A kind of Chinese medicine composition for the treatment of alopecia and preparation method thereof
Technical field
The present invention relates to a kind of medicine for the treatment of alopecia, be meant a kind of Chinese medicine composition for the treatment of alopecia especially, the invention still further relates to the preparation method of this Chinese medicine composition.
Background technology
Alopecia areata is the more common a kind of disease of department of dermatologry, clinical findings, because the quickening of rhythm of life, operating pressure strengthens, and increasing the weight of of environmental pollution in addition influenced the function of immune system of human body, and the patient who suffers from alopecia increases to some extent.According to clinical findings and relevant bibliographical information, primary disease has increasing trend, domestic 1766 male of Han nationality survey results is shown that the male pattern alopecia patients reach 533 people, and prevalence reaches 30.2%, and some national prevalences are then higher, reach 71% as Japan.In addition, and under tumor, cancer trend occurred frequently day by day, utilize put, the chemotherapeutic treatment means are also quite general, but put, caused alopecia does not have effective medicine to treat after the chemotherapy.Primary disease influences patient's appearance, along with the raising of living standards of the people, the treatment of primary disease is come into one's own day by day.
Western medical treatment alopecia, effect are still undesirable, particularly adopt the western medicine alopecia areata, though certain hair regrowth is arranged, side effect is big, the relapse rate height; The traditional Chinese medical science is thought, blood stored in the liver, and kidney storing essence, the essence and blood interpromoting relation in five elements, The liver and the kidney have a common source.Hair is the sign of blood condition again, the China of kidney, often because of deficiency of the liver and kindey, essence and blood loses void and early whitening of beard and hair, alopecia areata, alopecia totalis person, and often with invigorating the liver and kidney, benefiting essence-blood, is moisturized and is dispeled the wind to controlling the meridian dredging, so adopt nourishing the liver and kidney ruling by law to treat its special effect of alopecia more.Treatment alopecia Chinese patent medicine mainly contains: hair-growth ballet, Radix Angelicae Sinensis Tabellae, Qibao Meiran Dan, YANGXUE SHENGFA JIAONANG, Alopecia Pill etc., supply the of less types of patient's selection clinically, the huge market demand, the present inventor is by investigating to the kind and the document of Chinese patent medicine of treatment alopecia, think the Alopecia Pill reasonable recipe, its prescription derives from the Alopecia Pill of the 5th 172 pages in the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation, and standard No. is WS
3-B-1034-91, its prescription and preparation method are: [prescription] Radix Rehmanniae 74g, Radix Rehmanniae Preparata 74g, Radix Polygoni Multiflori Preparata 74g, Radix Angelicae Sinensis 49g, Radix Salviae Miltiorrhizae 49g, the Radix Paeoniae Alba (stir-fry) 49g, Fructus Schisandrae Chinensis 49g, Rhizoma Et Radix Notopterygii 25g, Fructus Chaenomelis 25g.[method for making] above nine flavors are ground into fine powder, sieve mixing.Every 100g powder adds refined honey 40~50g and an amount of water pill, makes water-honeyed pill, drying; Or add refined honey 120~130g and make big honeyed pills, promptly.Be monarch with Radix Rehmanniae Preparata, the Radix Polygoni Multiflori in the side, nourish liver and kidney, replenishing vital essence and blood, black beard and hair.Be aided with the Radix Rehmanniae, the Radix Paeoniae Alba, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae nourshing blood and promoting blood circulation again, nourshing Yin and drynsessmoistening prescription collateral dredging is that the Fructus Schisandrae Chinensis astringing QI is calmed the nerves, reinforcing the kindey to control nocturnal emission; Rhizoma Et Radix Notopterygii, Fructus Chaenomelis expelling wind and dampness, the battalion of passing unimpeded defends, and all medicines are grown the greasy fraud that hinders stomach in the system side.All medicines match, and based on benefit, are auxilliary to lead to, and dry profit is helped mutually, to play nourishing the liver and kidney, beneficial intensive culture blood, the merit of the hair growth promoting of dispeling the wind.This product invigorating kidney, promoting blood circulation, beneficial intensive culture blood, the hair growth promoting of dispeling the wind, evident in efficacy to diseases such as alopecia areata alopecia totalis, certain clinical practice basis is arranged.
But former dosage form is water-honeyed pill or big honeyed pills, and dosage form can not satisfy needs of patients.The long and medical material un-extracted of the disintegration time of pill causes the bioavailability of preparation lower, and the volatile oil component in the medical material also easily scatters and disappears in depositing process.Far can not reach present requirement,, its preparation process, quality standard be improved, it is developed to new dosage form, to satisfy patient's needs so the inventor selects the Alopecia Pill prescription to carry out new formulation development to drug standard.
Summary of the invention
A kind of Chinese medicine composition for the treatment of alopecia that one of them purpose of the present invention is to provide a kind of bioavailability height, good drug efficacy, dose of medical material few, transportation is easy to carry.
Another object of the present invention is to provide a kind of preparation method of this Chinese medicine composition.
Last purpose of the present invention is achieved in that a kind of Chinese medicine composition for the treatment of alopecia, it is water extract by 74 portions of Radix Rehmanniae, 74 parts of Radix Rehmanniae Preparata, 74 parts of Radix Polygoni Multiflori Preparatas, 49 parts of Radix Salviae Miltiorrhizaes, 49 parts of Radix Paeoniae Alba (parched)s, 25 portions of Fructus Chaenomeliss, the volatile oil clathrate compound of 49 parts of Radix Angelicae Sinensis, 49 parts of Fructus Schisandrae Chinensis, 25 portions of Rhizoma Et Radix Notopterygiis and water extract add an amount of adjuvant to be made, and above-mentioned deal is a weight portion.
Medicine described in above-mentioned a kind of Chinese medicine composition for the treatment of alopecia is capsule or tablet.
Back of the present invention one purpose is achieved in that a kind of preparation method for the treatment of the Chinese medicine composition of alopecia, comprises the steps:
A) ratio takes by weighing Radix Rehmanniae, Radix Rehmanniae Preparata, Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Radix Paeoniae Alba (parched), Fructus Chaenomelis, Radix Angelicae Sinensis, Fructus Schisandrae Chinensis and Rhizoma Et Radix Notopterygii by weight, and is standby;
B) Radix Angelicae Sinensis, Fructus Schisandrae Chinensis, Rhizoma Et Radix Notopterygii are extracted volatile oil with steam distillation, get volatile oil 1 and filtrate 2 after separating, filtering, medicinal residues decoct with water after-filtration and get filtrate 3, and are standby;
C) Radix Rehmanniae, Radix Rehmanniae Preparata, Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Radix Paeoniae Alba (parched), Fructus Chaenomelis are decocted with water twice, filter to get filtrate 4, standby;
D) above-mentioned filtrate 2, filtrate 3 and filtrate 4 are merged, be evaporated to 1.05~1.10/60 ℃ of relative densities; Centrifugal, spray drying gets dry extract 5;
E) with behind the volatile oil 1 usefulness beta-cyclodextrin inclusion compound, left standstill 24 hours under 10 ℃, filter volatile oil clathrate compound 6 and dry;
F) get dry extract 5 and add right amount of auxiliary materials, make the granule after drying, add volatile oil clathrate compound 6 and appropriate amount of auxiliary materials, capsule is suppressed in flakes or loaded into to mix homogeneously.
Medicinal residues in the preparation method of above-mentioned a kind of Chinese medicine composition for the treatment of alopecia in the step b) add 8 times of water gagings, decoct 1 hour.
Add for the first time 9 times of water gagings in the step c) in the preparation method of above-mentioned a kind of Chinese medicine composition for the treatment of alopecia and decocted 1.5 hours, add 7 times of water gagings for the second time and decocted 1 hour.
In the preparation method of above-mentioned a kind of Chinese medicine composition for the treatment of alopecia in the step e) baking temperature of volatile oil clathrate compound 6 be 60 ℃.
The present invention divides into groups according to medical material character, enriches flavour of a drug and carries out volatile oil and extract containing volatile oil component, and volatile oil can more stably be present in the preparation after extracting enclose; Medical material because of effective ingredient is extracted, thereby makes the quality of medicine more good after reasonably technology is extracted, and has improved bioavailability, can bring into play drug effect better; Simultaneously, be pressed into tablet or be filled to capsule and can significantly reduce its dose, use, carry more convenient; By drug effect, acute toxicity and long term toxicity test research to Chinese medicine composition of the present invention, the result shows that Chinese medicine composition of the present invention has determined curative effect, and few side effects is compared with former pill, and drug effect is stronger.
The specific embodiment
The preparation of embodiment 1 Chinese medicinal composition capsules agent of the present invention
A) ratio takes by weighing Radix Rehmanniae 242g, Radix Rehmanniae Preparata 242g, Radix Polygoni Multiflori Preparata 242g, Radix Salviae Miltiorrhizae 160g, Radix Paeoniae Alba (parched) 160g, Fructus Chaenomelis 82g, Radix Angelicae Sinensis 160g, Fructus Schisandrae Chinensis 160g and Rhizoma Et Radix Notopterygii 82g by weight, and is standby;
B) Radix Angelicae Sinensis, Fructus Schisandrae Chinensis, Rhizoma Et Radix Notopterygii are extracted volatile oil with steam distillation, get volatile oil 1 and filtrate 2 after separating, filtering, medicinal residues add 8 times of water gagings, decoct 1 hour after-filtration and get filtrate 3, and are standby;
C) Radix Rehmanniae, Radix Rehmanniae Preparata, Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Radix Paeoniae Alba (parched), Fructus Chaenomelis are decocted with water twice, add 9 times of water gagings for the first time and decocted 1.5 hours, add 7 times of water gagings for the second time and decocted 1 hour, the decocting liquid merging filters to get filtrate 4, and is standby;
D) above-mentioned filtrate 2, filtrate 3 and filtrate 4 are merged, be evaporated to 1.05~1.10/60 ℃ of relative densities; Centrifugal, spray drying gets dry extract 5;
E) with behind the volatile oil 1 usefulness beta-cyclodextrin inclusion compound, left standstill 24 hours under 10 ℃, filter volatile oil clathrate compound 6 and dry, the baking temperature of middle volatile oil clathrate compound 6 is 60 ℃;
F) get dry extract 5 and add right amount of auxiliary materials, make the granule after drying, add volatile oil clathrate compound 6 and appropriate amount of auxiliary materials, mix homogeneously is loaded into 1000 capsules.
The preparation of embodiment 2 Chinese medicine composition tablets of the present invention
Substantially the same manner as Example 1, different is that step f) is got dry extract 5 adding right amount of auxiliary materials, makes the granule after drying, adds volatile oil clathrate compound 6 and appropriate amount of auxiliary materials, and mix homogeneously is pressed into 1000 tablets of tablets.
The usage of above-mentioned capsule or tablet and consumption: oral, one time 3 (sheet), 3 times on the one.
Experimental example 1 effect experiment
Chinese medicine composition experimental result of the present invention is as follows:
1. the big or middle dosage group of Chinese medicine composition of the present invention has obvious facilitation to preputial glands; More remarkable to seminal fluid capsule and prostate effect; But it is not obvious to the levator ani effect; The tangible the kidney invigorating effect of Chinese medicine composition tool of the present invention.
2. to mice hemorrhagic anemia model, 3 dosage groups of Chinese medicine composition of the present invention all have the effect of tangible increase erythrocyte number and content of hemoglobin; To cyclophosphamide aplastic anemia anemia model, 3 dosage of Chinese medicine composition of the present invention all have obvious rising mouse red blood cell, leukocytic effect, but the effect of raising hemoglobin is not obvious.
3. the Chinese medicine composition of the present invention of high dose can obviously promote the effect of cropping rat and cropping Cavia porcellus hair growth, rat pathologic depilation due to the Tan Suan is also had the improvement effect of highly significant.
4. Chinese medicine composition Dichlorodiphenyl Acetate induced mice of the present invention abdominal cavity capillary permeability increases does not have obviously influence; Middle and high dosage can obviously suppress dimethylbenzene induced mice auricle edema; Heavy dose can obviously alleviate albumen injection and cause the rat paw edema reaction.
5. the Chinese medicine composition of the present invention of 3 dosage groups does not all have tangible influence to normal clearance in mice index; The middle and high dosage group of Chinese medicine composition of the present invention has the obvious suppression effect to mice auricle weight, but 3 dosage groups all do not have tangible influence to thymic weight and spleen weight; To the effect of being significantly improved of mice serum agglutinin.
In sum, Chinese medicine composition of the present invention has tangible kidney-replenishing blood-nourishing, short hair growth, antiinflammatory and immunoreation is had tangible potentiation.
Experimental example 2 acute toxicity tests
Mouse stomach is administered twice within one day, the accumulative total dosage is to observe a week continuously behind 16.8g dry extract/kg, do not find any dead mouse and tangible toxicity, the maximum tolerated dose that shows Chinese medicine composition of the present invention is greater than 16.8g dry extract/kg, be 75.6g crude drug/kg, being equivalent to the people intends belonging to nontoxic substantially with clinical dosage (0.051g/kg/d) 329.4 times.
Experimental example 3 long term toxicity tests
Rat continuous irrigation stomach gives Chinese medicine composition dry extract of the present invention (0.64,1.28 and 2.55g/kg) and is equivalent to 12.5,25 and 50 times of clinical consumption, gastric infusion 6 months, experimental result shows that rat growth promoter (body weight) and general behavior are not had obvious influence; Hematological indices such as hemoglobin, erythrocyte, numeration of leukocyte and classification are not made significant difference; Blood glucose, liver function and renal function to blood biochemistry checking do not have obvious influence; Histopathological examination shows that the heart, lung, liver,spleen,kidney, stomach, duodenum, thyroid, adrenal gland, testis and ovary are not had the obvious damage effect.The above results shows Chinese medicine composition of the present invention, and application safety is reliable within a certain period of time, can not produce tangible toxic action.