CN101099799A - Medicine for treating leucoderma by melanin regeneration - Google Patents

Abstract

The invention is concerned with a kind of medicine for curing leucoderma with melanin regeneration. It relates to balloonflower root, ducksmeat, tribulus terrestris, red sage root, angelica, chuanxiong rhizome, psoralea fruit, astragalus root in proportion. It takes effect quickly, just for 1 to 4 days, and it has short period of treatment, only for 1 to 2 times, and it has high cwith 84.2 percent of whole curative ratio and it is difficult to recurrence. It can reduce the blood viscosity and flowing property, improve microcirculation, enhance content of ceruloplasmin, reduce humoral immunity and enhance cellular immune function to promote melanin regeneration of skin. It has unconspicuous side reaction and effective safety for clinic application with low cost. It is easy for preparation to lighten economy burden of sick.

Description

A kind of medicine for the treatment of leucoderma by melanin regeneration

Technical field

The present invention relates to the leukodermic medicine of a kind of treatment, specifically a kind of is the Chinese patent medicine of feedstock production with the Chinese herbal medicine.

Background technology

Vitiligo claims again to lose disease in vain, is limitation white patch to occur with skin, and expanding gradually then is the dermatosis of main clinical manifestation.The sickness rate of vitiligo in natural crowd is about 0.15%～2%, also has report to be about 1～2% abroad; Primary disease can be with area, ethnic group, the colour of skin and is different.Along with the acceleration of process of industrialization, environmental pollution is serious day by day, and multiple factor such as iatrogenic, drug-induced disease surge all impels leukodermic sickness rate to increase year by year.The dark more people's sickness rate of general colour is high more.Though leucoderma disease is superficial, corroding the skin and the soul of patient health, badly damaged people's appearance, the spirit of dampening the people influences its orthobiosis, marriage, work and social activity, is one of worldwide difficult treatment.

Though domestic also have some to treat leukodermic Chinese patent medicine, take effect slow, the course of treatment is long, cure rate is low, curative effect is undesirable, the production cost height, patient economy burden is heavy.From domestic and international clinical treatment situation, therapy for vitiligo still is in the stage that produce effects is slow, the course of treatment is long, cure rate is low.

Summary of the invention

Technical problem to be solved by this invention is to provide a kind of have lung qi dispersing circulation of qi promoting, promoting blood circulation to remove obstruction in the collateral, microcirculation improvement, adjusting humoral immunity of organism and cellular immunization, the leukodermic medicine of treatment of recovery melanin regeneration function.

Solution of the present invention is based on motherland's traditional medicine to pathogenetic understanding of vitiligo and Therapeutic Principle, in conjunction with present-day medical knowledge, start with from lung and meridians, leukodermic etiology and pathogenesis has been carried out the analysis and the research of system, it is brand-new theoretical creatively to have proposed " black and white is with sick; black and white is ruled together ", on this basis, nurse one's health the scheme that combines with topical therapeutic according to integral body, achieve with reference to modern pharmacological research, from motherland's medical treasure-house, filter out lung qi dispersing gas, the meridian dredging, lively atmosphere blood, the natural edible-plant medicine of the body resistance strengthening and constitution consolidating, according to the theory of Chinese medical science prescription, skim the cream off milk, make its performance microcirculation improvement, regulate humoral immunity of organism and cellular immunization, recover effects such as melanin regeneration function, adopt Radix Platycodonis, Herba Spirodelae, puncturevine caltrop fruit, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Fructus Psoraleae, medicines such as the Radix Astragali are formed basic prescription, have developed a kind of medicine for the treatment of leucoderma by melanin regeneration.

The present invention is achieved in that a kind of medicine for the treatment of leucoderma by melanin regeneration, and the medicine material of making effective ingredient consists of,

Radix Platycodonis 6～18 weight portions

Herba Spirodelae 5～15 weight portions

Fructus Tribuli 9～20 weight portions

Radix Salviae Miltiorrhizae 6～18 weight portions

Radix Angelicae Sinensis 6～15 weight portions

Rhizoma Chuanxiong 6～15 weight portions

Fructus Psoraleae 10～18 weight portions

The Radix Astragali 6～15 weight portions.

The clinical use result of the present invention's medicine shows that following advantage is arranged:

1) instant effect, 1-4 days take effect; Short treating period, cure general 1-2 the course of treatment; The cure rate height, total cure rate 84.2%; Be difficult for recurrence.

2) have blood viscosity lowering, increase blood fluidity, microcirculation improvement, raising Ceruloplasmin content, reduce humoral immunization and strengthen the effect of cellular immune function, promote the skin melanin regeneration.

3) do not see that tangible toxicity is arranged, clinical practice is safe and effective.

4) expense is low.Compare with the leukodermic medicine of similar treatment, have cost low, be easy to advantages such as preparation, can alleviate patient's financial burden.

The specific embodiment

Further specify the present invention below.

The optimum weight proportioning of making the medicine material of effective ingredient is

Radix Platycodonis 9～15 weight portions

Herba Spirodelae 8～12 weight portions

Fructus Tribuli 10～15 weight portions

Radix Salviae Miltiorrhizae 9～16 weight portions

Radix Angelicae Sinensis 9～12 weight portions

Rhizoma Chuanxiong 9～12 weight portions

Fructus Psoraleae 12～16 weight portions

The Radix Astragali 9～12 weight portions.

A kind of preparation method of the present invention's medicine is:

1), above-mentioned raw materials is cleaned, dried and cut or smash to pieces;

2), with Rhizoma Chuanxiong, the Radix Astragali, Radix Angelicae Sinensis, Radix Platycodonis with cold water soak 15～25 minutes, decoct and extracted 30～40 minutes, filter, take out filtrate, and then add water, decocted 30～40 minutes, filtration merges filtrate twice.Filtrate after merging is concentrated with the cryogenic vacuum method, to the thick paste shape, dry, be ground into fine powder, cross 80～100 mesh sieves, stand-by;

3), the other medicines raw material was ground into the fine powder of 50～150 mesh sieves, again with above-mentioned extractum mix homogeneously, granulated then, drying, made the granule of the present invention's medicine.

Certainly, the present invention's medicine also can be made dosage forms such as being fit to oral powder, capsule.

For showing medicine of the present invention to leukodermic therapeutic effect, we have carried out clinical treatment research to 413 routine patients with vitiligo.In the research, the Clinical typing and the diagnostic criteria diagnoses and treatment of the leucoderma of formulating according to Chinese combination of Chinese and Western medicine Society of Dermatology and Venereology.

413 routine clinical symptoms typical cases.Get rid of depigmentation, nevus anemicus, albinism, senile white macula, the sun tan white macula left over after some deflorescence, be associated with serious primary disease such as blood vessel, kidney and hemopoietic system, the psychotic, medication in accordance with regulations, data are not judged cases such as curative effect person completely without method.

262 routine patients with vitiligo are seminar, and clinical symptoms typical case is according to the theory of Chinese medical science differentiation of symptoms and signs for classification of syndrome.Therapeutic Method is the granule of the present invention's for oral administration medicine, and 2 times on the one, each 5g respectively obeys 1 time sooner or later.

Select that medical history, the state of an illness, age are suitable with seminar, 151 routine patients with vitiligo of comparability are arranged is matched group.The treatment of control group method is BAILING PIAN for oral administration (produce in Guangdong, and lot number is 961106), one time 4,3 times on the one.

Two groups are three months a course of treatment, but continuous use 2-4 course of treatment.

1) histopathological examination method

To draw materials with the marginal portion in the white macula, with Fang Tena (Fontana) and DOPA (Dopa) staining, light microscopic the spy dye, and observes treatment front and back melanocyte and melanin granule.

Before the treatment, early stage skin lesion stratum basale melanocyte reduces, and late period, skin lesion district melanocyte lacked fully, and DOPA dyeing or silver dyeing do not show melanocyte, the visible big and melanocyte of distortion in edge, and branch is prominent long and be full of melanin granule.After the healing, visible white macula district and edge melanocyte form are normal.

2) statistical method

Collect all clinical datas of each patient, use t check and X2 check, data is carried out statistical procedures.

3) criterion of curative effect: with reference to Ministry of Health of the People's Republic of China " new Chinese medicine clinical research guideline ", recovery from illness: the white macula complete obiteration, recover the normal colour of skin, histopathological examination is normal.Produce effects: white macula disappears more than 50%, white macula disappearance part, and histopathological examination is normal.Effectively: white macula disappears and accounts for 20%～50% of original area, or more pigment island is arranged in white macula, and there have pigment demutation place to do histopathological examination to be normal.Invalid: no change or white macula enlarge before and after the treatment.

Clinical treatment found that 243 examples that 262 routine patients took effect in the seminar account for 92.7% in 1-4 days; 8 examples that took effect in 5-10 days account for 3.1%; 7 examples that took effect in 11-30 days account for 2.7%, and total effective rate is 98.5%.

And in the matched group 151 routine patients 10 days with interior 0 example that takes effect, 6 examples of imitating in 11-30 days account for 3.97%; 17 examples of imitating in 31-90 days account for 11.2%; 52 examples that took effect in 91-180 days account for 34.4%, total effective rate 49.7%.

The total effects contrast situation of seminar and matched group sees Table 1.

Table 1 seminar and matched group total effects are relatively

Group	The case sum	Curative effect (routine number)
							Cure (%)	Produce effects	Effectively	Invalid	Total effective rate
		Seminar	262	183(69.8)	54	21						4	98.5
Matched group	151						6(3.9)	20	49	76	49.7

X ²＝245.04 P＜0.001

Seminar's cure rate 69.8%, matched group cure rate 3.9%, seminar is 17.9 times of matched group.Seminar's total effective rate 98.5%, matched group total effective rate 49.7%, seminar is 1.98 times of matched group.Seminar obviously is better than matched group.Two groups cure rate, total effective rate contrast are learned by statistics and are handled, and utmost point significant difference (P＜0.001) is arranged.

The leukodermic efficacy result that seminar is five types sees Table 2

Five types of vitiligo efficacy results of table 2 seminar

Numbering	Type	Amount to	Seminar (routine %)
								Cure (%)	Produce effects	Effectively	Invalid	Total effective rate %
			1	The asthenia of qi and blood pattern of fever	92	63(68.5)	20						9	0	100
2	Spleen accumulates damp-heat type	66						57(86.4)	9	0	0	100
			3	Caused by hepatic stagnation qi stagnation	47	38(80.9)	9						0	0	100
4	The deficiency of the liver and kindey type	21						12(57.1)	5	3	1	95.2
			5	The meridians stasis type	36	13(36.1)	11						9	3	91.7

Five types of leukodermic cure rates: it is 86.4% that spleen accumulates damp-heat type, and caused by hepatic stagnation qi stagnation is 80.9%, and the asthenia of qi and blood pattern of fever is 68.5%, and the deficiency of the liver and kindey type is 57.1%, and the meridians stasis type is 36.1%.As seen curative effect is followed successively by spleen in proper order and accumulates damp-heat type＞caused by hepatic stagnation qi stagnation＞weak type of qi and blood＞deficiency of the liver and kindey type＞meridians stasis type.

The time situation that therapeutic effect appears in seminar and matched group skin lesion (white macula) sees Table 3.

The time ratio that effect appears in table 3 seminar and matched group

Group	Add up to	Time (d)
							1-4d	5-10d	11-30d	31-90d	91-181d
		Seminar's matched group	262 151	243(92.7％) 0(0)	8(3.1％) 0(0)	7(2.7％) 6(3.97％)						0 17(11.2％)	0 52(34.4％)

Seminar takes effect in most of 1-4 days, and average responding time is 3.1 days; Matched group took effect in most 91-180 days, and average responding time is 109.3 days.

In one course of treatment (90 days), two groups of responding times are learned processing (four form Precision Test methods) by statistics, and utmost point significant difference (P＜0.005) is arranged.

In two courses of treatment (180 days), two groups of responding times are learned processing by statistics, and utmost point significant difference is arranged

(P＜0.001)。Relatively see Table 4 the course of treatment that skin lesion recovers the normal colour of skin.

Table 4 seminar and matched group recover the course of treatment of the normal colour of skin and compare

Group	Add up to	Two to four courses of treatment (moon, routine number)
														-1	-2	-3	-4	-5	-6	-7	-8	-9	-10	-11	-12
		Seminar's matched group	262 ％ 151 ％	2 (0.76) 0	7 (2.67) 0	27 (10.31) 0	35 0	44 (13.35) 0	68 (16.79) 0	0 (25.92) 0	0 0	0 0	0 0													0 0 (1.32)	0 4 (2.64)

Annotate: " 1 " of going up in the table was represented within 1 month." 2 " expression " 1 month and more than, but less than 2 months ", the rest may be inferred by analogy.

Seminar's white macula recovered normal colour of skin majority at 3-5 month, and average course of treatment is 3.72 months.The matched group majority was at 11-12 month, and average course of treatment is 11.5 months.Seminar shortens 7.78 months than matched group the course of treatment.

Learn processing (four form Precision Test methods) by statistics, utmost point significant difference (P＜0.005) is arranged for two groups.

Allergy and untoward reaction situation relatively see Table 5.

Table 5 allergy and untoward reaction are relatively

Group	Case load	Have no adverse reaction	Untoward reaction
				Seminar's matched group	262 151	260 143	2(0.76) 8(5.30)

Medicine for external use has 0.76% patient pruritus to occur slightly burning in the seminar, the red pimple of the appearance that has, and symptom is died away after the drug withdrawal.Matched group has 5.30% patient allergy and untoward reaction to occur, and learning by statistics to handle for two groups has significant difference.

The recovery from illness patient follows up a case by regular visits to and relatively sees Table 6.

Table 6 recovery from illness patient follows up a case by regular visits to comparison (%)

Group	Case load	Recovery from illness	Follow up a case by regular visits to	Not recurrence	Recurrence (part recurrence)
						Seminar	262	183	158	152	6(3.8)
Matched group	151	6	6	1	5(83.3)

Two groups of part cured persons carry out the follow-up investigation of half a year to three year. and seminar's relapse rate 3.8%, matched group are 83.3%.Follow up a case by regular visits to the patient to two groups and carry out statistical procedures (four form Precision Test methods), utmost point significant difference (p＜0.005) is arranged.

By as can be seen above, the present invention's medicine has instant effect, short treating period, cure rate height, has no adverse reaction, is difficult for characteristics such as recurrence, and therapeutic effect is better than matched group greatly.

Be the experimentation data below.

With 42 routine patients in the above-mentioned seminar is observation group, is matched group with 40 routine healthy persons, the detection of the hemorheology before and after treating respectively, immunology, ceruloplasmin.

1) hemorheology detects

Reference value: the whole blood viscosity height is cut (200/s) 5.67 ± 0.54mPa.s, low (3/s) 7.90 ± 1.22mPa.s that cuts; Whole blood reduced viscosity: 6.06--0.32mPa.s, plasma viscosity 1.3-1.6mPa.s, ESR equation K value: 53 ± 40, erythrocyte sedimentation rate (ESR): 0-20 (mm/h), packed cell volume: 37-47 (1/1) the results are shown in Table 7.

Hemorheology change before and after the treatment of table 7 observation group ( N=42)

Blood viscosity (mPa.s)			The whole blood reduced viscosity	Plasma viscosity	ESR equation K value	Erythrocyte sedimentation rate ESR (mm/h)	Packed cell volume (%)
									Height is cut (200/)	Low cut (3/)
Treatment back t p before the treatment	6.35±1.05 5.67±0.90 3.24 ＜0.01	11.41±2.31 9.35±2.28 9.32 ＜0.01									11.25±1.80 10.36±1.32 2.49 ＜0.01	1.82±0.05 1.81±0.05 1 ＞0.05	67.33±26.65 74.86±32.09 1.5 ＞0.05	21.35±7.81 24.05±5.91 2.77 ＞0.05	44.93±3.58 42.15±3.30 3.66 ＜0.01

There were significant differences before and after the ESR treatment, P＜0.05; The whole blood viscosity height is cut, whole blood viscosity low is cut, whole blood reduced viscosity height is cut, the whole blood reduced viscosity low cut and the packed cell volume treatment before and after highly significant difference, P＜0.01 are all arranged.

2) ceruloplasmin detects (turbidimetry)

Reference value: 0.15-0.6mg/ml the results are shown in Table 8

The comparison of ceruloplasmin variation and matched group before and after the treatment of table 8 observation group (X ± s, mg/l)

	n	Before the treatment	After the treatment	t	p
						The t p of matched group observation group	40 42	0.52±0.26 0.23±0.28 4.86 ＜0.05	0.52±0.26 0.36±0.09 3.76 ＞0.05	3.79	0.01

Significantly be lower than matched group (P＜0.05) before observation group's Ceruloplasmin treatment, the treatment back does not have significance (P＞0.05) with the matched group difference.Difference highly significant (P＜0.01) before and after observation group's treatment.

3) immunology detection

1. humoral immunization is measured

Adopt the ARRAY360 automatization special proteins analyzer of U.S. Beckman department production to measure (the results are shown in Table 9,10), reference value, 6-60 year, IgG:6.5-16.0,1gA:0.35-3.5, IgM:0.5-3.0.

The comparison of immunoglobulin variation and matched group before and after the treatment of table 9 observation group (

G/l)

	n	Before the treatment			After the treatment
								IgA	IgG	IgM	IgA	IgG	IgM
		The t p of matched group observation group	40 42	1.80±0.16 2.48±1.53 2.83 ＜0.01	10.5±2.3 12.84±4.90 2.75 ＜0.01	1.45±0.08 1.49±1.00 0.25 ＞0.05	1.80±0.16 1.88±0.76 0.67 ＞0.05							10.5±2.3 10.21±3.20 0.4 7 ＞0.05	1.45±0.08 1.44±0.56 0.11 ＜0.05

Immunoglobulin variation comparison before and after the treatment of table 10 observation group ( G/l)

Index	n	Before the treatment	After the treatment	t	p
						IgA IgG IgM	42 42 42	2.48+1.53 12.48±4.90 1.49+1.00	1.885±0.76 10.21±3.20 1.442±0.56	2.27 2.89 0.28	＜0.01 ＜0.01 ＞0.05

Be significantly higher than matched group P＜0.01 before the IgT gA of observation group, the IgG treatment, the treatment back does not have significance (P＞0.05) with the matched group difference, has no significant change before the IsM treatment with after the treatment.Observation group's treatment back IgA, IgG has highly significant to improve (P＜0.01) before the treatment as seen from Table 10, and IgM changes no significance.

2. cellular immune function assay

The detection of a.T total lymphocyte count

E garland experiment (ERPT): adopt the glutaraldehyde cross-linking technology that McAb (monoclonal antibody) is combined with Shan Hong cell (SRBC), make the SRBC of sensitization.Operation in accordance with the law is with May-Gruenwalcl and the dyeing of Clemsa dye liquor, high power lens inspection, be stained with 3 above SRBC persons around the lymphocyte, be the garland positive cell. amount to several 200 lymphocytes, calculate rosette formation cell percentage ratio, the results are shown in Table 11 (reference value 60%-80%).

B. lymphocyte transformation experiment (LTT):

The morphology counting method: taking heparin anticoagulant fresh blood specimen adds mitogen phytohaemagglutinin (PHA), in accordance with the law operation.Drip the dyed blended liquid of Cleffisa-Wrlght on the blood sheet, add the Pn6.9 phosphate buffer, dry back the results are shown in Table 11 (about reference values 70%) with 200 lymphocytes of oily sem observation.

The detection of table 11T total lymphocyte count and lymphocyte transformation experiment

	n	Before the treatment		After the treatment
						ERFT(％)	LTT(％)	ERFT(％)	LTT(％)
		The t p of matched group observation group	40 42	58.1±12.30 49.8±12.01 3.05 ＜0.01	72.85±7.26 65.2±11.12 3.63 ＜0.01					58.1±12.30 54±7.32 1.82 ＞0.05	7 2.85±7.26 70.13±6.67 1.74 ＞0.05

The detection of T total lymphocyte count and lymphocyte transformation result of experiment, before the treatment, observation group is starkly lower than matched group P＜0.01, and after the treatment, two measurement results of observation group raise two groups of no significant differences (P＞0.05).

4) microcirculation detects

Measure nail fold microcirculation pipe loop situation (reference value: pipe loop bar is counted 8-15 bar/mm, and pipe loop length is 100-400um) with eyepiece micrometer.The results are shown in Table 12.

The comparison of microcirculation variation and matched group before and after the treatment of table 12 observation group (x ± s)

	n	Before the treatment					After the treatment
												Pipe loop bar number (bar/mm)	An input diameter (um)	An output diameter (um)	Loop top diameter (um)	Pipe loop length (um)	Pipe loop bar number (bar/mm)	An input diameter (um)	An output diameter (um)	Loop top diameter (um)	Pipe loop length (um)
		The t p of matched group observation group	40 42	9.0 ±1.0 7.26 ±1.63 5.80 ＜0.05	12 ±2 7.69 ±3.12 7.43 ＜0.01	15 ±3 9.69 ±3.04 7.52 ＜0.01	16 ±3 10.10 ±3.28 8.56 ＜0.01	200 ±50 151.21 ±51.94 4.33 ＜0.01	9.0 ±1.0 9.84 ±1.60 2.80 ＜0.01	12 ±2 11.83 ±2.20 0.37 ＞0.05	15 ±3 14.23 ±1.85 1.40 ＜0.05											16 ±3 14.06 ±2.23 3.34 ＜0.01	200 ±50 218.04 ±44.00 1.70 ＜0.01

Pipe is mixed bar digital display work and is lower than matched group (P＜0.05) before the observation group treatment, and an input diameter, an output diameter, loop top diameter, pipe loop length all highly significant are lower than matched group (P＜0.01).After the treatment, pipe loop bar number not only recovers but also significantly exceeds matched group (P＜0.01).Inlet branch directly recovers normally, with matched group indifference (P＞0.05).Apparent in view improvement before an output caliber and the treatment, but and matched group more variant than still (P＜0.05).Diameter treatment back, loop top has clear improvement before the treatment, but still has notable difference (P＜0.01) with the matched group ratio.Pipe loop length treatment back recovers normal, and has surpassed matched group (P＜0.01) very significantly.

Find by above experimental result, most indexs such as hemorheology of finding the patient before the treatment all show obviously unusual, present a kind of tangible high blood viscosity and microcirculation disturbance, Ceruloplasmin is also obviously low than the normal person, Immunoglobulin IgA, IgG are apparently higher than the normal person, humoral immune function strengthens, and T total cellular score, lymhocyte transformation rate reduce, and cellular immune function is low.The every index in treatment back obviously improves, and shows that the granule of the present invention's medicine has the effect of blood viscosity lowering, increase blood fluidity, microcirculation improvement, raising Ceruloplasmin content, reduction humoral immunization and enhancing cellular immune function.

We think thus, and the lung qi of human body is impaired, and the lung meridian QI-blood circulation is not smooth, and skin must not nourish, and causes depigmentation.The present invention's medicine by the QI invigorating lung qi dispersing increasing immunologic function, by promoting blood circulation to remove obstruction in the collateral improving hemorheology and microcirculation, thereby reach the function of recovering melanin regeneration.

The traditional Chinese medical science thinks that vitiligo and ailment said due to cold or exposure are attacked table, Lung Qi obstraction, and stagnation of QI and blood, deficiency of vital QI is relevant, so form basic prescription with medicines such as Radix Platycodonis, Herba Spirodelae, Fructus Tribuli, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, the Radix Astragali, Fructus Psoraleaes.Radix Platycodonis toil in the side and putting down, hardship are let out and are hotly loose the dispersing and elevation lung qi; Herba Spirodelae is hot cold, the light weight come-up, the function lung qi dispersing is delivered, " surgery great achievement " once with prescription, Herba Spirodelae ball by name, the kind white macula of controlling; Hot the loosing of Fructus Tribuli dispeled the wind.Single the grinding into powder with this product of " prescriptions worth thousand gold " record taken after mixing it with water, specially curing vitiligo.Common a surname of medicine-feeding sends out a lung qi, delivers and dispels the wind, and delivers to help lung qi dispersing, lung qi dispersing to be beneficial to deliver, be aided with mutually and coordinate.Lung governing skin and hair, transporation of body fluid.Lung qi a surname sends out normal, and body fluid must be failed, and spreading is in fur, the fur autotrophy.We are in conjunction with the mensuration that hemorheology is learned, and patients with vitiligo hemorheology cement degree increases, and are unfavorable for flowing of blood, so we have selected the hot temperature of Rhizoma Chuanxiong again for use, and the Radix Salviae Miltiorrhizae bitter cold, Radix Angelicae Sinensis Gan Xinwen, the most acrid in the mouth benefaction of three medicines all can blood circulation promoting and blood stasis dispelling.Rhizoma Chuanxiong again can circulation of qi promoting, and the capable then blood of gas is capable, share and brings out the best in each other.Blood stasis does not go, and fresh blood is not given birth to, failure of skin and muscle to be nourished.Medicine bleeding from anus ventilation row, fresh blood is easily given birth to, and skin is from profit.Both lung qi dispersing dispeled the wind, and blood-activating and qi-promoting helps the recovery of local patholoic change again.Radix Angelicae Sinensis is gentle still can enrich blood, Radix Astragali benefiting QI for strengthening the superficies, Fructus Psoraleae reinforcing the kidney and supporting YANG.The compatibility negative and positive of qi and blood is all mended mutually, takes into account healthy energy to improve patient's body constitution, builds up resistance.All medicines share the merit of playing lung qi dispersing gas, dispelling wind evil, qi and blood circulation promotion altogether, setting upright gas.In addition, discover that by experiment patients with vitiligo exists some immunologic function disorders, it is hyperfunction lowly to reach humoral immunization as some cellular immunization.After treatment, improvement is in various degree arranged.So we have selected the medicine of regulating immunologic function again emphatically for use.As the Radix Astragali, Rhizoma Chuanxiong etc. immune system all had certain dual regulation.Fructus Psoraleae then causes photosensitization, takes orally or is coated with outward, through daylight or ultraviolet radiation, can make local pigmentation.

Be the animal experiment data below.

1) experiment material

The granule of the present invention's medicine with its grinding, is configured to suspension with distilled water, 2g/ml, be divided into high, medium and low three dosage groups, gavage suspension 20g/kg, 10g/kg, 5g/kg respectively, be equivalent to 21.51 times, 10.75 times, 5.38 times of clinical human dosage respectively to animal.

BAILING PIAN, Foshan pharmacy one factory, lot number is 9805003-059, with its grinding, is configured to suspension with distilled water, 4 ℃ store for future use.Animal consumption 1.5g/kg is equivalent to 12.5 times of clinical human dosage.

Levodopa (L-DA), Mushroom Tyrosinase, phytohemagglutinin (PHA), Sigma company product.

Posterior pituitary injection, Tian Feng pharmaceutical factory, Shanghai, lot number is 9801002.

1, the 4-hydroquinone, chemical reagent factory in Beijing produces, lot number 980806.

721 spectrophotometers, Shanghai analytical tool factory.

LDF-2 type microcirculation blood flow analyzer, Tianjin Electronic Instruments Plant of Nankai.

Experiment Kunming white mouse, black flower Cavia porcellus, laboratory animal room of Shandong Prov. Sanitation and Antiepidemic Station provides, Shandong kinoplaszm word 980103.Laboratory animal is irritated gastric capacity: white mice 20ml/kg, black flower Cavia porcellus 10ml/kg.

Experimental data adopts statistics " t " method of inspection to organize a significant difference relatively.

2) the anti-hydroquinone of the granule of the present invention's medicine causes dermal melanin minimizing experiment

60 of healthy black flower Cavia porcelluss, body weight 260-280 gram, male female having concurrently is divided into six groups at random, with depilatory the back part of animal black wool sloughed (5 * 5cm).Wherein one group is the normal control group, does not add processing; Other five groups of modeling animals are coated with twice of 5% hydroquinone 0.5ml (morning 8:00 and afternoon 15:00), 20d continuously every day outside part, back depilation district.This five treated animal gives the granule and the BAILING PIAN filling stomach of ordinary water, the present invention's medicine every day respectively simultaneously.Test 21d, with Animal Anesthesia, at its back depilation district center bark fetching skin 1 * 1cm, conventional fixedly embedded section carries out melanin dyeing with ferrous sulfate Littie method, and light microscopic is observed 80 hair follicles down, calculates wherein melanin hair follicle number, the results are shown in Table 13.

The anti-hydroquinone of the granule of table 13 the present invention's medicine causes dermal melanin and reduces experimental result

Group	Dosage (g/kg)	Melanin hair follicle number (X ± SD)	P
				Granule the present invention's of granule the present invention of normal control model edition with parallel text invention granule BAILING PIAN *	----- ----- 5 10 20 1.5	69.5±7.2 32.8±5.4 35.2±9.1 46.5±10.2 49.8±7.1 37.5±6.6	＜0.01 ------ ＞0.05 ＜0.01 ＜0.01 ＞0.05

Annotate: each treated animal * group is 8, and all the other groups are 9.

Each group is carried out significant difference relatively with model control group.

3) granule of the present invention's medicine generates the influence of melanocyte amount to the dopachrome oxidation

Also improved with reference to methods such as Matsuda.At first with the granule of the present invention's medicine with phosphate buffer be diluted to height (100mg/ml), in the standby herb liquid of (50mg/ml), low (10mg/ml) three variable concentrations.The BAILING PIAN that grinds after filtering is diluted to standby medicinal liquid (50mg/ml) with phosphate buffer.With Mushroom Tyrosinase 1ml (100u) and levodopa liquid 1ml (1.5mg) mixing, 25 ℃ of incubation 5m. add the herb liquid 1ml of variable concentrations more respectively, put 25 ℃ and continue incubation 60m. with 1mol/L HCl0.2ml cessation reactions.Reactant mixture is centrifugal, 3000r/min, 15m abandons supernatant, and precipitate is washed 1 time with 60mol/L HCl, and distilled water is washed 2 times, and is centrifugal, and precipitate fully dissolves with 1mol/L NaOH 3ml, and is centrifugal, and supernatant is put spectrophotometer 400nm and is disposed the O.D value.The melanocyte growing amount is represented divided by the percentage rate of the O.D value of blank group with the O.D value of medicine group.The results are shown in Table 14.

The granule of table 14 the present invention's medicine generates the melanocyte amount to the dopachrome oxidation influences experimental result

Group	Dosage (mg/ml)	The melanin growing amount (%, X ± SD)	P
				Granule the present invention's of granule the present invention of BAILING PIAN the present invention granule	50 10 50 100	140.1±27.0 146.0±33.7 172.8±24.6 160.6±29.2	------ ＞0.05 ＜0.01 ＞0.05

n＝9

4) the anti-pituitrin of the granule of the present invention's medicine causes the microcirculation disturbance experiment

50 of healthy mices, body weight 14-16 gram, male female dual-purpose is divided into five groups at random; Gavage the granule and the BAILING PIAN of ordinary water, the present invention's medicine respectively, once a day, continuous 7d.During experiment animal is placed in the holder, expose its afterbody.Regulate laser microcirculation blood flow instrument, frequency response 12K hertz, time constant 0.22s, gain 10.Laser probe is placed animal tail China and foreign countries 1/3 intersection, and measuring this position blood flow is normal value.Animal tail vein injection pituitrin injection 0.2ml/ only repeats above mensuration behind the 2min, the results are shown in Table 15.

The anti-microcirculation disturbance experimental result of the granule of table 15 the present invention's medicine

Group	Dosage g/kg	Microcirculatory blood flow (X ± SD)		Blood flow slip (%)
					Normally	Annotate pituitrin
		Granule the present invention's of granule the present invention of matched group the present invention granule BAILING PIAN	----- 5 10 20 1.5				0.894±0.013 0.896±0.019 0.894±0.024 0.892±0.022 0.897±0.027	0.151±0.067 0.316±0.187* 0.565±0.105* 0.546±0.174* 0.496±0.144*	83.1 64.7 36.8 38.8 47.7

N=10 and matched group be * P＜0.01 relatively.

5) serum hemolysin level determination

50 of healthy mices, body weight 18-21 gram is divided into 5 groups at random, and male female half and half; Animals administer is all with experiment 2,3, once a day, and continuous 7d.Test the equal lumbar injection 5%CRBC0 of 1d animal.2ml/ only stimulates animal immune.Test 8d, win animal eyeball and get blood, centrifugal 3000 commentaries on classics/m, 10m, institute's serum of getting dilutes 100 times with NS: get dilute serum 1ml, add 5%CRBC0.5ml, 10% complement 0.5ml, mixing, 370 ℃ of water-bath incubation 30m, 0 ℃ of cessation reaction.Aforesaid liquid is centrifugal, and 3000 commentaries on classics/m, 10m, supernatant survey the O.D value in spectrophotometer 540nm place colorimetric, react the height of serum hemolysin level with the size of O.D value.The results are shown in Table 16.

Table 16 serum hemolysin level determination result

Group	Number of animals	Dosage (g/gk)	The OD value (X ± SD)	P
					Granule the present invention's of granule the present invention of matched group the present invention granule BAILING PIAN	10 10 10 10 10	------ 5.0 10.0 20.0 1.5	0.0703±0.0310 0.1471±0.1197 0.5077±0.132 0.3053±0.0833 0.2010±0.0557	----- ＞0.05 ＜0.01 ＜0.01 ＜0.01

6) phytohemagglutinin (PHA) stimulates lymphocyte transformation experiment (body internal stimulus revulsion)

50 of healthy male white mouses, body weight 18-20 gram is divided into 5 groups at random; Animals administer is with experiment 4), once a day, continuous 7d.Test 1d and give the equal intramuscular injection PHA of animal 10ml/kg, inject 3d continuously.When testing 8d, win animal eyeball, conventional smear, Switzerland's dyeing, oily mirror is 100 lymphocytes of counting down, and calculate the shared percentage rate of lymphoblast, with reflection lymphocyte transformation situation, the results are shown in Table 18.

Table 18 lymphocyte transformation experimental result

Group	Number of animals	Dosage (g/gk)	The lymphoblast value (%, X ± SD)	P
					Granule the present invention's of granule the present invention of matched group the present invention granule BAILING PIAN	10 10 10 10 10	------ 5.0 10.0 20.0 1.5	16.7±5.8 29.6±9.3 46.2±9.9 20.1±5.3 17.6±5.1	------ ＜0.01 ＜0.01 ＞0.05 ＞0.05

Show that by above pharmacodynamic study the hydroquinone of doses can make zoodermic melanin content reduce; (10g 20g/kg) can obviously resist the effect of hydroquinone, and dermal melanin content is increased and use the granule of the present invention's medicine simultaneously.Dopa oxidase is the important step of melanocyte synthesis of melanin.Experiment in vitro confirms that the granule of the present invention's of doses medicine (50mg/ml) can significantly promote dopa oxidase to generate melanin (P＜0.01).Prove absolutely, the granule of the present invention's medicine can resist the damaging action of some chemical substance to melanocyte, and can promote melanic chemosynthesis, this is that the granule of the present invention's medicine is treated one of leukodermic basic drug action, but its basic link that plays a role and mechanism wait further research and illustrates.

The experiment of anti-microcirculation disturbance shows, the granule of the present invention's medicine (5,10, but the 20g/kg) microcirculation disturbance due to the antagonism pituitrin significantly increases microcirculatory blood flow, presents the effect (P＜0.01) of microcirculation improvement.Give in the animal continuous application, the granule of heavy dose of the present invention's medicine can make the serum hemolysin level obviously raise, but show its enhancing body humoral immunity level; Its pair cell Immune Effects, only the granule of the present invention's of visible median dose medicine has potentiation, can promote lymphocyte transformation, surplus unknown significance influence.The granule of the present invention's medicine helps therapy for vitiligo undoubtedly to the effect of microcirculation and immunologic function, is one of important drug action reason of its treatment vitiligo.

In sum, the granule of the present invention's medicine can resist hydroquinone and cause dermal melanin minimizing effect, and the external melanin that promotes generates, and has microcirculation improvement and regulate humoral immunity of organism and cellular immune function.

Embodiment 1, take by weighing Radix Platycodonis 900g, Herba Spirodelae 500g, Fructus Tribuli 750g, Radix Salviae Miltiorrhizae 600g, Radix Angelicae Sinensis 750g, Rhizoma Chuanxiong 650g, Fructus Psoraleae 900g, Radix Astragali 750g cleans, dries and cuts or smash to pieces; Rhizoma Chuanxiong, the Radix Astragali, Radix Angelicae Sinensis, Radix Platycodonis are used cold water soak 20 minutes, decoct and extracted 35 minutes, filter, take out filtrate, and then add water, decocted 35 minutes, filtration merges filtrate twice.Filtrate after merging is concentrated with the cryogenic vacuum method, to the thick paste shape, dry, be ground into fine powder, cross 90 mesh sieves, stand-by; Other medicines were ground into 100 mesh sieve fine powders,, mixed back granulation, drying, made the granule of the present invention's medicine again with above-mentioned extractum mix homogeneously.

Embodiment 2, take by weighing Radix Platycodonis 400g, Herba Spirodelae 600g, Fructus Tribuli 1000g, Radix Salviae Miltiorrhizae 500g, Radix Angelicae Sinensis 500g, Rhizoma Chuanxiong 650g, Fructus Psoraleae 900g, Radix Astragali 750g cleans, dries and cuts or smash to pieces; Rhizoma Chuanxiong, the Radix Astragali, Radix Angelicae Sinensis, Radix Platycodonis are used cold water soak 20 minutes, decoct and extracted 35 minutes, filter, take out filtrate, and then add water, decocted 35 minutes, filtration merges filtrate twice.Filtrate after merging is concentrated with the cryogenic vacuum method, to the thick paste shape, dry, be ground into fine powder, cross 90 mesh sieves, stand-by; Other medicines were ground into 100 mesh sieve fine powders,, mixed back granulation, drying, made the granule of the present invention's medicine again with above-mentioned extractum mix homogeneously.

Embodiment 3, take by weighing Radix Platycodonis 400g, Herba Spirodelae 700g, Fructus Tribuli 500g, Radix Salviae Miltiorrhizae 750g, Radix Angelicae Sinensis 750g, Rhizoma Chuanxiong 300g, Fructus Psoraleae 600g, Radix Astragali 500g cleans, dries and cuts or smash to pieces; Rhizoma Chuanxiong, the Radix Astragali, Radix Angelicae Sinensis, Radix Platycodonis are used cold water soak 20 minutes, decoct and extracted 35 minutes, filter, take out filtrate, and then add water, decocted 35 minutes, filtration merges filtrate twice.Filtrate after merging is concentrated with the cryogenic vacuum method, to the thick paste shape, dry, be ground into fine powder, cross 90 mesh sieves, stand-by; Other medicines were ground into 100 mesh sieve fine powders,, mixed back granulation, drying, made the granule of the present invention's medicine again with above-mentioned extractum mix homogeneously.

Claims (2)

1, a kind of medicine for the treatment of leucoderma by melanin regeneration is characterized in that, the medicine material of making effective ingredient consists of,

Radix Platycodonis 6～18 weight portions

Herba Spirodelae 5～15 weight portions

Fructus Tribuli 9～20 weight portions

Radix Salviae Miltiorrhizae 6～18 weight portions

Radix Angelicae Sinensis 6～15 weight portions

Rhizoma Chuanxiong 6～15 weight portions

Fructus Psoraleae 10～18 weight portions

The Radix Astragali 6～15 weight portions.

2, the medicine of a kind for the treatment of leucoderma by melanin regeneration as claimed in claim 1 is characterized in that, wherein the weight proportion of each raw material is,

Radix Platycodonis 9～15 weight portions

Herba Spirodelae 8～12 weight portions

Fructus Tribuli 10～15 weight portions

Radix Salviae Miltiorrhizae 9～16 weight portions

Radix Angelicae Sinensis 9～12 weight portions

Rhizoma Chuanxiong 9～12 weight portions

Fructus Psoraleae 12～16 weight portions

The Radix Astragali 9～12 weight portions.