Oral pharmaceutical composition for treating vitiligo

Abstract

The application belongs to the field of traditional Chinese medicines, and relates to an oral medicine composition for treating leukoderma, which comprises 6-18 parts of Huangqi, 6-15 parts of Tusizi, 6-15 parts of Taizishen, 6-12 parts of Yujin and 6-12 parts of Hupu. The application provides the oral medicine composition for treating leukoderma, which can improve the total effective rate and promote the recovery of leukoplakia.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of traditional Chinese medicine, and relates to a pharmaceutical composition, in particular to an oral pharmaceutical composition for treating leukoderma. BACKGROUND

[0002] Modern medicine believes that leukoderma is a disease based on multiple genes and multiple factors, and its causes are mainly related to oxidative stress, autoimmunity, endocrine, heredity and other factors. Traditional Chinese medicine has recorded leukoderma for a long time, which is called “leukoderma”, “white patch”, “white patchy wind” and so on. As early as in the Sui Dynasty, there was a record in “Treatise on Various Diseases” by Xiaoyuanfang that “the color of the skin on the face, neck and body changes white, which is different from the flesh color, and does not cause itching and pain, which is called leukoderma”. It is believed that the causes of leukoderma are mainly liver qi stagnation, liver and kidney deficiency, wind evil invading the skin, qi and blood disharmony, qi stagnation and blood stasis for a long time, blood stasis in collaterals, and blood failing to nourish the skin. Although the disease is manifested in the skin, it is closely related to the spleen, liver and kidney, and it is often caused by repeated invasion of external evil or emotional damage, and it is slow and difficult to cure. It is recorded in “Discussion on Wind in Canon of Internal Medicine” that “wind evil is stored between the skin, and cannot be discharged outside or communicated inside, and blood stasis will occur for a long time”. The internal cause of leukoderma is mainly liver qi stagnation, long-term consumption or qi stagnation and blood stasis, deficiency of essence and blood, deficiency of liver and kidney, and finally qi and blood disharmony.

[0003] Traditional Chinese medicine believes that leukoderma is caused by liver qi stagnation, blood stasis, repeated invasion of wind and cold, and wind evil invading the skin, resulting in qi and blood disharmony. Traditional Chinese medicine has recorded the treatment of leukoderma in “Fifty-two Disease Prescriptions” since a long time ago. Since then, traditional Chinese medicine has treated leukoderma by soothing the liver and relieving depression, promoting blood circulation and removing blood stasis. Therefore, the leukoderma pharmaceutical composition is mainly prepared based on the treatment theory of soothing the liver and regulating qi, tonifying the liver and kidney, and promoting blood circulation and removing blood stasis. According to the above treatment principle, the oral pharmaceutical composition for treating leukoderma is developed through clinical treatment and laboratory drug research. At the beginning, the drug for tonifying the liver and kidney and promoting blood circulation and removing blood stasis is mainly used, and then the drug with antioxidant pharmacological effect is added according to the theory of traditional Chinese medicine pharmacology after laboratory drug research. After 20 years of clinical practice, the prescription is optimized and improved, and the present prescription is obtained. The present pharmaceutical composition for treating leukoderma has the effects of tonifying the liver and kidney, clearing heat and relieving depression, regulating qi, resisting oxidation, etc. The present pharmaceutical composition for treating leukoderma has the effects of tonifying the liver and kidney, clearing heat and relieving depression, regulating qi, resisting oxidation, etc.

[0004] The various traditional Chinese medicine ingredients constituting the vitiligo drug composition are initially subjected to traditional Chinese medicine fingerprint big data analysis. The effective components of each medicine are determined, such as the main component of Huangqin is baicalein. After the pharmacodynamic correlation research and in vitro cell and in vivo mouse experiments, it is confirmed that baicalein is one of the most significant traditional Chinese medicine monomers for activating the Nrf2 signaling pathway in melanocytes, and has better antioxidant effect when combined with berberine and honokiol. In the further research process of the vitiligo drug composition, thin layer chromatography is used for physical and chemical identification to ensure the existence of each effective component in the vitiligo drug composition, and the traditional Chinese medicine fingerprint similarity evaluation software is further used to analyze and evaluate the overall quality of the sample spectrum (including the peak number, peak position and peak height or peak area ratio of the chromatographic peak) and the content, so as to ensure the content of the antioxidant effective component.

[0005] Professor Zhu Renkang's textbook of "Chinese Medicine Surgery" summarizes the clinical experience of modern scholars in treating vitiligo. According to the long course of vitiligo, family history, and white hair in white spots, it is proposed that "liver and kidney deficiency, skin and hair are malnourished and white spots occur". According to the ancient classic prescription and the clinical experience of modern doctors, the drug combination is optimized: such as Xu et al. Vitiligo is treated by traditional Chinese medicine syndrome differentiation, and people with liver and kidney deficiency take Cistanche, Cuscuta, Ligustrum lucidum, Psoralea, Radix Rehmanniae Preparata, Prepared Radix Polygoni Multiflori, Earthworm, and Radix Angelicae Dahuricae. The total treatment course is 1-6 months, and the effective rate is 79%. SUMMARY

[0006] In order to solve the above technical problems in the background art, the present application provides an oral drug composition for treating vitiligo, which can improve the total effective rate and promote the recovery of white spots.

[0007] In order to achieve the above purpose, the present application adopts the following technical scheme:

[0008] An oral drug composition for treating vitiligo, characterized in that the oral drug composition for treating vitiligo comprises 6-18 parts of Huangqin, 6-15 parts of Cuscuta, 6-15 parts of Taizishen, 6-12 parts of Yujin, and 6-12 parts of Houpu by weight.

[0009] The oral drug composition for treating vitiligo comprises 6-15 parts of Huangqin, 9-15 parts of Cuscuta, 8-12 parts of Taizishen, 8-12 parts of Yujin, and 6-12 parts of Houpu by weight.

[0010] The oral drug composition for treating vitiligo comprises 9-15 parts of Huangqin, 12-15 parts of Cuscuta, 9-12 parts of Taizishen, 9-12 parts of Yujin, and 6-12 parts of Houpu by weight.

[0011] The oral medicine composition for treating vitiligo comprises 12 parts of Huangqi, 12 parts of Tu-si-zi, 9 parts of Tai-si-pan, 9 parts of Yu-jin and 9 parts of Hou-pu by weight.

[0012] The oral medicine composition for treating vitiligo further comprises 9-15 parts of Mo-han-lian, 6-18 parts of Nv-zhen-zi, 6-18 parts of Bu-gu-shi and 3-9 parts of Bai-ji-li by weight.

[0013] The oral medicine composition for treating vitiligo further comprises 9-12 parts of Mo-han-lian, 9-15 parts of Nv-zhen-zi, 6-15 parts of Bu-gu-shi and 5-9 parts of Bai-ji-li by weight.

[0014] The oral medicine composition for treating vitiligo further comprises 9-12 parts of Mo-han-lian, 12-15 parts of Nv-zhen-zi, 9-12 parts of Bu-gu-shi and 6-9 parts of Bai-ji-li by weight.

[0015] The oral medicine composition for treating vitiligo further comprises 12 parts of Mo-han-lian, 12 parts of Nv-zhen-zi, 9 parts of Bu-gu-shi and 6 parts of Bai-ji-li by weight.

[0016] The oral medicine composition for treating vitiligo further comprises 3-6 parts of Huang-lian and 3-10 parts of Gan-cuo by weight.

[0017] The oral medicine composition for treating vitiligo further comprises 3 parts of Huang-lian and 6 parts of Gan-cuo by weight.

[0018] The present application has the following advantages:

[0019] The application provides an oral medicine composition for treating vitiligo, which comprises 11 medicines including Huangqi, Tusizi, Taizishen, Yujin, Hupao, Mohanyanlian, Nuzhensizi, Buguqi, Baqili, Gancao and Huanglian. DETAILED DESCRIPTION

[0020] The application provides an oral medicine composition for treating vitiligo, which comprises 11 medicines including Huangqi, Tusizi, Taizishen, Yujin, Hupao, Mohanyanlian, Nuzhensizi, Buguqi, Baqili, Gancao and Huanglian.

[0021] Based on the aforementioned prescription and pharmacological effects, the oral pharmaceutical composition for treating vitiligo provided by the present application comprises 6-18 parts of Huangqi, 6-15 parts of Disiwu, 6-15 parts of Taizishen, 6-12 parts of Yujin and 6-12 parts of Huhou, and through the synergistic effect of the monarch drug and the ministerial drug, the purposes of resisting oxidation, tonifying liver and kidney and promoting qi circulation can be achieved; vitiligo is often accompanied by liver and kidney deficiency, and through tonifying liver and kidney and regulating the antioxidant capacity of melanocytes, the oxidative stress damage of melanocytes is inhibited, and the effects of liver and kidney homology and qi and blood double tonification are achieved. From the perspectives of traditional Chinese medicine and western medicine, the white spots of vitiligo can be repigmented faster and better. Preferably, the oral pharmaceutical composition for treating vitiligo comprises 6-15 parts of Huangqi, 9-15 parts of Disiwu, 8-12 parts of Taizishen, 8-12 parts of Yujin and 6-12 parts of Huhou, and more preferably, the oral pharmaceutical composition for treating vitiligo comprises 9-15 parts of Huangqi, 12-15 parts of Disiwu, 9-12 parts of Taizishen, 9-12 parts of Yujin and 6-12 parts of Huhou; for example, the oral pharmaceutical composition for treating vitiligo provided by the present application comprises 12 parts of Huangqi, 12 parts of Disiwu, 9 parts of Taizishen, 9 parts of Yujin and 9 parts of Huhou.

[0022] In addition, the oral pharmaceutical composition for treating vitiligo provided by the present application further comprises 9-15 parts of Eclipta prostrata, 6-18 parts of Ligustrum lucidum, 6-18 parts of Fructus Psoraleae and 3-9 parts of Tribulus terrestris for tonifying liver and kidney; preferably, 9-12 parts of Eclipta prostrata, 9-15 parts of Ligustrum lucidum, 6-15 parts of Fructus Psoraleae and 5-9 parts of Tribulus terrestris; more preferably, the oral pharmaceutical composition for treating vitiligo further comprises 9-12 parts of Eclipta prostrata, 12-15 parts of Ligustrum lucidum, 9-12 parts of Fructus Psoraleae and 6-9 parts of Tribulus terrestris; for example, the oral pharmaceutical composition for treating vitiligo provided by the present application further comprises 12 parts of Eclipta prostrata, 12 parts of Ligustrum lucidum, 9 parts of Fructus Psoraleae and 6 parts of Tribulus terrestris.

[0023] Secondly, the oral pharmaceutical composition for treating vitiligo provided by the present application further comprises 3-6 parts of Huanglian and 3-10 parts of Gancao for further improving the antioxidant effect; for example, Huanglian can be 3 parts and Gancao can be 6 parts.

[0024] Example 1: Preparation of different prescriptions

[0025] The inventors of the present application have obtained the following preferred ratio examples through long-term practice, as shown in Table 1:

[0026] Table 1 Oral pharmaceutical composition for treating vitiligo of different examples (unit: g)

[0027]

[0028]

[0029] Example 2: Preparation method

[0030] The preparation method of the oral pharmaceutical composition for treating vitiligo provided by the present application is: weighing the above medicinal materials according to the proportion, decocting twice with water, burning to open with large fire each time, decocting for half an hour with small fire, combining the decoction, filtering, and obtaining the oral decoction for treating vitiligo, which is orally taken before breakfast and dinner.

[0031] Example 3: Practice of clinical cases

[0032] The oral pharmaceutical composition for treating vitiligo provided by the present application can obviously relieve and treat different degrees of vitiligo symptoms. In the following, the oral pharmaceutical composition for treating vitiligo provided by the present application will be described in detail by taking the outpatient cases in clinical practice as the action object.

[0033] 1) Case selection criteria

[0034] In order to fully illustrate the curative effect of the oral pharmaceutical composition for treating vitiligo provided by the present application, 108 patients are selected from the dermatology outpatient patients of Xijing Hospital as the implementation object. Among the 108 patients, 45 are male and 63 are female, aged 8-62 years old, with a disease course of 1 month to 3 years, and an average of 6 months. Among the 108 patients, 38 are in the progression stage of vitiligo and 70 are in the stable stage of vitiligo; the skin lesions are of limited type, sporadic type, segmental type and generalized type. The selected cases can represent different stages of different vitiligo and have significant representativeness.

[0035] 2) Clinical manifestations

[0036] The skin lesions are pigmentation white spots, and some patients may present obvious pigment loss white spots, with clear boundaries, varying sizes, single or clustered in a certain part, and different shapes. The skin lesions are pigmented at the edge, and normal skin islands can also be seen in the white spot area, and part of the hair in the white spot area is white.

[0037] 3) Treatment method

[0038] The oral pharmaceutical composition for treating vitiligo provided by the present application has the functions of soothing liver and relieving depression, promoting qi and regulating qi, nourishing liver and kidney, resisting oxidation, regulating immunity, etc. Huangqi and Huanglian have the functions of resisting oxidation and improving the oxidative stress function of melanocytes. One month is a treatment course, and continuous treatment for 3 months.

[0039] 4) Curative effect determination criteria

[0040] The curative effect is determined according to the clinical classification and curative effect standard of vitiligo of the Pigment Disease Group of the Chinese and Western Medicine Combined Dermatovenereology Society in 2003. Among them, recovery: all the leukoplakia disappears and the normal skin color is restored. Marked effect: the leukoplakia partially disappears or shrinks and the area of the normal skin color restored accounts for 50% of the lesion area. Improvement: the leukoplakia partially disappears or shrinks. Ineffectiveness: the leukoplakia has no pigment regeneration or the range expands. The total effective rate (%) = (recovery + marked effect + improvement) / total cases x 100%.

[0041] 5) Treatment result

[0042] In the selected 108 patients, the different preparation examples in Table 1 are randomly selected for treatment, and after different medication times, clinical observation is carried out, 11 cases are recovered, 34 cases are markedly effective, 45 cases are effective, 18 cases are ineffective, and the total effective rate is 83.3%. Among them, 2 patients take effect in one month, which is manifested as partial disappearance or shrinkage of leukoplakia, which is related to the short course of the patient, and the onset time of the remaining patients is about 3 months. The treatment course is generally 3-6 months. During the medication period, no obvious adverse reactions are found.

[0043] Next, 6 cases of vitiligo with different disease histories in the selected 108 patients are selected as treatment examples to further illustrate the curative effect of the oral pharmaceutical composition provided by the application for treating vitiligo:

[0044] Treatment Example 1

[0045] Patient: Wang, male, 20 years old; chief complaint: scattered hypopigmentation macules on the trunk for one year, the patient has a family history of vitiligo, and the clinical manifestation is multiple hypopigmentation macules on the trunk. Laboratory examination: porcelain white fluorescence can be seen in Wood lamp detection. Dermatoscope: not excluded vitiligo, the oral pharmaceutical composition for treating vitiligo (Example 9) in Table 1 is selected as a prescription drug, the pharmaceutical composition shown in Example 9 in Table 1 is put into a sand pot, 400 ml of water is added, and decoction is carried out for one hour, the decoction and the dregs are separated, and the decoction is decocted for 2 times, and the decoction is orally taken, once a day, for one month; The patient has no adverse reaction symptoms, and a small amount of pigment islands can be seen in the leukoplakia. Subsequently, the dosage of the prescription is adjusted, that is, the pharmaceutical composition shown in Example 17 in Table 1 is used to continue taking for 1 month, and the patient has no new rash, and the pigment islands gradually increase, so the application can effectively prevent and treat vitiligo from further spreading and promote the recovery of leukoplakia.

[0046] Treatment Example 2

[0047] Patient: Li, male, 35 years old; chief complaint: pigment loss spots on the front chest for three years. Laboratory examination: porcelain white fluorescence can be seen by Wood lamp detection. Dermatoscope: consider vitiligo, diagnosed as vitiligo. Now select the oral pharmaceutical composition for treating vitiligo (Example 10) in Table 1 as a prescription drug, put the pharmaceutical composition shown in Example 10 in Table 1 into a sand pot, add 400ml of water, decoct for one hour, separate the decoction from the dregs, decoct for 2 times, take the decoction orally, once a day, and take for one month. Revisit found that the patient has no adverse reaction symptoms, and a small amount of pigment islands can be seen in the white spot. Subsequently, the amount of drug in the prescription is adjusted, that is, the pharmaceutical composition shown in Example 19 in Table 1 is continued to be taken for 1 month, and the patient has no new rash, and the pigment islands gradually increase, so the present application can effectively treat vitiligo and promote the recovery of white spots.

[0048] Treatment Example 3

[0049] Patient: Zhao, female, 23 years old; chief complaint: scattered pigment loss spots on the face for more than five years, and new white spots still appear after various treatments; laboratory examination: porcelain white fluorescence can be seen by Wood lamp detection. Dermatoscope: consider vitiligo, diagnosed as vitiligo. Now select the oral pharmaceutical composition for treating vitiligo (Example 11) in Table 1 as a prescription drug, put the pharmaceutical composition shown in Example 11 in Table 1 into a decoction pot, add 400ml of water, decoct for one hour, separate the decoction from the dregs, decoct for 2 times, take the decoction orally, once a day, and take for one month; Revisit found that the patient's skin is red at the white spot, and then the amount of drug in the prescription is adjusted, that is, the pharmaceutical composition shown in Example 18 in Table 1 is continued to be taken for 2 months, and the patient's white spot can see a small amount of pigment islands, and the patient is communicated in detail again, and the amount of drug in the prescription is adjusted, and the patient is encouraged to insist on taking the pharmaceutical composition shown in Example 19 in Table 1 for treatment, adjust the sleep and mood, take the medicine for 1 month, the patient's sleep is improved, the pigment islands gradually increase, and the patient's mood is improved, so continue to cooperate with the treatment, most of the white spots are subsided, and the patient's satisfaction is high. Therefore, the present application can effectively treat vitiligo and promote the subsidence of white spots.

[0050] Treatment Example 4

[0051] Patient: Qian Mou, male, 12 years old; chief complaint: pigment loss spots on both lower limbs for more than 2 months, no family history and allergy history; laboratory examination: porcelain white fluorescence can be seen in Wood lamp detection. Dermatoscope: consider vitiligo. Now select the oral pharmaceutical composition for treating vitiligo (Example 1) in Table 1 as the prescription drug, put the pharmaceutical composition shown in Example 1 in Table 1 into a decocting pot, add 400 ml of water, decoct for one hour, separate the decoction from the dregs, decoct for 2 times, and orally take the decoction once a day for one month; the patient is reexamined and describes that the color of the skin white spot is darker than before, then the dosage of the prescription drug is adjusted, that is, the pharmaceutical composition shown in Example 8 in Table 1 is continuously taken for 2 months, most of the white spots of the patient have repigmented, and the patient's family is very satisfied.

[0052] Treatment Example 5

[0053] Patient: Bai Mou, female, 17 years old; chief complaint: pigment loss spots on the back of the neck for 3 months, new white spots still occur after various treatments; laboratory examination: porcelain white fluorescence can be seen in Wood lamp detection. Dermatoscope: combined with the clinic, consider the diagnosis of vitiligo. Now select the oral pharmaceutical composition for treating vitiligo (Example 3) in Table 1 as the prescription drug, put the pharmaceutical composition shown in Example 3 in Table 1 into a decocting pot, add 400 ml of water, decoct for one hour, separate the decoction from the dregs, decoct for 2 times, and orally take the decoction once a day for one month; it is found in the reexamination that a small amount of pigment islands can be seen on the white spot of the patient, then the dosage of the prescription drug is adjusted, and the patient is instructed to continue taking the medicine shown in Example 7 in Table 1 for 3 months, the pigment islands gradually increase, and the white spots basically disappear after 4 months of treatment.

[0054] Treatment Example 6

[0055] Patient: Zhang Mou, male, 19 years old; chief complaint: pigment loss spots on the back of both hands for more than 5 years, new white spots still occur after various treatments; laboratory examination: porcelain white fluorescence can be seen in Wood lamp detection. Dermatoscope: diagnosis of vitiligo. Now select the oral pharmaceutical composition for treating vitiligo (Example 10) in Table 1 as the prescription drug, put the pharmaceutical composition shown in Example 10 in Table 1 into a decocting pot, add 400 ml of water, decoct for one hour, separate the decoction from the dregs, decoct for 2 times, and orally take the decoction once a day for one month; it is found in the reexamination that the skin of the white spot on the back of both hands of the patient is red, then the dosage of the prescription drug is adjusted, and the pharmaceutical composition shown in Example 17 in Table 1 is continuously taken for 1 month, a small amount of pigment islands can be seen on the white spot of the patient, oral taking of the original prescription is again consolidated for 2 months, the pigment islands gradually increase, the patient's mood improves, and then the treatment is continued for 2 months, most of the white spots disappear, and the patient and his family are satisfied. It can be seen that the present application can effectively treat vitiligo and promote the regression of white spots.

Claims

1. An oral pharmaceutical composition for treating vitiligo, characterized in that: The raw materials of the oral pharmaceutical composition for treating vitiligo are 6-18 parts by weight of scutellaria baicalensis, 6-15 parts of dodder seeds, 6-15 parts of pseudoginseng, 6-12 parts of turmeric and 6-12 parts of magnolia bark.

2. The oral pharmaceutical composition for treating vitiligo according to claim 1, wherein: The weight portion of the baicalensis is 6-15 parts; the weight portion of the dodder seed is 9-15 parts; the weight portion of the pseudoginseng is 8-12 parts; the weight portion of the turmeric is 8-12 parts; and the weight portion of the magnolia bark is 6-12 parts.

3. The oral pharmaceutical composition for treating vitiligo according to claim 2, characterized in that: The weight portion of the baicalensis is 9-15 parts; the weight portion of the dodder seed is 12-15 parts; the weight portion of the pseudoginseng is 9-12 parts; the weight portion of the turmeric is 9-12 parts; and the weight portion of the magnolia bark is 6-12 parts.

4. The oral pharmaceutical composition for treating vitiligo according to claim 3, characterized in that: The weight portion of the baicalensis is 12 parts; the weight portion of the dodder seed is 12 parts; the weight portion of the pseudo-ginseng is 9 parts; the weight portion of the turmeric is 9 parts; and the weight portion of the magnolia bark is 9 parts.

5. An oral pharmaceutical composition for treating vitiligo, characterized in that: The raw materials of the oral pharmaceutical composition for treating vitiligo are 6-18 parts by weight of scutellaria baicalensis, 6-15 parts of dodder seeds, 6-15 parts of pseudoginseng, 6-12 parts of curcuma aromatica, 6-12 parts of magnolia officinalis, 9-15 parts of eclipta prostrata, 6-18 parts of privet fruits, 6-18 parts of psoralea corylifolia and 3-9 parts of tribulus terrestris.

6. The oral pharmaceutical composition for treating vitiligo according to claim 5, characterized in that: The weight portion of the Eclipta prostrata is 9-12 parts; the weight portion of the Ligustrum lucidum fruit is 9-15 parts; the weight portion of the Psoralea corylifolia is 6-15 parts; and the weight portion of the Tribulus terrestris is 5-9 parts.

7. The oral pharmaceutical composition for treating vitiligo according to claim 6, characterized in that: The weight portion of the Eclipta prostrata is 9-12 parts; the weight portion of the Ligustrum lucidum fruit is 12-15 parts; the weight portion of the Psoralea corylifolia is 9-15 parts; and the weight portion of the Tribulus terrestris is 6-9 parts.

8. The oral pharmaceutical composition for treating vitiligo according to claim 7, characterized in that: The weight portion of the Eclipta prostrata is 12 parts; the weight portion of the Ligustrum lucidum fruit is 12 parts; the weight portion of the Psoralea corylifolia is 9 parts; and the weight portion of the Tribulus terrestris is 6 parts.

9. An oral pharmaceutical composition for treating vitiligo, characterized in that: The raw materials of the oral pharmaceutical composition for treating vitiligo are 6-18 parts by weight of scutellaria baicalensis, 6-15 parts of dodder seeds, 6-15 parts of pseudoginseng, 6-12 parts of curcuma aromatica, 6-12 parts of magnolia officinalis, 9-15 parts of eclipta prostrata, 6-18 parts of glossy privet fruits, 6-18 parts of psoralea corylifolia, 3-9 parts of tribulus terrestris, 3-6 parts of coptis chinensis and 3-10 parts of liquorice.

10. The oral pharmaceutical composition for treating vitiligo according to claim 9, characterized in that: The weight portion of the coptis root is 3 parts; the weight portion of the liquorice is 6 parts.

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