CN105343389B - A kind of drug for the treatment of of arthritis - Google Patents
A kind of drug for the treatment of of arthritis Download PDFInfo
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- CN105343389B CN105343389B CN201510766820.6A CN201510766820A CN105343389B CN 105343389 B CN105343389 B CN 105343389B CN 201510766820 A CN201510766820 A CN 201510766820A CN 105343389 B CN105343389 B CN 105343389B
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses drug of a kind for the treatment of of arthritis and preparation method thereof, the drug includes: Kadsura Root-bark 300-700 parts by weight；Fruit of negundo 300-700 parts by weight；Cape jasmine 100-200 parts by weight；Cortex moutan 50-150 parts by weight；Rheum officinale 100-300 parts by weight；Vomiting nut 100-200 parts by weight；Radix paeoniae rubra 50-150 parts by weight；Radix Angelicae Pubescentis 50-150 parts by weight；Cortex acanthopanacis 50-150 parts by weight；Rhizoma arisaematis 50-150 parts by weight；Camphor 50-150 parts by weight；Menthol 20-50 parts by weight；Wintergreen 50-150 parts by weight.The present invention simplifies flavour of a drug, camphor is added simultaneously, the Transdermal absorption of two taste medicine of menthol increase Traditional chinese medicine medicament plays a role locally, it will be controlled outside Traditional Chinese Medicine in conjunction with modern percutaneous technique, form herbal penetration therapy system, toxic side effect is small, and there are also certain pharmacological activity for some, and curing the disease and promoting two kinds of effects is combined into one, and meets the trend of current back to nature.
Description
Technical field
The present invention relates to a kind of Chinese medicine more particularly to a kind of drugs for the treatment of of arthritis.
Background technique
Osteoarthritis (ostarthritis, OA) is caused by a kind of retrogression pathological changes because of articular cartilage with hyperostosis
The raw arthropathy mainly to show, is the common disease of the middle-aged and the old, knee osteoarthritis is clinical onset in Osteoarthritis
The highest one kind of rate.With the extension of human longevity, the aging of social population, disease incidence is risen year by year.
Doctor trained in Western medicine still lacks effective clinically to the treatment of the disease in addition to suiting the medicine to the illness, alleviating symptom and row prosthetic replacement
Method.Current doctor trained in Western medicine there is no specific treatment in terms of symptomatic treatment, can mostly cause by non-steroidal drug long-term use more tight
The side effect of weight, including gastric ulcer, gastrorrhagia, very then hepatorenal damage etc., and surgical operation is costly, suffered pain and wound compared with
More, patient compliance is poor.
Osteoarthritis belongs to Chinese medicine " heumatism ", " knee numbness " scope, and the traditional Chinese medical herbal treatment disease has unique advantage, and Chinese medicine can
Improve local microcirculation, reduce intrabony pressure, generation that is anti-oxidant and inhibiting free radical, the production for reducing Osteoarthritis cell factor
It is raw etc..External treatment of tcm in Chinese traditional treatment can make direct stimulation of the affected part part by drug and physics, keep the efficacy of a drug through
Sick institute, treatment have more specific aim.Have the characteristics that simple and easy to do, economical and practical, Small side effects.Especially external treatment with Chinese medicine therapy.
External treatment of traditional Chinese medicine generally has local reaction sexual stimulus and drug effect double action, and institute's dosage is much smaller than dose for oral administration, passes through trouble
Sick part directly absorbs and plays a role, and can avoid toxic action of the drug to internal organs such as liver kidney and taste.It is especially empty to old children
Weak body is attacked and is mended when difficulty applies, or the patient that be unwilling to be taken medicine, or the illness that cannot be taken medicine, more suitable.But treatment bone at present
In arthritic effective Chinese medicine, drug component is excessive, is unfavorable for the production and application of drug；And it frequently can lead to itch, skin
The skin allergy symptom such as rash.
Summary of the invention
The present invention provides a kind of Chinese medicines for the treatment of of arthritis, and component is relatively fewer, are ensuring good therapeutic effect
In the case of, simplify drug composition.
First aspect of the present invention is to provide a kind of drug for the treatment of of arthritis, and active constituent includes and preferably constitutes are as follows:
A) crude drug part:
Kadsura Root-bark 300-700 parts by weight, more preferably 400-600 parts by weight, more preferably 450-500 parts by weight；Five-leaved chaste tree
Sub- 300-700 parts by weight, more preferably 400-600 parts by weight, more preferably 450-500 parts by weight；Cape jasmine 100-200 weight
Part, more preferably 120-180 parts by weight, more preferably 150-170 parts by weight；Cortex moutan 50-150 parts by weight, more preferably 60-
130 parts by weight, more preferably 80-100 parts by weight；Rheum officinale 100-300 parts by weight, more preferably 150-250 parts by weight, more preferably
For 180-200 parts by weight；Vomiting nut 100-200 parts by weight, more preferably 120-180 parts by weight, more preferably 150-160 weight
Part；Radix paeoniae rubra 50-150 parts by weight, more preferably 60-130 parts by weight, more preferably 80-100 parts by weight；Radix Angelicae Pubescentis 50-150 weight
Part, more preferably 60-130 parts by weight, more preferably 80-100 parts by weight；Cortex acanthopanacis 50-150 parts by weight, more preferably 70-
130 parts by weight, more preferably 100-120 parts by weight；Rhizoma arisaematis 50-150 parts by weight, more preferably 70-130 parts by weight, it is more excellent
It is selected as 100-120 parts by weight；
B) fines medicine part:
Camphor 50-150 parts by weight, more preferably 70-130 parts by weight, more preferably 100-120 parts by weight；Menthol 20-
50 parts by weight, more preferably 25-45 parts by weight, more preferably 30-40 parts by weight；Wintergreen 50-150 parts by weight, more preferably
60-120 parts by weight, more preferably 80-100 parts by weight.
Wherein, the drug can also include dressing, such as: preservative, matrix.
Wherein, the preservative such as sodium benzoate.
Wherein, preservative preferably≤8 parts by weight, more preferably≤7 parts by weight, more preferably 2-6 parts by weight, more preferably
For 3-5 parts by weight, more preferably 4.5-5 parts by weight.
Wherein, the matrix such as vaseline, liquid paraffin, lanolin, beeswax, animal oil, vegetable oil, single hard acid glycerol
Ester, octadecyl alcolol or in which any several mixture.
Wherein, the matrix is preferably 800-1500 parts by weight, more preferably 900-1400 parts by weight, more preferably
1000-1300 parts by weight, more preferably 1100-1200 parts by weight.
It is highly preferred that the matrix includes lanolin and vaseline.
Wherein, lanolin is preferably 80-150 parts by weight, more preferably 100-130 parts by weight, more preferably 110-120 weight
Measure part.
Wherein, vaseline is preferably 800-1400 parts by weight, more preferably 900-1300 parts by weight, more preferably 1000-
1200 parts by weight.
In a kind of preferred embodiment of first aspect of the present invention, the drug is preferably external preparation, such as pulvis, molten
It is liquid, tincture, lotion, ointment, emulsifiable paste, paste, plaster (patch), finish, gelling agent, plastics, liniment, any in spray
One or more, can be preferably ointment, emulsifiable paste, paste, plaster, any one or a few in gelling agent, more preferably soft
Paste.
The second aspect of the present invention is to provide a kind of preparation method of the drug for the treatment of of arthritis, comprising:
The component of A) crude drug part is added water to cook, decocting liquid is collected, is precipitated with alcohol, supernatant is taken to be concentrated, obtain clear cream；
By B) fines medicine component or further include that dressing composition is added in clear cream, mixes.
In a kind of preferred embodiment of the second aspect of the present invention, the decocting method is preferred are as follows:
The component of A) crude drug part water is decocted twice, each 10 times of weight waters, decocting time is at least 0.5h (more
Preferably 45 minutes, more preferably 1 hour, more preferably 1.5 hours)；Collect the medical fluid decocted twice and merging.More preferably
Ground, the medical fluid after merging are concentrated, and at least 1.5g crude drug/ml, more preferably at least 2.0g crude drug/ml are preferably concentrated into.
It is highly preferred that being impregnated before decocting for the first time.
It is highly preferred that it is 1.20-1.25g/cm that the supernatant, which is concentrated into relative density,3(50℃-60℃)。
Wherein, B) fines component is added in blending process, is preferably implemented at≤50 DEG C, more preferably≤40 DEG C at
Implement.
The present invention simplifies flavour of a drug, while the Transdermal absorption of camphor, two taste medicine of menthol increase Traditional chinese medicine medicament is added in part
It plays a role, will be controlled outside Traditional Chinese Medicine in conjunction with modern percutaneous technique, form herbal penetration therapy system, lanolin can absorb
Moisture in clear cream improves the water imbibition and penetrability of vaseline, and this kind of transdermal enhancer comes naturally, toxic side effect is small, Er Qieyou
There are also certain pharmacological activity, curing the disease and promoting two kinds of effects is combined into one, and meets the trend of current back to nature.
The present invention cures mainly function: it is promoting blood circulation to remove blood stasis, removing toxicity for detumescence, expelling wind and eliminating dampness, inducing meastruation to relieve menalgia, local organization can be increased
Blood circulation, temperature are got round by bribery, local muscle of loosening, ligament contracture, increase mobility, are eliminated swelling, are promoted the extensive of function of joint
It is multiple.It is mainly used for knee osteoarthritis.
Specific embodiment
Crude drug component
Fines medicine component
Camphor 100g menthol 40g wintergreen 150g
Camphor, menthol are ground into congruent melting.
Dressing composition
Sodium benzoate 4.58g lanolin 114.5g vaseline about 1000g
Medicine preparation
Crude drug component 2000g is taken, is added water to cook 2 times, 10 times of water, decoction 1h, decocting time start timing to boil every time,
Decoction process keeps slightly boiled.0.5h is impregnated before decocting for the first time.
300 mesh filter clothes filter after decocting every time, and secondary decocting liquid merges, and being concentrated under reduced pressure into 2:1, (g:mL, i.e., every mL are equivalent to
Crude drug 2g).
It is cooled to room temperature, 1 times of ethyl alcohol is added to be precipitated, stand for 24 hours, ethyl alcohol is recovered under reduced pressure to relatively close in leaching supernatant
Degree is 1.20-1.25 (50 DEG C -60 DEG C), obtains clear cream, generally 400-600g.
Temperature is controlled at 40 DEG C hereinafter, qinghuo reagent addition sodium benzoate mixing, sequentially adds lanolin, vaseline, camphor
It mixes, dispenses with menthol eutectic, wintergreen to obtain the final product.
Clinical test
1, data and method
1.1, clinical data
The diagnostic criteria about knee osteoarthritis is proposed in nineteen ninety-five referring to U.S.'s rheumatism institute, is selected 2012 1
Patients with Knee Osteoarthritis 152 to go to a doctor-in December, 2013 of the moon are research object.Patient is randomly divided into three groups, of the present invention group
52, the yellow three color groups of Shi Shi tri- with shangshi zhitong plaster, shangshi zhitong gao group each 50.Wherein of the present invention group (hereinafter referred to as " Costumes numbness group ") male
12, women 40, average age (60.92 ± 7.13) year, average course of disease (89.10) day；The yellow three color groups of Shi Shi tri- are (following
Referred to as " three colour cells ") male 13, women 37, average age (60.72 ± 9.03) year, average course of disease (79.38) day；Affection by dampness
Pain relieving ointment group (hereinafter referred to as " affection by dampness group ") male 17, women 33, average age (61.82 ± 10.60) year, average course of disease
(60.52) day.Through data detection, three groups are not statistically significant in gender, age, course of disease comparing difference, be it is balanced, have can
Compare property.Three groups of 152 cases are completed whole clinical observations, do not have and fall off.
1.2, treatment method
Costumes numbness group: being applied with, one every time, every dressing on the 2nd 1 time with ointment of the present invention, is affixed on pain affected part, and external application elasticity is taut
Band is fixed, and 2 weeks are 1 course for the treatment of.
Three colour cells: it is applied with the yellow Sanse ointment of Shi Shi tri-, one every time, every dressing on the 2nd 1 time, is affixed on pain affected part, external application
Elastoplast is fixed, and 2 weeks are 1 course for the treatment of.
Affection by dampness group: it is applied with shangshi zhitong plaster, shangshi zhitong gao (Huangshi medicine company, severity shown by an official on assuming office board), 2 every time, daily dressing 1 time is affixed on pain
Pain affected part, 2 weeks are 1 course for the treatment of.
Three groups of patients treat 15 days.
1.3, observation index and evaluation criterion
Observation index: arthralgia, get up after morning stiffness, walking when pain, maximum walking distance, stair activity feel, under
Crouching, the uneven road feel feel of row, tenderness, kneecap mobility, range of motion, swelling, adverse reaction and general curative effect, refer to each observation
Mark carries out Quantitative marking.The knee osteoarthritis seriousness and activity index Evaluation Method of reference Lequesne is in 5d, 10d, 15d
It observes, records the variation of corresponding sign and symptom (see Table 1 for details).
Efficacy assessment standard: pretherapy and post-treatment efficacy evaluation is carried out according to knee OA clinical score table.
Improvement rate=[(score value after score value-treatment before treating)/score value before treating] * 100%.
Improvement rate >=70% is excellent；>=50%,<70% is good；>=30%,<50% is can；< 30% is poor.
Safety evaluatio: the adverse reaction of externally applied ointment is mainly skin irritation reaction, may be gone out in therapeutic process
Existing adverse reaction, such as erythema, oedema, itch carry out detailed record strictly according to the facts, and analyze its reason, local skin
Skin irritative response standards of grading.
Table 1, Lequesne knee OA clinical score table
1.4, statistical method
All inspections are all made of two-sided test, think that difference is statistically significant with P≤0.05.1. measurement data: if
Data Normal Distribution, statistics description use mean ± standard deviationIt indicates, comparison among groups use single factor test variance
Analysis and SNK examine Multiple range test；If data disobey normal distribution, statistics description uses median (M), minimum value
(min) it is indicated with maximum value (max), comparison among groups are examined using Kruskal-Wallis H and Nemenyi method Multiple range test；Group
Interior comparison is examined using Wilcoxon.2. enumeration data: statistics description is using frequency, composition ratio, rate expression, analysis indexes two
When classification or unordered more classification, comparison among groups are using Chi-square Test and segmentation Chi-square Test；When analysis indexes are orderly more classification,
Comparison among groups are examined using Kruskal-Wallis H and Nemenyi method Multiple range test；The grade of multiple time point duplicate measurements
Data is analyzed using Generalized estimating equation.If three groups are compared, difference is statistically significant, and Multiple range test uses
Bonferroni method corrects α.
2, result
2.1, pretherapy and post-treatment clinical indexes scoring is compared
The pretherapy and post-treatment clinical indexes of three groups of patients --- arthralgia, get up after morning stiffness, walking when pain, maximum
Walking distance, stair activity feel, squat down, goes uneven road feel feel, tenderness, kneecap mobility, range of motion and swelling, except not
Good reaction scoring is outer, and each clinical indexes group difference is statistically significant (P < 0.001), each clinical observation of different therapy
Index scoring is different, and each clinical indexes show the curative effect of Costumes numbness group better than remaining two groups.Meanwhile three groups of each interview times
Think that group difference is statistically significant (P < 0.001) compared with each clinical indexes scoring before treatment, different therapy it is each
Clinical indexes scoring is different, and with the extension for the treatment of time, each clinical indexes scoring has the tendency that lower and lower.Three
Adverse reaction a situation arises the not statistically significant (χ of comparing difference after group patient's treatment2=4.229, P=0.121), Shang Buneng recognizes
Adverse reaction rate is different after treating for three groups of patients.
2.2, curative effect compares after treating
Three groups of statistically significant (χ of patients after curative treatment's comparing difference2=7.868, P=0.020 < 0.05), it can recognize
It is different for three groups of patients after curative treatment.Compared two-by-two through Nemenyi method, Costumes numbness group compared with affection by dampness group P=0.035,
Costumes numbness group P=0.088, affection by dampness group P=0.930 compared with three colour cells compared with three colour cells, it is believed that after Costumes numbness group patient treatment
Curative effect is better than affection by dampness group and three colour cells (see Table 2 for details).
Table 2, three groups of patients after curative treatment compare
3, it discusses
3.1, this researches show that:
The pretherapy and post-treatment every clinical indexes of three groups of patients, in addition to adverse reaction scoring, each group difference that scores has
Comparativity, each clinical indexes show the curative effect of Costumes numbness group better than remaining two groups.Illustrate that Costumes numbness is hurt cream and faced patient is various
Improvement in terms of bed symptom is more preferable compared with yellow three colors of Shi Shi tri- and shangshi zhitong plaster, shangshi zhitong gao.But three groups of patients are in adverse reaction side
Comparativity is not present in face scoring, therefore the adverse reaction rate between must not believe that three groups is variant.Illustrate clinically to use Costumes numbness
The safety for hurting cream treatment knee osteoarthritis is identical as yellow three colors of Shi Shi tri-, shangshi zhitong plaster, shangshi zhitong gao.
3.3, yellow three colors of traditional shangshi zhitong plaster, shangshi zhitong gao, Shi Shi tri- and Costumes numbness hurt cream
The severity shown by an official on assuming office board Shangshi Zhitong liquid extraction of Huangshi medicine company production is by Radix Aconiti Kusnezoffii, Radix Aconiti, olibanum, myrrh, raw Strychnos nux-vomica
The medicinal materials such as son, cloves, cortex cinnamomi, schizonepeta, radix saposhnikoviae, geranium wilfordii, cortex periplocae, centella, the rhizome of davallia, the root of Dahurain angelica, kaempferia galanga, rhizoma zingiberis, cooperation
Gaultherolin, menthol, borneol, camphor, liguidamber resinoid, belladonna liquid extract are made.There are wind-damp dispelling, the work of promoting blood circulation and stopping pain
With.It is mainly used for rheumatalgia, joint, courbature, the diseases such as strain.But this product is only the Symptomatic medicine of local pain, and unsuitable
Long-term or large area uses, and improper use easily causes the skin allergy symptom such as itch, fash；These deficiencies all limit its hair
Exhibition.
Sanse ointment is the famous externally applied drug of Shi school traumatology, can increase local organization by the direct therapeutic effect of drug
Blood circulation, temperature gets round by bribery, local muscle of loosening, ligament contracture, increases mobility, eliminates swelling, promotes function of joint
Restore, knee osteoarthritis is had a better effect.But Sanse ointment still comes with some shortcomings in use, mainly medicine
Taste is various, and only crude drug just amounts to 47 tastes, and configuration is inconvenient, while also increasing a possibility that patient is to drug anaphylaxis, thus
Limit his clinical application.
There is external-applied ointment of the present invention after being simplified to drug and being improved to preparation promoting blood circulation to remove blood stasis, removing toxic substances to disappear
The benefits of swollen, inducing meastruation to relieve menalgia, at the same be equipped with rheum officinale, radix paeoniae rubra enhances the function of its anti-inflammatory antispastic, dispelling stasis of blood and stimulating the menstrual flow, assistant with Radix Angelicae Pubescentis, cortex acanthopanacis,
Unprocessed Arisaema erubescens are the effect of taking its expelling wind and eliminating dampness, antispastic analgesic, strengthening the muscles and bones.Most importantly on this basis, add
Camphor, two medicine of menthol make remaining Chinese medicine efficiency preferably enter muscle channels and collaterals by table by the function of its infiltration, reach mitigation not
The suitable purpose for releasing pain.
Specific embodiments of the present invention are described in detail above, but it is merely an example, the present invention is simultaneously unlimited
It is formed on particular embodiments described above.To those skilled in the art, any couple of present invention carries out equivalent modifications and
Substitution is also all among scope of the invention.Therefore, without departing from the spirit and scope of the invention made by equal transformation and
Modification, all should be contained within the scope of the invention.
Claims (5)
1. a kind of drug for treating knee osteoarthritis, which is characterized in that active constituent are as follows:
A) crude drug part:
Kadsura Root-bark 300-700 parts by weight；Fruit of negundo 300-700 parts by weight；Cape jasmine 100-200 parts by weight；
Cortex moutan 50-150 parts by weight；Rheum officinale 100-300 parts by weight；Vomiting nut 100-200 parts by weight；
Radix paeoniae rubra 50-150 parts by weight；Radix Angelicae Pubescentis 50-150 parts by weight；Cortex acanthopanacis 50-150 parts by weight；
Rhizoma arisaematis 50-150 parts by weight；
B) fines medicine part:
Camphor 50-150 parts by weight；Menthol 20-50 parts by weight；Wintergreen 50-150 parts by weight；
Wherein, the drug further includes preservative and matrix, and the preservative is sodium benzoate, and≤8 parts by weight；The matrix
Including lanolin and vaseline, and lanolin is 80-150 parts by weight, and vaseline is 800-1400 parts by weight；
Wherein, the drug is external preparation.
2. drug according to claim 1, which is characterized in that the drug be pulvis, tincture, lotion, ointment, emulsifiable paste,
Paste, plaster, finish, gelling agent, plastics, liniment, any one or a few in spray.
3. treating the preparation method of the drug of knee osteoarthritis described in a kind of claim 1, comprising:
The component of A) crude drug part is added water to cook, decocting liquid is collected, is precipitated with alcohol, supernatant is taken to be concentrated, obtain clear cream；
B) fines medicine component, preservative and matrix are added in clear cream, mixed.
4. according to the method described in claim 3, it is characterized in that, by B) fines component is added in blending process, at≤50 DEG C
Lower implementation.
5. according to the method described in claim 3, it is characterized in that, the supernatant is concentrated under conditions of 50 DEG C -60 DEG C
Relative density is 1.20-1.25g/cm3。
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| CN101167937A (en) * | 2007-10-15 | 2008-04-30 | 辽宁好护士药业（集团）有限责任公司 | Traditional Chinese medicinal composition plaster for curing rheumatism or rheumatoid diseases and preparation method thereof |
| CN101612220A (en) * | 2009-07-21 | 2009-12-30 | 杭州市中医院 | External-application cream of treatment osteoarthritis and preparation method thereof |
| CN103735765A (en) * | 2014-01-09 | 2014-04-23 | 贵州康琦药械有限公司 | Plaster for activating collaterals and relieving pain and preparation method thereof |
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