CN100500173C - Medicine for treating rheumatism and rheumatoid disease, and its preparation method - Google Patents
Medicine for treating rheumatism and rheumatoid disease, and its preparation method Download PDFInfo
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Abstract
The invention relates to compound capsules for treating rheumatism and rheumatoid diseases and process for preparation, wherein the capsules are prepared from four kinds of Chinese medicinal materials including ants, large-leaf gentian root, orienavine, and tetrandra root. The preparing process comprises the steps of decompression low-temperature ethanol backflow extracting, and carrying out low-temperature vacuum drying.
Description
Technical field
The present invention relates to a kind of medicine for the treatment of rheumatism, rheumatoid disease and preparation method thereof, a kind of specifically rheumatism, the medicine of rheumatoid disease---complex ant collaterals-activating capsule for the treatment of diseases such as arthralgia that anemofrigid-damp arthralgia resistance causes, numbness, swelling distortion, joint stuffiness.
Background technology
Rheumatism and rheumatoid arthritis belong to traditional Chinese medical science arthromyodynia category, it is because the imbalance of human body the four stages in the course of an epidemic febrile disease; flesh table; meridians suffer the damp and hot invasion and attack of wind and cold; QI and blood meridian is that the pathogenic factor impatency causes passages through which vital energy circulates, skin, joint, bones and muscles pain, miserable numbness, joint stuffiness or arthroncus, stiff deformity; amyotrophy and moving obstacle have a strong impact on internal organs.The modern commonly used removing dampness of dispeling the wind, methods such as dispelling cold by warming the meridian treatment, according to investigations is 0.36% in the prevalence of China, primary disease is chronic, carrying out property, affecting conditions, and as not giving suitable treatment, the state of an illness develops gradually and increases the weight of, even maimed, more thorny in treatment, the difficult satisfactory effect that obtains.The medicine of treatment rheumatism atrophic arthritis all has some shortcomings and defective mostly at present.As: (1) is extracted and is not exclusively caused effective ingredient loss, curative effect to reduce.(2) purification degree is low, and taking dose is big, have in addition reach each 5-6.(3) onset is slow, curative effect is long.(4) the interpolation Western medicine that has, side effect is big, though rheumatism, rheumatoid arthritis have been played therapeutical effect, has destroyed the function of other internal organs.(5) cure the symptoms, not the disease, can not cure rheumatism, rheumatoid arthritis completely.Though alleviated disease.But patient has suffered the torment of disease again after drug withdrawal a period of time.Bringing tremendous loss aspect body and mind and the economic dispatch for the patient.
Summary of the invention
The objective of the invention is to provide a kind of decompression cold ethanol reflux, extract, technology, low-temperature vacuum drying prepared of adopting, synergism, the anti rheumatism action that can improve the patient immune function is strong, without any side effects, the treatment rheumatism for the treatment of both the principal and secondary aspects of a disease, medicine of rheumatoid disease and preparation method thereof.
The object of the present invention is achieved like this, and medicine of the present invention is to be made by the medicine of following weight proportion:
Formica fusca 60-64 part, Caulis Sinomenii 13-17 part, Radix Gentianae Macrophyllae 13-17 part, Radix Stephaniae Tetrandrae 6-10 part.
Medicine optimum weight proportioning of the present invention is: 62 parts of Formica fuscas, 15 parts of Caulis Sinomeniis, 15 parts of Radix Gentianae Macrophyllae, 8 parts of Radix Stephaniae Tetrandrae.
The method of above-mentioned each component being made medicine of the present invention is:
1., with Caulis Sinomenii, Radix Gentianae Macrophyllae, Radix Stephaniae Tetrandrae, pulverize separately becomes coarse powder, and is standby.
2., Formica fusca is ground into coarse powder, add 60% ethanol extraction three times with multi-function extractor, extract temperature and be controlled at 75--85 ℃, add 6 times of amount soak with ethanol 1 hour for the first time, reflux, extract, 4 hours adds the ethanol of 3 times of amounts, reflux, extract, 3 hours for the second time; Add 2 times of amounts for the third time, reflux, extract, 2 hours, gradation filters, merging filtrate, to there not being the alcohol flavor, being concentrated into relative density is the thick paste of 1.30 (20 ℃) with single economic benefits and social benefits concentrator decompression recycling ethanol, it is standby to be dried to dried cream with 50-60 ℃ of vacuum drying oven low temperature.
3., Caulis Sinomenii, Radix Gentianae Macrophyllae coarse powder are placed multi-function extractor, add 70% ethanol extraction twice, add 3 times of amount ethanol of medical material amount for the first time, soaked reflux, extract, 2 hours 1 hour; The 1 times of amount ethanol that adds for the second time the medical material amount, reflux, extract, 1 hour, gradation filters, and merging filtrate with single economic benefits and social benefits concentrator decompression recycling ethanol, is concentrated into relative density and is the extractum of 1.22-1.26 (20 ℃), and is standby; Residue after the alcohol extraction is added 3 times of water gagings to be decocted 1 hour, filter, concentrate with single economic benefits and social benefits concentrator, merge with above-mentioned extractum, being condensed into relative density is the thick paste of 1.30 (20 ℃), puts into trough type mixing machine, adds the Radix Stephaniae Tetrandrae coarse powder, mix homogeneously is put in the vacuum drying oven, temperature is controlled at is dried to dried cream below 80 ℃.
4., with above-mentioned dried cream and the above-mentioned dried cream mixing of Formica fusca in 2. in 3., put to pulverize in the unit and pulverize, cross 100 mesh sieves, standby.
5., 4. Chinese medicine powder is put into wet granulator; add appropriate amount of starch; make granule with 40-50% ethanol; put into boiling drier and carry out drying; with carrying out batch mixing behind the pelletizing machine granulate; carry out capsule charge with fully-automatic capsule filling machine then, carry out packing with Aluminium-coating Packer, packing promptly.
The compound preparation that medicine of the present invention---complex ant collaterals-activating capsule is made up of Formica fusca, Radix Gentianae Macrophyllae, Caulis Sinomenii, Radix Stephaniae Tetrandrae four flavor Chinese medicines.
Show that by clinical Formica fusca has activating blood circulation to dissipate blood stasis, expelling wind and removing dampness, the effect of strengthening the body resistance.Pharmacological evaluation shows, Formica fusca has significant antiinflammatory, calmness, analgesia, hepatoprotective, spasmolytic, effect such as antibiotic.Formica fusca can be improved the phagocytic index of macrophage, proves the raise immunity effect, and immune function of human body is had tangible two-phase regulating action.With the Formica fusca is compound preparation treatment rheumatism, the rheumatoid arthritis that monarch drug is formed, and humoral immunization is had the obvious suppression effect.Frank decline after the medication, rheumatoid factor is turned out cloudy, and the pair cell immunity has potentiation.Formica fusca can also excited pituitary adrenal system, and the adrenal cortex reinforcing function improves the body stress ability of pessimal stimulation to external world, the resistance against diseases of enhancing body.
Ministerial drug Caulis Sinomenii expelling wind and removing dampness, a surname's numbness collateral dredging.Say in " Wenling county drug resource register ": " wind dispelling is wet, and the meridian dredging is controlled anemofrigid-damp arthralgia, the arthroncus of knee, oncotic arthralgia of limbs.”
The adjuvant drug Radix Gentianae Macrophyllae is wind-damp dispelling not only, has the usefulness of the flourish muscle of invigorating blood circulation concurrently, for " the profit agent of wind medicine " thus arthromyodynia pay no attention to new for a long time, cold and heat all can, be the product that three numbness must be used.Say in " Mingyi Bielu ": " treat wind, do not have and ask newly for a long time, the whole body contraction is anxious, all applicable.”
But messenger drug Radix Stephaniae Tetrandrae, both wind-expelling pain-stoppings again can inducing diuresis to remove edema.Say in " Bencao Jingshu ": " row 12 is through wet " uses priming, through institute bitterly.
Four medicine compatibilities, strengthening vital QI to eliminate pathogenic factors complements each other.
Clinical therapeutic efficacy:
By a large amount of clinical practices prove that this product can reduce effectively that erythrocyte sedimentation rate that active rheumatism causes is accelerated and anti-" O " increase without any side effects and untoward reaction, safe and reliable, taking convenience, evident in efficacy.Can obviously improve symptoms such as the limbs joint cold type of pain is heavy, pain increase in intensity under coldness, pain alleviated while getting warmth, the heart, liver, kidney, hematuria routine, heart rate are not had influence, the significant difference to immunoglobulin before and after the treatment has the effect of human body immunity improving power.
By to the character of this product, differentiate that disintegration, moisture content, weight differential, assay, microbial limit keep sample, three batch samples in 3 years are examined entirely, every result all meets the regulation of this quality standard, shows that this product quality is stable.
The inventor treats above-mentioned sufferer 120 examples with Chinese medicine compound Formica fusca collaterals-activating capsule, through clinical observation in 5 years, fill in symptom, sign and do auxiliary examination projects such as erythrocyte sedimentation rate, anti-" O " blood, routine urinalysis, liver function, immunoglobulin by the observation plan requirement, light (+) of clinical symptoms, in (++), heavy (+++) fills in.Medication is obeyed complex ant collaterals-activating capsule 1-2 grain at every turn, and oral three times, one month is a course of treatment, carries out comprehensive review after finishing the course of treatment.Its The data t check, x
2Statistical procedures is carried out in check and rank test.Prove that it is evident in efficacy, now clinical research be reported as follows:
1., clinical data: this is organized among the 120 routine patients, male's 70 examples, women's 50 examples, age :≤30 years old person's 30 example, 31--40 year person's 41 examples, 41--50 year person's 35 examples, 51--60 year person's 8 examples, person's 6 examples more than 60 years old, the course of disease is less than 1 year 20 example, 1-5 78 examples, 22 examples more than 5 years.
2., Therapeutic Method: the Main Ingredients and Appearance of complex ant collaterals-activating capsule is: Formica fusca, Caulis Sinomenii, Radix Gentianae Macrophyllae, Radix Stephaniae Tetrandrae four Chinese medicine material, Caulis Sinomenii, Radix Gentianae Macrophyllae, Radix Stephaniae Tetrandrae are ground into coarse powder, standby.Formica fusca is ground into coarse powder, adds 60% ethanol extraction three times, adds 6 times of amounts for the first time and soaks reflux, extract, 4 hours 1 hour; Add for the second time 3 times of amounts, reflux, extract, 3 hours; Add 2 times of amounts for the third time, reflux, extract, 2 hours.Gradation filters, merging filtrate, and decompression recycling ethanol is not to there being the alcohol flavor, and being concentrated into relative density is the thick paste of 1.3 (20 ℃), and cold drying becomes dried cream, and is standby.Caulis Sinomenii, Radix Gentianae Macrophyllae coarse powder are placed multi-function extractor, add 70% ethanol extraction twice, add 3 times of amounts for the first time, soaked reflux, extract, 2 hours 1 hour; Add for the second time 1 times of amount, reflux, extract, 1 hour.Gradation filters, merging filtrate, and decompression recycling ethanol concentrates standby.Residue after the alcohol extraction is added 3 times of water gagings decocted 1 hour, filter, concentrate.Merge with above-mentioned alcohol extraction concentrated solution, being condensed into relative density is the thick paste of 1.3 (20 ℃), adds the Radix Stephaniae Tetrandrae coarse powder, mixes thoroughly, dry (temperature must not above 80 ℃), the dried cream mixing of dried cream and above-mentioned Formica fusca, pulverizing is sieved, make granule with 40%-50% ethanol, encapsulatedly make 1000, promptly.Each 1-2 grain, oral every day three times, one month is a course of treatment.Observe therapeutic effect one course of treatment, and the observation period is limited to three months.
3., observational technique:
All case choice criteria that meets go into to elect as to observe case person, fill in symptom, sign and do auxiliary examination projects such as erythrocyte sedimentation rate, anti-" O " blood, routine urinalysis, liver function, immunoglobulin by the observation plan requirement, light (+) of clinical symptoms, in (++), heavy (+++) fills in.Medication: obey 2 of medicines of the present invention, oral three times, one month is a course of treatment at every turn, carries out comprehensive review after finishing the course of treatment.Its The data t check, x
2Statistical procedures is carried out in check and rank test.
4., result:
Observation of curative effect the results are shown in Table 1.2.3.4.5
The influence of symptoms such as table 1. medicine of the present invention is heavy to the joint cold type of pain, swelling
Analyze through rank test that visible medicine of the present invention has clear improvement (P＜0.05) to symptoms such as joint cold type of pain, heavy, local fear of cold, pain increase in intensity under coldness, pain alleviated while getting warmths by table 1 and arthroncus, the not hot nothing touched are obviously improved (P〉0.05).
Table 2. medicine of the present invention is to tongue fur, pulse condition influence
By table 2 as seen, this product can be improved unusual picture of the tongue, pulse condition, treatment anteroposterior diameter X
2The very apparent general property difference of check processing existence (P＜0.01.)
The influence of medicine antagonism of the present invention " O ", erythrocyte sedimentation rate sees Table 3
The influence of table 3. medicine antagonism of the present invention " O ", erythrocyte sedimentation rate
As seen medicine of the present invention can obviously reduce anti-O erythrocyte sedimentation rate, there is significant differences (P＜0.001) in statistical procedures by table 3.
Influence sees Table 4 to medicine of the present invention to routine blood test
Table 4 medicine of the present invention influences routine blood test
Do not change having significantly before and after RBC, Hb, the WBC treatment by the visible medicine of the present invention of table 4, learn by statistics and handle zero difference (P〉0.01)
Medicine of the present invention sees Table 5. to the influence of immunoglobulin
Table 5. medicine of the present invention is to the influence of immunoglobulin
, learn by statistics and handle significant difference P＜0.05 IgA, IgM, the IgG effect of having clear improvement by the visible medicine of the present invention of table 5.
Comprehensive therapeutic effect:
This is organized, and clinical cure 24 examples account for 20% among the 120 routine patients, and produce effects 47 examples account for 39%, and effective 43 examples account for 36%, and invalid 6 examples account for 5%, total effective rate 95%.
From table 1.2.3.4.5 as can be seen, the complex ant collaterals-activating capsule has very significant therapeutical effect to rheumatism and rheumatoid disease, and anti rheumatism action is strong, and is without any side effects.
5., model case:
Liu's, man, 47 years old, Gongzhuling City grains bureau, on October 27th, 1996 examined, heavy, the swelling of conscious joint cold type of pain, local fear of cold, it is oral to give the complex ant collaterals-activating capsule, each 2, every day three times, after one month, patient's subjective symptoms disappears, and takes care of oneself, working properly, continue with 10 days as a means of consolidation.
Liu Xiaojing, woman, 40 years old, people from Changchun is operated in Tohoku Electric Power designing institute, and on October 29th, 1996 examined, conscious limbs are met cold pain, pain alleviated while getting warmth, stringy and tense pulse, it is oral to give the complex ant collaterals-activating capsule, and each 2, every day three times, after one month, patient's subjective symptoms completely without, through the check routine blood test, erythrocyte sedimentation rate is normal, clinical recovery.
Ou Shulan, woman, 46 years old, people from Changchun, Jilin Province, be operated in the First Automobile Group, on November 5th, 1996 examined, and conscious joint cold type of pain, heavy, swelling, to give the complex ant collaterals-activating capsule oral, each 2, every day three times, after one month, patient's subjective symptoms disappears, anti-" O " erythrocyte sedimentation rate reduces clinical recovery really through check.
6., discuss:
Complex ant collaterals-activating capsule of the present invention is by Formica fusca, and four Chinese medicine materials such as Radix Gentianae Macrophyllae are processed through extracting, the compound Chinese medicinal preparation of making, and with the principal agent Formica fusca, QI invigorating is kept fit, promoting blood circulation to remove obstruction in the collateral in the prescription.Accessory drugs Radix Gentianae Macrophyllae clearing away damp-heat, the Caulis Sinomenii the meridian dredging, diuresis, Radix Stephaniae Tetrandrae inducing diuresis to remove edema etc. reaches the effect of Eradicates rheumatism stopping numbness pain jointly.Formica fusca promptly is used for Eradicates and removes cold and dampness in ancient prescription, modern pharmacological research shows that Formica fusca not only has antiphlogistic effect; and have hepatoprotective concurrently; kidney tonifying, relieving asthma, teeth consolidating, the crow through functions such as hair color, the complex ant collaterals-activating capsule utilizes Formica fusca antiinflammatory hepatoprotective just; the merit of kidney tonifying; cooperate all medicines in treatment rheumatism, rheumatoid while, vitals such as protection liver, kidney make rheumatism, rheumatoid patient in treatment; keep the function of the normal immunity of body, play the effect of Synergistic.
Complex ant collaterals-activating capsule of the present invention, in production technology, adopt decompression cold ethanol reflux, extract, technology, advanced technologies such as low-temperature vacuum drying, this process route at first destroys active ingredient without high temperature, next is the continual renovation of solvent, guaranteed the abundant extraction and the reservation of active ingredient, active ingredient is resided in the medicine.So rapid-action, dissolubility height, bioavailability height.
In the formulation of end product quality standard, my company has increased assay on the basis of proper mass standard, and adopts domestic advanced high performance liquid chromatograph to measure the content of wherein active ingredient.In the checkout procedure of semi-finished product and finished product, the existing detection qualitatively has quantitative mensuration again, guarantees the quality control of active ingredient, also just guaranteed the quality of product like this.
Along with the raising of people to Formica fusca medical value understanding, Formica fusca is used for the treatment of rheumatism, and rheumatoid market enlarges gradually.Complex ant collaterals-activating capsule as the accurate word of traditional Chinese medicines, merit with expelling wind and removing dampness, relaxing muscles and tendons and activating QI and blood in the collateral, dispersing cold for relieving pain, be used for the treatment because of diseases such as arthralgia that anemofrigid-damp arthralgia resistance causes, swelling, joint stuffiness, the market prospect of this treatment medicine also will increase along with the continuous growth of social need.In rheumatism, rheumatoid very long therapeutic process, people are seeking treating both the principal and secondary aspects of a disease all the time, and can improve patient immune function's synergistic medicine.The complex ant collaterals-activating capsule is vast rheumatism, the ideal selection of rheumatoid patient.
In sum, rational prescription, advanced technology is added advanced detection method, guaranteed that this medicine is better than other the prescription of suiting the medicine to the illness when treatment rheumatism, rheumatoid disease, the complex ant collaterals-activating capsule is put the favor of the extremely vast rheumatism of Hou Dinghui, rheumatoid patient on market.
The specific embodiment
1., with Caulis Sinomenii 232.5 gram, Radix Gentianae Macrophyllae 232.5 grams, Radix Stephaniae Tetrandrae 132.5 gram pulverize separately become coarse powder, and are standby.
2., Formica fusca 1000 gram is ground into coarse powder, add 60% ethanol extraction three times, extract temperature and be controlled at 75--85 ℃ with multi-function extractor, add for the first time 6 times of amount soak with ethanol 1 hour, reflux, extract, 4 hours adds the ethanol of 3 times of amounts, reflux, extract, 3 hours the second time; Add 2 times of amounts for the third time, reflux, extract, 2 hours, gradation filters, merging filtrate, to there not being the alcohol flavor, being concentrated into relative density is the thick paste of 1.30 (20 ℃) with single economic benefits and social benefits concentrator decompression recycling ethanol, it is standby to be dried to dried cream with 50-60 ℃ of vacuum drying oven low temperature.
3., will be 1. in Caulis Sinomenii, Radix Gentianae Macrophyllae coarse powder place multi-function extractor, add 70% ethanol extraction twice, add 3 times of amount ethanol of medical material amount for the first time, soaked reflux, extract, 2 hours 1 hour; The 1 times of amount ethanol that adds for the second time the medical material amount, reflux, extract, 1 hour, gradation filters, and merging filtrate with single economic benefits and social benefits concentrator decompression recycling ethanol, is concentrated into relative density and is the extractum of 1.22-1.26 (20 ℃), and is standby; Residue after the alcohol extraction is added 3 times of water gagings to be decocted 1 hour, filter, concentrate with single economic benefits and social benefits concentrator, merge with above-mentioned extractum, being condensed into relative density is the thick paste of 1.30 (20 ℃), puts into trough type mixing machine, adds 1. middle Radix Stephaniae Tetrandrae coarse powder, mix homogeneously is put in the vacuum drying oven, temperature is controlled at is dried to dried cream below 80 ℃.
4., with above-mentioned dried cream and the above-mentioned dried cream mixing of Formica fusca in 2. in 3., put to pulverize in the unit and pulverize, cross 100 mesh sieves, standby.
5., 4. Chinese medicine powder is put into wet granulator; add appropriate amount of starch; make granule with 40-50% ethanol; put into boiling drier and carry out drying; with carrying out batch mixing behind the pelletizing machine granulate, carry out capsule charge with fully-automatic capsule filling machine then, carry out packing with Aluminium-coating Packer; encapsulatedly make 1000, promptly.
Claims (4)
1, a kind of treatment rheumatism, the medicine of rheumatoid disease is characterized in that: it is the medicament of being made by following materials of weight proportions medicine:
Formica fusca 60-64 part, Caulis Sinomenii 13-17 part, Radix Gentianae Macrophyllae 13-17 part, Radix Stephaniae Tetrandrae 6-10 part.
2, treatment rheumatism according to claim 1, the medicine of rheumatoid disease is characterized in that: wherein the proportioning of each crude drug is:
62 parts of Formica fuscas, 15 parts of Caulis Sinomeniis, 15 parts of Radix Gentianae Macrophyllae, 8 parts of Radix Stephaniae Tetrandrae.
3, treatment rheumatism according to claim 1 and 2, the medicine of rheumatoid disease is characterized in that: described medicament is a capsule.
4, treatment rheumatism according to claim 3, the process for preparing medicine of rheumatoid disease is characterized in that the preparation method of described capsule is as follows:
1., with Caulis Sinomenii, Radix Gentianae Macrophyllae, Radix Stephaniae Tetrandrae, pulverize separately becomes coarse powder, and is standby;
2., Formica fusca is ground into coarse powder, add 60% ethanol extraction three times with multi-function extractor, extract temperature and be controlled at 75--85 ℃, add 6 times of amount soak with ethanol 1 hour for the first time, reflux, extract, 4 hours adds the ethanol of 3 times of amounts, reflux, extract, 3 hours for the second time; Add 2 times of amounts for the third time, reflux, extract, 2 hours, gradation filters, and merging filtrate is not distinguished the flavor of to there being alcohol with single economic benefits and social benefits concentrator decompression recycling ethanol, is concentrated into 20 ℃ of following relative densities and is 1.30 thick paste, and it is standby to be dried to dried cream with 50-60 ℃ of vacuum drying oven low temperature;
3., will be 1. in Caulis Sinomenii, Radix Gentianae Macrophyllae coarse powder place multi-function extractor, add 70% ethanol extraction twice, add 3 times of amount ethanol of medical material amount for the first time, soaked reflux, extract, 2 hours 1 hour; The 1 times of amount ethanol that adds for the second time the medical material amount, reflux, extract, 1 hour, gradation filters, and merging filtrate with single economic benefits and social benefits concentrator decompression recycling ethanol, is concentrated into 20 ℃ of following relative densities and is 1.22-1.26 extractum, and is standby; Residue after the alcohol extraction is added 3 times of water gagings to be decocted 1 hour, filter, concentrate with single economic benefits and social benefits concentrator, merge with above-mentioned extractum, be condensed into 20 ℃ of following relative densities and be 1.30 thick paste, put into trough type mixing machine, add 1. in the Radix Stephaniae Tetrandrae coarse powder, mix homogeneously is put in the vacuum drying oven, temperature is controlled at is dried to dried cream below 80 ℃;
4., with above-mentioned dried cream and the above-mentioned dried cream mixing of Formica fusca in 2. in 3., put to pulverize in the unit and pulverize, cross 100 mesh sieves, standby;
5., 4. Chinese medicine powder is put into wet granulator; add appropriate amount of starch; make granule with 40-50% ethanol; put into boiling drier and carry out drying; with carrying out batch mixing behind the pelletizing machine granulate; carry out capsule charge with fully-automatic capsule filling machine then, carry out packing with Aluminium-coating Packer, packing promptly.
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| CN109045141A (en) * | 2018-10-30 | 2018-12-21 | 闫癸江 | Chinese medicine composition, preparation and application |
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