegm. It is used for vitiligo caused by qi stagnation and blood stasis, and wind evil spreading to the skin.

[0036] Compared with the prior art, the present invention has the following beneficial effects:

[0037] This prescription uses peach kernel as the main medicine to promote blood circulation, remove blood stasis and remove heat from the blood, safflower and salvia miltiorrhiza as the assistant medicines to assist peach kernel in promoting blood circulation and removing blood stasis, and Cyperus rotundus, Angelica dahurica, and Vernonia ovata as the adjuvant medicines to soothe the liver and relieve depression, promote qi circulation, and dispel wind and cold. All the medicines together have the effects of promoting blood circulation, removing blood stasis, and dispelling wind and eliminating phlegm. This prescription can be used for vitiligo caused by qi stagnation and blood stasis, and wind evil spreading to the skin. Symptoms include scattered white spots with clear edges and pigmentation, irregular shape, accompanied by chest and flank distension or pain, purple tongue or petechiae, and sluggish pulse. It has a good effect on the treatment of vitiligo, with a total effective rate of 91.67%. DETAILED DESCRIPTION

[0038] In order to better understand the technical content of the present invention, specific embodiments are provided below to further illustrate the present invention.

[0039] Unless otherwise specified, the experimental methods used in the embodiments of the present invention are all conventional methods.

[0040] Unless otherwise specified, the materials, reagents, etc. used in the embodiments of the present invention can be obtained from commercial sources.

[0041] Example 1

[0042] The prescription of Liuwei Xiaobosan is: 9g of boiled peach kernel, 9g of safflower, 6g of salvia miltiorrhiza, 6g of cyperus rotundus, 15g of angelica dahurica and 15g of vernonia anthelmintic.

[0043] The above medicinal ingredients total 60g, grind into fine powder, divide into 30 packets, 2g / packet, take 1 packet at a time, 3 times a day, the daily dosage of raw medicine is 6g.

[0044] Example 2

[0045] The prescription of Liuwei Xiaobosan is: 11g of boiled peach kernel, 7g of safflower, 8g of salvia miltiorrhiza, 8g of cyperus rotundus, 13g of angelica dahurica and 13g of vernonia anthelmintic.

[0046] The above medicinal ingredients total 60g, grind into fine powder, divide into 30 packets, 2g / packet, take 1 packet at a time, 3 times a day, the daily dosage of raw medicine is 6g.

[0047] Example 3

[0048] The prescription of Liuwei Xiaobosan is: 8g of boiled peach kernel, 11g of safflower, 4g of salvia miltiorrhiza, 4g of cyperus rotundus, 16g of angelica dahurica and 17g of vernonia anthelmintic.

[0049] The above medicinal ingredients total 60g, grind into fine powder, divide into 30 packets, 2g / packet, take 1 packet at a time, 3 times a day, the daily dosage of raw medicine is 6g.

[0050] Clinical research example

[0051] 1. Research Methods

[0052] Referring to the relevant contents of the "Guidelines for Clinical Research of New Chinese Medicines" (edited by Zheng Xiaoyu, 1st edition, May 2002), 60 medical records that met the inclusion criteria were randomly selected from outpatients from January 2019 to December 2023, and clinical data were collected. Statistical analysis and efficacy determination were performed to evaluate the effectiveness and safety of Liuwei Xiaobo Powder.

[0053] 2. General Information

[0054] Among the 60 patients, there were 35 male patients and 25 female patients, with an average age of (34.03±11.78) years old. The patients had symptoms of scattered white spots with clear edges and pigmentation, irregular shapes, accompanied by chest and flank distension or pain, purple tongue or petechiae, and sluggish pulse.

[0055] 3. Diagnostic Criteria

[0056] (I) Diagnosis is made according to the Chinese Journal of Clinical Dermatology:

[0057] 1. The skin lesions are depigmented white spots, localized or generalized, with different sizes and shapes, clear boundaries, smooth skin at the white spots, no atrophy, desquamation, etc., and the edges may be surrounded by pigment bands;

[0058] 2. It can occur anywhere on the body, mostly in areas that are exposed to the sun, friction, wrinkles, and trauma. It is often distributed symmetrically and can affect hair follicles and mucous membranes.

[0059] 3. It can occur at any age, but is more common in children and young adults, and generally there is no conscious discomfort;

[0060] 4. Histopathology showed a significant lack of epidermal melanocytes and melanin granules, and a complete lack of DOPA-positive melanocytes in the basal layer, consistent with the changes of melanocyte destruction;

[0061] 5. Exclude diseases such as non-pigmented nevus, anemic nevus, and tinea versicolor.

[0062] (2) Classification: According to the standards of the "Consensus on Diagnosis and Treatment of Vitiligo (2021 Edition)", it is divided into segmental type, common type, mixed type and undetermined type.

[0063] 1. Non-segmental vitiligo (vitiligo vulgaris): includes disseminated, generalized, face-neck, acral and mucosal types.

[0064] (1) Scattered type: white spots are scattered, multiple, often symmetrically distributed, with ≥2 white spots and an area ≤ 50% of the body surface area;

[0065] (2) Generalized type: scattered white spots merge with each other, with irregular shapes, and islands of normal skin may remain in the middle, with an area > 50% of the body surface area;

[0066] (3) Facial and neck type, acrofacial type: white spots occur on the face, neck or extremities, and a few are accompanied by generalized white spots on the body;

[0067] (4) Mucosal type: leukoplakia affects ≥ 2 mucosal sites.

[0068] 2. Segmental vitiligo: usually refers to unilateral asymmetric vitiligo distributed along a certain cutaneous nerve segment (completely or partially matching the skin segment). In a few cases, it can be distributed bilaterally in multiple segments.

[0069] 3. Mixed vitiligo: segmental and non-segmental types coexist.

[0070] 4. Undetermined type of vitiligo (formerly localized type): refers to a single skin lesion with an area of ​​level 1, which cannot be determined as segmental or non-segmental type at the time of consultation.

[0071] 3. TCM diagnostic criteria

[0072] According to the "Expert Consensus on Traditional Chinese Medicine Treatment of Vitiligo" (2017 edition) and in accordance with the "Diagnosis and Efficacy Standards for Traditional Chinese Medicine Dermatology Diseases" issued by the State Administration of Traditional Chinese Medicine, the patient was diagnosed with Qi stagnation and blood stasis syndrome.

[0073] Main symptoms: scattered white spots with clear edges, pigmentation and irregular shapes;

[0074] Secondary symptoms: fullness or pain in the chest and flanks;

[0075] Tongue and pulse: dark purple tongue or with petechiae, thin white fur, sluggish pulse.

[0076] IV. Inclusion Criteria

[0077] ① Meet the standards of the "Vitiligo Diagnosis and Treatment Consensus (2021 Edition)" and be diagnosed with disseminated, facial and neck, or undetermined vitiligo. ② Meet the diagnosis of Qi stagnation and blood stasis syndrome in traditional Chinese medicine. ③ Adults over 18 years old will be tested. ④ Patients give informed consent and voluntarily accept treatment. Able to complete treatment and follow-up as required.

[0078] 5. Exclusion criteria

[0079] ① Those who have color loss, anemic nevus, albinism left after certain rashes have subsided; and those who have white spots, senile white spots, colorless nevus, solar white spots, etc. caused by other diseases; ② Skin lesions occur in special parts such as eyelids, lips or genitals; ③ Those with local inflammation, blisters, erosions, ulcers and other skin damage on the white spots; ④ Those who are pregnant or breastfeeding and have plans to have children within 6 months; ⑤ Those with a history of allergic dermatitis and solar dermatitis; ⑥ Those with serious causes such as heart, liver, kidney, hematopoietic, and metabolic systems ⑦ Patients with jaundice, liver and kidney dysfunction, laboratory tests ALT, AST, GGT (γ-GT), Tbil>1.5×ULN, Cr>1×ULN; ⑧ Patients with uncontrolled hypertension or hypotension: sitting systolic blood pressure ≥180mmHg or <90mmHg at rest, diastolic blood pressure ≥120mmHg or <60mmHg; ⑨ Patients with hemophilia, coagulation disorders or other bleeding tendencies; ⑩ Patients with scar constitution or allergies, or those with NB - Those who are allergic to or cannot tolerate UVB; those who have received more than 100 light (or photochemotherapy) therapies in the past; those who have used steroid preparations, calcineurin inhibitors (tacrolimus ointment, pimecrolimus cream, etc.), vitamin D3 derivatives (calcipotriol ointment, tacalcitol ointment, etc.), phosphodiesterase 4 (PDE-4) inhibitors, Janus kinase (JAK) inhibitors, depigmenting agents (20% hydroquinone monophenyl ether, 20% hydroquinone cream, etc.) within the past 2 weeks; those who have used steroid preparations, calcineurin inhibitors (tacrolimus ointment, pimecrolimus cream, etc.) within the past 4 weeks Those who have received melanocyte stimulating hormone analogs, such as afamelanotide; or received systemic immunomodulatory drugs, such as glucocorticoids, methotrexate, cyclosporine, calcineurin inhibitors, Janus kinase (JAK) inhibitors; or Chinese patent medicines with therapeutic effects (Bailing Tablets, Baishi Pills, Compound Anti-Chemistry Banjiuju Pills, Qubai Babuqi Tablets, Compound Kali Cumin Tincture, etc.) and physical therapy (plum blossom needles, fire needles, moxibustion, etc.); those who have participated in other clinical trials within 3 months.

[0080] 6. Test process

[0081] Natural selection was used to enter the drug-only treatment group, and 60 eligible patients were screened.

[0082] Treatment drugs: 9g of boiled peach kernel, 9g of safflower, 6g of salvia miltiorrhiza, 6g of cyperus rotundus, 15g of angelica dahurica, 15g of vernonia anthelmintic, a total of 60g of the above medicines, divided into 30 packets, 1 packet at a time, taken with warm water after meals, 3 times a day, each time taking 2g of raw medicine. According to the standards of the "Consensus on Diagnosis and Treatment of Vitiligo (2021 Edition)", 90 days is set as a course of treatment, and a total of one course of treatment is observed.

[0083] ① Conduct safety tests such as blood routine, liver and kidney function, urine routine, ECG, etc.; liver and kidney function tests must at least include ALT, AST, ALP, GGT, TBil, DBil, ALB, BUN, SCr; ② Record the target white spot area; ③ Complete the evaluation of efficacy indicators such as TCM syndrome score and Vitiligo Area Score Index (VASI).

[0084] VII. Efficacy indicators

[0085] 1. Vitiligo Area Scoring Index (VASI): The body surface is divided into 5 areas to calculate the area of ​​depigmentation: hands, upper limbs (excluding hands), trunk, lower limbs (excluding feet) and feet, among which the axilla is included in the upper limbs, and the groin and buttocks are included in the lower limbs. The face and neck are not included in the final score and can be evaluated separately. The area of ​​depigmentation can be estimated by the palm method. One palm unit (including the palm and the palm surface of all fingers) is calculated as 1% of the body surface area. The total score of VASI is the sum of the number of palm units with skin lesions in each area of ​​the body × the degree of depigmentation of the unit, and the score ranges from 0 to 100. The evaluation of the degree of depigmentation is shown in Table 5.

[0086] Table 5 Pigment loss degree evaluation table

[0087] 0 No pigment loss 10％ Only a few spots of depigmentation 25％ The area of ​​pigment loss is smaller than the area without pigment loss 50％ The area of ​​pigment loss is equal to the area without pigment loss 75％ The area of ​​pigment loss is larger than the area without pigment loss 90％ A few remaining pigment spots 100％ Complete loss of pigment

[0088] 2. TCM syndrome scores and efficacy indicators are shown in Table 6.

[0089] Table 6 TCM syndrome scores and efficacy indicators

[0090]

[0091] 8. Efficacy Evaluation

[0092] 1. Evaluation criteria for efficacy of Western medicine

[0093] According to the "Clinical Classification and Efficacy Standards for Vitiligo (2003 Revised Draft)", the white spot area index is evaluated into 4 levels: cured, markedly effective, improved, and ineffective.

[0094] Cured: All white spots disappeared and the skin color returned to normal.

[0095] Significantly effective: White spots partially disappear or shrink, and the area restored to normal skin color accounts for ≥50% of the skin lesion area.

[0096] Improvement: The white spots partially fade or shrink.

[0097] Ineffective: White spots do not regenerate pigment or their area expands.

[0098] 2. Evaluation criteria for TCM efficacy

[0099] Recovery: Clinical symptoms and signs of TCM disappear;

[0100] Markedly effective: clinical symptoms and signs of TCM are significantly improved (the percentage of symptoms after treatment is reduced by ≥50% compared with that before treatment);

[0101] Effective: TCM clinical symptoms and signs have improved (the percentage of symptoms after treatment is reduced by ≥10% and <50% compared with before treatment);

[0102] Ineffective: There was no significant improvement in TCM clinical symptoms and signs (the percentage of symptoms after treatment decreased by <10% compared with before treatment).

[0103] Symptom percentage reduction rate (%) = (symptom percentage before treatment - symptom percentage after treatment) ÷ symptom percentage before treatment × 100%.

[0104] 9. Statistical Methods

[0105] SPSS 25.0 software was used for statistical analysis. Count data were expressed as rate (%) and mean ± standard deviation. The difference was statistically significant when P < 0.05, and extremely statistically significant when P < 0.01.

[0106] 10. Results

[0107] 1. The results of efficacy evaluation are shown in Table 7 below

[0108] Table 7 Efficacy evaluation results

[0109]

[0110] The clinical efficacy was markedly effective in 33 cases, with a marked effectiveness rate of 55.00%; effective in 22 cases, with an effectiveness rate of 36.67%; ineffective in 5 cases, with an ineffective rate of 8.33%; and the total effective rate was 91.67%.

[0111] 2. Comparison of TCM syndrome scores between the two groups

[0112] Table 8 TCM syndrome score results

[0113]

[0114] Summary: TCM symptoms were improved after treatment, and the difference before and after treatment was statistically significant (P < 0.05).

[0115] 3. Security Analysis

[0116] Before and after treatment, all patients underwent safety tests such as blood routine, liver and kidney function, urine routine, ECG, etc., and the data showed no abnormalities and no obvious adverse reactions were observed.

[0117] 11. Analysis

[0118] Ancient medical books record the etiology and pathogenesis of vitiligo. Puji Fang believes that "lung heat is strong, wind evil takes advantage of it, wind and heat are combined, and the blood circulation is blocked in the muscles, which does not dissipate for a long time, so this is the case"; Yi Zong Jin Jian believes that "vitiligo, the flesh color suddenly turns white, and it is not painful or itchy, because the wind evil attacks the skin, causing the qi and blood to be out of harmony"; Yi Lin Gaicuo points out that "vitiligo" is "caused by blood stasis in the skin"; Su Chuang Tiao Jing Lun points out that "blood and qi are not harmonious, and all diseases and changes are caused"; Zhu Bing Yuan Hou Lun believes that "vitiligo" is "caused by wind evil attacking the skin, and blood and qi are not harmonious". It can be seen that the ancient doctors' understanding of the etiology and pathogenesis of vitiligo is mostly based on the attack of wind evil, qi and blood disharmony, and internal heat. Emotional frustration, liver qi stagnation, qi stagnation and blood stasis; or traumatic injuries, blood stasis that cannot be transformed, can all block the meridians, make the skin lose nourishment, and form white spots. For example, the Authentic Surgery believes that white spots can be divided into two types: purple and white. Purple is caused by blood stagnation, and white is caused by qi stagnation. "It is always caused by heat and rheumatism, which stagnates the pores and causes qi and blood to stagnate." The Correction of Errors in Medicine points out more clearly that "vitiligo is caused by blood stasis in the skin." It can be seen that ancient doctors believed that the cause of vitiligo involves the lungs, liver, and heart, and is related to wind, heat, dampness, qi, and blood. The pathogenesis is qi and blood disharmony or qi stagnation and blood stasis, and the disease is located in the skin. Ancient doctors believed that this disease was caused by wind evil spreading in the skin, qi and blood disharmony, or qi and blood stasis.

[0119] In this prescription, peach kernel is bitter, sweet and neutral, and it belongs to the heart, liver and large intestine meridians. It can activate blood circulation and remove blood stasis. Li Gao: "It can treat heat entering the blood chamber, blood stagnation in the abdomen, hot and dry itchy skin blood, and blood coagulation in the skin." "The Secret of Using Medicines" says: "Peach kernel, bitterness can relieve stagnant blood, and sweetness can produce new blood, so it must be used to coagulate blood. It can also remove heat from the blood." "Ben Cao Jing Su": "Blood is yin, tangible, and circulates throughout the body. Once it is stagnant, it will cause symptoms, blood stasis, blood stasis, or women's menstrual blockage, or blood accumulation due to beatings and injuries, and hard pain caused by blood stagnation under the heart. All of these are caused by the foot Jueyin, because it is the organ that stores blood. Peach kernel is bitter and can relieve stagnation, spicy and can disperse knots, sweet and warm and can relieve the liver, so it is mainly used for the above symptoms. When the blood stagnation under the heart is removed, the qi will go down, and the cough and reverse will stop." Peach kernel can activate blood circulation, remove blood stasis, and remove heat from the blood, so it is the main medicine.

[0120] Safflower is pungent and warm. It belongs to the heart and liver meridians. It can promote blood circulation and remove blood stasis, promote menstruation and activate collaterals. "Ben Cao Yan Yi Buyi" says: "Safflower can break up retained blood and nourish blood." Salvia miltiorrhiza is bitter and slightly cold. It belongs to the heart and liver meridians. It can promote blood circulation and remove blood stasis, relieve pain, clear the heart and relieve vexation, cool blood and eliminate carbuncle. "Bie Lu" says: "It can nourish blood, remove chronic diseases and qi in the heart and abdomen, strengthen the waist and spine, and relieve stiffness in the feet, and remove wind evil and retained heat. Long-term use is beneficial to people." "Ben Cao Cong Xin" says: "Salvia miltiorrhiza nourishes the heart, removes blood stasis and promotes new blood... It has the same function as the four ingredients (one ingredient of Salvia miltiorrhiza powder has the same function as the four ingredients) and is an important medicine for gynecology." "Yunnan Ben Cao" also has a record: "Salvia miltiorrhiza... one ingredient can equal the blood-tonifying function of the four ingredients." Moreover, when doctors use Salvia miltiorrhiza nowadays, they always say: "One ingredient of Salvia miltiorrhiza has the same function as the four ingredients." Safflower and Salvia miltiorrhiza help peach kernel to promote blood circulation and remove blood stasis as the assistant medicine.

[0121] Cyperus rotundus, pungent, slightly bitter, slightly sweet, neutral. It enters the liver, spleen, and triple burner meridians. It soothes the liver and relieves depression, regulates qi and relieves fullness, regulates menstruation and relieves pain. "Compendium of Materia Medica": "The aroma of Cyperus rotundus is neutral but not cold, fragrant and can spread, its taste is mostly pungent and can disperse, slightly bitter can descend, slightly sweet can harmonize. When it is raw, it goes up to the chest and diaphragm, and reaches the skin..." Wang Haogu: "Cyperus rotundus must be used for qi stagnation and blood qi. Stir-frying it until it is black can stop bleeding and treat metrorrhagia. Using it more often can also move qi." Angelica dahurica, pungent, warm. It enters the stomach, large intestine, and lung meridians. It relieves the exterior and dispels cold, dispels wind and relieves pain. "Southern Yunnan Materia Medica": "It removes wandering wind on the skin, stops stomach cold abdominal pain, cold pain, and pain caused by cold and dampness all over the body." Li Gao: Angelica dahurica is commonly used to treat wind. Its aroma is fragrant and can open the nine orifices. It is indispensable for sweating on the surface. Vernonia anthelminticum is recorded in the Chinese Ethnological Pharmacy: "bitter, cool." "It clears away heat and inflammation, promotes blood circulation and removes blood stasis, kills insects and removes spots. It is used for vitiligo, roundworms, pinworms, sores, boils, swelling and pain." Modern pharmacology has proven that it has an activating effect on tyrosinase, can increase the skin's sensitivity to ultraviolet rays, and has a dose-dependent enhancing effect on tyrosinase activity and melanin production. Cyperus rotundus, Angelica dahurica, and Vernonia anthelminticum are adjuvants that soothe the liver and relieve depression, promote qi, and dispel wind and cold.

[0122] This prescription uses peach kernel as the main medicine which can promote blood circulation, remove blood stasis and remove heat from the blood, safflower and salvia miltiorrhiza as the assistant medicines which help peach kernel promote blood circulation and remove blood stasis, and cyperus rotundus, angelica dahurica and vernonia ovata as the adjuvant medicines which can soothe the liver and relieve depression, promote qi circulation, and dispel wind and cold. The whole prescription can promote blood circulation, remove blood stasis, dispel wind and eliminate irritation, and is used for vitiligo caused by qi stagnation, blood stasis, and wind evil spreading to the skin. The medicines complement each other and have good therapeutic effects, with a total effective rate of 91.67%.

[0123] 12. Conclusion

[0124] Liuwei Xiaobosan has the effects of promoting blood circulation, removing blood stasis, dispelling wind and eliminating phlegm. It is an effective preparation for treating vitiligo caused by qi stagnation, blood stasis, and wind evil spreading to the skin, and it has good safety.

[0125] Comparative study example

[0126] The comparative prescription 1 of Liuwei Xiaobosan is: boiled peach kernel 9g, safflower 5g, salvia miltiorrhiza 10g, cyperus rotundus 6g, angelica dahurica 15g and vernonia anthelmintic 15g.

[0127] Comparative prescription 2 of Liuwei Xiaobosan is: boiled peach kernel 7g, safflower 7g, salvia miltiorrhiza 6g, cyperus rotundus 10g, angelica dahurica 15g and vernonia anthelmintic 15g.

[0128] The above medicinal ingredients total 60g, grind into fine powder, divide into 30 packets, 2g / packet, take 1 packet at a time, 3 times a day, the daily dosage of raw medicine is 6g.

[0129] After research and statistics, the total effective rate of comparative prescription 1 is 87.50% (n=40), and the total effective rate of comparative prescription 2 is 82.50% (n=40). The therapeutic efficacy and effective rate are lower than those in Example 1.

[0130] Example 4

[0131] The dosage form is changed from powder to capsule, and the prescription is converted according to 1000 capsules. After rounding, the fixed prescription quantity of 1000 capsules is calculated.

[0132] The formula of Liuwei Xiaobo Capsule is: 60g of stewed peach kernel, 60g of safflower, 40g of salvia miltiorrhiza, 40g of cyperus rotundus, 100g of angelica dahurica and 100g of anthelmintic Vernonia.

[0133] The preparation process is as follows:

[0134] 1. Take the Chinese medicine slices in the prescription, sterilize them with circulating steam for 60 minutes, take them out, and dry them (55℃~60℃);

[0135] 2. Crush the dried Chinese herbal medicine slices and pass through a 60-mesh sieve;

[0136] 3. Mix the powder for 30 minutes and mix well;

[0137] 4. Put it into No. 0 hollow capsules, make 1000 capsules, each capsule contains 0.4g;

[0138] 5. Packaging, ready to go.

[0139] The above is a preferred embodiment of the present invention. It should be pointed out that a person skilled in the art can make several improvements and modifications without departing from the principle of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A six-flavor Chinese medicine composition, characterized in that: The invention comprises the following components by weight: 8-12 parts of peach kernel, 7-11 parts of safflower, 4-8 parts of salvia miltiorrhiza, 4-8 parts of cyperus rotundus, 13-17 parts of angelica dahurica and 13-17 parts of vernonia anthelmintic.

2. A six-flavor Chinese medicine composition according to claim 1, characterized in that: The invention comprises the following components by weight: 8-10 parts of peach kernel, 8-10 parts of safflower, 5-7 parts of salvia miltiorrhiza, 5-7 parts of cyperus rotundus, 14-16 parts of angelica dahurica and 14-16 parts of anthelmintic Vernonia.

3. A six-flavor Chinese medicine composition according to claim 2, characterized in that: The invention comprises the following components by weight: 9 parts of peach kernel, 9 parts of safflower, 6 parts of salvia miltiorrhiza, 6 parts of cyperus rotundus, 15 parts of angelica dahurica and 15 parts of anthelmintic Vernonia grandiflora.

4. A six-flavor Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The peach kernels include stewed peach kernels.

5. A six-flavor Chinese medicine preparation, characterized in that: The invention comprises the Liuwei Xiaobo Chinese medicine composition as described in any one of claims 1 to 4, and pharmaceutically acceptable excipients.

6. A Liuwei Xiaobo Chinese medicine preparation according to claim 5, characterized in that: The Liuwei Xiaobo Chinese medicine preparation includes one of capsules, pills and tablets.

7. Use of the Liuwei Xiaobo Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a drug for treating vitiligo.

8. The use according to claim 7, characterized in that: The six-flavor Xiaobo Chinese medicine composition is used in preparing medicines for treating vitiligo caused by qi stagnation and blood stasis and wind evil spreading in the skin.

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