Background technology
Vitiligo is a kind of common pigment obstacle dermatoses, is one of the world's dermopathic three big pertinacious diseases.Its Clinical symptoms shows as mainly that melanocyte reduces or disappears and the depigmentation speckle occurs.Its harm has a strong impact on patient's appearance, psychology, work and inter personal contact.Epidemiological study to 4292 routine patients shows that about 64.3% patient just sent out the age less than 20 years old; These children and between twenty and fifty patient's great majority have personal lifestyle and psychological puzzlement in various degree; And have influence on their life, work; A lot of aspects such as marriage, the patient of part psychologically handicapped even for this reason sprout the thought of committing suicide has brought huge pressure also for family and society.Therefore, early prevention has received widely with effective treatment vitiligo and having paid close attention to.Because present leukodermic pathogenesis is still undistinct, so its treatment is still relatively more difficult.
Modern medicine thinks that vitiligo is that polygenic inheritance is the basis, the disease of multifactor fellowship, and its cause of disease is main relevant with factors such as oxidative stress, autoimmune, endocrine, heredity.Motherland's medical science has leukodermic record very early, is called " leucoderma ", " vitiligo ", " vitiligo " etc., and the record of " face and neck health skin and flesh complexion changed are white; different with yellowish pink, the pain of also not itching, the leucoderma of meaning " is promptly arranged in " General Treatise on the Cause and Symptoms of Diseases " of Sui Dynasty Chao Yuanfang (550-630 A.D.); Think that the leukodermic cause of disease belongs to depression of liver-QI, deficiency of both the liver and kidney, ailment said due to cold or exposure visitor in the skin space between skin and muscles more, qi-blood disharmony, with the passing of time qi depression to blood stasis, venation block, blood are not supported skin and formed, though pathological changes shows skin; But closely related with internal organs such as taste, Liver and kidney; Whenever, hinder repeatedly outbreak because of feeling exopathogen or feelings will again, the course of disease is slow, and touching difficulty more." element ask wind opinion a piece of writing " cloud " pathogenic wind hiding in the skin must not be let out outward, interior must not leading to, for a long time and blood stasis ".The endogenous cause of ill of vitiligo morbidity is mainly depression of liver-QI, prolonged illness consumption or qi depression to blood stasis, and the damage of essence insufficiency of blood, deficiency of the liver and kindey, inside and outside phase factor is eventually to qi-blood disharmony and send out and be primary disease.Leukodermic characteristics of incidence is this with the hepatic and renal YIN deficiency, and qi depression to blood stasis is mark, and wherein liver, kidney are topmost pathological changes internal organs, and excess syndrome is rare, is many with deficiency syndrome.So therapy for vitiligo should be controlled from the Liver and kidney opinion, is main with depressed liver-energy dispersing and QI regulating, liver and kidney tonifying, holds concurrently with methods such as blood circulation promoting and blood stasis dispelling, invigorating spleen and dispelling wind-evils.Have at present both at home and abroad a variety ofly to the medicine of therapy of vitiligo, but curative effect is all imprecise, and have go back toxic side effect.
Summary of the invention
In order to solve the above-mentioned technical problem that exists in the background technology, the invention provides a kind of have than high curative rate, safety and have no side effect be used to treat leukodermic pharmaceutical composition.
Technical solution of the present invention is: the invention provides a kind of leukodermic pharmaceutical composition that is used to treat, its special character is: saidly be used to treat leukodermic pharmaceutical composition and comprise that weight portion is 12~30 parts the Radix Rehmanniae, 6~12 parts Radix Angelicae Sinensis, 12~25 parts Radix Paeoniae Rubra, 10~25 parts Caulis Spatholobi and 6~15 parts Fructus Psoraleae preparation.
Above-mentionedly be used to treat leukodermic pharmaceutical composition and comprise that also weight portion is the Rhizoma Chuanxiong of 6~12g part, 10~30 parts Radix Codonopsis, 5~15 parts Radix Scutellariae and 12~25 parts Fructus Ligustri Lucidi.
Above-mentionedly be used to treat leukodermic pharmaceutical composition and comprise that also weight portion is 10~15 parts Spica Prunellae and 3~6 parts Herba Menthae.
Above-mentionedly be used to treat leukodermic pharmaceutical composition and comprise that also weight portion is 3~10 parts a Radix Glycyrrhizae.
Above-mentionedly be used to treat leukodermic pharmaceutical composition and comprise that weight portion is 13~25 parts the Radix Rehmanniae, 8~11 parts Radix Angelicae Sinensis, 13~22 parts Radix Paeoniae Rubra, 13~24 parts Caulis Spatholobi and 8~14 parts Fructus Psoraleae preparation.
Above-mentionedly be used to treat leukodermic pharmaceutical composition and comprise that weight portion is 14~18 parts the Radix Rehmanniae, 9~10 parts Radix Angelicae Sinensis, 15~20 parts Radix Paeoniae Rubra, 16~22 parts Caulis Spatholobi and 10~13 parts Fructus Psoraleae preparation.
Above-mentionedly be used to treat leukodermic pharmaceutical composition and also comprise medically acceptable excipient.
The above-mentioned dosage form that is used to treat leukodermic pharmaceutical composition is Chinese medicine granules, tablet, oral liquid or capsule.
Advantage of the present invention is:
The invention provides a kind of leukodermic pharmaceutical composition that is used to treat, this pharmaceutical composition comprises plurality of Chinese such as the Radix Rehmanniae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Paeoniae Rubra, Caulis Spatholobi, Radix Codonopsis, Fructus Psoraleae, Radix Scutellariae, Fructus Ligustri Lucidi, Spica Prunellae, Herba Menthae and Radix Glycyrrhizae.These Chinese medicines have depressed liver-energy dispersing and QI regulating, blood circulation promoting and blood stasis dispelling, kidney and spleen invigorating, in addition, there are some researches show have dispersing the stagnated live-QI to relieve the stagnation of QI, the Chinese medicine of blood circulation promoting and blood stasis dispelling, expelling wind and removing dampness, nourishing the liver and kidney function, can also adjust body's immunological function, can make stable disease.In the prescription of Chinese medicine preparation of the present invention, Fructus Psoraleae, Fructus Ligustri Lucidi liver and kidney tonifying; Caulis Spatholobi enrich and benefit essence and blood, promoting blood circulation to remove obstruction in the collateral; Spica Prunellae, Herba Menthae liver clearing and depression relieving, the wind in the blood of dispelling; Radix Scutellariae heat clearing and damp drying, cooling blood for hemostasis; Herba Menthae, Rhizoma Chuanxiong are joined Radix Angelicae Sinensis, but the Radix Paeoniae Rubra circulation of qi promoting is soothing the liver, blood circulation promoting and blood stasis dispelling; But Radix Codonopsis is joined Radix Angelicae Sinensis, Rhizoma Chuanxiong tonifying QI to promote blood circulation, thereby makes " the capable then blood of gas is capable ".The Radix Rehmanniae, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Rhizoma Chuanxiong enrich blood nourishing blood and promoting blood circulation, disperse blood stasis and dredge collateral can promote that blood is capable, improve blood circulation, contain the meaning that " control wind and control blood earlier, the blood sector-style is from going out " arranged; Radix Glycyrrhizae reinforcing the heart spleen invigorating, the property of medicine that is in harmonious proportion; All medicines share the merit of playing nourishing the liver and kidney, nourishing blood to expel wind, blood circulation promoting and blood stasis dispelling altogether, thereby make the recovery of the unobstructed adjustment of blood operation pigment cell function.The present invention has depressed liver-energy dispersing and QI regulating, blood circulation promoting and blood stasis dispelling, kidney and spleen invigorating, adjusting immunity, can promote functions such as melanocyte regeneration and melanic formation; Surplus clinical tens thousand of routine patients ten, observe in year; Be used to treat vitiligo and have clinical efficacy preferably, and have no side effect.The present invention can prepare various dosage forms, such as tablet, oral liquid etc. be easy to carry, convenient drug administration, dosage is little, high, the strong drug action of active constituent content, mouthfeel is good, has reduced the inconvenience that long-term oral Chinese medicine decoction taste is bitter and boil medicine.
The specific embodiment
Inventor of the present invention develops the leukodermic pure Chinese medicinal preparation of the higher treatment of a kind of cure rate through long-term research practice, and drug safety and having no side effect.The prescription of this Chinese medicine preparation is: the Radix Rehmanniae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Paeoniae Rubra, Caulis Spatholobi, Radix Codonopsis, Fructus Psoraleae, Radix Scutellariae, Fructus Ligustri Lucidi, Spica Prunellae, Herba Menthae, Radix Glycyrrhizae.Have depressed liver-energy dispersing and QI regulating, blood circulation promoting and blood stasis dispelling, kidney and spleen invigorating, regulate functions such as immunity, can promote melanocyte regeneration and melanic formation.In addition, there are some researches show have dispersing the stagnated live-QI to relieve the stagnation of QI, the Chinese medicine of blood circulation promoting and blood stasis dispelling, expelling wind and removing dampness, nourishing the liver and kidney function, can also adjust body's immunological function, can make stable disease.In the prescription of Chinese medicine preparation of the present invention, Fructus Psoraleae, Fructus Ligustri Lucidi liver and kidney tonifying; Caulis Spatholobi enrich and benefit essence and blood, promoting blood circulation to remove obstruction in the collateral; Spica Prunellae, Herba Menthae liver clearing and depression relieving, the wind in the blood of dispelling; Radix Scutellariae heat clearing and damp drying, cooling blood for hemostasis; Herba Menthae, Rhizoma Chuanxiong are joined Radix Angelicae Sinensis, but the Radix Paeoniae Rubra circulation of qi promoting is soothing the liver, blood circulation promoting and blood stasis dispelling; But Radix Codonopsis is joined Radix Angelicae Sinensis, Rhizoma Chuanxiong tonifying QI to promote blood circulation, thereby makes " the capable then blood of gas is capable ".The Radix Rehmanniae, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Rhizoma Chuanxiong enrich blood nourishing blood and promoting blood circulation, disperse blood stasis and dredge collateral can promote that blood is capable, improve blood circulation, contain the meaning that " control wind and control blood earlier, the blood sector-style is from going out " arranged; Radix Glycyrrhizae reinforcing the heart spleen invigorating, the property of medicine that is in harmonious proportion; All medicines share the merit of playing nourishing the liver and kidney, nourishing blood to expel wind, blood circulation promoting and blood stasis dispelling altogether, thereby make the recovery of the unobstructed adjustment of blood operation pigment cell function.
Provided by the present inventionly be used to treat leukodermic pharmaceutical composition and comprise that by weight portion be 12~30 parts the Radix Rehmanniae, 6~12 parts Radix Angelicae Sinensis, 12~25 parts Radix Paeoniae Rubra, 10~25 parts Caulis Spatholobi, 6~15 parts Fructus Psoraleae, the Rhizoma Chuanxiong of 6~12g part, 10~30 parts Radix Codonopsis, 5~15 parts Radix Scutellariae, 12~25 parts Fructus Ligustri Lucidi, 10~15 parts Spica Prunellae, 3~6 parts Herba Menthae and 3~10 parts Radix Glycyrrhizae preparation; As preferably, can select weight portion is 13~25 parts the Radix Rehmanniae, 8~11 parts Radix Angelicae Sinensis, 13~22 parts Radix Paeoniae Rubra, 13~24 parts Caulis Spatholobi and 8~14 parts Fructus Psoraleae and the preparation of other component; Preferred, can select weight portion is 14~18 parts the Radix Rehmanniae, 9~10 parts Radix Angelicae Sinensis, 15~20 parts Radix Paeoniae Rubra, 16~22 parts Caulis Spatholobi and 10~13 parts Fructus Psoraleae and the preparation of other component.
Except that above-mentioned each necessary component; For the ease of preparation of pharmaceutical compositions provided by the present invention being become various dosage forms portable and easy to use; For example during medicament such as Chinese medicine granules, tablet, oral liquid or capsule, also need be to increasing some medically acceptable excipient, for example soybean oil in the above-mentioned component; Starch, deionized water etc. can both be implemented in the present invention.
Inventor of the present invention obtains following optimal components ratio embodiment through secular practice:
Embodiment |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
The Radix Rehmanniae (g) |
12 |
14 |
18 |
22 |
25 |
28 |
30 |
12 |
14 |
15 |
17 |
19 |
21 |
22 |
23 |
Radix Angelicae Sinensis (g) |
9 |
8 |
10 |
12 |
11 |
6 |
7 |
12 |
10 |
8 |
6 |
5 |
7 |
9 |
11 |
Radix Paeoniae Rubra (g) |
25 |
22 |
20 |
18 |
16 |
14 |
12 |
11 |
13 |
15 |
17 |
19 |
21 |
23 |
25 |
Caulis Spatholobi (g) |
10 |
13 |
16 |
19 |
21 |
23 |
24 |
25 |
23 |
21 |
24 |
19 |
15 |
14 |
17 |
Fructus Psoraleae (g) |
15 |
14 |
13 |
10 |
9 |
7 |
6 |
14 |
10 |
9 |
6 |
7 |
12 |
14 |
11 |
Rhizoma Chuanxiong (g) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
12 |
10 |
9 |
8 |
7 |
6 |
5 |
11 |
Radix Codonopsis (g) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
20 |
15 |
28 |
10 |
22 |
30 |
11 |
15 |
Radix Scutellariae (g) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
7 |
9 |
11 |
13 |
15 |
6 |
8 |
Fructus Ligustri Lucidi (g) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
25 |
22 |
19 |
16 |
14 |
12 |
13 |
15 |
Spica Prunellae (g) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
11 |
Herba Menthae (g) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
Radix Glycyrrhizae (g) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Embodiment |
16 |
17 |
18 |
19 |
20 |
21 |
22 |
23 |
24 |
25 |
The Radix Rehmanniae (g) |
25 |
27 |
29 |
30 |
28 |
24 |
21 |
20 |
18 |
15 |
Radix Angelicae Sinensis (g) |
12 |
10 |
8 |
9 |
6 |
7 |
8 |
10 |
12 |
13 |
Radix Paeoniae Rubra (g) |
23 |
22 |
21 |
18 |
15 |
16 |
20 |
14 |
15 |
10 |
Caulis Spatholobi (g) |
18 |
16 |
10 |
13 |
14 |
17 |
16 |
19 |
21 |
22 |
Fructus Psoraleae (g) |
12 |
14 |
15 |
10 |
9 |
8 |
14 |
5 |
6 |
11 |
Rhizoma Chuanxiong (g) |
7 |
9 |
11 |
12 |
14 |
8 |
8 |
7 |
10 |
9 |
Radix Codonopsis (g) |
17 |
19 |
21 |
22 |
26 |
23 |
24 |
14 |
15 |
20 |
Radix Scutellariae (g) |
9 |
10 |
12 |
14 |
8 |
7 |
9 |
5 |
11 |
12 |
Fructus Ligustri Lucidi (g) |
17 |
19 |
21 |
22 |
13 |
14 |
25 |
18 |
21 |
16 |
Spica Prunellae (g) |
13 |
15 |
12 |
10 |
12 |
14 |
15 |
16 |
13 |
15 |
Herba Menthae (g) |
3 |
4 |
5 |
6 |
3 |
5 |
4 |
6 |
4 |
3 |
Radix Glycyrrhizae (g) |
0 |
0 |
0 |
3 |
5 |
6 |
7 |
8 |
9 |
10 |
Several prescriptions in inventor's picked at random the foregoing description have also been observed this Chinese medicine preparation pastille serum to melanocyte propagation and the synthetic influence of melanocyte through experimentation.Adopt mtt assay to measure the influence (result see table 1) of pastille serum to melanocyte propagation, the result shows through variance analysis, and group difference has significance (F=4.5456, P<0.05).With blank control group relatively, this Chinese medicine preparation and positive controls can obviously promote melanocyte propagation (P is equal for q=49.49, q=55.45<0.05), this Chinese medicine preparation group difference of comparing with positive controls does not have significance (q=2.86.P>0.05).Adopt the NaOH method to observe this Chinese medicine preparation pastille serum to the synthetic influence of melanocyte (result sees table 2) simultaneously, experimental result shows that this Chinese medicine preparation reaches the synthetic obvious facilitation that all has to melanocyte propagation.
Table 1 is respectively organized MTT and is measured as a result table 2 and respectively organize NaOH and measure result (ng/10
6Cell)
Select for use provided by the present inventionly to be used to treat leukodermic pharmaceutical composition when carrying out in vitro tests, choose different regions respectively, patients with vitiligo experimenter in various degree tests, and its result is following:
1, chooses Radix Rehmanniae 14g, Radix Angelicae Sinensis 8g, Radix Paeoniae Rubra 22g, Caulis Spatholobi 13g and Fructus Psoraleae 14g (referring to embodiment 2) decocte with water 30 minutes, it is boiled be Chinese medicine decoction, slight patients with vitiligo 30 people are carried out human trial; Male 21 people wherein, women 9 people, age distribution is in 20-39 year; Sooner or later respectively take Chinese medicine decoction once, each 200~300ml, 30 days each courses of treatment every day; Use 3 courses of treatment continuously, each detailed inspection course of treatment has or not whole body and local untoward reaction, and itemized record to 3 end course of treatment; Its result shows that 30 people all do not have part or systemic adverse reactions, and 19 people of obviously alleviating the vitiligo symptom and taking a favorable turn; Can alleviate 3 people of vitiligo symptom, complete 8 invalid people, its total effective rate accounts for 73.3%.
2, choose Radix Rehmanniae 15g, Radix Angelicae Sinensis 8g, Radix Paeoniae Rubra 15g, Caulis Spatholobi 21g, Fructus Psoraleae 9g, Rhizoma Chuanxiong 9g, Radix Codonopsis 28g, Radix Scutellariae 9g and Fructus Ligustri Lucidi 19g (referring to embodiment 10) and process the Chinese medicinal granule electuary by conventional method, 50 people carry out human trial to the moderate patients with vitiligo, wherein male 26 people; Women 24 people, age distribution is in 35-45 year, and morning, noon and afternoon every day are respectively taken the Chinese medicinal granule electuary once; About each 100ml, 30 days each courses of treatment, use 2 courses of treatment continuously; Each detailed inspection course of treatment has or not whole body and local untoward reaction, and itemized record to 2 end course of treatment, and its result shows; 50 people all do not have part or systemic adverse reactions, and 34 people of obviously alleviating the vitiligo symptom and taking a favorable turn, 5 people that can alleviate the vitiligo symptom; Complete 11 invalid people, its total effective rate accounts for 78%.
3, choose and process tablet after Radix Rehmanniae 23g, Radix Angelicae Sinensis 11g, Radix Paeoniae Rubra 25g, Caulis Spatholobi 17g, Fructus Psoraleae 11g, Rhizoma Chuanxiong 11g, Radix Codonopsis 15g, Radix Scutellariae 8g, Fructus Ligustri Lucidi 15g, Spica Prunellae 11g and Herba Menthae 5g (referring to embodiment 15) add medically acceptable excipient (starch or soybean oil) by conventional method, 126 people carry out human trial to the moderate patients with vitiligo, wherein male 69 people; Women 57 people, age distribution is in 25-49 year, and sooner or later respectively take tablet once every day; Each 3,30 days each courses of treatment, use 3 courses of treatment continuously; Each detailed inspection course of treatment has or not whole body and local untoward reaction; And itemized record to 3 end course of treatment, its result shows that 126 people all do not have part or systemic adverse reactions; And 98 people of obviously alleviating the vitiligo symptom and taking a favorable turn; Can alleviate 12 people of vitiligo symptom, complete 16 invalid people, its total effective rate accounts for 87.3%.
4, choose and process capsule after Radix Rehmanniae 21g, Radix Angelicae Sinensis 8g, Radix Paeoniae Rubra 20g, Caulis Spatholobi 16g, Fructus Psoraleae 14g, Rhizoma Chuanxiong 8g, Radix Codonopsis 24g, Radix Scutellariae 9g, Fructus Ligustri Lucidi 25g, Spica Prunellae 15g, Herba Menthae 4g and Radix Glycyrrhizae 7g (referring to embodiment 22) add medically acceptable excipient (starch or soybean oil) by conventional method, 94 people carry out human trial to the moderate patients with vitiligo, wherein male 26 people; Women 68 people, age distribution is in 20-55 year, and morning, noon and afternoon every day are respectively taken capsule once; Each 2,30 days each courses of treatment, use 3 courses of treatment continuously; Each detailed inspection course of treatment has or not whole body and local untoward reaction; And itemized record to 3 end course of treatment, its result shows that 94 people all do not have part or systemic adverse reactions; And 85 people of obviously alleviating the vitiligo symptom and taking a favorable turn; Can alleviate 6 people of vitiligo symptom, complete 3 invalid people, its total effective rate accounts for 97%.