CN102139087A - Medicament for treating rheumatoid arthritis and preparation method thereof - Google Patents

Abstract

The invention relates to a medicament for treating rheumatoid arthritis, which is prepared by taking notopterygium root, radix angelicae pubescentis, orientvine, zedoary, common burreed rhizome, prepared rehmannia root, clematis root, radix sileris, ephedra, corydalis tuber, radix cyathulae, chuanxiong rhizome, cassia, ginger, licorice, amomun fruit and draconis sanguis as raw materials according to the following steps of: (1) firstly, mixing draconis sanguis, corydalis tuber, amomun fruit and 1/2 radix sileris, and crushing into fine powder for later use; (2) adding the other raw medicines into water the weight of which is 3 times of that of the other raw medicines for decocting twice (for 2 hours for the first time and for 1.5 hours for the second time), mixing the decoctions, filtering, and concentrating the filtered solution into thick paste the relative density of which is 1.23-1.26; and (3) adding the fine powder prepared in the step (1) into the thick paste, uniformly mixing, drying, crushing into 100-120-mesh fine powder, encapsulating, and sterilizing and disinfecting to obtain a capsule product. The medicament provided by the invention effectively exerts the traditional Chinese medicine compatibility and has the advantages of expelling wind and clearing away cold, eliminating dampness and dredging channels and promoting blood circulation and stopping pain.

Description

A kind of medicine for the treatment of rheumatoid arthritis and preparation method thereof

Technical field

The present invention relates to a kind of medicine, particularly relating to a kind of is the medicine of the treatment rheumatoid arthritis of feedstock production with Chinese medicine.The invention still further relates to the preparation method of this medicine.

Background technology

(Rheumatoid Arthrits RA) is autoimmune disease based on the synovium of joint chronic inflammatory disease to rheumatoid arthritis, can cause arthralgia, then cause cartilage destruction, the joint space narrows down, and late period, deformity in various degree finally appearred in joint deformity.Part patient also pathological changes outside the joint can occur, comprises heart damage, vasculitis, lung damage, eye infringement etc.The arthropathy of general rheumatoid arthritis can only be disabled, rare causing death, but performance or its complication have lethal possible in the joint outside.Show that according to statistics RA all has morbidity in the whole world, average attack rate is 1%, and China's prevalence is 0.3%～0.4%, and sickness rate is and increases trend year by year, if diagnosis and treatment in time, 70% patient can be disabled after the several years, and average life shortens 10～15 years.In fact, rheumatism is one of high morbidity of China always, account for the data that state provides according to the vice chairman of rheumatism branch of Chinese Medical Association chestnut, present domestic rheumatoid, systemic lupus erythematosus (sle), dry syndrome, patients with ankylosing spondylitis reach about 1,970 ten thousand people, osteoarthritis patient has 3,000 ten thousand people approximately, and wherein rheumatoid arthritis and ankylosing spondylitis have become the population of China disability and the second largest cause of disease that disables.

The pathogeny of RA is not clear and definite fully as yet, thinks relevant with factors such as autoimmune, environment, antibacterial, virus, heredity, gonadal hormone and the neural mental status at present, and the purpose of treatment mainly is control and prevention destruction of joint.The treatment of RA at present comprises Drug therapy, surgical intervention and Psychological rehabilitation therapy etc.The various treatment RA medicines of current domestic and international clinical practice only alleviating pain, alleviate or delay development of inflammation, all can not control destruction of joint fully.The common drug of treatment RA has NSAID (non-steroidal anti-inflammatory drug) (NSAID), improves 5 big classes such as state of an illness antirheumatic (DMARD), glucocorticoid (GC), biological preparation and plant amedica.Rheumatoid arthritis is because the course of disease and clinical manifestation differ, and its treatment also presents various scheme.The case history of being in hospital of having researched and analysed 207 parts of such patients is arranged, and investigation shows: price costlinesses such as immunomodulator, untoward reaction are also more, and the patient is difficult for accepting; The intracavitary administration medication accounts for 16.7%, but because the increase of hospitalization cost, inspection fee, injection and other medical expenses, its consumption amount of money but accounts for 38.32% of total amount, and average price is also higher; Oral medication accounts for 78.7%, and its consumption amount but only accounts for 38.32% of total amount, and the mean treatment price is minimum.This studies show that the treatment atrophic diseases is still based on oral.But; the patient of numerous oral western medicine treatments obvious toxic and side effects usually can occur and lose clinical efficacy gradually after several years; the state of an illness of most of patients can not obtain permanently effective control as a result; and Chinese medicine at therapeutic effect, improve the whole body situation, there is irreplaceable effect aspect such as improve the quality of living, so Chinese patent medicine becomes the preferential selection of vast patient with rheumatoid arthritis gradually.

Summary of the invention

The objective of the invention is to bring into play traditional Chinese medical science combination drug, across-the-board regulation bodily fuctions's characteristics, a kind of expelling wind and cold is provided, eliminating dampness and dredging channels, the medicine of the treatment rheumatoid arthritis of promoting blood circulation and stopping pain.

Another goal of the invention of the present invention provides the preparation method of this medicine.

The objective of the invention is the dialectical process that is applicable to the clinical treatment rheumatoid arthritis of reason, method, side, medicine the traditional Chinese medical science.By the dialectical cause of disease of the four methods of diagnosis and eight key links, pathogenesis, syndrome, make treatment side's medicine.Exactly by the four diagnostic methods: hear, ask, hope, cut; The utilization eight guiding principles for diagnosis, negative and positive, table reason, cold and heat and asthenia and sthenia are made a clear distinction the etiology and pathogenesis syndrome, determine principle-method-recipe-medicines.Its emphasis is that differentiation of eight pricipales, etiological analysis and differentiation, the differentiation of disease according to pathological changes of the viscera and their and QI and blood are dialectical.Rheumatoid arthritis belongs to " arthromyodynia " category in Chinese medicine, theory of Chinese medical science is thought " numbness person closes also, and is also obstructed ", arthromyodynia is because of wind, cold, wet, heat, pathogens such as silt, the retardance meridians, QI-blood circulation is obstructed, and shows as arthroncus, pain is aching and tired, numb, diseases such as joint stuffiness, the etiology and pathogenesis characteristics of development take place with regard to its disease, especially with wind, cold, the three kinds of pathogens that wet more sees, thus interior through saying " it is numbness that wet three gas of wind and cold are mixed extremely ", secondly be obstinate disease, prolonged illness becomes the stasis of blood, stasis of blood resistance meridians form, and we's main symptom of controlling is the wet congestion resistance network type arthromyodynia of holding concurrently of clinical common wind and cold folder, and its pathogenesis is that wind-cold damp pathogen is invaded human body, the retardance meridians, with the passing of time QI-blood circulation is not smooth, gives birth to and the resistance network blockage of main and collateral channels in the blood stasis, send out and be arthromyodynia, so determined expelling wind and cold, eliminating dampness and dredging channels, the rule of treatment of promoting blood circulation and stopping pain.

Based on above-mentioned Therapeutic Principle, medicine of the present invention is to be crude drug with following parts of medicines by weight:

Rhizoma Et Radix Notopterygii 150～182, Radix Angelicae Pubescentis 150～182, Caulis Sinomenii 150～182, Rhizoma Wenyujin Concisum 150～182, rhizoma sparganic 150～182, Radix Rehmanniae Preparata 150～182, Radix Clematidis 120～146, Radix Saposhnikoviae 120～146, Herba Ephedrae 120～146, Rhizoma Corydalis 120～146, Radix Cyathulae 120～146, Rhizoma Chuanxiong 90～109, Cortex Cinnamomi 60～73, Rhizoma Zingiberis Recens 60～73, Radix Glycyrrhizae 30～36, Fructus Amomi 20～23, Sanguis Draxonis 9～11.

Said medicine can be made any dosage form on the pharmaceutics, as decoction, pill, powder, capsule;

The preferred dosage form of the present invention is a capsule.

The concrete preparation method of capsule of the present invention is: according to parts by weight

1) earlier Sanguis Draxonis, Rhizoma Corydalis, Fructus Amomi, 1/2 Radix Saposhnikoviae are mixed and to be ground into fine powder standby.

2) all the other crude drug are added 3 times of water gagings again and decoct secondaries, 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, and it is 1.23～1.26 thick paste that filtrate is concentrated into relative density.

3) fine powder that then step 1) made adds mix homogeneously in the thick paste, and drying is ground into during 100～120 purpose fine powders incapsulate, and sterilization is made the capsule product.

In the prescription of the present invention, Rhizoma Et Radix Notopterygii is to dispel wind-cold damp pathogen above the waist, and Radix Angelicae Pubescentis is dispeled the following wind-cold damp pathogen of waist with stopping numbness pain, is the monarch drug of full side; Caulis Sinomenii, the pain relieving of Radix Clematidis eliminating dampness and dredging channels, Radix Saposhnikoviae, Herba Ephedrae, Rhizoma Zingiberis Recens diaphoresis damp eliminating from sweating, are ministerial drug in the hope of wet altogether; And help with Rhizoma Wenyujin Concisum, Sanguis Draxonis, Rhizoma Corydalis, Rhizoma Chuanxiong, rhizoma sparganic blood-activating and qi-promoting, removing obstruction in the collateral to relieve pain, the cold-damp in the diffusing meridians of Cortex Cinnamomi, Radix Cyathulae invigorating the liver and kidney, bone and muscle strengthening, Radix Rehmanniae Preparata nourishes blood and seeks, and Fructus Amomi is amusing and is regulated the flow of vital energy; Radix Glycyrrhizae is concocted all medicines for making, and plays expelling wind and cold altogether, eliminating dampness and dredging channels, the merit of promoting blood circulation and stopping pain.Be used for the wind-cold damp pathogen obstruction of collaterals by blood stasis type arthromyodynia of holding concurrently.Main treatment rheumatoid arthritis also can be used for stiff rachitis, gouty, rheumatic and degenerative osteoarthritis etc.

For showing therapeutic effect of the present invention, randomly draw the 155 routine cold-damp stasis of blood type patient with rheumatoid arthritis of holding concurrently and carry out clinical observation research, the result is as follows:

Diagnostic criteria:

1) Western medicine diagnose, standard by stages: with reference to " new Chinese medicine clinical research guideline " and national combination of Chinese and Western medicine rheumatism meeting revised standard.

2) Chinese medical discrimination standard: formulate with reference to " new Chinese medicine clinical research guideline ".

3) case is rejected standard: below 16 years old or the over-65s person; The bad person of darling renal function; Gestation or suckling person; The psychotic; Used the antirheumatic person in 2 weeks; Do not take medicine in accordance with regulations or the infull person of data.

Physical data

Two groups of patient's sexes, age, course of disease there was no significant difference see Table 1:

Table 1 liang group patient sex, age, course of disease distribution table

Learn by statistics and handle, compare with matched group, ^*P＞0.05

Therapeutic scheme: oral medicine of the present invention is organized in treatment, each 4,3 times on the one, takes after meal; Matched group is taken WANGBI CHONGJI, and by specification is taken.

Therapeutic outcome sees Table 2, table 3:

Table 2 liang group patient total effects relatively

Annotate: compare with matched group, ^*P＜0.05

Curative effect determinate standard wherein:

Clinical cure: tcm clinical practice symptom, sign disappear or basic the disappearance, and the disease integration reduces 〉=95%;

Produce effects: tcm clinical practice symptom, sign are obviously improved, and the disease integration reduces 〉=70%;

Effectively: tcm clinical practice symptom, sign all take a favorable turn, and the disease integration reduces 〉=30%;

Invalid: tcm clinical practice symptom, sign do not have obvious improvement, even increase the weight of, the disease integration reduces less than 30%;

Conclusion: Drug therapy cold-damp of the present invention stasis of blood type rheumatoid arthritis 120 examples of holding concurrently, effective percentage reaches 90.8%, shows that the Drug therapy cold-damp of the present invention stasis of blood type rheumatoid arthritis of holding concurrently is evident in efficacy, does not see obvious adverse reaction in the therapeutic process.

The comparison of cardinal symptom and sign before and after the table 3 liang group treatment

Annotate: relatively preceding with the treatment of this group, ^*P＜0.05.

Conclusion: medicine of the present invention is being eliminated the cold-damp stasis of blood type rheumatoid arthritis cardinal symptom of holding concurrently, improve and the recovery function of joint, reduce the positive rate aspect of ESR, CRP and RF, evident in efficacy, greatly removed patient's misery, and used for many years, have only the part patient to reflect gastrointestinal upset, not seeing has tangible Liver and kidney and other internal organs toxicity, and its effectiveness and safety have obtained certainly, and the treatment rheumatoid arthritis is had higher clinic value.

The specific embodiment

Embodiment 1:

Take by weighing raw material by following proportioning:

Rhizoma Et Radix Notopterygii 150g, Radix Angelicae Pubescentis 150g, Caulis Sinomenii 150g, Rhizoma Wenyujin Concisum 150g, rhizoma sparganic 150g, Radix Rehmanniae Preparata 150g, Radix Clematidis 120g, Radix Saposhnikoviae 120g, Herba Ephedrae 120g, Rhizoma Corydalis 120g, Radix Cyathulae 120g, Rhizoma Chuanxiong 90g, Cortex Cinnamomi 60g, Rhizoma Zingiberis Recens 60g, Radix Glycyrrhizae 30g, Fructus Amomi 20g, Sanguis Draxonis 9g.

Concrete preparation method is:

1) earlier Sanguis Draxonis, Rhizoma Corydalis, Fructus Amomi, 1/2 Radix Saposhnikoviae are mixed and to be ground into fine powder standby.

2) all the other crude drug are added 3 times of water gagings again and decoct secondaries, 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, and it is 1.23 thick paste that filtrate is concentrated into relative density.

3) fine powder that then step 1) made adds mix homogeneously in the thick paste, and drying is ground into during 100 purpose fine powders incapsulate, and sterilization is made the capsule product.

Using method:

One time 4,3 times on the one, one after each meal.

Embodiment 2:

Take by weighing raw material by following proportioning:

Rhizoma Et Radix Notopterygii 182g, Radix Angelicae Pubescentis 182g, Caulis Sinomenii 182g, Rhizoma Wenyujin Concisum 182g, rhizoma sparganic 182g, Radix Rehmanniae Preparata 182g, Radix Clematidis 146g, Radix Saposhnikoviae 146g, Herba Ephedrae 146g, Rhizoma Corydalis 146g, Radix Cyathulae 146g, Rhizoma Chuanxiong 109g, Cortex Cinnamomi 73g, Rhizoma Zingiberis Recens 73g, Radix Glycyrrhizae 36g, Fructus Amomi 23g, Sanguis Draxonis 11g.

Concrete preparation method is:

1) earlier Sanguis Draxonis, Rhizoma Corydalis, Fructus Amomi, 1/2 Radix Saposhnikoviae are mixed and to be ground into fine powder standby.

2) all the other crude drug are added 3 times of water gagings again and decoct secondaries, 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, and it is 1.26 thick paste that filtrate is concentrated into relative density.

3) fine powder that then step 1) made adds mix homogeneously in the thick paste, and drying is ground into during 120 purpose fine powders incapsulate, and sterilization is made the capsule product.

Using method:

One time 4,3 times on the one, one after each meal.

Embodiment 3:

Take by weighing raw material by following proportioning:

Rhizoma Et Radix Notopterygii 165g, Radix Angelicae Pubescentis 165g, Caulis Sinomenii 165g, Rhizoma Wenyujin Concisum 165g, rhizoma sparganic 165g, Radix Rehmanniae Preparata 165g, Radix Clematidis 130g, Radix Saposhnikoviae 130g, Herba Ephedrae 130g, Rhizoma Corydalis 130g, Radix Cyathulae 130g, Rhizoma Chuanxiong 100g, Cortex Cinnamomi 68g, Rhizoma Zingiberis Recens 68g, Radix Glycyrrhizae 33g, Fructus Amomi 21g, Sanguis Draxonis 10g.

Concrete preparation method is:

1) earlier Sanguis Draxonis, Rhizoma Corydalis, Fructus Amomi, 1/2 Radix Saposhnikoviae are mixed and to be ground into fine powder standby.

2) all the other crude drug are added 3 times of water gagings again and decoct secondaries, 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, and it is 1.25 thick paste that filtrate is concentrated into relative density.

3) fine powder that then step 1) made adds mix homogeneously in the thick paste, and drying is ground into during 110 purpose fine powders incapsulate, and sterilization is made the capsule product.

Using method:

One time 4,3 times on the one, one after each meal.

Claims (2)

1. medicine for the treatment of rheumatoid arthritis is characterized in that being made by following parts of medicines by weight:

Rhizoma Et Radix Notopterygii 150～182, Radix Angelicae Pubescentis 150～182, Caulis Sinomenii 150～182, Rhizoma Wenyujin Concisum 150～182, rhizoma sparganic 150～182, Radix Rehmanniae Preparata 150～182, Radix Clematidis 120～146, Radix Saposhnikoviae 120～146, Herba Ephedrae 120～146, Rhizoma Corydalis 120～146, Radix Cyathulae 120～146, Rhizoma Chuanxiong 90～109, Cortex Cinnamomi 60～73, Rhizoma Zingiberis Recens 60～73, Radix Glycyrrhizae 30～36, Fructus Amomi 20～23, Sanguis Draxonis 9～11.

2. according to the described a kind of preparation method for the treatment of the medicine of rheumatoid arthritis of claim 1, it is characterized in that: comprise that the following step poly-: according to parts by weight

1) earlier Sanguis Draxonis, Rhizoma Corydalis, Fructus Amomi, 1/2 Radix Saposhnikoviae are mixed and to be ground into fine powder standby.

2) all the other crude drug are added 3 times of water gagings again and decoct secondaries, 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, and it is 1.23～1.26 thick paste that filtrate is concentrated into relative density.

3) fine powder that then step 1) made adds mix homogeneously in the thick paste, and drying is ground into during 100～120 purpose fine powders incapsulate, and sterilization is made the capsule product.