CN106729577B - Traditional Chinese medicine composition for treating rheumatism and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating rheumatism and preparation method thereof Download PDFInfo
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Abstract
A traditional Chinese medicine composition for treating rheumatism and its preparation method, the active prescription in the traditional Chinese medicine composition is composed of (by weight parts) Ningpo Yam rhizome extract 7-10, caulis Spatholobi extract 6-8, and Zingiberis rhizoma extract 2-5. The preparation method comprises the following steps: extracting rhizoma Discoreae Nipponicae and Zingiberis rhizoma with ethanol under reflux, adsorbing with resin, eluting, concentrating, and drying the eluate. Decocting caulis Spatholobi in water, and concentrating and drying to obtain water extractive solution. Mixing the extracts, adding medicinal adjuvants, and making into conventional dosage form to obtain the Chinese medicinal composition for treating rheumatism. The invention has the beneficial effects that: the active components are used as the medicine in the form of the extract of the active components, the active parts are complete, the compatibility of the active components and the regulation of the component proportion are clear, and the material basis is clear. Corresponding pharmacodynamic evaluation is carried out aiming at the migratory arthralgia in the rheumatic arthralgia, the action mechanism is clear, and the curative effect is obviously improved.
Description
Technical Field
The invention relates to the field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for treating rheumatism.
Background
The rheumatism is a group of diseases caused by obstruction of qi and blood and failure of nourishing of tendons and vessels and joints, the diseases are more hidden and slow, the disease course is longer, and the treatment is difficult, and the rheumatism is considered by traditional Chinese medicine to be divided into migratory arthralgia, painful arthralgia, migratory arthralgia and heat arthralgia. In a plurality of medicines for treating the rheumatism, although western medicines can relieve temporary pains but cannot radically cure the rheumatism, a plurality of traditional Chinese medicines are not subjected to dialectical application due to different causes, the invention analyzes and positions main treatment components in the medicines based on the above points, effectively improves the utilization of active components, definitely aims at the rheumatism and the rheumatism, and provides a more effective and safer medicinal preparation for patients.
The prior patent CN101108243A discloses a preparation method of a traditional Chinese medicine preparation for treating rheumatic arthralgia and a corresponding patent CN101108243A discloses a preparation method of the traditional Chinese medicine preparation for treating rheumatic arthralgia, which is rough, wide in treatment range and numerous in main treatment symptoms. Although the raw material medicines of the invention are the yam, the caulis spatholobi and the dried ginger, the invention uses the definite active component extract as the medicine, aims at the characteristics of skin numbness, limb joint stress and the like of rheumatism and rheumatism, accurately extracts, separates and purifies various active components in the medicine, and regulates the compatibility and proportion of the components, so that the medicine effect substance of the invention has clear basis and is obviously different from the patent CN101108243A and the corresponding preparation patent CN 101108243A. The invention has definite clinical indications, pharmacodynamics evaluation is carried out on rheumatism impaling arthralgia, and compared with the patent CN101108243A and the corresponding preparation patent CN101108243A, the curative effect of the preparation of the invention is more obvious.
Disclosure of Invention
The invention aims to provide a raw material proportion of a traditional Chinese medicine composition for treating rheumatism.
The invention also aims to provide a preparation method of the traditional Chinese medicine composition for treating rheumatism.
The invention provides a traditional Chinese medicine composition for treating rheumatism involving the hands, which comprises the following active components in parts by weight: 7-10 parts of a dioscorea nipponica makino extract, 6-8 parts of a caulis spatholobi extract and 2-5 parts of a dried ginger extract.
In order to improve the treatment effect of the invention
The yam extract of the invention contains steroidal saponin compounds. The steroid saponin compounds in the Ningpo Yam rhizome extract mainly comprise dioscin, tenninal saponin and water-soluble saponin. The weight percentage of the steroidal saponins compounds of the yam in the yam extract is more than 70 percent.
The caulis spatholobi extract contains flavonoid compounds. The weight percentage of the flavonoid compounds in the caulis spatholobi extract is more than 60 percent.
The dried ginger extract of the invention contains gingerol compounds. The weight percentage of gingerol compounds in the dried ginger extract is more than 60 percent.
The preparation method of the traditional Chinese medicine composition comprises the following steps:
(1) ningpo Yam rhizome extract
Cutting a yam medicinal material into 1-2 cm long sections, adding 50-70% ethanol, and performing reflux extraction for 2-3 times, wherein the solvent amount is 8-12 times of that of the medicinal material in 90-120 minutes each time. Mixing decoctions, concentrating to 0.5g crude drug per ml extract, passing through treated AB-8 type macroporous adsorbent resin column, eluting with 3-5 times column volume of water, discarding eluate, eluting with more than 60% 4-6 times column volume of ethanol, collecting ethanol eluate, concentrating under reduced pressure, drying, and pulverizing into fine powder.
(2) Caulis Spatholobi extract
Taking a caulis spatholobi medicinal material, cutting into slices of 2-3 mm, adding water, decocting for 2-3 times, each time for 90-120 minutes, wherein the water adding amount is 8-10 times of that of the medicinal material. And combining the decoctions, and concentrating to obtain thick paste with the relative density of 1.12-1.20 for later use. And adding 95% ethanol to enable the alcohol content to reach 60%, standing for 12 hours, filtering, taking a subsequent filtrate, recovering ethanol, concentrating to 0.5g crude drug per milliliter of extract, passing through treated polyamide adsorption resin, eluting with 3-5 times of column volume of water, discarding the eluent, eluting with more than 60% of 4-6 times of column volume of ethanol, collecting the ethanol eluent, concentrating under reduced pressure, drying, and crushing into fine powder for later use.
(3) Extract of dried ginger
Taking a dried ginger medicinal material, cutting into 1-2 cm slices, adding 70-90% ethanol, performing reflux extraction for 1-2 times, performing reflux extraction for 90-120 minutes each time, wherein the solvent amount is 6-8 times of that of the medicinal material, combining decoction, concentrating to 0.5g crude drug per milliliter of extract, passing through treated D101 macroporous adsorption resin, eluting with 3-5 times of column volume of water, discarding eluate, eluting with more than 60% of 4-6 times of column volume of ethanol, collecting ethanol eluate, concentrating under reduced pressure, drying, and crushing into fine powder for later use.
(4) Mixing 7-10 parts by weight of the dioscorea nipponica makino extract obtained in the step (1), 6-8 parts by weight of the caulis spatholobi extract obtained in the step (2) and 2-5 parts by weight of the dried ginger extract obtained in the step (3), and preparing the mixture into capsules, tablets, granules, dropping pills, soft capsules, dispersible tablets, orally disintegrating tablets, sustained release tablets, controlled release tablets and oral liquid by using pharmaceutically acceptable excipients to obtain the traditional Chinese medicine composition for treating rheumatism.
The traditional Chinese medicine composition for treating rheumatism and the preparation method thereof provided by the invention have the beneficial effects that:
1. the invention uses the active ingredient extract form as the medicine, the active part is complete, the compatibility of the active ingredients and the proportion regulation of the ingredients are clear, and the material basis is clear.
2. The invention carries out corresponding pharmacodynamic evaluation aiming at the migratory arthralgia in the rheumatic arthralgia, has clear action mechanism and obviously improved curative effect.
Experiment of drug effect
The invention carries out pharmacodynamic research aiming at the clinical indication of rheumatism and migratory arthralgia, and compared with a preparation patent CN101108243A preparation and a commercially available product of rheumatism and rheumatalgia tablet, the research is as follows:
1. influence of the preparation of the invention on the type II collagen-induced arthritis CIA rat primary synovial cells
Preparing collagen emulsion with final concentration of 2mg/ml with Complete Freund's Adjuvant (CFA) and 4mg/ml collagen emulsion, sensitizing, and strengthening immunity 7 days after sensitization by the same method, rinsing rat synovial tissue successfully molded in PBS, digesting with 0.2% type II collagenase at 37 deg.C for 4h, centrifuging to remove supernatant, culturing cell precipitate in 37 deg.C 5% CO2 incubator, preparing cell suspension from 4 generations of synovial cells, adding into 96-well culture plate, 1 × 104Each well was 100. mu.L, and the cells were incubated at 37 ℃ in a 5% CO2 incubator. The cells are treated by adding medicine in groups, each group is provided with 8 compound holes, the final concentration of the preparation is 600mg/mL and 300mg/mL respectively, the final concentration of the original patent CN101108243A preparation is 600mg/mL, and the concentration of positive control MTX is 1 mg/L. After 24 hours of administration, 10. mu.L of MTT was added to each well, and the mixture was incubated at 37 ℃ for 4 hours, and the supernatant was discarded, and the absorbance (A value) of each well was measured at a wavelength of 570 nm.
1.2 measurement of contents of IL-l β, IL-6 and TNF- α in synovial cell culture supernatant of C1A
The synovial cells and the sample were incubated together in the same manner as 1.3, and after 24 hours of administration, cell supernatants were collected, and the levels of IL-l β, IL-6, and TNF- α in the synovial extracellular fluids of each group were determined with reference to the ELISA kit instructions.
2. Effect of the preparation of the present invention on rat type II collagen-induced arthritis model (CIA)
2.1 establishing a model: same as 1
2.2 grouping and administration
Wistar male rats 105 were randomly divided into 7 groups, namely a normal group, a model group, a rheumatism pain tablet group (0.9g/ml), an original patent CN101108243A preparation group (0.8g/ml), a high, medium and low dosage group (1.6, 0.8, 0.4g/ml) of the preparation of the invention, and 15 rats were each group. Divided dosing was started on day 1 after the initial immunization, 1 time daily. The normal group and the model group were given equal volumes of vehicle, and each group was given for 35 consecutive days.
2.3 Observation index
2.3.1 Effect on pathological morphology of kicked joints in CIA rats
After the experimental rat is sacrificed, the whole right hind paw is taken down and fixed in 4% of the poly formic acid for pathological examination.
2.3.2 measurement of the content of IL- β, IL-6, IL-8 and TNF-a in CIA rat serum
And (3) taking blood from the abdominal aorta, standing, centrifuging at 2500rpm/min for 20min, separating serum, taking supernatant for determination, and determining the contents of IL-1 β, IL-6, IL-8 and TNF-a in the serum of the CIA rat by adopting an ELISA method.
2.3.3 measurement of IL- β, IL-6, IL-8, and TNF-a contents in the synovial tissue of CIA rat
Weighing synovial membrane tissue blocks about 100mg, adding 10 times volume of physiological saline, fully grinding, centrifuging at 4 ℃ for 15 minutes at 10000 × g in a high-speed centrifuge, taking supernatant, and measuring the contents of IL-1 β, IL-6, IL-8 and TNF-a in the synovial membrane tissues of CIA rats by adopting an ELISA method.
3. The effect of the preparation of the invention on the increase of permeability of capillary vessels in abdominal cavity of mice caused by acetic acid
60 Kunming mice, half male and half female, with body weight of 20 + -2 g, were randomly divided into 6 groups: model control group, positive control group (rheumatism pain tablet 1.9g/ml), original patent CN101108243A preparation group (1.8g/ml) and high, medium and low dosage groups (3.0, 1.8, 0.6g/ml) of the preparation of the invention, and 10 of the groups. The ig administration is continued for 7 days, once a day, and the model control group is given the same volume of vehicle. 30min after the last administration, the tail vein was injected with 1% Evans blue 0.1mL/10g, and immediately subjected to intraperitoneal injection of 0.1mL/10g acetic acid solution to cause inflammation, the mice were sacrificed for 30min, the abdominal cavity was rinsed with 5mL physiological saline, and the rinsing solution was subjected to 610nm colorimetry using a microplate reader to determine the absorbance (OD) value.
Inhibition rate (dose OD to model control OD)/model control OD × 100%
4. Effect of the preparation of the present invention on carrageenan-induced foot swelling in rats
70 SD rats with body weight of 200 g and 20g are divided into 7 groups at random, namely a blank control group, a model control group, a positive control group (rheumatism pain tablet 0.9g/ml), an original patent CN101108243A preparation group (0.8g/ml) and high, medium and low dose groups (1.6, 0.8 and 0.4g/ml) of the preparation of the invention, and 10 rats in each group. Ig is administered for 7 consecutive days. The vehicle was administered to the blank control group and the model control group at the same volume. The toe thickness was measured 1h after the last administration, and then 0.1mL of 1% carrageenan physiological saline was injected into the subcutaneous tissue of the left hind limb toe of the rat to cause inflammation, and the swollen and swollen degree of the toe of the rat was measured 1h, 2h, 4h and 6h after the administration.
5. Effect of the formulations of the invention on latency of pain response in mice
ICR mice, male and female half, weight 18g ~ 22 g. 60 mice are randomly divided into 6 groups, namely a blank control group, a positive control group (aspirin is given 400 mg.kg-1), a former patent CN101108243A preparation group (1.8g/kg) and high, medium and low dose groups (3.0, 1.8 and 0.6g/kg) of the preparation of the invention, wherein each group comprises 10 mice. Continuously administering ig with the administration volume of 10ml/kg for 7 days, and observing tail flick time at 1h, 2h and 3h after the last administration.
Results of the experiment
1. Influence of the preparation of the invention on the type II collagen-induced arthritis CIA rat primary synovial cells
1.1 proliferation potency on CIA rat primary synoviocytes
The A value of the synovial cells of rats in the administration group is smaller than that of the control group, wherein the A value of the synovial cells of rats in the preparation (600mg/mL) group and the positive control group is obviously reduced to be lower than that of the synovial cells of rats in the control group (P <0.05 or P <0.01), and the A value of the synovial cells of rats in the original patent CN101108243A preparation (600mg/mL) group and the preparation (300mg/mL) group is similar in size, which indicates that the preparation can inhibit the proliferation of the synovial cells of the CIA rats in vitro, and the effect is better than that of the preparation in the original patent CN 101108243A. Detailed description is shown in tables 1-1
TABLE 1-1 proliferation of synovial cells in various groups of rats
Compared with a blank control group, the # P is less than 0.01, compared with a model group: p < 0.05.
1.2 influence on the content of TNF- α, IL-l β and IL-10 in the synovial cell culture supernatant of CIA rat
Compared with a control group, the administration group has reduced TNF- α and IL-1 β levels and increased IL-10 levels, wherein the preparation (600mg/mL) group and the MTX group have significantly reduced TNF- α and IL-l β levels and increased IL-10 levels (P <0.05 or P <0.01), and the original patent CN101108243A preparation (600mg/m) group and the preparation (300mg/mL) group have equivalent regulation effects on TNF- α, IL-l β and IL-10 levels of synovial cell extracellular fluid of rats.
Table 1-2 changes of synovial extracellular fluid TNF- α, IL-l β and IL-10 of each group of rats
Compared with a blank control group, the # P is less than 0.01, compared with a model group: p < 0.05.
2.1 Effect on CIA model rat kicking joint histopathology
The staining pattern of the rat manic-arthropathy patch HE shows: the blank rat knee joint cartilage is smooth and has no damage, the synovial tissue structure is complete, the cells are arranged orderly, and inflammatory cell infiltration and vascular proliferation phenomena do not occur; the rat cartilage tissue structure of the model group is damaged, synovial cells obviously proliferate, are irregularly arranged and disordered, have a large amount of inflammatory cell infiltration, meanwhile, a synovial pannus is formed, and even a plurality of sections can see the synovial to the cartilage surface to invade the growth of the synovial; the damage degree of the cartilage tissue of the rat in the rheumatism and cold pain tablet group is less, the arrangement of synovial cells is more disordered, the synovial tissue hyperplasia can be seen, but the inflammatory cell infiltration is less; the original patent CN101108243A preparation has the advantages that the synovial tissue is slightly hyperplastic, the arrangement of synovial cells is disordered, and pannus is formed; the synovium tissue surface of the low-dose group of the preparation is thickened, inflammatory cell infiltration can be seen, the arrangement of synovium cells is disordered, pannus is formed, and a few cartilages are damaged; the preparation of the invention has smooth cartilage surface, no cartilage destruction, mild synovium hyperplasia, regular cell morphology, less inflammatory cell infiltration and no pannus formation in a high-dose group.
2.2C 1A determination of IL-l β, IL-6, IL-8 and TNF- α content in rat serum and synovial tissue
As shown in tables 2-1 and 2-2, IL-l β, IL-6, IL-8 and TNF- α in serum and synovial tissue of a model group rat are obviously increased compared with a normal group (P <0.01), which shows that the inflammatory response of the model group rat is obvious, the preparation of the invention has obvious difference (P <0.05) in high, medium (1.6g/kg, 0.8g/kg) and rheumatic pain groups, can reduce the contents of IL-l β, IL-6, IL-8 and TNF- α in serum and synovial tissue of a C1A rat, but the contents of IL-l β, IL-8656, IL-8 and TNF- α in 101108243A (1.6g/kg) of the original patent CN 5 preparation can also reduce the contents of IL-l 8656, IL-8 and TNF- α in serum and synovial tissue of the rat, but the preparation of the invention has no obvious effect compared with the same dosage compared with the preparation of the invention, the preparation of the invention has high and medium dosage groups of IL-l β, IL-6, IL-8, TNF-364, and the effect of reducing inflammatory response of the serum and CN 23, which is better than the detection results of the original patent CN 24.
Table 2-1 comparison of the contents of IL-l β, IL-6, IL-8 and TNF- α in the serum of each group of rats (see below)
n＝15)
Note, # P <0.05, # P <0.01 as compared to the normal group; comparison with model group of P <0.05, P <0.01
Table 2-2 comparison of IL-l β, IL-6, IL-8 and TNF- α contents in synovial tissue of rats (A)
n＝15)
Note, # P <0.05, # P <0.01 as compared to the normal group; comparison with model group of P <0.05, P <0.01
3. The effect of the preparation of the invention on the increase of permeability of capillary vessels in abdominal cavity of mice caused by acetic acid
After the acetic acid solution is injected into the abdominal cavity of the mouse, the OD value is obviously increased, which shows that the permeability of the capillary vessels in the abdominal cavity is obviously increased; compared with a model control group, OD values of all administration groups are reduced, wherein the rheumatism pain tablet, the preparation of the invention with high dose (3.0g/kg) and medium dose (1.8g/kg) groups can obviously inhibit the increase of the permeability of the capillary vessel in the abdominal cavity of the mouse caused by acetic acid, which indicates that the preparation of the invention has stronger inhibition effect on the acute inflammatory exudation caused by the acetic acid, wherein the effect of high dose is most obvious, and the effect of the original patent CN101108243A preparation (1.8g/kg) on inhibiting the permeability of the capillary vessel in the abdominal cavity of the mouse caused by the acetic acid is similar to that of the preparation with low dose. The results are shown in tables 3-1, and the preparation can reduce the permeability of the capillary vessels of mice, and has a certain dose-effect relationship, and the effect is better than that of the original patent CN101108243A preparation.
TABLE 3-1 Effect of the formulations of the present invention on mouse capillary Permeability (
n＝10)
Note # P <0.01 compared to blank and # P <0.05 compared to model.
4. Effect of the preparation of the present invention on carrageenan-induced foot swelling in rats
After injection of 1% carrageenan in the left hind paw of the rat, significant swelling of the paw occurred. The results are shown in tables 4-1, and compared with the model group, the toe swelling degrees of the rats are obviously different in 1h, 2h, 3h, 4h and 6h in the blank group (P is less than 0.001); compared with a model group, the preparation has the advantages that the high and medium doses (1.6 and 0.8g/kg) of the preparation are obviously different from the toe swelling degrees of rats 1h, 2h, 3h, 4h and 6h after inflammation (P is less than 0.05, P is less than 0.01 and P is less than 0.001); compared with a model group, the preparation has the advantages that the low dose (0.4g/kg) of the preparation has different toe swelling degrees (P is less than 0.05) of rats at 1h, 2h, 4h and 6h after inflammation, and the toe swelling degrees (P is less than 0.01 and P is less than 0.001) of rats at 2h, 4h and 6h after inflammation; compared with a model group, the original patent CN101108243A preparation (0.8g/kg) has different toe swelling degrees (P <0.05) of rats at 1h, 2h and 4h after inflammation, has obvious difference (P <0.01) at 6h after inflammation, but has lower inhibition effect on the toe swelling degree of the rats than the preparation of the invention with the same dose, and has no obvious difference on the toe swelling degree compared with the model group at 3h with the most obvious inflammatory reaction. See table below for details.
TABLE 4-1 Effect of the formulations of the present invention on carrageenan-induced swelling of rat feet: (
n＝10)
Note, ## # P <0.001 compared with the normal group; comparison with model group of P <0.05, P <0.01, P <0.001
5. Effect of the formulations of the invention on latency of pain response in mice.
Compared with the blank group, the preparation of the invention has high (3.0g/kg) and medium dose (1.8g/kg), prolongs the tail flick time (P is less than 0.001 and P is less than 0.01) of the mice after 1h, 2h and 3h of the last administration, and has obvious effect, and compared with the blank group, the preparation of the invention has low dose (0.6g/kg), obviously prolongs the tail flick time (P is less than 0.01 and P is less than 0.05) of the mice after 1h, 2h and 3h of the last administration. Compared with the blank group, the original patent CN101108243A preparation (1.8g/kg) prolongs the tail flick time of the mice at 1h and 3h after the last administration (P < 0.05). The preparation of the invention can obviously prolong the tail flicking time of mice and is obviously superior to the original patent CN101108243A preparation. The details are shown in the following tables 5-1.
TABLE 5-1 Effect of the inventive preparation samples on the reaction latency of tail flick pain in mice: (
n＝10)
Note P <0.05, P <0.01, P <0.001 compared to blank groups.
The pathogenesis of rheumatism is mainly deficiency of liver and kidney, deficiency of qi and blood, local qi stagnation and blood stasis, meridian obstruction as targets, thus activating blood circulation to dissipate blood stasis, and improving tissue microcirculation state becomes the main link of the disease, research proves that after long-term joint braking of various reasons, pathological changes such as contracture, synovial hyperplasia and the like of soft tissues around joints can be caused, so that the dynamics of joints are changed, under abnormal stress state, synovial mucin depolymerization and hyaluronic acid component are reduced, the lubricity is reduced, the mechanical abrasion of cartilage surface is increased, the pathological changes of the braked arthritis are similar to that of clinically seen osteoarthritis, IL- β, IL-6, IL-8 and TNF- α in cytokines are important mediators involved in the pathogenesis process of arthritis, are important regulators of inflammation reaction, the initiating factors of inflammation are regulating inflammation, the disturbance effects of interleukin series inflammatory factors on the metabolism of articular chondrocytes are mainly expressed by inhibiting characteristic of hyaluronic acid, IX synthesis of IX, II, I, III synthesis of cartilage cell, and IL-induced cell proliferation inhibition of cytokine secretion of rat cartilage cell proliferation, and macrophage proliferation, the pathological changes of rat's receptor, the rat's collagen, the rat's inflammation, the rat's endothelial cell proliferation, the rat's collagen, the rat's inflammation is induced by the rat's collagen, the rat's inflammation, the rat's collagen, the rat's inflammation, the rat's inflammation, the's blood's, the's inflammation, the's blood's inflammation, the's blood.
The composition has the obvious effect of treating rheumatism arthralgia.
Detailed Description
Example one
(1) The yam rhizome medicinal material is taken, cut into 1-2 cm long sections, added with 50-70% ethanol for reflux extraction for 2-3 times, and the solvent amount is 8-12 times of that of the yam rhizome medicinal material every 90-120 minutes. Mixing decoctions, concentrating to 0.5g crude drug per ml extract, passing through treated AB-8 type macroporous adsorbent resin column, eluting with 3-5 times column volume of water, discarding eluate, eluting with more than 60% 4-6 times column volume of ethanol, collecting ethanol eluate, concentrating under reduced pressure, drying, and pulverizing into fine powder.
(2) Taking a caulis spatholobi medicinal material, cutting into slices of 2-3 mm, adding water, decocting for 2-3 times, each time for 90-120 minutes, wherein the water adding amount is 8-10 times of that of the medicinal material. And combining the decoctions, and concentrating to obtain thick paste with the relative density of 1.12-1.20 for later use. And adding 95% ethanol to enable the alcohol content to reach 60%, standing for 12 hours, filtering, taking a subsequent filtrate, recovering ethanol, concentrating to 0.5g crude drug per milliliter of extract, passing through treated polyamide adsorption resin, eluting with 3-5 times of column volume of water, discarding the eluent, eluting with more than 60% of 4-6 times of column volume of ethanol, collecting the ethanol eluent, concentrating under reduced pressure, drying, and crushing into fine powder for later use.
(3) Taking a dried ginger medicinal material, cutting into 1-2 cm slices, adding 70-90% ethanol, performing reflux extraction for 1-2 times, performing reflux extraction for 90-120 minutes each time, wherein the solvent amount is 6-8 times of that of the medicinal material, combining decoction, concentrating to 0.5g crude drug per milliliter of extract, passing through treated D101 macroporous adsorption resin, eluting with 3-5 times of column volume of water, discarding eluate, eluting with more than 60% of 4-6 times of column volume of ethanol, collecting ethanol eluate, concentrating under reduced pressure, drying, and crushing into fine powder for later use.
(4) And (3) adding starch into 7 parts by weight of the dioscorea nipponica makino extract obtained in the step (1), 7 parts by weight of the suberect spatholobus stem extract obtained in the step (2) and 5 parts by weight of the dried ginger extract obtained in the step (3), mixing uniformly, granulating and drying to obtain the traditional Chinese medicine composition granules for treating rheumatism.
Example two
(1) The preparation method of the first embodiment is used for preparing the dioscorea nipponica makino extract, the suberect spatholobus stem extract and the dried ginger extract,
(2) mixing 8 parts by weight of rhizoma dioscoreae nipponicae extract, 6 parts by weight of caulis spatholobi extract and 4 parts by weight of rhizoma zingiberis extract with starch, mixing uniformly, granulating, drying and encapsulating to obtain the traditional Chinese medicine composition capsule for treating rheumatism.
EXAMPLE III
(1) The preparation method of the first embodiment is used for preparing the dioscorea nipponica makino extract, the suberect spatholobus stem extract and the dried ginger extract,
(2) mixing 10 parts by weight of the dioscorea nipponica makino extract, 8 parts by weight of the suberect spatholobus stem extract and 2 parts by weight of the dried ginger extract, crushing into fine powder with the fineness of 80-120 meshes, adding starch, mixing and tabletting to obtain the traditional Chinese medicine composition tablet for treating rheumatism.
Claims (2)
1. A traditional Chinese medicine composition for treating rheumatism, which is characterized in that: the active components of the composition comprise the following raw materials in parts by weight:
7-10 parts of a dioscorea nipponica makino extract, 6-8 parts of a suberect spatholobus stem extract and 2-5 parts of a dried ginger extract;
the preparation method comprises the following steps:
(1) ningpo Yam rhizome extract
Taking a dioscorea nipponica medicinal material, cutting the dioscorea nipponica medicinal material into long sections of 1-2 cm, adding 50-70% of ethanol for reflux extraction for 2-3 times, each time lasting for 90-120 minutes, wherein the solvent amount is 8-12 times of that of the medicinal material, merging decoction, concentrating to 0.5g of crude drug per milliliter, passing through an AB-8 type macroporous adsorption resin column after treatment, eluting with 3-5 times of column volume of water, discarding eluate, eluting with more than 60% of 4-6 times of column volume of ethanol, collecting ethanol eluate, concentrating under reduced pressure, drying, and crushing into fine powder for later use;
(2) caulis Spatholobi extract
Taking a caulis spatholobi medicinal material, cutting into slices of 2-3 mm, adding water, decocting for 2-3 times, each time for 90-120 minutes, adding water in an amount which is 8-10 times that of the medicinal material, mixing decoction, concentrating to thick paste with the relative density of 1.12-1.20 for later use, adding 95% ethanol to enable the ethanol content to reach 60%, standing for 12 hours, filtering, taking subsequent filtrate, recovering ethanol, concentrating to 0.5g of extract of the crude drug per milliliter, passing through treated polyamide adsorption resin, eluting with 3-5 times of column volume of water, discarding the eluent, eluting with more than 60% of 4-6 times of column volume of ethanol, collecting ethanol eluent, concentrating under reduced pressure, drying, and crushing into fine powder for later use;
(3) extract of dried ginger
Taking a dried ginger medicinal material, cutting into 1-2 cm slices, adding 70-90% ethanol, performing reflux extraction for 1-2 times, each time for 90-120 minutes, wherein the solvent amount is 6-8 times of that of the medicinal material, combining decoctions, concentrating to 0.5g of an extracting solution of the crude drug per milliliter, passing through treated D101 macroporous adsorption resin, eluting with 3-5 times of column volume of water, discarding the eluent, eluting with more than 60% of 4-6 times of column volume of ethanol, collecting ethanol eluent, concentrating under reduced pressure, drying, and crushing into fine powder for later use;
(4) mixing 7-10 parts by weight of the dioscorea nipponica makino extract obtained in the step (1), 6-8 parts by weight of the caulis spatholobi extract obtained in the step (2) and 2-5 parts by weight of the dried ginger extract obtained in the step (3), and preparing a pharmaceutically acceptable excipient into capsules, tablets, granules, dropping pills and oral liquid to obtain the traditional Chinese medicine composition for treating rheumatism;
the yam extract contains steroidal saponin compounds which are one of main active components of the composition; the steroid saponin compounds in the dioscorea nipponica makino extract mainly comprise dioscin, tenninal saponin and water-soluble saponin; the weight percentage of the steroidal saponins compounds of the yam in the yam extract is more than 70 percent;
the caulis spatholobi extract contains flavonoid compounds which are one of the active components of the composition; the weight percentage of the flavonoid compounds in the caulis spatholobi extract is more than 60 percent;
the dried ginger extract contains gingerol compounds which are one of the active components of the composition; the weight percentage of gingerol compounds in the dried ginger extract is more than 60 percent.
2. The preparation method of the traditional Chinese medicine composition for treating rheumatism involving the hands of the patient according to claim 1 is characterized by comprising the following steps:
(1) ningpo Yam rhizome extract
Taking a dioscorea nipponica medicinal material, cutting the dioscorea nipponica medicinal material into long sections of 1-2 cm, adding 50-70% of ethanol for reflux extraction for 2-3 times, each time lasting for 90-120 minutes, wherein the solvent amount is 8-12 times of that of the medicinal material, merging decoction, concentrating to 0.5g of crude drug per milliliter, passing through an AB-8 type macroporous adsorption resin column after treatment, eluting with 3-5 times of column volume of water, discarding eluate, eluting with more than 60% of 4-6 times of column volume of ethanol, collecting ethanol eluate, concentrating under reduced pressure, drying, and crushing into fine powder for later use;
(2) caulis Spatholobi extract
Taking a caulis spatholobi medicinal material, cutting into slices of 2-3 mm, adding water, decocting for 2-3 times, each time for 90-120 minutes, adding water in an amount which is 8-10 times that of the medicinal material, mixing decoction, concentrating to thick paste with the relative density of 1.12-1.20 for later use, adding 95% ethanol to enable the ethanol content to reach 60%, standing for 12 hours, filtering, taking subsequent filtrate, recovering ethanol, concentrating to 0.5g of extract of the crude drug per milliliter, passing through treated polyamide adsorption resin, eluting with 3-5 times of column volume of water, discarding the eluent, eluting with more than 60% of 4-6 times of column volume of ethanol, collecting ethanol eluent, concentrating under reduced pressure, drying, and crushing into fine powder for later use;
(3) extract of dried ginger
Taking a dried ginger medicinal material, cutting into 1-2 cm slices, adding 70-90% ethanol, performing reflux extraction for 1-2 times, each time for 90-120 minutes, wherein the solvent amount is 6-8 times of that of the medicinal material, combining decoctions, concentrating to 0.5g of an extracting solution of the crude drug per milliliter, passing through treated D101 macroporous adsorption resin, eluting with 3-5 times of column volume of water, discarding the eluent, eluting with more than 60% of 4-6 times of column volume of ethanol, collecting ethanol eluent, concentrating under reduced pressure, drying, and crushing into fine powder for later use;
(4) mixing 7-10 parts by weight of the dioscorea nipponica makino extract obtained in the step (1), 6-8 parts by weight of the caulis spatholobi extract obtained in the step (2) and 2-5 parts by weight of the dried ginger extract obtained in the step (3), and preparing a pharmaceutically acceptable excipient into capsules, tablets, granules, dropping pills and oral liquid to obtain the traditional Chinese medicine composition for treating rheumatism.
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