CN101264188B - Orally-administered medicinal liquor for treating rheumatic arthritis and preparation thereof - Google Patents

Orally-administered medicinal liquor for treating rheumatic arthritis and preparation thereof Download PDF

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CN101264188B
CN101264188B CN2008100178475A CN200810017847A CN101264188B CN 101264188 B CN101264188 B CN 101264188B CN 2008100178475 A CN2008100178475 A CN 2008100178475A CN 200810017847 A CN200810017847 A CN 200810017847A CN 101264188 B CN101264188 B CN 101264188B
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李新田
林昱
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Abstract

The invention relates to an oral medicinal wine for rheumatoid arthritis; the ingredients and the account of the raw materials for preparing the medicinal wine are: 750 plus or minus 70 cassia twig, 750 plus or minus 70 cyathula root, 546 plus or minus 50 Qiannianjian, 750 plus or minus 70 cortex eucommia, 564 plus or minus 50 oikzae, 376 plus or minus 30 cassia bark, 750 plus or minus 70 barrenwort, 376 plus or minus 30 aconite, 564 plus or minus 50 myrrh, 188 plus or minus 20 grilled nux vomica, 564 plus or minus 50 papaya, 564 plus or minus 50 lumbricus, 938 plus or minus 90 ephedra, 564 plus or minus 50 angelica sinensis, 564 plus or minus 50 dodder, and 564 plus or minus 50 liquorice root. The oral medicinal wine has the effect of activating blood circulation to dissipate blood stasis, dispelling wind and taking away the pain, dispelling coldness and dehumidification, and relaxing muscles and tendons. Considering human body as a whole, in the principle of treating both manifestation and root cause of disease, the composing prescription applies discriminative treat, and the medicinal wine strengthens medicine effect with wine. Compared with the prior medicines curing rheumatoid arthritis, the oral medicinal wine has the advantages of short course, quick results, high cure rate, the total effective rate being 91%, no side effect, and low price.

Description

A kind of oral medicinal liquor for the treatment of rheumatic arthritis and preparation method thereof
Technical field
The present invention relates to the pharmaceutical product technical field, particularly a kind of oral Chinese medicine medicated wine for the treatment of rheumatic arthritis and preparation method thereof.
Background technology
Rheumatic arthritis is common clinical, and frequently-occurring disease, this disease get and hotly then subtract, and meets cold then acute.Especially the peasant who is located in the mountain area is engaged in heavy physical work, is subjected to the invasion and attack of mountain area humidity all the year round in addition, makes that the sickness rate of this disease is higher, and is characterized in prolonged and does not heal, and pain is acute, has caused very big influence for people's work and life.Not seeing for a long time has satisfied medicine, and it is big that Western medicine commonly used is taken toxic and side effects for a long time, to the patient brought great misery and psychologically, economically pressure.
Summary of the invention
The object of the invention provides a kind of oral medicinal liquor for the treatment of rheumatic arthritis and preparation method thereof, to reach the rheumatic arthritis better therapeutic effect.
Specifically, the oral medicinal liquor of treatment rheumatic arthritis is that Chinese medicine with following weight parts soaks in proper amount of white spirit and makes:
Ramulus Cinnamomi 750 ± 70, Radix Achyranthis Bidentatae 750 ± 70, Rhizoma Homalomenae 546 ± 50, the Cortex Eucommiae 750 ± 70, Cortex schizophragmatis integrifolii radicis 564 ± 50, Cortex Cinnamomi 376 ± 30, Herba Epimedii 750 ± 70, Radix Aconiti Lateralis Preparata 376 ± 30, Myrrha 564 ± 50, Semen Strychni (processed) 188 ± 20, Fructus Chaenomelis 564 ± 50, Pheretima 564 ± 50, Herba Ephedrae 938 ± 90, Radix Angelicae Sinensis 564 ± 50, Semen Cuscutae 564 ± 50, Radix Glycyrrhizae 564 ± 50.
The preferential medicated wine drug weight ratio of recommending of the present invention is:
Ramulus Cinnamomi 750, Radix Achyranthis Bidentatae 750, Rhizoma Homalomenae 546, the Cortex Eucommiae 750, Cortex schizophragmatis integrifolii radicis 564, Cortex Cinnamomi 376, Herba Epimedii 750, Radix Aconiti Lateralis Preparata 376, Myrrha 564, Semen Strychni (processed) 188, Fructus Chaenomelis 564, Pheretima 564, Herba Ephedrae 938, Radix Angelicae Sinensis 564, Semen Cuscutae 564, Radix Glycyrrhizae 564.
The preparation method of medicated wine of the present invention:
Get above 16 flavor Chinese crude drugs merging and be ground into coarse powder, be immersed in right amount in the percolation vat with Chinese liquor, stir every day 1~2 time, soaked for 2 weeks, filter, filtrate is added Chinese liquor to 50000ml, stirs well placement, filters, and is sub-packed in the 10ml ampoule, seal, and packing, promptly.
Qualitative and quantitative analysis:
[character] this product is brown xanchromatic liquid, gas perfume (or spice), acrid in the mouth hardship.
[inspection] contains amount of alcohol and should be 35~45% (according to an appendix IX of Chinese Pharmacopoeia version in 2005 M).
The TLC of [discriminating] 1, Radix Angelicae Sinensis differentiates: get this product 40ml, the 30ml that adds diethyl ether gets ether solution after extracting, and volatilizes, and the 1ml that adds diethyl ether dissolves as need testing solution.Other gets Radix Angelicae Sinensis control medicinal material 0.5g, and the same legal system that adds diethyl ether is shone medical material solution in pairs.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2005) test, draw above-mentioned 2 kinds of each 10ul of solution respectively, point is on same silica gel g thin-layer plate, with normal hexane-ethyl acetate (9: 1) is developing solvent, launches, and takes out, dry, put earlier under the uviol lamp (365nm) and inspect, in the test sample chromatograph, be identical strong blue and white fluorescence mottle in Radix Angelicae Sinensis control medicinal material chromatograph relevant position; Spray 20% perchloric acid solution again, 105 ℃ to be heated to mottle clear.
2, the TLC of Semen Strychni differentiates: get this product 40ml, add chloroform 50ml and dense ammonia 5ml, and close plug, jolting 5 minutes was placed 2 hours, filtered, and got chloroform layer filtrate, evaporated into 5ml, as need testing solution.Other gets strychnine and strychnine reference substance, and chlorination is copied into the mixed solution that every 1ml contains 2mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2005) test, draw above-mentioned 2 kinds of each 10ul of solution respectively, point is on same silica gel g thin-layer plate, with toluene-acetone-ethanol-strong ammonia solution (4: 5: 0.6: 0.4) be developing solvent, launch, take out, dry, spray is with rare bismuth potassium iodide test solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
[assay] uses the content (an appendix VI of Chinese Pharmacopoeia version in 2005 D) of strychnine in the high effective liquid chromatography for measuring Semen Strychni (processed).
Chromatographic condition and system suitability test: with the octadecylsilane chemically bonded silica is filler, with acetonitrile-0.01mol/L sodium heptanesulfonate and 0.02mol/L potassium dihydrogen phosphate mixed in equal amounts solution (regulating pH value 2.8 with 10% phosphoric acid) (21: 79) is mobile phase, and the detection wavelength is 260nm.Number of theoretical plate calculates by the strychnine peak should be not less than 5000.
The preparation precision of reference substance solution takes by weighing the strychnine reference substance, makes the solution that every 1ml contains strychnine 0.12mg with methanol, in contrast product solution.
The preparation precision of need testing solution is measured medicated wine 50ml, and 100 ℃ of heated volatiles are to the extractum shape, hydro-oxidation sodium test solution 3ml, shake well was placed 30 minutes, the accurate chloroform 20ml that adds, close plug, take by weighing weight, put in the water-bath reflux, extract, 2 hours, put cold, take by weighing weight, replenish the weight that loses with chloroform, shake up, put in the separatory funnel, divide and get chloroform extracted solution, filter with the filter paper that is covered with a small amount of anhydrous sodium sulfate, discard filtrate just, precision is measured subsequent filtrate 3ml, place the 10ml measuring bottle, be diluted to scale with methanol, shake up, promptly.
Assay method precision is respectively measured reference substance solution and each 4 μ l of need testing solution, injects chromatograph of liquid and measures.Measurement result sees Table.
Table: the strychnine assay result of medicated wine
Figure GSB00000450577200041
The content of this medicated wine strychnine should be 0.182~0.240 (mg.ml -1).
Stability study:
Whether effectively stable in order to investigate this medicated wine, it is an amount of to get three batches the sample of producing in 2005~2006 years, pack according to conventional Production and Packaging style, in indoor natural conditions (10~30 ℃ of room temperatures, relative humidity 40~85%) deposits under, respectively from the same day, 1 month, 3 months, 6 months, 12 months sampling of producing, according to " Chinese pharmacopoeia version standard in 2005 is checked comprehensively.
Table: the study on the stability of medicated wine
+ be that identification is positive.
Conclusion: investigate the result and show that this product was deposited 1 year under indoor natural conditions, steady quality can satisfy the needs of hospital preparation production and use.
Toxicologic study
Purpose: observe the safety of white mice n of high dose oral medicated wine.
Material: (1) medicated wine: the court centers for making of pharmaceutical preparations produce.(2) animal: 40 of Kunming kind white mice, male and female half and half, body weight 20 ± 2.0g, Mus 2-3 in age month.(3) experimental technique: get 40 of healthy mices, male and female half and half, body weight 20 ± 2.0g Mus 2-3 in age month, is divided into 2 groups: administration group and blank group (45% ethanol) at random.After water 12h is can't help in the white mice fasting, give every mice lavage, convert 100 times into adult's dosage with the 1ml capacity.White mice freely absorbs feedstuff and water during the administration, and the receptacle temperature remains on 24 ± 4 ℃, and humidity is 40~60%.Observed altogether 7 days.(4) experimental result: mice lavage has ethanol anesthesia phenomenon after about 10 minutes.Recover normal after 2 hours, compare no abnormality seen, successive administration all survivals in 7 days with matched group.Put to death white mice after 7 days, each main organs is carried out gross necropsy, two groups of color, sizes that compare each main organs are all no abnormal.(5) conclusion: oral this medicated wine is safe.
Medicated wine of the present invention is at the cause of disease and the symptom of rheumatic arthritis, Semen Strychni (processed) removing obstruction in the collateral to relieve pain in this oral medicinal liquor prescription, mass dissipating and swelling eliminating; Ramulus Cinnamomi, Cortex Cinnamomi, Herba Ephedrae, Radix Aconiti Lateralis Preparata can pursue wind, promoting the flow of QI-blood by warming the meridian by cold expelling; Radix Achyranthis Bidentatae, Rhizoma Homalomenae, Semen Cuscutae, Herba Epimedii, Cortex Eucommiae invigorating the liver and kidney, bone and muscle strengthening, wind-expelling pain-stopping; Radix Angelicae Sinensis, Pheretima blood circulation promoting and blood stasis dispelling, all medicine compatibilities have synergism.Be the needs of clinical treatment, this Chinese medicine preparation is mixed with a kind of taking with easy to carry, stable in properties, quality controllable, Chinese medicine medicated wine safely and effectively.
Oral medicinal liquor provided by the invention is a Chinese medicine preparation, and this preparation is mainly used in treatment rheumatic arthritis, has the effect of blood circulation promoting and blood stasis dispelling, wind-expelling pain-stopping, dispelling cold and removing dampness, channels sootheing and network vessel quickening.Tradition motherland medical science thinks that rheumatism belongs to the arthromyodynia category, and body is under the situation of QI and blood deficiency, and the blood vessels meridians are checked in wind, the three evil merging invasion and attack of trembling with fear, wet, and QI-blood circulation is not freely caused a disease.Show as that muscles and bones, muscle, joint are tingle, the symptom of QI and blood obturation such as distending pain and joint stuffiness.If arthromyodynia is prolonged for a long time and is not healed, then invade the whole body connective tissue, influence other organ dysfunction.According to the proved recipe of long-term clinical application, with this disease of traditional Chinese medical herbal treatment, studied successfully treating both the principal and secondary aspects of a disease, determined curative effect, toxic and side effects is little, and low-cost Chinese medicine preparation oral medicinal liquor is subjected to patient's welcome deeply.
This product has the effect of blood circulation promoting and blood stasis dispelling, wind-expelling pain-stopping, dispelling cold and removing dampness, channels sootheing and network vessel quickening.Its preparation method is: selected Chinese medicinal material, remove impurity, pulverizing medicinal materials is become coarse powder, immersion, filters, staticly settles, fine straining, finished product packing, seals, packs.Prescription is considered from human body integral, adopts dialectical executing to control, in line with the principle for the treatment of both the principal and secondary aspects of a disease, and the wine assisting drug medicament curative effect enhancement.Compare with the medicine of existing treatment rheumatic arthritis, have short treating period, instant effect, cure rate height, total effective rate and reach 91%, have no side effect and characteristics that price is low.Because of be the medicated wine taking convenience, absorb easily, the patient easily accepts, is convenient to preserve, not perishable, help suitability for industrialized production.
Description of drawings
Accompanying drawing is a medicated wine preparation technology flow chart of the present invention.
The specific embodiment
Medicated wine Chinese medicine of the present invention consists of:
Ramulus Cinnamomi 750g, Radix Achyranthis Bidentatae 750g, Rhizoma Homalomenae 546g, Cortex Eucommiae 750g, Cortex schizophragmatis integrifolii radicis 564g, Cortex Cinnamomi 376g, Herba Epimedii 750g, Radix Aconiti Lateralis Preparata 376g, Myrrha 564g, Semen Strychni (processed) 188g, Fructus Chaenomelis 564g, Pheretima 564g, Herba Ephedrae 938g, Radix Angelicae Sinensis 564g, Semen Cuscutae 564g, Radix Glycyrrhizae 564g.
Get above 16 flavor Chinese crude drugs merging and be ground into coarse powder, be immersed in the percolation vat, stir every day 1~2 time, soaked for 2 weeks with Chinese liquor an amount of (Chinese liquor is the submergence medicine at least), filter, filtrate is added Chinese liquor to 50000ml, stirs well placement, filters, be sub-packed in the 10ml ampoule, seal, packing, promptly.
The efficacy result of medicated wine treatment rheumatic arthritis patient 400 examples of the present invention is reported as follows:
(1) case selection and grouping: diagnostic criteria is a diagnosis basis according to " the new Chinese medicine clinical research guideline " that Ministry of Health of the People's Republic of China 1993 formulates, totally 400 routine patients, male 190 examples, women 210 examples; The oldest person 61 years old, reckling 18 years old; Average 38 years old.Take turns outpatient service by 2 doctors case is divided into Chinese medicinal liquor group and matched group each 200 examples, two groups age and sex there was no significant difference at random.
(2) contrast Therapeutic Method:
The matched group medication:
The oral indometacin tablets 25mg of routine dose, prednisone 10mg, one day three times.
The medication of Chinese medicinal liquor group:
Take Chinese medicinal liquor, one day three times, each 10mL, treatment was observed 30 days altogether, and therapeutic outcome sees the following form.
" new Chinese medicine clinical research guideline " the 212nd page of curative effect determinate standard that curative effect determinate standard was formulated according to Ministry of Health of the People's Republic of China in 1993.
Table: medicated wine treatment group and treatment of control group arthritis curative effect be (n=200) relatively
Figure GSB00000450577200071
Annotate: learn by statistics and handle, two group differences have significance meaning (P<0.05).
(4) conclusion: medicated wine treatment group is compared with matched group, and arthritic therapeutic effect is had notable difference.Particularly, be fit to take for a long time, and that hormone medicine and indomethacin are taken toxic and side effects for a long time is big, causes patient to tolerate and abandoning cure or use Chinese medicine preparation instead because medicated wine is pure Chinese medicinal preparation.
Tradition motherland medical science thinks that rheumatism belongs to the arthromyodynia category, and body is under the situation of QI and blood deficiency, and the blood vessels meridians are checked in wind, the three evil merging invasion and attack of trembling with fear, wet, and QI-blood circulation is not freely caused a disease.Show as that muscles and bones, muscle, joint are tingle, the symptom of QI and blood obturation such as distending pain and joint stuffiness.If arthromyodynia is prolonged for a long time and is not healed, then invade the whole body connective tissue, influence other organ dysfunction.Oral medicinal liquor provided by the invention is a Chinese medicine preparation, and this preparation is mainly used in treatment rheumatic arthritis, has the effect of blood circulation promoting and blood stasis dispelling, wind-expelling pain-stopping, dispelling cold and removing dampness, channels sootheing and network vessel quickening.
At the cause of disease and the symptom of rheumatic arthritis, Semen Strychni (processed) removing obstruction in the collateral to relieve pain in this oral medicinal liquor prescription, mass dissipating and swelling eliminating; Ramulus Cinnamomi, Cortex Cinnamomi, Herba Ephedrae, Radix Aconiti Lateralis Preparata can pursue wind, promoting the flow of QI-blood by warming the meridian by cold expelling; Radix Achyranthis Bidentatae, Rhizoma Homalomenae, Semen Cuscutae, Herba Epimedii, Cortex Eucommiae invigorating the liver and kidney, bone and muscle strengthening, wind-expelling pain-stopping; Radix Angelicae Sinensis, Pheretima blood circulation promoting and blood stasis dispelling, all medicine compatibilities have synergism.Be the needs of clinical treatment, this Chinese medicine preparation is mixed with a kind of taking with easy to carry, stable in properties, quality controllable, have no side effect, safe and effective, the Chinese medicine medicated wine that welcome by the patient, and be suitable for suitability for industrialized production.

Claims (2)

1. oral medicinal liquor for the treatment of rheumatic arthritis is characterized in that Chinese medicine with following weight parts soaks to make in proper amount of white spirit:
Ramulus Cinnamomi 750 ± 70, Radix Achyranthis Bidentatae 750 ± 70, Rhizoma Homalomenae 546 ± 50, the Cortex Eucommiae 750 ± 70, Cortex schizophragmatis integrifolii radicis 564 ± 50, Cortex Cinnamomi 376 ± 30, Herba Epimedii 750 ± 70, Radix Aconiti Lateralis Preparata 376 ± 30, Myrrha 564 ± 50, Semen Strychni (processed) 188 ± 20, Fructus Chaenomelis 564 ± 50, Pheretima 564 ± 50, Herba Ephedrae 938 ± 90, Radix Angelicae Sinensis 564 ± 50, Semen Cuscutae 564 ± 50, Radix Glycyrrhizae 564 ± 50.
2. the oral medicinal liquor of treatment rheumatic arthritis according to claim 1 is characterized in that Chinese medicine with following weight parts soaks to make in proper amount of white spirit:
Ramulus Cinnamomi 750, Radix Achyranthis Bidentatae 750, Rhizoma Homalomenae 546, the Cortex Eucommiae 750, Cortex schizophragmatis integrifolii radicis 564, Cortex Cinnamomi 376, Herba Epimedii 750, Radix Aconiti Lateralis Preparata 376, Myrrha 564, Semen Strychni (processed) 188, Fructus Chaenomelis 564, Pheretima 564, Herba Ephedrae 938, Radix Angelicae Sinensis 564, Semen Cuscutae 564, Radix Glycyrrhizae 564.
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CN102935154A (en) * 2012-12-06 2013-02-20 冷凤珍 Traditional Chinese medicinal preparation for treating lumbar disc herniation
CN108815327A (en) * 2018-09-18 2018-11-16 朱志合 The externally applied ointment and preparation method thereof for treating rheumatic waist-leg pain prolapse of lumbar intervertebral disc osteoproliferation

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