CN105726646A - Medicine composition for treating rheumatoid arthritis through immune adjustment and preparation method of medicine composition - Google Patents
Medicine composition for treating rheumatoid arthritis through immune adjustment and preparation method of medicine composition Download PDFInfo
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Abstract
The invention provides a medicine composition for treating rheumatoid arthritis through immune adjustment and a preparation method of the medicine composition, and relates to the field of traditional Chinese medicines. Effective components comprise the following raw medicines: maca, ginseng, loranthus parasiticus and rhizoma corydalis. The medicine composition provided by the invention can adjust the immune and internal secretion systems to suppress generation of pathopoiesia antibodies, and is quick in rheumatoid arthritis treatment effect and high in effectiveness.
Description
Technical field
The present invention relates to the field of Chinese medicines, particularly relate to a kind of rheumatoid pharmaceutical composition of immune modulating treatment and preparation method thereof.
Background technology
Rheumatoid arthritis (RA) is chronic, the systemic disease based on inflammatory synovitis that a kind of cause of disease is not bright.Patient's hands, the foot multi-joint of Minor articulus, symmetry, aggressive arthritis, serum rheumatoid factor (SRF) (RF) is involved positive with organ outside joint, severe patient can cause joint deformity and afunction, ability to act and the quality of life of patient are had a strong impact on, it is the one of the main reasons of China's adult's disability, causes serious domestic problem and burden on society.
The RF of about 90% rheumatoid arthritis (RA) patient is positive.In clinical medicine, RF can be divided into IgM, IgA, IgG and IgE four type, is cause antigen-reactive due to infectant, internal creates to deform a kind of antibody that lgG antibody is antigen, therefore is also called anti antibody.A small amount of rheumatoid factor can regulate vivo immunization reaction, accelerates bacteria removal and infects, it is to avoid inflammation damnification.But the generation of too much RF, with the generation of a series of rheumatoid diseases with develop closely related, such as RF, systemic lupus erythematosus (sle) etc..
RF treatment with western mainly adopts non-steroidal antiinflammatory drugs to treat, and has anti-inflammatory analgesic effect.But majority Western medicine drug therapy need to be taken medicine all the life, and side effect is relatively big, and drug withdrawal is easily recurred.Patient's middle and late stage needs to coordinate immunologic purging such as plasmapheresis, immunoadsorption etc., even coordinates surgical operation to carry out joint replacement, and medical treatment cost is high, and patient suffering is big, recovers slowly.Existing Traditional Chinese Medicine therapy mainly divides for oral administration and the big class of external application two, and interior application treatment is long for the course for the treatment of, takes effect slow, DeGrain;External application is only capable of short-term relief disease, cures the symptoms, not the disease.And medicament categories used is various, ingredient cannot effectively be extracted and infiltrate through focus;XOR extraction process performance difficulty, it is difficult to realize large-scale industrial production.
Summary of the invention
For solving existing rheumatoid class medicine, cannot the fast and effeciently rheumatoid arthritis state of an illness, and the problem of side effect great Yi recurrence, the present invention provides a kind of rheumatoid pharmaceutical composition of immune modulating treatment, this pharmaceutical composition is rapid-action, not easily recurs after drug withdrawal.
The preparation method that present invention also offers the rheumatoid pharmaceutical composition of a kind of immune modulating treatment, the method technique is simple, can fully extract active component in crude drug, it is easy to industrialization.
According to the present invention, provide a kind of rheumatoid pharmaceutical composition of immune modulating treatment, the crude drug making active component includes: Maca 42-78 weight portion, ecdyson class crude drug 35-62 weight portion, Radix Ginseng 9-31 weight portion, Herba Taxilli 5-15 weight portion, Radix Notoginseng 13-29 weight portion, Rhizoma Corydalis 2-8 weight portion, Ganoderma 5-11 weight portion, Radix Angelicae Sinensis 10-25 weight portion.
Preferably, described crude drug includes Maca 57-63 weight portion, ecdyson class crude drug 43-55 weight portion, Radix Ginseng 17-22 weight portion, Herba Taxilli 8-13 weight portion, Radix Notoginseng 18-24 weight portion, Rhizoma Corydalis 3-6 weight portion, Ganoderma 7-9 weight portion, Radix Angelicae Sinensis 13-23 weight portion.
According to the present invention, described ecdyson class crude drug preferably includes: one or more in Radix Cyanotis vagae, Radix Achyranthis, one hundred days green grass or young crops, more preferably Radix Achyranthis.In a preferred embodiment of the invention, containing inokosterone in described pharmaceutical composition, it is preferable that described inokosterone content in active component is 18-23wt%.
Heretofore described active component refers to have treatment and/or prevent rheumatoid arthritis effect, by the therapeutic component except adjuvant of the treated acquisition of crude drug.Described adjuvant is preferably the figuration additives used when described pharmaceutical composition is made as preparation, it is preferred at least one in starch, cyclodextrin, sodium chloride, glucose and water.
The preparation method that present invention also offers the rheumatoid pharmaceutical composition of a kind of immune modulating treatment, comprises the following steps that:
S1 weighs crude drug Maca, Radix Ginseng, Radix Notoginseng and Radix Angelicae Sinensis by raw material weight proportioning, section, dry, standby.
S2 weighs step S1 gained Maca, Radix Ginseng, Radix Notoginseng and Radix Angelicae Sinensis and Herba Taxilli, Rhizoma Corydalis, Ganoderma lucidum seu Japonicum, Arillus Longan and ecdyson class crude drug by raw material weight proportioning, pulverizes, and adds ethanol, boils, and soaks, and filters, obtains alcohol and boil liquid and medicinal residues;Described medicinal residues add water, boils, soak, filter, obtain water cooking liquid and secondary medicinal residues;Merge twice gained and boil liquid, concentration, obtain concentrated medicament, standby.
S3 takes S2 gained secondary medicinal residues, mixes with ethanol water, and cell breakage is ultrasonic, solid-liquid separation, takes liquid, obtains ultrasonic medicinal liquid.
S4 is by S2 gained concentrated medicament with the ultrasonic medicinal liquid mixing of S3 gained, and spray drying obtains active component.
Method produced according to the present invention, in step s3, the cell breakage ultrasonic time used is preferably 2-30min, more preferably 5-12min.
In some of the preferred embodiment of the invention, described pharmaceutical composition is finally made as Chinese medicine preparation.Described Chinese medicine preparation includes for pill, enteric-coated tablet, thin film tablet, synusia agent, extended release preparation, durative action preparation, dragee, suppository, plaster, paste, granule, microcapsule, micro-preparation, nanometer formulation, capsule, enteric-coated capsules, sublingual lozenge, lyophilized powder, powder, ointment, ointment, gel, cream, dispersant, liposome, syrup, sweet perfume (or spice) spills agent, solution, for the dropping liquid to eye ear or nasal administration, suspension, body fluid, medicinal tea, oral liquid, medicated wine or injection, it is preferably granule, lyophilized powder, suppository, capsule, oral liquid or injection, it most preferably is granule, oral liquid or injection.
Maca selected by the present invention, includes macamides (macamides), it is possible to improve HPT and hypothalamic pituitary adrenal axis, balanced human's endocrine.It has been investigated that, ecdyson contained by the present invention, it is possible to balance hormonal system further, with saponins component in Radix Ginseng and Radix Notoginseng and Ganoderma synergism, adjustment lymphocyte immune cell, it is suppressed that virulence factor anti antibody generates.Herba Taxilli, Radix Notoginseng, Rhizoma Corydalis and Ganoderma selected by the present invention, active, reduction joint tissue cellular immunization sensitivity of calming the nerves.Selected Maca, Radix Ginseng, Radix Notoginseng and Radix Angelicae Sinensis can nourish training unit, recover to attack the soft tissue of joint damage caused and osteodystrophy for a long time because of virulence factor.
Find after further study, ecdyson contained by pharmaceutical composition of the present invention and Maca alkene (macaenes) can promote that protein in body synthesizes, active Radix Notoginseng, Maca consolidates, Arillus Longan training unit and Rhizoma Corydalis pine muscle synergism under, recover joint muscle group nutrition, lax ligament, improves joint motion ability.
According to the present invention, described preparation method is first boiled through alcohol, boiled process tentatively extracts the active component in described drug regimen raw material, through appropriateness ultrasonic cell disintegration, it is possible to extract the internal active component of medicine further.This process advantages of simple, ensure that the medicine active component being prone to be subject to external force failure loss can be previously extracted, and can fully extract the ecdyson in the intracellular macamides of Maca and ecdyson class crude drug, and other are difficult to the other drug active component of extraction.Spray drying method used by the present invention can farthest keep the biological activity of macamides and saponins component.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention is further explained explanation, it should be appreciated that the scope of the present invention is not limited to this.
Embodiment 1
S1 weighs crude drug Maca 57kg, Radix Ginseng 17kg, Radix Notoginseng 18kg and Radix Angelicae Sinensis 23kg by raw material weight proportioning, removes impurity, section, dries, standby.
S2 weighs step S1 gained Maca, Radix Ginseng, Radix Notoginseng and Radix Angelicae Sinensis by raw material weight proportioning, and Herba Taxilli 10kg, Rhizoma Corydalis 3kg, Ganoderma 7kg and ecdyson class crude drug Radix Achyranthis 55kg, co-grinding, add the ethanol of five times of weight, boil, continue to soak 3 hours, filter, obtain alcohol and boil liquid and medicinal residues;Described medicinal residues add the water of treble amount, boils, continue to soak 2 hours, filter, obtain water cooking liquid and secondary medicinal residues;Merging twice gained and boil liquid, heating evaporation concentrates, and obtains concentrated medicament to three times of crude drug gross weight, standby.
S3 takes S2 gained secondary medicinal residues, mixes with the 15wt% ethanol water of double weight, the ultrasonic 12min of cell breakage, solid-liquid separation, takes liquid, obtain ultrasonic medicinal liquid.
S4 is by S2 gained concentrated medicament with the ultrasonic medicinal liquid mixing of S3 gained, and spray drying obtains active component, adds adjuvant pelletize, is made as medicament composition granule agent.
In the present embodiment crude drug, the hypocotyl epidermis of Maca used is black.
The present embodiment gained medicament composition granule agent, detects (GC-MS) detection through gas chromatograph-mass spectrometer and learns, in active component, inokosterone content is 23wt%.
Embodiment 2
S1 weighs crude drug Maca 60kg, Radix Ginseng 22kg, Radix Notoginseng 20kg and Radix Angelicae Sinensis 13kg by raw material weight proportioning, removes impurity, section, dries, standby.
S2 weighs step S1 gained Maca, Radix Ginseng, Radix Notoginseng and Radix Angelicae Sinensis by raw material weight proportioning, and Herba Taxilli 8kg, Rhizoma Corydalis 5kg, Ganoderma 8g and ecdyson class crude drug Radix Achyranthis 48kg, co-grinding, add the ethanol of five times of weight, boil, continue to soak 3 hours, filter, obtain alcohol and boil liquid and medicinal residues;Described medicinal residues add the water of treble amount, boils, continue to soak 2 hours, filter, obtain water cooking liquid and secondary medicinal residues;Merging twice gained and boil liquid, heating evaporation concentrates, and obtains concentrated medicament to three times of crude drug gross weight, standby.
S3 takes S2 gained secondary medicinal residues, mixes with the 15wt% ethanol water of double weight, the ultrasonic 9min of cell breakage, solid-liquid separation, takes liquid, obtain ultrasonic medicinal liquid.
S4 is by S2 gained concentrated medicament with the ultrasonic medicinal liquid mixing of S3 gained, and spray drying obtains active component, adds glucose and water mixing fill, is made as drug composition oral liquid.
In the present embodiment crude drug, the hypocotyl epidermis of Maca used is black.
The present embodiment gained drug composition oral liquid, detects (GC-MS) detection through gas chromatograph-mass spectrometer and learns, in active component, inokosterone content is 18wt%.
Embodiment 3
S1 weighs crude drug Maca 63kg, Radix Ginseng 21kg, Radix Notoginseng 24kg and Radix Angelicae Sinensis 18kg by raw material weight proportioning, removes impurity, section, dries, standby.
S2 weighs step S1 gained Maca, Radix Ginseng, Radix Angelicae Sinensis and Radix Notoginseng by raw material weight proportioning, and Herba Taxilli 10kg, Rhizoma Corydalis 6kg, Ganoderma 9g and ecdyson class crude drug Radix Achyranthis 43kg, co-grinding, add the ethanol of five times of weight, boil, continue to soak 3 hours, filter, obtain alcohol and boil liquid and medicinal residues;Described medicinal residues add the water of treble amount, boils, continue to soak 2 hours, filter, obtain water cooking liquid and secondary medicinal residues;Merging twice gained and boil liquid, heating evaporation concentrates, and obtains concentrated medicament to three times of crude drug gross weight, standby.
S3 takes S2 gained secondary medicinal residues, mixes with the 15wt% ethanol water of double weight, the ultrasonic 22min of cell breakage, solid-liquid separation, takes liquid, obtain ultrasonic medicinal liquid.
S4 is by S2 gained concentrated medicament with the ultrasonic medicinal liquid mixing of S3 gained, and spray drying obtains active component, with 0.85% normal saline mixing fill, is made as medicine composition injection.
In the present embodiment crude drug, the hypocotyl epidermis of Maca used is black.
The present embodiment gained medicine composition injection, detects (GC-MS) detection through gas chromatograph-mass spectrometer and learns, in active component, inokosterone content is 22wt%.
Clinical trial:
Below in conjunction with clinical testing data, beneficial effects of the present invention is described.
1. physical data inventor collects the court's example patient with rheumatoid arthritis in March 194-2013 years in March, 2011, wherein male 65 examples, female 129 example, age 43-67 year, the state of an illness 5 months-3 years.It is randomly divided into test group 98 and matched group 96 example.Each group of no significant difference in sex, age, the course of disease and complication, and cut out other associated treatment medicines more than two weeks, there is comparability.
2. stiff more than one hour of morning of diagnostic criteria patient, more than three arthroncuss, subcutaneous have rheumatoid nodules, and rheumatoid factor RF-IgM is positive, and titer is at more than 1:32.
3. Therapeutic Method test group takes the medicament composition granule agent described in embodiment 1 by 50g crude drug/kg body weight every day, and a point morning and evening takes for twice.Matched group presses the diclofenac of 5mg/kg body weight every day, and a point morning and evening takes for twice.It was for two courses for the treatment of Monday, continuously ten courses for the treatment of of treatment, and with examining 1 year.
4. criterion of therapeutical effect is effective: cardinal symptom disappears, and freely, swelling disappears sufferer joint motion, and RF-IgM index is normal.Alleviate: symptom starts to take a turn for the better, and thyroid swelling alleviates, and RF-IgM indexing section takes a turn for the better.Invalid: symptom and index are without taking a turn for the better or increasing the weight of.Recurrence: observing effective patient after terminating three months ten courses for the treatment of, symptoms of rheumatoid arthritis reappears and increases the weight of, RF-IgM index is positive.
5. after ten courses for the treatment of, observing the change of conditions of patients, therapeutic outcome is as follows:
Patient with rheumatoid arthritis change of illness state after 10 courses for the treatment of of table
Group | Number | Effective | Alleviate | Invalid | Total effective rate | Recurrence |
Test group | 98 | 76 (77.6%) | 22 (22.4%) | 0 | 100% | 0 |
Matched group | 96 | 19 (19.8%) | 25 (26.0%) | 52 (54.2%) | 45.8% | 36 (81.8%) |
From table 1 data result, can be seen that rheumatic arthritis can be reached obvious therapeutic effect by the present invention, and long-term treatment terminate the course for the treatment of after not easily recur.
6. following up a case by regular visits in process in patient's diagnosis and treatment, inventor have found that, use in the test group of present invention treatment, patient articular cartilage's tissue all has improvement in various degree, and articular ligament can relax, and recovers elasticity, and joint reactivates.But matched group only has 12 example patients after RF-IgM index is alleviated, ankylosis symptom makes moderate progress.
Although the present invention is described in detail, but it will be understood by those skilled in the art that the amendment in spirit and scope of the invention will be apparent from.However, it should be understood that each several part of each side of present invention record, different detailed description of the invention and the various features enumerated can be combined or all or part of exchange.In each above-mentioned detailed description of the invention, those can suitably combine with other embodiment with reference to the embodiment of another embodiment, and this is by understand by those skilled in the art.Additionally, it will be understood to those of skill in the art that description above is only the mode of example, it is no intended to the restriction present invention.
Claims (9)
1. the rheumatoid pharmaceutical composition of immune modulating treatment, the crude drug making active component includes: Maca 42-78 weight portion, ecdyson class crude drug 35-62 weight portion, Radix Ginseng 9-31 weight portion, Herba Taxilli 5-15 weight portion, Radix Notoginseng 13-29 weight portion, Rhizoma Corydalis 2-8 weight portion, Ganoderma 5-11 weight portion, Radix Angelicae Sinensis 10-25 weight portion.
2. pharmaceutical composition according to claim 1, it is characterized in that, described crude drug includes Maca 57-63 weight portion, ecdyson class crude drug 43-55 weight portion, Radix Ginseng 17-22 weight portion, Herba Taxilli 8-13 weight portion, Radix Notoginseng 18-24 weight portion, Rhizoma Corydalis 3-6 weight portion, Ganoderma 7-9 weight portion, Radix Angelicae Sinensis 13-23 weight portion.
3. pharmaceutical composition according to claim 1 and 2, it is characterised in that described ecdyson class crude drug includes: one or more in Radix Cyanotis vagae, Radix Achyranthis, one hundred days green grass or young crops, it is preferred to Radix Achyranthis.
4. the pharmaceutical composition according to any one of claim 1-3, it is characterised in that containing inokosterone in described pharmaceutical composition, it is preferable that described inokosterone content in active component is 18-23wt%.
5. the pharmaceutical composition according to any one of claim 1-4, it is characterised in that described active component refers to have treatment and/or prevention rheumatoid arthritis effect, by the crude drug therapeutic component except adjuvant through preparing.
6. pharmaceutical composition according to claim 5, it is characterised in that described adjuvant is that described pharmaceutical composition is made as the figuration additives of use during preparation, it is preferred at least one in starch, cyclodextrin, sodium chloride, glucose and water.
7. a preparation method for the rheumatoid pharmaceutical composition of immune modulating treatment, processing step includes:
S1 weighs crude drug Maca, Radix Ginseng, Radix Notoginseng and Radix Angelicae Sinensis by raw material weight proportioning, section, dry, standby;
S2 weighs step S1 gained Maca, Radix Ginseng, Radix Notoginseng and Radix Angelicae Sinensis and Herba Taxilli, Rhizoma Corydalis, Ganoderma lucidum seu Japonicum, Arillus Longan and ecdyson class crude drug by raw material weight proportioning, pulverizes, and adds ethanol, boils, and soaks, and filters, obtains alcohol and boil liquid and medicinal residues;Described medicinal residues add water, boils, soak, filter, obtain water cooking liquid and secondary medicinal residues;Merge twice gained and boil liquid, concentration, obtain concentrated medicament, standby;
S3 takes S2 gained secondary medicinal residues, mixes with ethanol water, and cell breakage is ultrasonic, solid-liquid separation, takes liquid, obtains ultrasonic medicinal liquid;
S4 is by S2 gained concentrated medicament with the ultrasonic medicinal liquid mixing of S3 gained, and spray drying obtains active component.
8. preparation method according to claim 7, it is characterised in that in step s3, the cell breakage ultrasonic time used is 3-20min, it is preferable that 4-9min.
9. the preparation method according to claim 7 or 8, it is characterized in that, described pharmaceutical composition is finally made as Chinese medicine preparation, and described Chinese medicine preparation is preferably granule, tablet, lyophilized powder, suppository, capsule, oral liquid or injection, it is also preferred that for granule, oral liquid or injection.
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CN1903259A (en) * | 2005-07-29 | 2007-01-31 | 天津天士力现代中药研究开发有限公司 | Method for extraction and separation of moutan bark |
CN101406632A (en) * | 2008-12-08 | 2009-04-15 | 刘恩伦 | Medicament for treating rheumatism and rheumatoid and preparation thereof |
CN102225155A (en) * | 2011-06-16 | 2011-10-26 | 成都中医药大学 | Medicament composition for treating pulmonary fibrosis |
CN103027985A (en) * | 2011-10-10 | 2013-04-10 | 姜永芳 | Medicine composition for treating rheumatoid arthritis and preparation method of medicine composition |
CN103301326A (en) * | 2013-06-14 | 2013-09-18 | 马守荣 | Medicament for treating rheumatism, rheumatoid and pain or rheumatism in lower extremities and waist |
CN104096130A (en) * | 2014-07-15 | 2014-10-15 | 上海中医药大学附属岳阳中西医结合医院 | Traditional Chinese medicine composition for treating rheumatoid arthritis |
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CN1903259A (en) * | 2005-07-29 | 2007-01-31 | 天津天士力现代中药研究开发有限公司 | Method for extraction and separation of moutan bark |
CN101406632A (en) * | 2008-12-08 | 2009-04-15 | 刘恩伦 | Medicament for treating rheumatism and rheumatoid and preparation thereof |
CN102225155A (en) * | 2011-06-16 | 2011-10-26 | 成都中医药大学 | Medicament composition for treating pulmonary fibrosis |
CN103027985A (en) * | 2011-10-10 | 2013-04-10 | 姜永芳 | Medicine composition for treating rheumatoid arthritis and preparation method of medicine composition |
CN103301326A (en) * | 2013-06-14 | 2013-09-18 | 马守荣 | Medicament for treating rheumatism, rheumatoid and pain or rheumatism in lower extremities and waist |
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