CN106266821A - A kind of compositions treating rheumatoid arthritis and solid preparation thereof and preparation method - Google Patents
A kind of compositions treating rheumatoid arthritis and solid preparation thereof and preparation method Download PDFInfo
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- CN106266821A CN106266821A CN201610417635.0A CN201610417635A CN106266821A CN 106266821 A CN106266821 A CN 106266821A CN 201610417635 A CN201610417635 A CN 201610417635A CN 106266821 A CN106266821 A CN 106266821A
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Abstract
The present invention provides a kind of compositions treating rheumatoid arthritis, said composition is mainly by Herba Leonuri, Herba speranskiae tuberculatae, Herba Agrimoniae, the crude drug compositions such as Caulis Sinomenii, and also provide the solid preparation containing said composition and preparation method, said composition has good effect to treatment rheumatoid arthritis, play expelling wind and removing dampness, removing obstruction in the collateral to relieve pain, mass dissipating and swelling eliminating, diuresis, promoting blood circulation and stopping pain, effect of dampness the kidney invigorating, rheumatoid arthralgia pain can be treated, the arthroncus of knee, arthrodynia of extremities, numb, numbness fistula card etc., there is analgesia, antiinflammatory, detumescence, diuresis, blood pressure lowering, arrhythmia, histamine releasing, regulation immunity, excited spinal nerves reflection function, improve cerebral cortex sensory centre.Body nonspecific immunity, cellular immunization and humoral immunization are all had inhibitory action, particularly can substantially eliminate rheumatoid factor.
Description
Technical field
The invention belongs to the field of Chinese medicines, particularly to a kind of compositions treating rheumatoid arthritis and solid preparation thereof and
Preparation method.
Background technology
Rheumatoid arthritis is clinical common swells and ache the systemic autoimmune disease being characterized with periphery Minor articulus,
Being caused autoimmune function disorderly by factor inductions such as infection, gene mutation, T, bone-marrow-derived lymphocyte immunne response increase to main disease
Reason mechanism, the immunne response at periphery local joint causes joint to produce synovial membrane inflammation, shows as red and swollen heat pain and function of joint
Obstacle.The environment such as cold, moist can induce this disease.Clinical manifestation is: many onsets are slow, can have the migrans pain of extremity Minor articulus
Bitterly, the joint, position such as later wrist, elbow, knee ankle joint becomes big.During treating this disease, with Chinese medicine composition it is mainly
Only, such as pharmaceutical composition of a kind of rheumatic and rheumatoid and preparation method thereof disclosed in CN1650923, its be by the Radix Astragali, Radix Angelicae Sinensis,
Scalding, Radix Aconiti etc. 60 taste crude drug composition；The and for example Chinese patent medicine of CN104435926 disclosed treatment rheumatic Bi syndrome, its be by
Caulis Trachelospermi, Rhizoma Smilacis Chinensis etc. 10 taste crude drug be prepared from；One disclosed in CN103893639 treats rheumatic rheumatoid arthritis
Chinese medicine composition, it becomes to be grouped into by Caulis Sinomenii, Caulis Trachelospermi, Radix Angelicae Sinensis etc., etc..Disclosed in prior art, compositions is many
Several therapeutic effect to rheumatoid arthritis are not notable, and Relapse rate outbreak, unsatisfactory curative effect.
Summary of the invention
In order to solve above-mentioned technical problem, the present invention provides a kind of compositions treating rheumatoid arthritis, said composition
There is effect of the highest treatment rheumatoid arthritis.
The concrete technical scheme of the present invention is as follows:
The present invention provides a kind of compositions treating rheumatoid arthritis, and said composition is mainly by the raw material of following weight portion
It is prepared from:
The present invention is drawn by substantial amounts of test, uses 22 group of being prepared from of taste raw material of Chinese medicine medicine such as Herba Leonuri, Rhizoma Smilacis Chinensis
Compound has good effect to treatment rheumatoid arthritis, plays expelling wind and removing dampness, removing obstruction in the collateral to relieve pain, mass dissipating and swelling eliminating, diuresis, work
Blood and relieving pain, effect of dampness the kidney invigorating, can treat rheumatoid arthralgia pain, the arthroncus of knee, arthrodynia of extremities, numbness, numbness fistula card etc., have
Analgesia, antiinflammatory, detumescence, diuresis, blood pressure lowering, arrhythmia, histamine releasing, regulation spinal nerves reflection function immune, excited,
Improve cerebral cortex sensory centre.Body nonspecific immunity, cellular immunization and humoral immunization are all had inhibitory action, particularly
Can substantially eliminate rheumatoid factor (RF).
Further improve, in the compositions of the treatment rheumatoid arthritis that the present invention provides raw materials used also include as follows
The composition of weight portion:
Semen Strychni (processed) 30-40 Radix Notoginseng 30-40.
After the present invention adds above-mentioned 2 kinds of compositions in the composition, not only further increase treatment rheumatoid arthritis
Effect, it may also be used for treatment trigeminal neuralgia.
Preferably, in the compositions for the treatment of rheumatoid arthritis, the parts by weight of each raw material are:
In order to carry and instant, compositions and adjuvant are made solid preparation by the present invention, and described solid preparation is glue
Wafer, pill, tablet, powder or granule；The ratio of weight and number of described compositions and adjuvant is 1:0.5-1.8.
Wherein, solid preparation is preferably capsule.
Further improve, the adjuvant in capsule include weight portion be the maltose alcohol of 1.5-3 part, weight portion be 0.2-
The sodium palmitate of 0.5 part and the polyoxyethylene alkyl ether that weight portion is 2-5 part.The present invention can by adding above-mentioned 3 kinds of adjuvants
Form microsphere with compositions, it is possible to increase the stability of capsule, the effect of slow release can be played simultaneously；And activity can also be promoted
The absorption of composition.
Further improving, described adjuvant also includes the poly-of pregelatinized starch that weight portion is 0.5-2 part and 0.1-0.3 part
Methyl methacrylate.By adding pregelatinized starch and the mixture of polymethyl methacrylate in adjuvant, not only play
The effect of lubrication, has simultaneously facilitated the mixing of each composition, it is ensured that the content uniformity of compositions.
Further improving, described adjuvant also includes stearic palmitamide and the glue of 0.2-0.5 part that weight portion is 1-2 part
State silicon dioxide.Make the capsule can be in 10min by adding the mixture of stearic palmitamide and colloidal silica
All disintegrates, improve disintegration.
Another aspect of the present invention additionally provides the preparation method of compositions, and described method comprises the steps:
1) it is the Rhizoma Smilacis Chinensis of 20-30 part, the Caulis Trachelospermi of 10-35 part, 100-150 part by Semen Strychni (processed), Radix Notoginseng and weight portion
Caulis Sinomenii, the Rhizoma Anemarrhenae of 20-30 part, the Radix Paeoniae Alba (parched) of 25-35 part are pulverized, and prepare medicated powder, standby；
2) Rhizoma Smilacis Chinensis of residuals weight part, Caulis Trachelospermi, Caulis Sinomenii, the Rhizoma Anemarrhenae, Radix Paeoniae Alba (parched) and remaining raw material are joined 1000-
The yellow wine of 15000mL decocts, decocts 3 times, filter respectively, merging filtrate, concentrate, prepare thick paste；
3) by step 1) medicated powder and the step 2 that prepare) the thick paste mixing for preparing, it is dried, crosses 100 mesh sieves, obtain compositions.
The compositions prepared by above method has the effect higher treating rheumatoid arthritis.
The compositions that the present invention provides is mainly used in treating rheumatoid arthritis.
The compositions of the treatment rheumatoid arthritis that the present invention provides can expelling wind and removing dampness, removing obstruction in the collateral to relieve pain, mass dissipating and swelling eliminating, profit
Urine, promoting blood circulation and stopping pain, dampness the kidney invigorating, can treat rheumatoid arthralgia pain, the arthroncus of knee, arthrodynia of extremities, numbness, numbness fistula card etc., tool
There are analgesia, antiinflammatory, detumescence, diuresis, blood pressure lowering, arrhythmia, histamine releasing, regulation spinal nerves immune, excited reflection merit
Can, improve cerebral cortex sensory centre.Body nonspecific immunity, cellular immunization and humoral immunization all there is inhibitory action.Face
Bed is used for treating rheumatoid arthritis, rheumatic arthritis, limbs joint pain, cerebrovascular sequelae and trigeminal neuralgia,
There is obvious curative effects, particularly can substantially eliminate rheumatoid factor (RF).
Detailed description of the invention
Embodiment 1
A kind of compositions treating rheumatoid arthritis, said composition is grouped into by the one-tenth of following weight:
Embodiment 2
A kind of compositions treating rheumatoid arthritis, said composition is grouped into by the one-tenth of following weight:
Embodiment 3
A kind of compositions treating rheumatoid arthritis, said composition is grouped into by the one-tenth of following weight:
The preparation method of described compositions:
1) it is the Rhizoma Smilacis Chinensis of 20-30 part, the Caulis Trachelospermi of 10-35 part, the Caulis Sinomenii of 100-150 part, 20-30 part by weight portion
The Rhizoma Anemarrhenae, the Radix Paeoniae Alba (parched) of 25-35 part are pulverized, and prepare medicated powder, standby；
2) Rhizoma Smilacis Chinensis of residuals weight part, Caulis Trachelospermi, Caulis Sinomenii, the Rhizoma Anemarrhenae, Radix Paeoniae Alba (parched) and remaining raw material are joined 1000-
The yellow wine of 15000mL decocts, decocts 3 times, filter respectively, merging filtrate, concentrate, prepare thick paste；
3) by step 1) medicated powder and the step 2 that prepare) the thick paste mixing for preparing, it is dried, crosses 100 mesh sieves, obtain compositions.
Embodiment 4
A kind of compositions treating rheumatoid arthritis, said composition is grouped into by the one-tenth of following weight:
Embodiment 5
A kind of compositions treating rheumatoid arthritis, said composition is grouped into by the one-tenth of following weight:
The preparation method of described compositions:
1) it is the Rhizoma Smilacis Chinensis of 20g, the Caulis Trachelospermi of 10g, the Caulis Sinomenii of 100g part, the knowing of 20g by Semen Strychni (processed), Radix Notoginseng and weight
Radix Paeoniae Alba (parched) female, 25g is pulverized, and prepares medicated powder, standby；
2) Rhizoma Smilacis Chinensis of residuals weight part, Caulis Trachelospermi, Caulis Sinomenii, the Rhizoma Anemarrhenae, Radix Paeoniae Alba (parched) and remaining raw material are joined 1000-
The yellow wine of 15000mL decocts, decocts 3 times, filter respectively, merging filtrate, concentrate, prepare thick paste；
3) by step 1) medicated powder and the step 2 that prepare) the thick paste mixing for preparing, it is dried, crosses 100 mesh sieves, obtain compositions.
Embodiment 6 capsule
The consumption of each composition of capsule is:
The preparation method of described capsule:
1) compositions is prepared according to the method for embodiment 3；
2) by compositions and maltose alcohol, it is dispersed in the dehydrated alcohol that weight portion is 30 parts, prepares dispersion liquid；Will
Dispersion liquid magnetic stirring apparatus is at 1000r min-1, stir at 5 DEG C, prepare suspension；By sodium palmitate and polyxyethylated
Ether adds in the dehydrated alcohol that weight portion is 10-30 part, stirs, and prepares oil phase；Suspension is added in oil phase,
1000r·min-1, stir at 5 DEG C, be spray-dried, then by petroleum ether three times, drying at room temperature, prepared particle size range is
The compositions microsphere of 15 μm；
3) compositions microsphere is filled in capsule shells, prepares capsule.
Embodiment 7 capsule
The consumption of each composition of capsule is:
Capsule is prepared according to the method for embodiment 6.
Embodiment 8 capsule
The consumption of each composition of capsule is:
The preparation method of described capsule:
1) compositions is prepared according to the method for embodiment 3；
2) by compositions and maltose alcohol, it is dispersed in the dehydrated alcohol that weight portion is 400 parts, prepares dispersion liquid；
By dispersion liquid magnetic stirring apparatus at 1000r min-1, stir at 5 DEG C, prepare suspension；By sodium palmitate and polyoxyethylene alkane
Base ether adds in the dehydrated alcohol that weight portion is 10-30 part, stirs, and prepares oil phase；Suspension is added in oil phase,
1000r·min-1, stir at 5 DEG C, be spray-dried, then by petroleum ether three times, drying at room temperature, prepared particle size range is
The compositions microsphere of 25 μm；
3) compositions is mixed homogeneously with pregelatinized starch and polymethyl methacrylate, prepare mixture；
4) mixture is filled in capsule shells, prepares capsule.
Embodiment 9 capsule
The consumption of each composition of capsule is:
Capsule is prepared according to the method for embodiment 8.
Embodiment 10 capsule
The consumption of each composition of capsule is:
The preparation method of described capsule:
1) compositions is prepared according to the method for embodiment 3；
2) by compositions and maltose alcohol, it is dispersed in the dehydrated alcohol that weight portion is 50 parts, prepares dispersion liquid；Will
Dispersion liquid magnetic stirring apparatus is at 1000r min-1, stir at 5 DEG C, prepare suspension；By sodium palmitate and polyxyethylated
Ether adds in the dehydrated alcohol that weight portion is 20 parts, stirs, and prepares oil phase；Suspension is added in oil phase, at 1000r
min-1, stir at 5 DEG C, be spray-dried, then by petroleum ether three times, drying at room temperature, prepared particle size range is 20 μm
Compositions microsphere；
3) compositions is mixed with pregelatinized starch, polymethyl methacrylate, stearic palmitamide and colloidal silica
Close uniformly, prepare mixture；
4) mixture is filled in capsule shells, prepares capsule.
Embodiment 11
The consumption of each composition of capsule is:
Capsule is prepared according to the method for embodiment 10.
Embodiment 12 capsule
The consumption of each composition of capsule is:
Capsule is prepared according to the method for embodiment 10.
Reference examples 1 capsule
The consumption of each composition of capsule is:
Compositions 10g of embodiment 1
Maltose alcohol 1.875g
Polyoxyethylene alkyl ether 2.5g
Capsule is prepared according to the method for embodiment 6.
Reference examples 2 capsule
The consumption of each composition of capsule is:
Capsule is prepared according to the method for embodiment 5.
Reference examples 3
A kind of compositions treating rheumatoid arthritis, said composition is grouped into by the one-tenth of following weight:
Reference examples 4
A kind of compositions treating rheumatoid arthritis, said composition is grouped into by the one-tenth of following weight:
Test example 1 vitro release determination test
The drug release rate detection of capsule: with reference to 2010 editions version " Chinese Pharmacopoeia " annex XIXD vitro drug release degree inspections
Look into.
Take above example 6, reference examples 1 and the capsule of comparative example 2 respectively, put in medicament dissolution instrument, in 1h,
2h, 4h, 6h, 12h, 16h, 24h are separately sampled, detect dissolution percentage rate by high performance liquid chromatography, and calculate the accumulation of medicine
Release percentage rate, the results are shown in Table 1.
Dissolution (%) result of the test of table 1 inventive samples
The capsule of embodiment 6 slowly discharges in 24h as can be seen from the table, and the capsule of reference examples 1-2 is at 12h
The most all discharge, and there is serious peak valley phenomenon.
Test example 2 effect measuring disintegration
1. select colloidal silica, carboxymethyl starch sodium, the stearic palmitamide of different ratio and colloidal silica,
Remaining composition is identical with the composition in embodiment 10；According to the regulation in Chinese Pharmacopoeia, the disintegration surveying capsule surveys it
Emulsifying effectiveness to compositions, the results are shown in Table 2；
The impact on capsule disintegration of table 2 different auxiliary material
As can be seen from the table, stearic palmitamide and the colloidal silica mixture of the special parts by weight of the present invention are used
It is remarkably improved the disintegration of capsule.
Test example 3 stability test
1. accelerated test
Example 6, reference examples 1 and the capsule of reference examples 2, all at temperature 40 DEG C ± 2 DEG C, relative humidity is 75%
Placing 6 months under conditions of ± 5%, testing, 1 month period, 2 months, 3 months, 6 the end of month are separately sampled once, detect glue
The character of wafer, color and luster, abnormal smells from the patient, main constituent content (labelled amount %), moisture, it was found that the every finger of the capsule of embodiment 6
Mark has no significant change；And the color of the capsule of reference examples 1 and reference examples 2 substantially deepens, the labelled amount of main constituent significantly drops
Low, moisture increases.
2. long term test
Example 6, reference examples 1 and the capsule of reference examples 2, all at temperature 25 DEG C ± 2 DEG C, relative humidity is 60%
Place 12 months under conditions of ± 10%, testing 0 month period, 3 months, 6 months, 9 months, 12 the end of month separately sampled one
Secondary, detect the character of capsule, color and luster, main constituent content (labelled amount %), moisture, it was found that the capsule of embodiment 6 is each
Item index has no significant change；And the color of the capsule of reference examples 1 and reference examples 2 substantially deepens, the content of main component is bright
Aobvious decline, moisture increases.
It can be seen that maltose alcohol, sodium palmitate and polyoxyethylene alkyl ether mixed from accelerated test and long term test
Compound is remarkably improved the stability of capsule, lacks one of them composition, or changes one of them composition, stablizing of capsule
Property decline.
Test example 4 effectiveness comparison
The therapeutic effect of 4.1 pairs of rheumatoid arthritis
One, research contents
1. object of study
Filter out rheumatoid arthritis patients 60 example meeting inclusive criteria, be divided into according to table of random number completely random and controlling
Treat 1 group, treat 2 groups, compare 1 group and comparison 2 groups, to bases such as sex, age, the course of disease and the associated conditions data of four groups of patients
Line data compare, no significant difference (P > 0.05), have comparability.Refer to table 3.
3 four groups of patient baseline's data of table compare
Note: DAS28: disease activity index；ESR: erythrocyte sedimentation rate；CRP:C reactive protein；HAQ marks: quality of life
Scale score.
2. patient's inclusive criteria
Inclusive criteria
1) ACR 1987 rheumatoid arthritis or the diagnostic criteria of ACR/EULAR 2010 rheumatoid arthritis are met.
2) disease activity index DAS28 ＞ 3.2.
3) patient age 18-70 year.
4) patient's signed Informed Consent Form.
Exclusion standard
1) the x-ray Steinbrocker classification of hands and wrist belongs to IV grade of person.
2) liver, kidney disease and serious heart disease person are suffered from.
3) suffer from addition to rheumatoid arthritis other rheumatic autoimmune diseases such as: SLE, scleroderma etc..
4) suffers from other inflammatory arthritis patient in addition to rheumatoid arthritis, such as gout, Lyme disease etc..
5) women that trimester of pregnancy, age of sucking and plan are become pregnant in the recent period.
6) other drug clinical trial patient was participated in nearly three months.
3. packet and administration
Treat 1 group: the capsule that the compositions of embodiment 1 and adjuvant are made, each 3, day 2-3 time, take after the meal；
Treat 2 groups: the capsule that the compositions of embodiment 4 and adjuvant are made, each 3, day 2-3 time, take after the meal；
Compare 1 group: the capsule that the compositions of reference examples 1 and adjuvant are made, each 3, day 2-3 time, take after the meal；
Compare 2 groups: the capsule that the compositions of reference examples 2 and adjuvant are made, each 3, day 2-3 time, take after the meal；
4. treatment time: 12 weeks.
5. observation index
Clinical indices: the entirety of Disease Activity is commented by rest pain, arthroncus number, articular pain number, grip, doctor
Valency, patient's overall evaluation to Disease Activity.
Lab index: erythrocyte sedimentation rate (ESR) and c reactive protein (CRP) calculate the improvement percentage rate of indices.
Function of joint is assessed: use rheumatoid arthritis patients to commonly use HAQ scale to patient's physiology, psychology, social function
Carry out comprehensive assessment.
DAS28 marks: patient carries out before and after treatment DAS28 scoring, evaluates the disease activity of patient.
6. curative effect evaluation standard (Americanism damp disease association rheumatoid arthritis standard in 1987, ACR)
ACR20: tenderness close joint number, swollen joint number, rest pain, doctor evaluation, patient assessment, functional assessment, erythrocyte sedimentation rate or
CRP improvement reaches more than 20%；
ACR50: tenderness close joint number, swollen joint number, rest pain, doctor evaluation, patient assessment, functional assessment, erythrocyte sedimentation rate or
CRP improvement reaches more than 50%；
ACR70: tenderness close joint number, swollen joint number, rest pain, doctor evaluation, patient assessment, functional assessment, erythrocyte sedimentation rate or
CRP improvement reaches more than 70%.
7. adverse reaction monitoring
Liver and kidney function, blood, routine urinalysis, rabat and Electrocardioscopy is carried out before test；When going to a doctor or follow up a case by regular visits to every time after treatment
Should observe and record the contingent uncomfortable performance of patient, and analyze the relation of adverse events and test medicine.Occur bad instead
Should afterwards regular follow-up observe untoward reaction lapse to situation.
8. statistical analysis
Employing SPSS 15.0 statistical analysis software is calculated by statistical analysis.All of statistical test all uses bilateral
Inspection, P ＜ 0.05 thinks that checked difference is statistically significant.
Two, result
2.1. different time sections ACR20 therapeutic evaluation
In different time sections, four groups of patients being carried out ACR20 evaluation, therapeutic outcome is shown in Table 4.
The ACR20 therapeutic evaluation of 4 four groups of patients of table
Treat 1 group as can be seen from the table and treatment 2 groups is effective at the ACR20 of the 4th week, the 8th week and the 12nd week for the treatment of
Rate is apparently higher than compareing 1 group and comparison 2 groups, and the ACR20 effective percentage for the treatment of 2 groups is better than treatment 1 group.
2.2DAS28 evaluate
Before and after treatment, the DAS28 to patient is evaluated, with DAS28 ＜ 2.6 for clinical remission standard；2.6 ＜ DAS28 ＜
3.2 pass judgment on for low mobility, observe the disease activity situation of patient after treatment is finished, the results are shown in Table 5.
Table 5DAS28 evaluation result
As can be seen from the table, treat 1 group and treatment 2 groups has 6 and 8 example patients to be in clinical relieving period respectively.And compare 1
Group and comparison 2 groups only have 2 and 4 example patients to be in clinical relieving period；Treat 1 group to be significantly higher than with the clinical remission rate treating 2 groups
Compare 1 group and comparison 2 groups；And the clinical remission rate treating 2 groups is significantly higher than treatment 1 group.
Three, discuss
The compositions of the present invention nourishes blood softening the hard mass, and effect of inducing diuresis to remove edema has preferable curative effect for rheumatoid arthritis.
And the effective percentage of ACR20 can be effectively improved, reduce the scoring of patient DAS28, make patient be in the low active stage of disease.
ACR20 is an important finger of the assessment rheumatoid arthritis entirety state of an illness of Americanism damp disease association formulation in 1987
Mark, mainly by arthroncus number, articular pain number, patient to the assessment of pain, patient to the overall evaluation of disease, doctor to disease
The sick overall evaluation, erythrocyte sedimentation rate/c reactive protein are constituted.In these 7, front 2 improvement degree reach 20%, in remaining five at least
There are 3 improvement reaching 20% i.e. can be defined as ACR20 effective.Present invention research observes four groups of patients' in different time points
ACR20 index, finds that the compositions of the present invention can significantly improve the effective percentage of ACR20, when the crude drug of the present composition
When changing, the effective percentage of ACR20 reduces.
DAS28 be by Europe wind resistance damp disease Union Recommendation the finger of disease activity index of assessment rheumatoid arthritis
Mark, is made up of indexs such as the assessment of pain and erythrocyte sedimentation rate/c reactive proteins arthroncus number, articular pain number, patient.DAS28 is low
Represent that patient is in disease-free period in 2.6, less than 3.2, be in low active stage higher than 2.6 explanation diseases.The combination of the present invention
Thing treatment rheumatoid arthritis can make more patient be in low mobility phase or the catabasis of disease, can be significantly more efficient
The Clinical efficacy of the compositions of the present invention is described.
4.2 pairs of prosopalgic therapeutic effect
One, test case
Selecting the 45 prosopalgic voluntary patients of example, irrespective of sex, the age, the course of disease, the state of an illness were without substantially between 35-78 year
Difference (P ＞ 0.05).
Two, diagnosis basis
1) there is paroxysmal lightning sample in face nervi trigeminus distributed areas, the sample that lancinates is sudden has an intense pain, and lasts the several seconds
To several minutes, showing effect time and again, character is identical, has the intermittent catabasis；
2) paroxysmal pain is positioned at the one or more of nervi trigeminus distributed areas, side, not the criminal's of crossing the border larynx, occipitalia or
Offside；
3) patient Chang Yin mouth, tongue motion or external irritant cause paroxysmal pain, Face and cheek, lip, oral cavity often to deposit " a trigger
Point "；
4) the no positive sign of neurologic check, sensation and the masticatory muscles of nervi trigeminus distributed areas are the most without exception.
Three, efficacy assessment standard
Recovery from illness: pain is wholly absent, other simultaneous phenomenons disappear.
Effective: pain substantially alleviates, other simultaneous phenomenons disappear.
Effective: pain relief, attack times significantly reduces before relatively treating, and other simultaneous phenomenons all have and to a certain degree improve.
Invalid: pain degree and attack times all without improving, even increase the weight of.
Four, it is grouped and is administered
45 example affected nerves of patients with trigeminal neuralgias are randomly divided into 1 group of 15 example for the treatment of, treat 2 group of 15 example, compare 1 group of 15 example；Treatment 1
Group gives the compositions of the embodiment of the present invention 1, treats 2 groups of compositionss giving the embodiment of the present invention 3, compares 1 group and gives commercially available
Carbamazepine Tablets；Treat 1 group and treatment is administered orally 3 times 2 groups of every days, each 5g (crude drug)；Compare 1 group to take to specifications, even
Continue and take 60 days.
Five, result
The patient for the treatment of group and matched group is all administered 60 days, pays a return visit and calculate relapse rate after half a year, and therapeutic effect compares and is shown in Table
6。
Effects in treating trigeminal neuralgia is compared by table 6 treatment group and matched group
Treat 2 groups and be respectively provided with diversity (P compared with treatment 1 group and comparison 1 groupa<0.05)。
Six, conclusion
As seen from table, the embodiment of the present invention 4 provide compositions good to prosopalgic therapeutic effect, cure rate up to
90%, and relapse rate is low.
Claims (9)
1. the compositions treating rheumatoid arthritis, it is characterised in that described compositions mainly former by following weight portion
Material is prepared from:
2. the compositions treating rheumatoid arthritis as claimed in claim 1, it is characterised in that prepare used by described compositions
Raw material also includes the composition of following weight portion:
Semen Strychni (processed) 30-40 Radix Notoginseng 30-40.
3. the compositions treating rheumatoid arthritis as claimed in claim 2, it is characterised in that described compositions is raw materials used
Parts by weight as follows:
4. a solid preparation, including compositions and the adjuvant of the arbitrary described treatment rheumatoid arthritis of claim 1-3, its
Being characterised by, described solid preparation is capsule, pill, tablet, powder or granule；Described compositions and the weight portion of adjuvant
Number ratio is 1:0.5-1.8.
5. solid preparation as claimed in claim 4, it is characterised in that described solid preparation is capsule, and described adjuvant includes
Weight portion be the maltose alcohol of 1.5-3 part, weight portion be the sodium palmitate of 0.2-0.5 part and polyoxy second that weight portion is 2-5 part
Allylic alkylation ether.
6. solid preparation as claimed in claim 5, it is characterised in that described adjuvant also includes that weight portion is the pre-of 0.5-2 part
Gel starch and the polymethyl methacrylate of 0.1-0.3 part.
7. solid preparation as claimed in claim 6, it is characterised in that described adjuvant also includes the tristearin that weight portion is 1-2 part
Palmitamide and the colloidal silica of 0.2-0.5 part.
8. the preparation method of the compositions described in a claim 1, it is characterised in that described method comprises the steps:
1) it is the Rhizoma Smilacis Chinensis of 20-30 part, the Caulis Trachelospermi of 10-35 part, the bluish glaucoma of 100-150 part by Semen Strychni (processed), Radix Notoginseng and weight portion
Rattan, the Rhizoma Anemarrhenae of 20-30 part, the Radix Paeoniae Alba (parched) of 25-35 part are pulverized, and prepare medicated powder, standby；
2) Rhizoma Smilacis Chinensis of residuals weight part, Caulis Trachelospermi, Caulis Sinomenii, the Rhizoma Anemarrhenae, Radix Paeoniae Alba (parched) and remaining raw material are joined 1000-
The yellow wine of 15000mL decocts, decocts 3 times, filter respectively, merging filtrate, concentrate, prepare thick paste；
3) by step 1) medicated powder and the step 2 that prepare) the thick paste mixing for preparing, it is dried, crosses 100 mesh sieves, obtain compositions.
9. the compositions of the treatment rheumatoid arthritis as described in claim 1-3 is arbitrary is used for treating rheumatoid arthrosis in preparation
Application in scorching or prosopalgic medicine.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610417635.0A CN106266821A (en) | 2016-06-14 | 2016-06-14 | A kind of compositions treating rheumatoid arthritis and solid preparation thereof and preparation method |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610417635.0A CN106266821A (en) | 2016-06-14 | 2016-06-14 | A kind of compositions treating rheumatoid arthritis and solid preparation thereof and preparation method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108686141A (en) * | 2018-07-24 | 2018-10-23 | 李靖 | A kind of pharmaceutical composition and preparation method thereof for treating rheumatism gout |
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| CN103055226A (en) * | 2012-10-27 | 2013-04-24 | 孙丽君 | Traditional Chinese medicine composition for treating rheumatoid arthritis and preparation method of traditional Chinese medicine composition |
| CN104547472A (en) * | 2014-12-10 | 2015-04-29 | 深圳先进技术研究院 | Pharmaceutical composition for treating rheumatoid arthritis, preparation method and patch thereof |
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| CN103055226A (en) * | 2012-10-27 | 2013-04-24 | 孙丽君 | Traditional Chinese medicine composition for treating rheumatoid arthritis and preparation method of traditional Chinese medicine composition |
| CN104547472A (en) * | 2014-12-10 | 2015-04-29 | 深圳先进技术研究院 | Pharmaceutical composition for treating rheumatoid arthritis, preparation method and patch thereof |
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| CN108686141A (en) * | 2018-07-24 | 2018-10-23 | 李靖 | A kind of pharmaceutical composition and preparation method thereof for treating rheumatism gout |
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Application publication date: 20170104 |