A traditional Chinese medicine composition for preventing and treating idiopathic arthritis and its preparation method

Abstract

The present invention belongs to the field of traditional Chinese medicine technology, specifically to a kind of Chinese medicine composition for reducing uric acid and preventing and treating idiopathic arthritis and its preparation method.A kind of Chinese medicine composition, in parts by mass, is prepared from the following raw materials:300-700 parts of peony leaf extract, 100-500 parts of rhizoma smilacis Glabrae, 100-200 parts of herba plantains, 100-200 parts of rhizoma alismatis, 100-140 parts of fructus hovenii and 5-10 parts of chicory powder.The present invention selects peony leaf extract, rhizoma smilacis Glabrae, herba plantains, rhizoma alismatis, fructus hovenii and chicory powder, and is not limited to the dosage forms such as Chinese medicine tablets obtained through processes such as ethanol reflux extraction, decoction, concentration, spray drying and tableting.By discovering to hyperuricemia rat model experiment and idiopathic arthritis rat model experiment, the Chinese medicine composition of the present invention provides support for developing the Chinese medicine medicine for reducing uric acid and preventing and treating idiopathic arthritis.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for lowering uric acid and preventing and treating idiopathic arthritis and a preparation method thereof. Background Art

[0002] Gout is a group of metabolic diseases caused by disorders in purine metabolism and / or uric acid excretion. Urate deposits in joints can induce recurrent attacks of gouty acute arthritis, the deposition of tophi, and joint deformities. Severe gout patients can also suffer kidney damage, leading to uric acid kidney stones and chronic interstitial nephritis. Hyperuricemia is the primary biochemical basis for the development of gout and is the "fourth high" after hypertension, hyperglycemia, and hyperlipidemia, seriously endangering human health. Currently, the main drugs used to treat hyperuricemia and gout include febuxostat, allopurinol, colchicine, benzbromarone, and probenecid. However, long-term use of these drugs will generally result in varying degrees of toxic side effects.

[0003] Juvenile idiopathic arthritis is a common rheumatic autoimmune disease in children and has gradually become one of the main causes of disability in children. Its most serious problem is the susceptibility to growth disorders, leading to short stature in adulthood. The reasons may be related to disease activity, growth hormone deficiency and side effects of drug treatment, especially the use of hormones. Although the incidence of juvenile idiopathic arthritis is low, once the disease occurs, it will affect the life trajectory of the child and have a great impact on the family and society. The treatment of juvenile idiopathic arthritis generally uses glucocorticoids, immunosuppressants and biological agents. The use of hormones is the main cause of growth disorders and bone destruction in children. Although biological agents have shown good short-term clinical efficacy, most patients still relapse after interruption of treatment or during treatment, and related adverse reactions often occur.

[0004] Traditional Chinese medicine (TCM) has multiple targets, multiple components, and minimal toxicity and side effects. Therefore, searching for drugs from TCM to lower uric acid and prevent and treat idiopathic arthritis is undoubtedly an advantageous treatment strategy.

[0005] The information disclosed in this background technology section is only intended to enhance understanding of the overall background of the invention and should not be regarded as an admission or any form of suggestion that the information constitutes the prior art already known to a person skilled in the art. Summary of the Invention

[0006] The object of the present invention is to provide a composition for lowering uric acid and preventing and treating idiopathic arthritis and a preparation method thereof, so as to solve the problems of the prior art in the background technology.

[0007] To achieve the above object, the present invention provides the following technical solutions:

[0008] The first object of the present invention is to provide a traditional Chinese medicine composition for lowering uric acid and preventing and treating idiopathic arthritis, which is prepared from the following raw materials, in parts by mass: 300-700 parts of peony leaf extract, 100-500 parts of smilax glabra, 100-200 parts of plantain, 100-200 parts of oriental rhizome, 100-140 parts of hovenia dulcis fruit and 5-10 parts of chicory powder.

[0009] Preferably, the preparation method is prepared from the following raw materials, in parts by mass: 500 parts of peony leaf extract, 300 parts of Smilax glabra, 150 parts of plantain, 150 parts of oriental rhizome, 120 parts of Hovenia dulcis fruit and 8 parts of chicory powder.

[0010] Preferably, the preparation method of the peony leaf extract is as follows: add 8-10 times the weight of water to the peony leaves, decoct for 1 hour, filter, and collect the filtrate; add 8 times the weight of water to the filter residue, decoct for 40 minutes, filter, combine the two filtrates, and concentrate to a relative density of 1.13-1.15 g / cm 3 The clear paste is spray-dried to obtain the peony leaf extract.

[0011] The second object of the present invention is to provide the use of the traditional Chinese medicine composition in the preparation of uric acid-lowering drugs.

[0012] The third object of the present invention is to provide the use of the traditional Chinese medicine composition in the preparation of a method for preventing and treating idiopathic arthritis.

[0013] The fourth object of the present invention is to provide the use of the traditional Chinese medicine composition in preparing pharmaceutical formulations and clinically acceptable solid dosage forms such as but not limited to tablets, capsules, granules, etc.

[0014] A fifth object of the present invention is to provide a method for preparing the Chinese medicine tablet, comprising the following steps:

[0015] S1. Weigh the raw materials in proportion by mass;

[0016] S2. Take Smilax glabra and Hovenia dulcis and add 6-10 times the mass fraction of 70% ethanol and reflux extract twice, each time for 1 hour, collect the extract, recover the ethanol, and concentrate under reduced pressure to a thick paste;

[0017] S3. Take plantain and Alisma orientalis and add 6-10 times water and decocted twice, the first time for 1h and the second time for 30min. The decoctions were combined, filtered, concentrated to a relative density of 1:1.15, and spray-dried to obtain a dry powder.

[0018] S4. Take the thick paste prepared in S2, the dry powder prepared in S3, the peony extract and the chicory powder, stir and mix them thoroughly, granulate, shape the whole particles, press them into plain tablets, dry them, and package them.

[0019] Preferably, in step S2, the relative density of the thick paste is 1.35 g / cm3 .

[0020] Preferably, in step S4, the weight of the plain tablets is 0.6 g / tablet.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] (1) The present invention selects peony leaf extract, Smilax glabra, plantain, rhizoma alismatis, Hovenia dulcis and chicory powder, and prepares Chinese medicine tablets through ethanol reflux extraction, decoction, concentration, spray drying and tableting. The preparation process is simple.

[0023] (2) Experiments on a hyperuricemia rat model revealed that the Chinese medicine tablets of the present invention can significantly reduce serum uric acid levels and serum XOD activity, effectively increase UUA / UCR, improve uric acid excretion fraction and uric acid excretion per unit glomerular filtration, reduce glomerular uric acid load rate, and improve kidney damage caused by hyperuricemia. Therefore, the Chinese medicine composition of the present invention provides support for the development of Chinese medicines for lowering uric acid.

[0024] (3) Experiments on rats with idiopathic arthritis revealed that the rats treated with the Chinese medicine tablets of the present invention had improved mental state and food intake; the ankle circumferences of the rats were shorter and the local skin temperature of the ankle joints was lower; the rats' gait returned to normal; and the Chinese medicine tablets effectively reduced the levels of IL-1β, TNF-α, and PGE2 in the rat serum. Therefore, the Chinese medicine composition of the present invention provides support for the development of Chinese medicines for the prevention and treatment of idiopathic arthritis. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 The present invention is the effect of the Chinese medicine tablet on serum uric acid, creatinine, urea nitrogen and XOD in hyperuricemia rats;

[0026] Figure 2 The effect of the Chinese medicine tablet of the present invention on excretion-related indices in hyperuricemia rats;

[0027] Figure 3 The effect of the Chinese medicine tablet of the present invention on the important organ indexes of hyperuricemia rats;

[0028] Figure 4 To investigate the effect on renal pathological changes in hyperuricemia rats;

[0029] Figure 5 The process of modeling idiopathic arthritis;

[0030] Description of main reference numerals:

[0031] Figure 1 In the chart, A--serum uric acid; B--serum xanthine oxidase activity; C--serum creatinine; D--serum urea nitrogen. * P<0.05,** P < 0.01, *** P < 0.001, **** P<0.0001.

[0032] Figure 2 In the chart, A refers to urine uric acid; B refers to urine creatinine; C refers to 24-hour urine volume; D refers to fractional excretion of uric acid; E refers to urine uric acid / urine creatinine; F refers to fractional excretion of creatinine; G refers to uric acid excretion per unit glomerular filtration; H refers to glomerular uric acid loading rate. * P<0.05, ** P < 0.01, *** P < 0.001, **** P<0.0001.

[0033] Figure 3 In the figure, A--kidney index; B--liver index; C--spleen index; D--thymus index; E--heart index; F--brain index. *** P<0.001. DETAILED DESCRIPTION

[0034] The following is a clear and complete description of the technical solution of the present invention. Obviously, the embodiments described are part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without making creative efforts are within the scope of protection of the present invention.

[0035] Example 1

[0036] A Chinese medicine tablet is prepared by the following steps:

[0037] S1. Weigh 500g of peony leaf extract, 300g of Smilax glabra, 150g of plantain, 150g of Alisma orientalis, 120g of Hovenia dulcis, and 8g of chicory powder;

[0038] S2. Take Smilax glabra and Hovenia dulcis and add 8 times the mass fraction of 70% ethanol and reflux extract twice, each time for 1 hour. Collect the extract, recover the ethanol, and concentrate under reduced pressure to 1.35g / cm 3 (80℃) thick paste;

[0039] S3. Plantago and Alisma orientalis were decocted twice with 8 times the amount of water, first for 1 hour and second for 30 minutes. The decoctions were combined, filtered, concentrated to a relative density of 1:1.15, and spray-dried to obtain a dry powder.

[0040] S4. Take the thick paste prepared in S2, the dry powder prepared in S3, the peony extract and the chicory powder, stir and mix thoroughly, granulate, shape the particles, press into plain tablets (0.6 g / tablet), dry them, and package them.

[0041] The preparation method of the peony leaf extract is as follows: add 8 times the weight of water to the peony leaves, boil for 1 hour, filter, and collect the filtrate; add 8 times the weight of water to the filter residue, boil for 40 minutes, filter, combine the two filtrates, and concentrate to a relative density of 1.14g / cm 3 The clear paste is prepared at 50°C and spray-dried to obtain the dry powder, which is the peony leaf extract.

[0042] Example 2 :Effects on hyperuricemia rats

[0043] 1. Materials

[0044] 1.1 Experimental Animals

[0045] SPF male SD rats, weighing 200 ± 20 g, were provided by the Experimental Animal Research Center of Air Force Medical University [Certificate No.: SCXK(ARMY)2019-001].

[0046] Animals were acclimated for one week with a normal diet and water intake. The room temperature was maintained at 22-26°C, humidity at 50-70%, and a 12-h light / dark cycle. All animal manipulations and treatments during the experiment complied with the Animal Welfare and Ethics Guidelines of the Experimental Animal Center of the Air Force Medical University (approval number: IACUC-20230037).

[0047] 1.2 Drugs and reagents

[0048] See Table 1.

[0049] Table 1-1 Experimental reagents and manufacturers

[0050]

[0051] 1.3 Instruments

[0052] See Table 2.

[0053] Table 2 Experimental instrument models and manufacturers

[0054]

[0055] 2 Methods

[0056] 2.1 Establishment, grouping and drug administration of hyperuricemia rat model

[0057] After one week of adaptive feeding, the rats were randomly divided into a blank group (NC), a model group (HUA), a Chinese medicine tablet group (100 mg / kg, 200 mg / kg, and 400 mg / kg, the Chinese medicine tablets were prepared as described in Example 1), and a positive drug allopurinol (AP, 10 mg / kg) and a benzbromarone (BZM, 10 mg / kg) group, with 10 rats in each group.

[0058] The model and each treatment group were gavaged with 250 mg / kg potassium oxonate and 100 mg / kg hypoxanthine to establish the model. One hour later, the corresponding therapeutic drugs were given by gavage at 10 mL / kg per day. All drugs were dissolved in 0.5% CMC-Na. The blank group was given the same dose of 0.5% CMC-Na for 21 consecutive days.

[0059] 2.2 Sample collection and testing indicators

[0060] 2.2.1 Uric acid excretion related indicators

[0061] On the 20th day of administration, the rats were placed in metabolic cages for 24 hours to collect urine, which was then centrifuged at 3500 rpm for 15 minutes and the supernatant was separated for detection.

[0062] 24-hour uric acid excretion (24-hour UUA) = Uv × UUA

[0063] Fractional excretion of uric acid (FEUA)% = (UUA × Scr) / (SUA × Ucr) × 100;

[0064] Creatinine clearance (Ccr)% = Uv × Ucr / (Scr × 1440);

[0065] Glomerular uric acid load rate (FLur)% = Ccr × SUA;

[0066] Uric acid excretion per unit glomerular filtration (EurGF) = (UUA × Scr) / Ucr;

[0067] Urine uric acid / urine creatinine ratio = UUA / Ucr.

[0068] 2.2.2 Determination of serum uric acid, creatinine, urea nitrogen and xanthine oxidase (XOD) activity

[0069] At 9:00 pm, rats were fasted but not watered for 12 hours. On the 21st day, blood was collected from the abdominal aorta of each rat, 1 hour after the last administration. The blood was kept at room temperature for 2 hours and centrifuged at 3500 rpm for 15 minutes to separate the serum. The rats in each group were tested according to the manufacturer's instructions.

[0070] 2.2.3 Determination of related organ indices

[0071] After blood collection, the liver, kidney, spleen, thymus, heart and brain tissues of the rats were quickly removed, the organ weights were weighed and the data were recorded. After weighing, the organs were placed in 4% paraformaldehyde for fixation and preservation.

[0072] Organ index (%) = organ mass (g) / rat body mass after fasting (g) × 100%

[0073] 2.2.4 Observation of rat kidney pathology

[0074] After weighing, one kidney of 5 rats was randomly fixed in 4% paraformaldehyde for HE staining and MASSON staining, and the kidneys of the other 5 rats were fixed in anhydrous ethanol for urate staining.

[0075] 2.3 Statistical analysis

[0076] SPSS 23.0 statistical software was used for analysis. The groups were compared using one-way analysis of variance, with P < 0.05 indicating a statistically significant difference, and P < 0.01 indicating a statistically significant difference.

[0077] 3 Results

[0078] 3.1 Serum, creatinine, urea nitrogen levels, and xanthine oxidase activity in rats

[0079] See the results Figure 1 .

[0080] Depend on Figure 1 It can be seen that compared with the blank group, the serum uric acid, creatinine, and urea nitrogen levels of rats in the hyperuricemia model group were significantly increased (P<0.01), and the serum xanthine oxidase activity tended to increase; compared with the model group, the high-dose group of the Chinese medicine tablet of the present invention and the positive drug allopurinol significantly reduced the serum uric acid level and serum XOD activity (P<0.05, P<0.01).

[0081] 3.2 Uric acid excretion indicators

[0082] See the results Figure 2 .

[0083] Depend on Figure 2 It can be seen from the indicators related to promoting uric acid excretion that the Chinese medicine tablets of the present invention can effectively improve UUA / UCR, increase uric acid excretion fraction and uric acid excretion per unit glomerular filtration, and reduce glomerular uric acid load rate.

[0084] 3.3 Major organ index

[0085] See the results Figure 3 .

[0086] Depend on Figure 3 It can be seen that compared with the blank group, the kidney index of the model group rats was significantly increased (P<0.01), and the Chinese medicine tablets of the present invention had a tendency to reduce it. The Chinese medicine tablets of the present invention had no effect on the indexes of other organs.

[0087] 3.4 Renal pathology observation

[0088] See the results Figure 4 .

[0089] Depend on Figure 4 It can be seen that compared with the blank group, HE staining of the kidneys of the rats in the model group showed brown deposits of urate, glomerular atrophy, tubular dilation, and vacuolar degeneration; MASSON staining showed partial fibrosis changes in the kidneys; urate staining showed urate deposits in the renal tubules. The above changes were improved to varying degrees after the administration of Chinese medicine tablets.

[0090] In summary, the Chinese medicine tablets of the present invention can significantly reduce serum uric acid levels and serum XOD activity, effectively increase UUA / UCR, improve uric acid excretion fraction and uric acid excretion per unit glomerular filtration, reduce glomerular uric acid load rate, and improve the damage to the kidneys caused by hyperuricemia. Therefore, the Chinese medicine composition of the present invention provides support for the development of traditional Chinese medicines for lowering uric acid.

[0091] Example 3 :Effects on idiopathic arthritis rats

[0092] 1. Materials

[0093] 1.1 Experimental Animals

[0094] SPF male SD rats, weighing 200 ± 20 g, were provided by the Experimental Animal Research Center of Air Force Medical University [Certificate No.: SCXK(ARMY)2019-001].

[0095] Animals were acclimated for one week with a normal diet and water intake. The room temperature was maintained at 22-26°C, humidity at 50-70%, and a 12-h light / dark cycle. All animal manipulations and treatments during the experiment complied with the Animal Welfare and Ethics Guidelines of the Experimental Animal Center of the Air Force Medical University (approval number: IACUC-20230037).

[0096] 1.2 Drugs and reagents

[0097] See Table 3.

[0098] Table 3 Experimental reagents and manufacturers

[0099]

[0100] 1.3 Instruments

[0101] See Table 4.

[0102] Table 4 Experimental instrument models and manufacturers

[0103]

[0104]

[0105] 2 Methods

[0106] 2.1 Reagent Preparation

[0107] Preparation of urate solution: Use a precision balance to weigh 500 mg of urate crystals and place them in a weighing bottle. Add 2 mL of Tween 80 as a solubilizer, then slowly add normal saline. Heat in a water bath and stir evenly until the urate crystals are completely dissolved. Add normal saline again to make the volume up to 20 mL and mix well. The urate concentration is 25 mg / mL. Seal the bottle cap and place it in an autoclave for sterilization. Store at 4°C. Return to room temperature and shake well before use.

[0108] Preparation of colchicine solution: Weigh 12 mg of colchicine and add 120 mL of ultrapure water to a solution with a concentration of 0.1 mg / mL. Dissolve thoroughly and shake well, then store in a refrigerator at 4°C until use.

[0109] 2.2 Animal grouping

[0110] After one week of adaptive feeding, the rats were randomly divided into a blank group, a model group, low-dose, medium-dose, and high-dose Chinese medicine tablet groups, and a positive drug allopurinol group, with 10 rats in each group.

[0111] 2.3 Establishment of rat idiopathic arthritis model

[0112] A 10% chloral hydrate solution was injected intraperitoneally into the rat at a dose of 3.5 mL / kg. After the rat was fully anesthetized, the outer side of the right posterior ankle joint was selected as the insertion site, and 75% medical alcohol was used for local disinfection. The ankle joint was flexed 90°, and the needle was inserted at a 15° angle along the inner side of the Achilles tendon. After the needle mouth entered at an angle of 45°, it was inserted into the ankle joint cavity. There was a slight sense of emptiness when it entered the cavity. 0.2 mL of urate solution (25 mg / mL) was injected into the joint cavity. After the injection was completed, a successful injection was observed when the contralateral joint capsule was obviously swollen. The normal group was given the same dose of normal saline using the same operation method. The above experimental procedures were all performed in accordance with aseptic operation. Figure 4 .

[0113] 2.4 Intervention methods

[0114] (1) Normal group: Normal feeding, no treatment.

[0115] (2) Model group: After the idiopathic arthritis model was established, no treatment was given.

[0116] (3) Colchicine group: After the idiopathic arthritis model was established, colchicine (1 mg / kg) was administered by gavage every day for 3 consecutive days.

[0117] (4) Chinese medicine tablet group: After the idiopathic arthritis model was established, different doses of Chinese medicine tablets (100 mg / kg, 200 mg / kg and 400 mg / kg) were administered by gavage every day for 3 consecutive days.

[0118] 2.5 Sample collection and testing indicators

[0119] 2.5.1 General

[0120] Observe and record the changes in body weight, food and water intake, fur glossiness, mental state, etc. of each group of rats during the experiment.

[0121] 2.5.2 Ankle skin temperature

[0122] The skin temperature of the ankle joint of each group of rats was measured and recorded using an electronic thermometer before modeling and 6h, 12h, 24h, 48h and 72h after modeling. The same position was measured three times in a row and the average value was taken.

[0123] 2.5.3 Ankle swelling

[0124] The wire-tying method was used to measure and record the circumference of the right hind ankle joint of each group of rats before modeling and 6h, 12h, 24h, 48h and 72h after modeling. The circumference was measured 0.5mm below the ankle joint for 3 consecutive times and the average value was taken.

[0125] 2.5.4 Gait classification

[0126] The gait changes of rats in each group were observed and recorded before modeling and 6h, 12h, 24h, 48h and 72h after modeling (see Table 5).

[0127] Table 5 Gait classification standards

[0128]

[0129] 2.5.5 Determination of IL-1β, TNF-α and PGE2 levels in rat serum by ELISA

[0130] After the final dose, each rat was weighed and anesthetized with 10% chloral hydrate at an intraperitoneal injection of 3.5 mL / kg. After successful anesthesia, the rat's abdominal cavity was opened to identify the abdominal aorta, and blood was collected by puncturing the abdominal aorta with a 10 mL syringe. The collected blood was allowed to stand at room temperature for 2 hours. The centrifuge was precooled to 4°C in advance. The blood sample was then centrifuged at 3500 rpm for 15 minutes to separate the serum and plasma. The upper serum layer was aspirated with a pipette into 2 mL centrifuge tubes and placed in a -80°C freezer until use.

[0131] 2.5.6 Determination of related organ indices

[0132] After blood collection, the liver, kidney and spleen of the rats were quickly removed, the organ weights were weighed and the data were recorded. After weighing, the organs were fixed in 4% paraformaldehyde for preservation.

[0133] Liver index (%) = liver mass (g) / rat body mass after fasting (g) × 100%;

[0134] Renal index (%) = kidney mass (g) / rat fasting body mass (g) × 100%;

[0135] Spleen index (%) = spleen mass (g) / rat body mass after fasting (g) × 100%.

[0136] 2.6 Statistical analysis methods

[0137] SPSS 23.0 statistical software was used for analysis. The groups were compared using one-way analysis of variance, with P < 0.05 indicating a statistically significant difference, and P < 0.01 indicating a statistically significant difference.

[0138] 3 Experimental results

[0139] 3.1 General Condition of Rats

[0140] During the experiment, no deaths occurred in the rats of each group. The rats in the normal group were in good mental state, had flexible reactions to the outside world, and had normal food and water intake. After modeling, the ankle joints of the rats in the model group were significantly swollen, and they walked slowly. Some rats showed a "three-legged walking" gait, and their food intake was lower than that of the normal group. The rats in the colchicine group were in poor mental state and had slow reactions to the outside world. The tails of the rats were stained with loose stools, indicating that the rats in the colchicine group had diarrhea, and had obvious weight loss and reduced food intake. The rats in the low, medium, and high dose groups of the Chinese medicine tablets of the present invention were in good mental state, reacted to the outside world as usual, and had improved food intake compared with the model group.

[0141] 3.2 Rat ankle circumference

[0142] The results are shown in Table 6.

[0143] Table 6 Ankle circumference of rats in each group at each time point (cm, n=10)

[0144]

[0145]

[0146] Note: Compared with the normal group, ## P<0.01; compared with the model group, * P<0.05, ** P<0.01.

[0147] As shown in Table 6, before modeling, there was no statistical difference in the ankle joint circumference of the rats in each group (P>0.05); 6h, 12h, 24h, 48h and 72h after modeling, the ankle joint circumference of the rats in the model group increased significantly compared with the normal group (P<0.01); compared with the model group, the ankle joint circumference of the rats in the colchicine group and the low-, medium- and high-dose groups of the Chinese medicine tablet of the present invention were shorter (P<0.05, P<0.01).

[0148] 3.3 Rat ankle skin temperature

[0149] The results are shown in Table 7.

[0150] Table 7 Ankle joint local skin temperature of rats in each group at different time points (℃, n=10)

[0151]

[0152] Note: Compared with the normal group, ## P<0.01; compared with the model group, * P<0.05, ** P<0.01.

[0153] As shown in Table 7, before modeling, there was no statistical difference in the local skin temperature of the ankle joints of the rats in each group (P>0.05); 6h, 12h, 24h, 48h and 72h after modeling, compared with the normal group, the local skin temperature of the ankle joints of the rats in the model group increased (P<0.01); compared with the model group, the local skin temperature of the ankle joints of the rats in the colchicine group and the low-, medium- and high-dose groups of the Chinese medicine tablet of the present invention was lower (P<0.05, P<0.01).

[0154] 3.4 Gait classification of rats at different time points

[0155] The results are shown in Tables 8-9.

[0156] Table 8 Gait classification of rats at different time points

[0157]

[0158] Table 9 Gait classification of rats at different time points

[0159]

[0160] As shown in Tables 8-9, before modeling, the rats in each group had normal gait.

[0161] 6 hours after modeling, the rats in the model group developed slight lameness, with the tested lower limbs slightly bent. Some rats developed moderate lameness, with the tested lower limbs just touching the ground. The rats in the colchicine group and the low-, medium-, and high-dose groups of the Chinese medicine tablet of the present invention all showed abnormal gait, which was milder than that in the model group.

[0162] 12h-24h after modeling, the number of rats with moderate lameness in the model group gradually increased, and one rat developed severe lameness, with the lower limbs of the test rat leaving the ground and walking on three legs. The degree of lameness of the rats in the colchicine group and the low-, medium-, and high-dose groups of the Chinese medicine tablets of the present invention was milder than that of the rats in the model group, and no rats developed three-legged walking.

[0163] 48 hours after modeling, rats in the model group developed moderate lameness, of which 2 developed severe lameness. The degree of lameness in the colchicine group and the low, medium and high dose groups of the Chinese medicine tablet of the present invention gradually increased compared with the model group, but no rats developed severe lameness.

[0164] 72 hours after modeling, the rats in the model group still had mainly moderate lameness, with one rat having severe lameness; the gait of the rats in the colchicine group and the low-, medium-, and high-dose groups of the Chinese medicine tablet of the present invention gradually improved, with mild lameness being the most common. Among them, the gait of one rat in the medium-dose group of the Chinese medicine tablet of the present invention and the gait of two rats in the high-dose group returned to normal.

[0165] 3.5 Related organ index

[0166] The results are shown in Table 10.

[0167] Table 10 Liver index, kidney index and spleen index ( n=10)

[0168]

[0169] Note: Compared with the normal group, ** P<0.01.

[0170] As shown in Table 10, compared with the normal group, there was no statistical difference in the liver index, kidney index and spleen index of the model group and gel group, while the liver index and kidney index of the colchicine group increased significantly, with statistical differences (P < 0.01).

[0171] 3.6 Serum IL-1β, TNF-α, and PGE2 levels

[0172] The results are shown in Table 11.

[0173] Table 11 Serum IL-1β, TNF-α and PGE2 levels in rats of each group ( n=10)

[0174]

[0175]

[0176] Note: Compared with the normal group, ## P<0.01; compared with the model group, ** P<0.01.

[0177] As shown in Table 11, compared with the normal group, the serum IL-1β, TNF-α and PGE2 levels of the rats in the model group were significantly increased (P < 0.01); compared with the model group, the low-, medium- and high-dose groups of Chinese medicine tablets and the colchicine group could effectively reduce the serum IL-1β, TNF-α and PGE2 levels of the rats (P < 0.01).

[0178] In summary, experiments on rats with idiopathic arthritis found that the use of the Chinese medicine tablets of the present invention improved the rats' mental state and food intake; the rats' ankle circumferences were shortened, the local ankle skin temperature was lower, the rats' gait returned to normal, and the tablets effectively reduced the rats' serum IL-1β, TNF-α, and PGE2 levels. Therefore, the Chinese medicine composition of the present invention provides support for the development of Chinese medicines for the prevention and treatment of idiopathic arthritis.

[0179] The foregoing descriptions of specific exemplary embodiments of the present invention are for purposes of illustration and description. These descriptions are not intended to limit the invention to the precise forms disclosed, and it is apparent that many variations and modifications are possible in light of the foregoing teachings. The exemplary embodiments have been selected and described for the purpose of explaining the specific principles of the invention and their practical application, thereby enabling those skilled in the art to realize and utilize a variety of exemplary embodiments of the invention and various options and modifications. The scope of the invention is intended to be defined by the claims and their equivalents.

Claims

1. A Chinese medicine composition for preventing and treating idiopathic arthritis, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by mass: 300-700 parts of peony leaf extract, 100-500 parts of smilax glabra, 100-200 parts of plantain, 100-200 parts of oriental rhizome, 100-140 parts of hovenia dulcis fruit and 5-10 parts of chicory powder; wherein, The preparation method of the peony leaf extract comprises the following steps: adding 8-10 times the weight of clean water to the peony leaves, decocting for 1 hour, filtering, and collecting the filtrate; adding 8 times the weight of clean water to the filter residue, decocting for 40 minutes, filtering, combining the secondary filtrates, and concentrating to a relative density of 1.13-1.15 g / cm 3 The clear paste is spray-dried to obtain the peony leaf extract.

2. The Chinese medicine composition for preventing and treating idiopathic arthritis according to claim 1, characterized in that The invention is prepared from the following raw materials in parts by mass: 500 parts of peony leaf extract, 300 parts of smilax glabra, 150 parts of plantain, 150 parts of oriental dwarf lily, 120 parts of hovenia dulcis fruit and 8 parts of chicory powder.

3. A Chinese medicine tablet, characterized in that: The Chinese medicine tablet is prepared from the Chinese medicine composition for preventing and treating idiopathic arthritis according to claim 1.

4. A method for preparing the Chinese medicine tablet according to claim 3, characterized in that: The following steps are involved: S1 weigh the raw materials in parts by mass ratio; S2. Take Smilax glabra and Hovenia dulcis and add 6-10 times the mass fraction of 70% ethanol and reflux and extract twice, each time for 1h, collect the extract, recover ethanol, and concentrate under reduced pressure to a thick paste; S3. Take plantain and Alisma add 6-10 times water and boil twice, the first time for 1h and the second time for 30min. Combine the decoctions, filter, concentrate to a relative density of 1:1.15, spray dry to obtain a dry powder. S4. The thick paste prepared in S2, the dry powder prepared in S3, the peony extract, and the chicory powder are thoroughly mixed, granulated, granulated, pressed into plain tablets, dried, and packaged.

5. The preparation method according to claim 4, characterized in that In step S2, the relative density of the thick paste is 1.35 g / cm 3 .

6. The preparation method according to claim 4, characterized in that In step S4, the plain tablets comprise 0.6 g / tablet.

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