CN100368004C - Chinese medicinal composition for treating psoriasis, its preparation and quality control - Google Patents
Chinese medicinal composition for treating psoriasis, its preparation and quality control Download PDFInfo
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- CN100368004C CN100368004C CNB2004100746333A CN200410074633A CN100368004C CN 100368004 C CN100368004 C CN 100368004C CN B2004100746333 A CNB2004100746333 A CN B2004100746333A CN 200410074633 A CN200410074633 A CN 200410074633A CN 100368004 C CN100368004 C CN 100368004C
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Abstract
The present invention discloses a Chinese medicinal composition and relates to a preparation method and a quality control method of the composition. The medicinal composition comprises dahurian angelica root, ledebouriella root, bupleurum root, rice sprout, etc. and is used for treating psoriasis, acnes and neurodermatitis. The preparation method of the present invention comprises the following steps: alcohol is added to all the medicines in the prescription, except for the rice sprout, for extracting and filtering the medicines by counter flow, and the filter liquor is mixed; the medicinal dregs and the rice sprout are jointly decocted in water and are filtered; the filter liquor is mixed with the extracting solution of the alcohol; the filter liquor and the extracting solution of the alcohol are filled and sealed. The preparation realized by the preparation method and the quality control method of the present invention has the advantages of outstanding curative effect and controllable quality.
Description
Invention field
The present invention relates to a kind of Chinese medicine composition and preparation method thereof and method of quality control, particularly a kind of psoriasic Chinese medicine composition and preparation method thereof and method of quality control of being used for the treatment of.
Background technology
Psoriasis is a kind of agnogenio and common chronic, recurrent, FFI erythroderma desquamativum, is one of intractable dermatosis of medical circle at present.
The traditional Chinese medical science uses the dialectical treatment psoriasis that combines with differential diagnosis of diseases to accumulate rich experience in secular clinical practice, studies confirm that Chinese medicine psoriasis determined curative effect has than remarkable advantages.Compare with doctor trained in Western medicine, Chinese traditional treatment has following characteristics: emphasize determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, pay attention to the integral body medical treatment advantage of compound recipe, it is obvious to improve clinical symptoms, toxic and side effects is little, and Chinese medicine has wide material sources, lower-price characteristic, therefore, fully excavate the psoriasic rich experiences of Chinese medicine, in conjunction with research and the Chinese medicine latest developments of modern medicine, develop a kind of determined curative effect to primary disease, cheap, be fit to China's national situation, carry taking convenience, the psoriasic Chinese patent medicine of the treatment that has no side effect has important theoretical meaning and value for clinical application, and will fill up the blank in this field, for numerous patients and family bring glad tidings.Preparation of the present invention is to cure for many years on psoriasic effective proved recipe basis, the middle medicine to the certain therapeutical effect of psoriasis tool that adopts modern advanced pharmaceutical technology to develop.In clinical use, find, preparation of the present invention can make the clinical symptoms of acne and neurodermatitis be improved, verify through clinical experiment, preparation of the present invention is effective to acne vulgaris and neurodermatitis really, but the technology that former approval is produced finds that in the production practices in several years the volatile oil collection rate of the Radix Angelicae Dahuricae etc. is lower, and the production cycle is longer, has had a strong impact on its commercial Application; And lack assay in its method of quality control.
Summary of the invention
One object of the present invention is to disclose a kind of Chinese medicine composition; Another object of the present invention is to disclose a kind of psoriasic Chinese medicine composition that is used for the treatment of; The 3rd purpose of the present invention is to disclose a kind of preparation method of Chinese medicine composition; The object of the invention also is to disclose a kind of method of quality control of Chinese medicine composition.
The crude drug of pharmaceutical composition of the present invention is formed and proportioning following (by weight):
Radix Angelicae Dahuricae 20-30 weight portion Radix Saposhnikoviae 15-25 weight portion
Radix Bupleuri 15-25 weight portion Fructus Setariae Germinatus 15-25 weight portion
It is (by weight) that the crude drug of pharmaceutical composition of the present invention is formed optimum ratio:
The Radix Angelicae Dahuricae 24 weight portion Radix Saposhnikoviaes 20 weight portions
Radix Bupleuri 20 weight portion Fructus Setariae Germinatuss 20 weight portions
The crude drug of pharmaceutical composition of the present invention is formed and proportioning following (by weight):
Radix Angelicae Dahuricae 20-30 weight portion Rhizoma Ligustici 15-25 weight portion Radix Saposhnikoviae 15-25 weight portion
Radix Bupleuri 15-25 weight portion Fructus Setariae Germinatus 15-25 weight portion
It is (by weight) that the crude drug of pharmaceutical composition of the present invention is formed optimum ratio:
The Radix Angelicae Dahuricae 24 weight portion Rhizoma Ligusticis 20 weight portion Radix Saposhnikoviaes 20 weight portions
Radix Bupleuri 20 weight portion Fructus Setariae Germinatuss 20 weight portions
It is (by weight) that the crude drug of pharmaceutical composition of the present invention is formed optimum ratio:
The Radix Angelicae Dahuricae 28 weight portion Rhizoma Ligusticis 16 weight portion Radix Saposhnikoviaes 24 weight portions
Radix Bupleuri 16 weight portion Fructus Setariae Germinatuss 24 weight portions
It is (by weight) that the crude drug of pharmaceutical composition of the present invention is formed optimum ratio:
The Radix Angelicae Dahuricae 26 weight portion Rhizoma Ligusticis 24 weight portion Radix Saposhnikoviaes 16 weight portions
Radix Bupleuri 24 weight portion Fructus Setariae Germinatuss 16 weight portions
The crude drug of pharmaceutical composition of the present invention is formed and proportioning following (by weight):
Radix Angelicae Dahuricae 20-30 weight portion Radix Saposhnikoviae 15-25 weight portion Rhizoma Cyperi 10-20 weight portion
Radix Bupleuri 15-25 weight portion Fructus Setariae Germinatus 15-25 weight portion Rhizoma Atractylodis 15-25 weight portion
It is (by weight) that the crude drug of pharmaceutical composition of the present invention is formed optimum ratio:
The Radix Angelicae Dahuricae 24 weight portion Radix Saposhnikoviaes 20 weight portion Rhizoma Cyperis 15 weight portions
Radix Bupleuri 20 weight portion Fructus Setariae Germinatuss 20 weight portion Rhizoma Atractylodis 20 weight portions
Preparation of drug combination method of the present invention:
The prescription flavour of a drug, except that Fructus Setariae Germinatus, four flavors such as all the other Radixs Angelicae Dahuricae add alcohol reflux 2-3 time, and each 1-2 hour, filter, merging filtrate reclaims ethanol; Medicinal residues and Fructus Setariae Germinatus add water to be fried in shallow oil 1-2 hour altogether, filtered, and the filtrate appropriateness concentrates, merge with above-mentioned ethanol extract, and cold preservation 24-48 hour, filter, add the water adjustment, embedding, sterilization promptly, can be made into clinical acceptable forms, comprises liquid preparations such as medicated wine.
The method of quality control of the preparation that the present invention makes contains one or more in following discriminating and/or the content assaying method, and discriminating in the method for quality control of the present invention and content assaying method are:
Discrimination method is selected from one or more in the following method:
A, get preparation 50ml of the present invention, add diethyl ether and extract 2 times, 40ml for the first time, 30ml merges ether solution (water layer is standby) for the second time, volatilizes, and residue adds ethanol 0.5ml makes dissolving, as need testing solution; Other gets Rhizoma Ligustici control medicinal material 0.5g, the 25ml that adds diethyl ether, and supersound process 5-10 minute, filter, filtrate volatilizes, and residue adds ethanol 1ml makes dissolving, in contrast medical material solution; According to thin layer chromatography (" an appendix VI of Chinese pharmacopoeia version in 2000 B) test, draw above-mentioned need testing solution 10 μ l, control medicinal material solution 1 μ l, put respectively on same silica gel g thin-layer plate, with 7-9: the cyclohexane of 1-3 ratio-acetic acid second vinegar is developing solvent, launches, and takes out, dry, put under the ultra-violet lamp (365nm) and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical blue and white fluorescence speckle.
B, get and differentiate a item aqueous solution down, with water saturated n-butanol extraction 2 times, 30ml at every turn, merging n-butyl alcohol liquid, add the equal-volume ammonia solution, shake up, place layering, get upper strata liquid, the reclaim under reduced pressure n-butyl alcohol is to doing, and residue adds methanol 1ml makes dissolving, as need testing solution; Other gets Radix Bupleuri control medicinal material 5g, the 30ml that adds diethyl ether, and reflux, extract, 20-40 minute, discard ether solution, residue volatilizes ether, adds methanol 30ml, and water-bath reflux, extract, 20-40 minute filters, and reclaim under reduced pressure methanol is to doing; Residue adds water 15ml makes dissolving, and with water saturated n-butanol extraction three times, each 15ml is equipped with control medicinal material solution with legal system; Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000); Draw each 5 μ l of above-mentioned two kinds of solution, put respectively in same and contain on the silica gel g thin-layer plate that carmethose is a binding agent, with 60-70: 30-40: lower floor's solution that the chloroform-methanol-water of 5-15 ratio is placed below 10 ℃ is developing solvent, launch, take out, dry, spray is with 1% dimethylaminobenzaldehyde sulphuric acid ethanol liquid (1: 10), 100-110 ℃ of baking several minutes, daylight was inspected.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of at least two same colors.
Content assaying method is:
Measure according to high performance liquid chromatography (" appendix VID of Chinese pharmacopoeia version in 2000); With octadecylsilane chemically bonded silica is filler; 30-40: the methanol of 60-70 ratio-0.5% acetic acid is mobile phase; The detection wavelength is 320nm; Number of theoretical plate calculates by the ferulic acid peak should be not less than 2500; It is an amount of that precision takes by weighing the ferulic acid reference substance, adds methanol and make the solution that every 1ml contains 10 μ g, promptly gets (keeping in Dark Place) reference substance solution; Precision is measured preparation 10ml of the present invention, puts in the separatory funnel, is respectively 10mL 5 times with ether extraction, 10ml, 8ml, 8ml, 5ml merges ether solution, and ether liquid extracts 3 times with 5% sodium carbonate liquor, each 10ml discards ether liquid, merges sodium carbonate liquor, reuse hydrochloric acid adjust pH to 2, be respectively 10ml 4 times with ether extraction, 10ml, 8ml, 5ml, combined ether liquid is put evaporate to dryness in the tepidarium, residue add an amount of methanol make the dissolving and move in the 10ml measuring bottle, be diluted to scale with methanol, shake up, filter, promptly get (keeping in Dark Place) need testing solution with microporous filter membrane (0.45 μ m); Accurate respectively reference substance solution and each 10 μ l of test sample dissolving of drawing inject liquid phase bag spectrometer, measure, and the every ml of preparation of the present invention contains Rhizoma Ligustici in ferulic acid (C10H1004), must not be less than 10.0 μ g.
The proposition of volatile components such as the present invention adopts the high concentration ethanol reflux, extract,, the assurance Radix Angelicae Dahuricae and liposoluble constituent; And shortened the production cycle greatly; The preparation expelling wind and removing dampness of its realization, antipruritic heat clearing away is applicable to psoriasis (psoriasis), acne and neurodermatitis.The preparation stabilization that the present invention realizes, quality controllable.
The pharmacodynamics of the made alcohol extraction preparation of the present invention is partly carried out preliminary study show that this medicated wine not only has antiinflammatory preferably, analgesic activity, and can obviously improve or regulate immunologic function, improve local microcirculation, also have antibiotic preferably, itching-relieving action simultaneously.
Following experimental example is used to further specify the present invention:
Experimental example 1: antiinflammation
1. proinflammatory agent is brought out the influence of mice ear inflammation
Get 40 of mices, be divided into four groups at random, each Mus ig administration, once a day, continuous three days; The high low dosage group of preparation of the present invention is respectively: 7.8g/kg (0.3ml/20g), 3.9g/kg (0.3ml/20g), Etretinate electuary group is 12g/kg, matched group gives the isometric(al) normal saline, 1h after the last administration, 0.1ml is applied to two of mouse right ears with proinflammatory agent (dimethylbenzene), left side ear compares, behind the 4h with the garden shape rustless steel punching pin of diameter 9mm with about two auricles sweep away, weigh respectively, with left and right sides ear weight difference as swelling degree index, table 1 is the result show, the high and low dose group of preparation of the present invention has the obvious suppression effect to mice ear inflammation.
The influence of table 1 pair mouse ear inflammation
| Group | Number of animals (only) | Dosage group (g/kg) | Auricle swelling degree (mg) |
| Matched group preparation group of the present invention Etretinate group | 10 10 10 10 | 0 3.9 7.8 12 | 9.8±3.77 7.07±2.70 6.88±1.66* 9.03±3.35 |
Compare with matched group: * P＜0.05
2. to the bullate influence of rat granuloma
40 of rats, be divided into four groups at random, behind the etherization in the heavy sterilization of two each heeling-in 20ml of side oxter in one of cotton balls, each organizes rat ig administration respectively, dosage is the same, continuous three days, put to death on 8th, peel off granuloma induced by implantation of cotton pellets, weigh, deduct the former weight of cotton balls and promptly get granuloma weight at 90 ℃ of baking 1h, disclose from table 2 result, preparation of the present invention has significant inhibitory effect to the rat granuloma.
The bullate influence of table 2 pair rat granuloma
| Group | Number of animals (only) | Dosage group (g/kg) | Granuloma weight (mg) |
| Matched group preparation group of the present invention Etretinate group | 10 10 10 10 | 0 3.9 7.8 12 | 102.8±7.24 75.0±10.98** 61.1±7.48** 77.3±9.03** |
Compare with the contrast knob: * * P＜0.01
Experimental example 2: Dichlorodiphenyl Acetate causes the influence of white mice writhing response
Get 40 of mices, grouping, route of administration, time and dosage are the same, 1h after the last administration, the acetic acid normal saline 0.1ml/10g body weight of ipl%, what observed and recorded was respectively organized mice in 30 minutes turns round the body number of times, and table 3 is the result show, this medicine reduces the body number of times explanation preparation of the present invention of turning round that acetic acid causes significantly significant analgesia role.
The influence of table 3 Dichlorodiphenyl Acetate induced mice writhing response
| Group | Number of animals (only) | Dosage group (g/kg) | 30min turns round the body number of times |
| Matched group preparation group of the present invention Etretinate group | 10 10 10 10 | 0 3.9 7.8 12 | 33.3±3.59 20.7±4.1** 19.0±3.94** 21.6±5.64** |
Compare with matched group: * * P＜0.01
Experimental example 3: itching-relieving action
19 of Cavia porcelluss are divided into 4 groups at random, 4 of matched groups, each 5 of three administration groups, the equal ig administration of each Mus, matched group gives the isometric(al) normal saline, and continuous 5 days, the experiment proxima luce (prox. luc), hair is shaved on the right back instep of each Mus, tests the same day, abrades right back instep with coarse sandpaper and shaves (the area 1cm of hair place
2), 30min after the last administration, beginning is only dripped 0.01% 0.05ml/ of histamine phosphate at the wound surface place, the back complies with 0.01% every 3min, 0.02%, 0.03%, 0.04% progressive concentration, only be 0.05ml/ at every turn, directly cause and Cavia porcellus occurs and later lick right back foot, later to lick the right back histamine phosphate's total amount that is given when sufficient be itch-threshold to occur Cavia porcellus at last, record and itch-threshold of each group relatively: as seen from Table 4, preparation of the present invention has the effect that improves the Cavia porcellus itch-threshold, and antipruritic effect is obvious.
Table 4 itching-relieving action result
| Group | Number of animals (only) | Dosage group (g/kg) | 30min turns round the body number of times |
| Matched group preparation group of the present invention Etretinate group | 4 5 5 5 | 0 3.9 7.8 12 | 45.0±10.0 295.0±22.08** 372.0±49.69** 221.0±52.25** |
Compare with matched group: * * P＜0.01
Experimental example 4: to Immune Effects
1. to mouse immune organ weight's influence:
Get 40 of 15～17g mices, grouping, route of administration dosage is with 1.1, once a day, and continuous 7 days, in the 8th day the dislocation of mice cervical vertebra is put to death, cut open and get spleen and thymus scales/electronic balance weighing, calculate its weight in wet base index (g/10g body weight).Can find out that from table 5 this medicine can obviously increase the weight of mouse spleen and thymus;
The influence of table 5 pair mouse immune organ department weight (
The g/10g body weight)
| Group | Number of animals (only) | Dosage group (g/kg) | Spleen | Thymus |
| Matched group preparation group of the present invention Etretinate group | 10 10 10 10 | 0 3.9 7.8 12 | 0.0416±0.0084 0.0586±0.0063** 0.0614±0.008** 0.0573±0.0076** | 0.0279±0.0016 0.0396±0.0075** 0.0393±0.009** 0.0317±0.0025** |
Compare with matched group: * * P＜0.01
2. to the influence of Turnover of Mouse Peritoneal Macrophages (M φ) phagocytic function: the experiment grouping, route of administration, dosage is with 1.1, once a day, continuous five days, 2h after the last administration, each only organizes equal lumbar injection 5% chicken red blood cell of mice (CRBC) suspension 0.5ml/, puts to death animal behind the 12h, cuts off abdominal cavity skin, intraperitoneal injection of saline water 2ml: the pavilion flicking is rubbed abdominal part, get peritoneal fluid after 2 minutes and be tiled on the microscope slide, hatch 30min for 37 ℃, wash away free cell and dry up, fix with 1: 1 acetone-methanol solution, Gicmsa-wright dyeing is done the oily mirror in back and is checked counting down, calculates percentage rate and phagocytic index that 200 abdominal cavity M φ engulf CRBC, the result shows from table 6, and this medicine high dose group can significantly improve the phagocytic function of mouse peritoneal M φ.
The influence of table 6 pair Turnover of Mouse Peritoneal Macrophages phagocytic function
| Group | Number of animals (only) | Dosage group (g/kg) | Phagocytic percentage (%) | Phagocytic index (%) |
| Matched group preparation group of the present invention Etretinate group | 10 10 10 10 | 0 3.9 7.8 12 | 29.4±5.5 31.6±5.2 35.3±4.7* 33.4±4.1 | 0.409±0.074 0.513±0.10* 0.556±0.114** 0.522±0.085** |
Compare with the contrast level: * P＜0.05 * * P＜0.01
3. the influence that CRBC immune mouse hemolytic antibody is generated: get 60 of mices, be divided into 6 groups at random, administration group ig every day is administered once, matched group gives the isometric(al) normal saline, continuous 6 days, after administration the 3rd, 5 days except that matched group and normal group, all the other respectively organize equal ipCTX liquid 60mg/kg secondary, and after administration the 2nd day in addition, each organizes mice, and lumbar injection 20%CRBC suspension 0.2ml/ was only respectively, immunity 1 time, after the immunity 5 days, each is organized mouse orbit and gets blood, collects serum, with 100 times of normal saline dilute serums, add 10%CRBC 0.5ml and 10% guinea pig blood 1ml, other establish blank pipe (with normal saline for serum) and CRBC HD50 pipe 37 ℃ hatch cool off 15min in 30min and the ice bath after, centrifugal 2000rpm, 10min, get supernatant 2ml, add equivalent normal saline mixing, in 721 type spectrophotometer 560nm place colorimetrics, recording light density, the half hemolysis value (HC50) of calculating mice serum sample:
Can find out that from table 7 this medicine is significantly increased to the hemolytic antibody level of CTX immunosuppressant animal.
The influence that table 7 pair mice serum hemolytic antibody generates
| Group | Number of animals (only) | Dosage group (g/kg) | HC50 |
| Matched group preparation group of the present invention cyclophosphamide group ring+preparation group ring of the present invention+Etretinate group | 10 10 10 10 10 10 | 0 7.8 60mg 60mg+3.9 60mg+7.8 60mg+12 | 610±65.83 635±66.82 265.5±57.66 507.5±45.72** 526.5±80.76** 505±79.76** |
Compare with the cyclophosphamide group: * * p＜0.01
Experimental example 5: the Mice Auricle circulation is influenced
Get 76 of mices, be divided into three groups at random, administration group ig preparation 7.8g/kg of the present invention (0.3ml/20g), Chinese liquor group and matched group ig8 ° Chinese liquor and normal saline 0.3ml/20g body weight, each organize mice respectively at administration after 30min, 60min with 1% pentobarbital sodium solution 0.05ml/10gip anesthesia, lies on the back and is fixed on the Mus plate.Two pick up the ears respectively places a plastic bottle closure that height is moderate under the exterior feature, carefully cut off the fine, soft fur of auricle dorsal part with eye scissors, and at auricle outside dropstone wax oil, auricle is pasted mutually with the plastic bottle closure level, microscope amplifies 50 times of blood flow rate and flows of observing in its blood capillary under falling to penetrating cold light source then, shows the local microcirculation effect that improves significantly of this medicine from table 8 result.
Table 8 pair Auricle Microcirculation influence
| Group | Number of animals (only) | Time behind the medicine (min) | Flow velocity (Vmm/S) | Flow (Qum 3/S) |
| Matched group Chinese liquor group preparation group of the present invention | 16 30 30 | 30 60 30 60 30 60 | 0.26±0.063 0.26±0.063 0.34±0.059** 0.25±0.061 0.36±0.095** 0.39±0.12△ | 1.5×10 3±516.39 1.5×10 3±516.39 2.13×10 3±516.39 1.53×10 3±516.39 2.2×10 3±676.12 2.53×10 3±639.94△ |
Compare with matched group: * * P＜0.01 (30 '), compare with the Chinese liquor group: △ P＜0.01 (60 ')
Experimental example 6: antibacterial action
Get 40 of mices, be divided into 4 groups at random, can make staphylococcus and 0.5ml/ infecting mouse of streptococcus bacterium liquid lumbar injection of 90% dead mouse during with trial test, each bacterium liquid is selected two groups of mices, and (wherein one group is control animal, one group is the administration animal), infect each Mus of back and isolate nursing, the administration group is 12 hours ig administration 7.8g/kg before and after infection bacteria species respectively, secondary is given 15.6g/kg altogether, matched group gives the equivalent normal saline, observe mortality rate in the mice 48 hours: the results are shown in Table 9, from table, can find out that preparation of the present invention has bacterial-infection resisting effect preferably.
The influence of bacterial infection in the table 9 pair animal body
| Group | Number of animals (only) | Bacterial infection (hundred million/ml) | Mortality rate (death/sum) in the 48h |
| Matched group preparation group of the present invention matched group preparation group of the present invention | 10 10 10 10 | Staphylococcus (9 * 10 -2) staphylococcus (9 * 10 -2) streptococcus (2) streptococcus (2) | 8/10 3/10* 10/10 4/10** |
Compare with matched group: * P＜0.05 * * P＜0.01
Embodiment 1:
Radix Angelicae Dahuricae 24g Radix Saposhnikoviae 20g Radix Bupleuri 20g Fructus Setariae Germinatus 20g
The prescription flavour of a drug, except that Fructus Setariae Germinatus, its excess-three flavor adds alcohol reflux twice, and each 1.5 hours, filter, merging filtrate reclaims ethanol.Medicinal residues and Fructus Setariae Germinatus add water to be fried in shallow oil 1.5 hours altogether, filtered, and the filtrate appropriateness concentrates, and merged with above-mentioned ethanol extract, and cold preservation 48 hours filters, and add water and be adjusted to 1000ml, embedding, sterilization, promptly.Oral, a 30～50ml, an order 2 times, or follow the doctor's advice.Time spent shakes up, and children's is cut down according to the circumstance.
Embodiment 2:
Radix Angelicae Dahuricae 28g Radix Saposhnikoviae 24g Radix Bupleuri 16g Fructus Setariae Germinatus 16g
The prescription flavour of a drug, except that Fructus Setariae Germinatus, its excess-three flavor adds alcohol reflux twice, and each 1.5 hours, filter, merging filtrate reclaims ethanol.Medicinal residues and Fructus Setariae Germinatus add water to be fried in shallow oil 1.5 hours altogether, filtered, and the filtrate appropriateness concentrates, and merged with above-mentioned ethanol extract, and cold preservation 48 hours filters, and add water and be adjusted to 1000ml, embedding, sterilization, promptly.Oral, a 30～50ml, 2 times on the one, or follow the doctor's advice.Time spent shakes up, and children's is cut down according to the circumstance.
Embodiment 3:
Radix Angelicae Dahuricae 24g Rhizoma Ligustici 20g Radix Saposhnikoviae 20g Radix Bupleuri 20g Fructus Setariae Germinatus 20g
The prescription flavour of a drug, except that Fructus Setariae Germinatus, four flavors such as all the other Radixs Angelicae Dahuricae add alcohol reflux twice, and each 1.5 hours, filter, merging filtrate reclaims ethanol.Medicinal residues and Fructus Setariae Germinatus add water to be fried in shallow oil 1.5 hours altogether, filtered, and the filtrate appropriateness concentrates, and merged with above-mentioned ethanol extract, and cold preservation 48 hours filters, and add water and be adjusted to 1000ml, embedding, sterilization, promptly.Oral, a 30～50ml, 2 times on the one, or follow the doctor's advice.Time spent shakes up, and children's is cut down according to the circumstance.
Embodiment 4:
Radix Angelicae Dahuricae 28g Rhizoma Ligustici 16g Radix Saposhnikoviae 24g Radix Bupleuri 16g Fructus Setariae Germinatus 24g
The prescription flavour of a drug, except that Fructus Setariae Germinatus, four flavors such as all the other Radixs Angelicae Dahuricae add alcohol reflux 3 times, and each 2 hours, filter, merging filtrate reclaims ethanol.Medicinal residues and Fructus Setariae Germinatus add water to be fried in shallow oil 2 hours altogether, filtered, and the filtrate appropriateness concentrates, and merged with above-mentioned ethanol extract, and clarification is left standstill in cold preservation 24 hours, filters, and add water and be adjusted to 1000ml, embedding, sterilization, promptly.Oral, a 30～50ml, 2 times on the one, or follow the doctor's advice.Time spent shakes up, and children's is cut down according to the circumstance.
Embodiment 5:
Radix Angelicae Dahuricae 26g Rhizoma Ligustici 24g Radix Saposhnikoviae 16g Radix Bupleuri 24g Fructus Setariae Germinatus 16g
The prescription flavour of a drug, except that Fructus Setariae Germinatus, four flavors such as all the other Radixs Angelicae Dahuricae add alcohol reflux 2 times, and each 1 hour, filter, merging filtrate reclaims ethanol.Medicinal residues and Fructus Setariae Germinatus add water to be fried in shallow oil 1 hour altogether, filtered, and the filtrate appropriateness concentrates, and merged with above-mentioned ethanol extract, and cold preservation 48 hours filters, and add water and be adjusted to 1000ml, embedding, sterilization, promptly.Oral, a 30～50ml, 2 times on the one, or follow the doctor's advice.Time spent shakes up, and children's is cut down according to the circumstance.
Embodiment 6:
Radix Angelicae Dahuricae 24g Radix Saposhnikoviae 20 Radix Bupleuri 20g Fructus Setariae Germinatus 20g Rhizoma Cyperi 15g Rhizoma Atractylodis 20g
The prescription flavour of a drug, except that Fructus Setariae Germinatus, four flavors such as all the other Radixs Angelicae Dahuricae add alcohol reflux 2 times, and each 2 hours, filter, merging filtrate reclaims ethanol.Medicinal residues and Fructus Setariae Germinatus add water to be fried in shallow oil 2 hours altogether, filtered, and the filtrate appropriateness concentrates, and merged with above-mentioned ethanol extract, and cold preservation 36 hours filters, and add water and be adjusted to 1000ml, embedding, sterilization, promptly.Oral, a 30～50ml, 2 times on the one, or follow the doctor's advice.Time spent shakes up, and children's is cut down according to the circumstance.
Embodiment 7:
Radix Angelicae Dahuricae 26g Radix Saposhnikoviae 16g Radix Bupleuri 24g Fructus Setariae Germinatus 16g Rhizoma Cyperi 12g Rhizoma Atractylodis 16g
The prescription flavour of a drug, except that Fructus Setariae Germinatus, four flavors such as all the other Radixs Angelicae Dahuricae add alcohol reflux 2 times, and each 1 hour, filter, merging filtrate reclaims ethanol.Medicinal residues and Fructus Setariae Germinatus add water to be fried in shallow oil 2 hours altogether, filtered, and the filtrate appropriateness concentrates, and merged with above-mentioned ethanol extract, and cold preservation 48 hours filters, and add water and be adjusted to 1000ml, embedding, sterilization, promptly.Oral, a 30～50ml, 2 times on the one, or follow the doctor's advice.Time spent shakes up, and children's is cut down according to the circumstance.
Embodiment 8: the discrimination method of this compositions:
Get preparation 50ml of the present invention, add diethyl ether and extract 2 times, 40ml for the first time, 30ml merges ether solution (water layer is standby) for the second time, volatilizes, and residue adds ethanol 0.5ml makes dissolving, as need testing solution; Other gets Rhizoma Ligustici control medicinal material 0.5g, the 25ml that adds diethyl ether, and supersound process 5 minutes filters, and filtrate volatilizes, and residue adds ethanol 1ml makes dissolving, in contrast medical material solution; According to thin layer chromatography (" an appendix VI of Chinese pharmacopoeia version in 2000 B) test, draw above-mentioned need testing solution 10 μ l, control medicinal material solution 1 μ l, put respectively on same silica gel g thin-layer plate, cyclohexane-acetic acid second vinegar with 8: 2 ratios is developing solvent, launches, and takes out, dry, put under the ultra-violet lamp (365nm) and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical blue and white fluorescence speckle.
Embodiment 9: the discrimination method of this compositions:
A, get preparation 50ml of the present invention, add diethyl ether and extract 2 times, 40ml for the first time, 30ml merges ether solution (water layer is standby) for the second time, volatilizes, and residue adds ethanol 0.5ml makes dissolving, as need testing solution; Other gets Rhizoma Ligustici control medicinal material 0.5g, the 25ml that adds diethyl ether, and supersound process 5 minutes filters, and filtrate volatilizes, and residue adds ethanol 1ml makes dissolving, in contrast medical material solution; According to thin layer chromatography (" an appendix VI of Chinese pharmacopoeia version in 2000 B) test, draw above-mentioned need testing solution 10 μ l, control medicinal material solution 1 μ l, put respectively on same silica gel g thin-layer plate, cyclohexane-acetic acid second vinegar with 8: 2 ratios is developing solvent, launches, and takes out, dry, put under the ultra-violet lamp (365nm) and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical blue and white fluorescence speckle.
B, get and differentiate a item aqueous solution down, with water saturated n-butanol extraction 2 times, 30ml at every turn, merging n-butyl alcohol liquid, add the equal-volume ammonia solution, shake up, place layering, get upper strata liquid, the reclaim under reduced pressure n-butyl alcohol is to doing, and residue adds methanol 1ml makes dissolving, as need testing solution; Other gets Radix Bupleuri control medicinal material 5g, the 30ml that adds diethyl ether, and reflux, extract, 30 minutes discards ether solution, and residue volatilizes ether, adds methanol 30ml, and water-bath reflux, extract, 30 minutes filters, and reclaim under reduced pressure methanol is to doing; Residue adds water 15ml makes dissolving, and with water saturated n-butanol extraction three times, each 15ml is equipped with control medicinal material solution with legal system; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B); Draw each 5 μ l of above-mentioned two kinds of solution, put respectively in same and contain on the silica gel g thin-layer plate that carmethose is a binding agent, lower floor's solution of placing below 10 ℃ with the chloroform-methanol-water of 65: 35: 10 ratios is developing solvent, launch, take out, dry, spray is with 1% dimethylaminobenzaldehyde sulphuric acid ethanol liquid (1: 10), 105 ℃ of bakings several minutes, daylight was inspected.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of at least two same colors.
Embodiment 10:The content assaying method of this composition granule:
Measure according to high performance liquid chromatography (" appendix VID of Chinese pharmacopoeia version in 2000); With octadecylsilane chemically bonded silica is filler; The methanol of 35: 65 ratios-0.5% acetic acid is mobile phase; The detection wavelength is 320nm; Number of theoretical plate calculates by the ferulic acid peak should be not less than 2500; It is an amount of that precision takes by weighing the ferulic acid reference substance, adds methanol and make the solution that every 1ml contains 10 μ g, promptly gets (keeping in Dark Place) reference substance solution; Precision is measured preparation 10ml of the present invention, puts in the separatory funnel, is respectively 10mL 5 times with ether extraction, 10ml, 8ml, 8ml, 5ml merges ether solution, and ether liquid extracts 3 times with 5% sodium carbonate liquor, each 10ml discards ether liquid, merges sodium carbonate liquor, reuse hydrochloric acid adjust pH to 2, be respectively 10ml 4 times with ether extraction, 10ml, 8ml, 5ml, combined ether liquid is put evaporate to dryness in the tepidarium, residue add an amount of methanol make the dissolving and move in the 10ml measuring bottle, be diluted to scale with methanol, shake up, filter, promptly get (keeping in Dark Place) need testing solution with microporous filter membrane (0.45 μ m); Accurate respectively reference substance solution and each 10 μ l of test sample dissolving of drawing inject liquid phase bag spectrometer, measure, and the every ml of preparation of the present invention contains Rhizoma Ligustici in ferulic acid (C10H1004), must not be less than 10.0 μ g.
Embodiment 11:The method of quality control of this composition granule:
A, get preparation 50ml of the present invention, add diethyl ether and extract 2 times, 40ml for the first time, 30ml merges ether solution (water layer is standby) for the second time, volatilizes, and residue adds ethanol 0.5ml makes dissolving, as need testing solution; Other gets Rhizoma Ligustici control medicinal material 0.5g, the 25ml that adds diethyl ether, and supersound process 10 minutes filters, and filtrate volatilizes, and residue adds ethanol 1ml makes dissolving, in contrast medical material solution; According to thin layer chromatography (" an appendix VI of Chinese pharmacopoeia version in 2000 B) test, draw above-mentioned need testing solution 10 μ l, control medicinal material solution 1 μ l, put respectively on same silica gel g thin-layer plate, cyclohexane-acetic acid second vinegar with 7: 3 ratios is developing solvent, launches, and takes out, dry, put under the ultra-violet lamp (365nm) and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical blue and white fluorescence speckle.
B, get and differentiate a item aqueous solution down, with water saturated n-butanol extraction 2 times, 30ml at every turn, merging n-butyl alcohol liquid, add the equal-volume ammonia solution, shake up, place layering, get upper strata liquid, the reclaim under reduced pressure n-butyl alcohol is to doing, and residue adds methanol 1ml makes dissolving, as need testing solution; Other gets Radix Bupleuri control medicinal material 5g, the 30ml that adds diethyl ether, and reflux, extract, 25 minutes discards ether solution, and residue volatilizes ether, adds methanol 30ml, and water-bath reflux, extract, 35 minutes filters, and reclaim under reduced pressure methanol is to doing; Residue adds water 15ml makes dissolving, and with water saturated n-butanol extraction three times, each 15ml is equipped with control medicinal material solution with legal system; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B); Draw each 5 μ l of above-mentioned two kinds of solution, put respectively in same and contain on the silica gel g thin-layer plate that carmethose is a binding agent, lower floor's solution of placing below 10 ℃ with the chloroform-methanol-water of 70: 30: 10 ratios is developing solvent, launch, take out, dry, spray is with 1% dimethylaminobenzaldehyde sulphuric acid ethanol liquid (1: 10), 105 ℃ of bakings several minutes, daylight was inspected.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of at least two same colors.
C, content assaying method:
Measure according to high performance liquid chromatography (" appendix VID of Chinese pharmacopoeia version in 2000); With octadecylsilane chemically bonded silica is filler; The methanol of 40: 60 ratios-0.5% acetic acid is mobile phase; The detection wavelength is 320nm; Number of theoretical plate calculates by the ferulic acid peak should be not less than 2500; It is an amount of that precision takes by weighing the ferulic acid reference substance, adds methanol and make the solution that every 1ml contains 10 μ g, promptly gets (keeping in Dark Place) reference substance solution; Precision is measured preparation 10ml of the present invention, puts in the separatory funnel, is respectively 10mL 5 times with ether extraction, 10ml, 8ml, 8ml, 5ml merges ether solution, and ether liquid extracts 3 times with 5% sodium carbonate liquor, each 10ml discards ether liquid, merges sodium carbonate liquor, reuse hydrochloric acid adjust pH to 2, be respectively 10ml 4 times with ether extraction, 10ml, 8ml, 5ml, combined ether liquid is put evaporate to dryness in the tepidarium, residue add an amount of methanol make the dissolving and move in the 10ml measuring bottle, be diluted to scale with methanol, shake up, filter, promptly get (keeping in Dark Place) need testing solution with microporous filter membrane (0.45 μ m); Accurate respectively reference substance solution and each 10 μ l of test sample dissolving of drawing inject liquid phase bag spectrometer, measure, and the every ml of preparation of the present invention contains Rhizoma Ligustici in ferulic acid (C10H1004), must not be less than 10.0 μ g.
Claims (15)
1. psoriasic Chinese medicine composition of treatment is characterized in that this pharmaceutical composition made by following raw material medicaments:
Radix Angelicae Dahuricae 20-30 weight portion Radix Saposhnikoviae 15-25 weight portion
Radix Bupleuri 15-25 weight portion Fructus Setariae Germinatus 15-25 weight portion.
2. the described pharmaceutical composition of claim 1 is characterized in that this pharmaceutical composition made by following raw material medicaments:
The Radix Angelicae Dahuricae 24 weight portion Radix Saposhnikoviaes 20 weight portions
Radix Bupleuri 20 weight portion Fructus Setariae Germinatuss 20 weight portions.
3. psoriasic Chinese medicine composition of treatment is characterized in that this pharmaceutical composition made by following raw material medicaments:
Radix Angelicae Dahuricae 20-30 weight portion Rhizoma Ligustici 15-25 weight portion Radix Saposhnikoviae 15-25 weight portion
Radix Bupleuri 15-25 weight portion Fructus Setariae Germinatus 15-25 weight portion.
4. pharmaceutical composition as claimed in claim 3 is characterized in that this pharmaceutical composition made by following raw material medicaments:
The Radix Angelicae Dahuricae 24 weight portion Rhizoma Ligusticis 20 weight portion Radix Saposhnikoviaes 20 weight portions
Radix Bupleuri 20 weight portion Fructus Setariae Germinatuss 20 weight portions.
5. psoriasic Chinese medicine composition of treatment is characterized in that this pharmaceutical composition made by following raw material medicaments:
Radix Angelicae Dahuricae 20-30 weight portion Radix Saposhnikoviae 15-25 weight portion Rhizoma Cyperi 10-20 weight portion
Radix Bupleuri 15-25 weight portion Fructus Setariae Germinatus 15-25 weight portion Rhizoma Atractylodis 15-25 weight portion.
6. the described pharmaceutical composition of claim 5 is characterized in that this pharmaceutical composition made by following raw material medicaments:
The Radix Angelicae Dahuricae 24 weight portion Radix Saposhnikoviaes 20 weight portion Rhizoma Cyperis 15 weight portions
Radix Bupleuri 20 weight portion Fructus Setariae Germinatuss 20 weight portion Rhizoma Atractylodis 20 weight portions.
7. as claim 3 or 4 described preparation of drug combination methods, it is characterized in that this method is:
Above flavour of a drug, except that Fructus Setariae Germinatus, all the other four flavors add alcohol reflux 2-3 time, and each 1-2 hour, filter, merging filtrate reclaims ethanol; Medicinal residues and Fructus Setariae Germinatus add water to be fried in shallow oil 1-2 hour altogether, filtered, and the filtrate appropriateness concentrates, merge with above-mentioned ethanol extract, and cold preservation 24-48 hour, filter, add the water adjustment, embedding, sterilization, promptly.
8. claim 3 or 4 described preparation of drug combination methods is characterized in that this method is:
Above flavour of a drug, except that Fructus Setariae Germinatus, all the other four flavors add alcohol reflux twice, and each 1.5 hours, filter, merging filtrate reclaims ethanol; Medicinal residues and Fructus Setariae Germinatus add water to be fried in shallow oil 1.5 hours altogether, filtered, and the filtrate appropriateness concentrates, and merged with above-mentioned ethanol extract, and cold preservation 48 hours filters, and adds the water adjustment, embedding, and sterilization, promptly.
9. as the method for quality control of claim 3 or 4 described pharmaceutical compositions, it is characterized in that comprising in this method in the following discrimination method one or more:
A, get the preparation 50ml that this pharmaceutical composition makes, add diethyl ether and extract 2 times, 40ml for the first time, 30ml merges ether solution for the second time, volatilizes, and residue adds ethanol 0.5ml makes dissolving, as need testing solution; Other gets Rhizoma Ligustici control medicinal material 0.5g, the 25ml that adds diethyl ether, and supersound process 5-10 minute, filter, filtrate volatilizes, and residue adds ethanol 1ml makes dissolving, in contrast medical material solution; According to thin layer chromatography test, draw above-mentioned need testing solution 10 μ l, control medicinal material solution 1 μ l puts respectively on same silica gel g thin-layer plate, and with 7-9: the cyclohexane of 1-3 ratio-acetic acid second vinegar is developing solvent, launches, and takes out, and dries, and puts under the ultra-violet lamp and inspects; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical blue and white fluorescence speckle;
B, get the aqueous solution under a item, with water saturated n-butanol extraction 2 times, each 30ml merges n-butyl alcohol liquid, adds the equal-volume ammonia solution, shakes up, and places layering, gets upper strata liquid, and the reclaim under reduced pressure n-butyl alcohol is to doing, and residue adds methanol 1ml makes dissolving, as need testing solution; Other gets Radix Bupleuri control medicinal material 5g, the 30ml that adds diethyl ether, and reflux, extract, 20-40 minute, discard ether solution, residue volatilizes ether, adds methanol 30ml, and water-bath reflux, extract, 20-40 minute filters, and reclaim under reduced pressure methanol is to doing; Residue adds water 15ml makes dissolving, and with water saturated n-butanol extraction three times, each 15ml is equipped with control medicinal material solution with legal system; Test according to thin layer chromatography; Draw each 5 μ l of above-mentioned two kinds of solution, put respectively in same and contain on the silica gel g thin-layer plate that carmethose is a binding agent, with 60-70: 30-40: lower floor's solution that the chloroform of 5-15 ratio---methanol---water is placed below 10 ℃ is developing solvent, launch, take out, dry, spray is with 1% dimethylaminobenzaldehyde sulphuric acid ethanol liquid, 100-110 ℃ of baking several minutes, daylight was inspected; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of at least two same colors.
10. method of quality control as claimed in claim 9 is characterized in that comprising in this method in the following discrimination method one or more:
A, get the preparation 50ml that this pharmaceutical composition makes, add diethyl ether and extract 2 times, 40ml for the first time, 30ml merges ether solution for the second time, volatilizes, and residue adds ethanol 0.5ml makes dissolving, as need testing solution; Other gets Rhizoma Ligustici control medicinal material 0.5g, the 25ml that adds diethyl ether, and supersound process 5 minutes filters, and filtrate volatilizes, and residue adds ethanol 1ml makes dissolving, in contrast medical material solution; According to thin layer chromatography test, draw above-mentioned need testing solution 10 μ l, control medicinal material solution 1 μ l puts respectively on same silica gel g thin-layer plate, is developing solvent with the cyclohexane-acetic acid second vinegar of 8: 2 ratios, launches, and takes out, and dries, and puts under the ultra-violet lamp and inspects; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical blue and white fluorescence speckle;
B, get and differentiate a item aqueous solution down, with water saturated n-butanol extraction 2 times, 30ml at every turn, merging n-butyl alcohol liquid, add the equal-volume ammonia solution, shake up, place layering, get upper strata liquid, the reclaim under reduced pressure n-butyl alcohol is to doing, and residue adds methanol 1ml makes dissolving, as need testing solution; Other gets Radix Bupleuri control medicinal material 5g, the 30ml that adds diethyl ether, and reflux, extract, 30 minutes discards ether solution, and residue volatilizes ether, adds methanol 30ml, and water-bath reflux, extract, 30 minutes filters, and reclaim under reduced pressure methanol is to doing; Residue adds water 15ml makes dissolving, and with water saturated n-butanol extraction three times, each 15ml is equipped with control medicinal material solution with legal system; Test according to thin layer chromatography; Draw each 5 μ l of above-mentioned two kinds of solution, put respectively in same and contain on the silica gel g thin-layer plate that carmethose is a binding agent, lower floor's solution that chloroform with 65: 35: 10 ratios---methanol---water is placed below 10 ℃ is developing solvent, launch, take out, dry, spray is with 1% dimethylaminobenzaldehyde sulphuric acid ethanol liquid, 105 ℃ of bakings several minutes, daylight was inspected; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of at least two same colors.
11. method of quality control as claimed in claim 9 is characterized in that comprising in this method following content assaying method:
According to high effective liquid chromatography for measuring; With octadecylsilane chemically bonded silica is filler; 30-40: the methanol of 60-70 ratio-0.5% acetic acid is mobile phase; The detection wavelength is 320nm; Number of theoretical plate calculates by the ferulic acid peak should be not less than 2500; It is an amount of that precision takes by weighing the ferulic acid reference substance, adds methanol and make the solution that every 1ml contains 10 μ g, promptly gets reference substance solution; Precision is measured the preparation 10ml that this pharmaceutical composition makes, and puts in the separatory funnel, is respectively 10mL 5 times with ether extraction, 10ml, 8ml, 8ml, 5ml merges ether solution, and ether liquid extracts 3 times with 5% sodium carbonate liquor, each 10ml discards ether liquid, merges sodium carbonate liquor, reuse hydrochloric acid adjust pH to 2, be respectively 10ml 4 times with ether extraction, 10ml, 8ml, 5ml, combined ether liquid is put evaporate to dryness in the tepidarium, residue add an amount of methanol make the dissolving and move in the 10ml measuring bottle, be diluted to scale with methanol, shake up, filter, promptly get need testing solution with microporous filter membrane; Accurate respectively reference substance solution and each 10 μ l of test sample dissolving of drawing inject liquid phase bag spectrometer, measure, and the every ml of the preparation that this pharmaceutical composition makes contains Rhizoma Ligustici in ferulic acid (C10H10O4), must not be less than 10.0 μ g.
12. method of quality control as claimed in claim 9 is characterized in that comprising in this method following content assaying method:
According to high effective liquid chromatography for measuring; With octadecylsilane chemically bonded silica is filler; The methanol of 35: 65 ratios-0.5% acetic acid is mobile phase; The detection wavelength is 320nm; Number of theoretical plate calculates by the ferulic acid peak should be not less than 2500; It is an amount of that precision takes by weighing the ferulic acid reference substance, adds methanol and make the solution that every 1ml contains 10 μ g, promptly gets reference substance solution; Precision is measured the preparation 10ml that this pharmaceutical composition makes, and puts in the separatory funnel, is respectively 10mL 5 times with ether extraction, 10ml, 8ml, 8ml, 5ml merges ether solution, and ether liquid extracts 3 times with 5% sodium carbonate liquor, each 10ml discards ether liquid, merges sodium carbonate liquor, reuse hydrochloric acid adjust pH to 2, be respectively 10ml 4 times with ether extraction, 10ml, 8ml, 5ml, combined ether liquid is put evaporate to dryness in the tepidarium, residue add an amount of methanol make the dissolving and move in the 10ml measuring bottle, be diluted to scale with methanol, shake up, filter, promptly get need testing solution with microporous filter membrane; Accurate respectively reference substance solution and each 10 μ l of test sample dissolving of drawing inject liquid phase bag spectrometer, measure, and the every ml of the preparation that this pharmaceutical composition makes contains Rhizoma Ligustici in ferulic acid (C10H10O4), must not be less than 10.0 μ g.
13. method of quality control as claimed in claim 9 is characterized in that containing in this method in following discriminating and/or the content assaying method one or more:
A, get the preparation 50ml that this pharmaceutical composition makes, add diethyl ether and extract 2 times, 40ml for the first time, 30ml merges ether solution for the second time, volatilizes, and residue adds ethanol 0.5ml makes dissolving, as need testing solution; Other gets Rhizoma Ligustici control medicinal material 0.5g, the 25ml that adds diethyl ether, and supersound process 10 minutes filters, and filtrate volatilizes, and residue adds ethanol 1ml makes dissolving, in contrast medical material solution; According to thin layer chromatography test, draw above-mentioned need testing solution 10 μ l, control medicinal material solution 1 μ l puts respectively on same silica gel g thin-layer plate, is developing solvent with the cyclohexane-acetic acid second vinegar of 7: 3 ratios, launches, and takes out, and dries, and puts under the ultra-violet lamp and inspects; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical blue and white fluorescence speckle;
B, get and differentiate a item aqueous solution down, with water saturated n-butanol extraction 2 times, 30ml at every turn, merging n-butyl alcohol liquid, add the equal-volume ammonia solution, shake up, place layering, get upper strata liquid, the reclaim under reduced pressure n-butyl alcohol is to doing, and residue adds methanol 1ml makes dissolving, as need testing solution; Other gets Radix Bupleuri control medicinal material 5g, the 30ml that adds diethyl ether, and reflux, extract, 25 minutes discards ether solution, and residue volatilizes ether, adds methanol 30ml, and water-bath reflux, extract, 35 minutes filters, and reclaim under reduced pressure methanol is to doing; Residue adds water 15ml makes dissolving, and with water saturated n-butanol extraction three times, each 15ml is equipped with control medicinal material solution with legal system; Test according to thin layer chromatography; Draw each 5 μ l of above-mentioned two kinds of solution, put respectively in same and contain on the silica gel g thin-layer plate that carmethose is a binding agent, lower floor's solution that chloroform with 70: 30: 10 ratios---methanol---water is placed below 10 ℃ is developing solvent, launch, take out, dry, spray is with 1% dimethylaminobenzaldehyde sulphuric acid ethanol liquid, 105 ℃ of bakings several minutes, daylight was inspected; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of at least two same colors;
C, content assaying method:
According to high effective liquid chromatography for measuring; With octadecylsilane chemically bonded silica is filler; The methanol of 40: 60 ratios-0.5% acetic acid is mobile phase; The detection wavelength is 320nm; Number of theoretical plate calculates by the ferulic acid peak should be not less than 2500; It is an amount of that precision takes by weighing the ferulic acid reference substance, adds methanol and make the solution that every 1ml contains 10 μ g, promptly gets reference substance solution; Precision is measured the preparation 10ml that this pharmaceutical composition makes, and puts in the separatory funnel, is respectively 10mL 5 times with ether extraction, 10ml, 8ml, 8ml, 5ml merges ether solution, and ether liquid extracts 3 times with 5% sodium carbonate liquor, each 10ml discards ether liquid, merges sodium carbonate liquor, reuse hydrochloric acid adjust pH to 2, be respectively 10ml 4 times with ether extraction, 10ml, 8ml, 5ml, combined ether liquid is put evaporate to dryness in the tepidarium, residue add an amount of methanol make the dissolving and move in the 10ml measuring bottle, be diluted to scale with methanol, shake up, filter, promptly get need testing solution with microporous filter membrane; Accurate respectively reference substance solution and each 10 μ l of test sample dissolving of drawing inject liquid phase bag spectrometer, measure, and the every ml of the preparation that this pharmaceutical composition makes contains Rhizoma Ligustici in ferulic acid (C10H10O4), must not be less than 10.0 μ g.
14. as claim 1,2,3,4, the application of 5 or 6 described pharmaceutical compositions in preparation treatment psoriasis, acne and neurodermatitis medicine.
15. the application of pharmaceutical composition as claimed in claim 14 is characterized in that described this medicine has antiinflammatory, analgesia, adjusting immunity, antibiotic or itching relieving effect.
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| CN106266458B (en) * | 2016-09-26 | 2020-11-10 | 上海市静安区共和新路街道社区卫生服务中心 | A Chinese medicinal composition for treating psoriasis and neurodermatitis, and its application |
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| 银屑净口服液治疗银屑病260例. 刘光珍.北京中医药大学学报，第17卷第6期. 1994 * |
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