A traditional Chinese medicine composition for treating ankylosing spondylitis, its preparation method, and its application.

Abstract

This invention belongs to the field of traditional Chinese medicine. Specifically, it relates to a traditional Chinese medicine composition, preparation method, and application for treating ankylosing spondylitis. The raw materials include 10-20 parts of Achyranthes bidentata, 10-20 parts of Dipsacus asper, 5-15 parts of Astragalus complanatus, 5-15 parts of Curculigo orchioides, 10-15 parts of Spatholobus suberectus, 10-20 parts of Salvia miltiorrhiza, 5-10 parts of Liquidambar formosana, 5-10 parts of Clematis chinensis, 10-15 parts of Clematis armandii, 5-15 parts of Pinus massoniana, and 5-15 parts of Scrophularia ningpoensis. This formula is meticulously formulated, addressing both the root cause and the symptoms: it combines tonification and purgation, nourishing the liver and kidneys to treat the root cause, while also dispelling wind and cold, and promoting blood circulation to treat the symptoms. This formula can be used to treat ankylosing spondylitis with symptoms of liver and kidney deficiency, qi and blood stagnation, and cold-dampness obstruction, such as pain, stiffness, and limited mobility in the spine or sacroiliac joints, with significant stiffness upon waking and relief after activity, or accompanied by peripheral joint pain, aversion to cold, cold limbs, dark tongue or ecchymosis, and a deep, hesitant or wiry pulse.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition, preparation method, and application for treating ankylosing spondylitis. Background Technology

[0002] Ankylosing spondylitis (AS) is a chronic, progressive, and disabling disease that begins with microinflammation of the sacroiliac joints and the spinal axis. Modern molecular biology has confirmed that the core pathology of AS lies not in simple surface inflammation, but in the pathological abnormal proliferation of synovial fibroblasts (AS-Fls) and the abnormal cartilage matrix destruction and pathological new bone formation (spinal ankylosis fusion) mediated by Wnt pathway regulatory proteins (such as DKK-1). Currently, commonly used nonsteroidal anti-inflammatory drugs (NSAIDs) can only relieve local inflammatory pain and are unable to inhibit the irreversible ossification process of the spine; while biologics have the limitations of secondary infection risk and single target. Traditional Chinese medicine has unique advantages in improving microcirculation and regulating the bone immune microenvironment through multiple targets. However, existing patented traditional Chinese medicine compound formulas for AS mostly focus on macroscopic "dispelling wind and dampness," lacking evidence of targeted intervention on core microscopic pathogenesis such as "abnormal ossification" and "synovial cell proliferation cycle." Therefore, there is an urgent need to develop a modern Chinese medicine composition with scientific compatibility and a definite mechanism that can cut off proliferative signals from the systemic circulation and reshape the ossification microenvironment. Summary of the Invention

[0003] This invention provides a traditional Chinese medicine composition for treating ankylosing spondylitis that has a definite curative effect and conforms to pharmacopoeia standards, as well as its preparation method and application.

[0004] The technical solution of this invention:

[0005] The traditional Chinese medicine composition provided by this invention is based on the treatment principle of "tonifying the liver and kidneys and strengthening tendons and bones" and "activating blood circulation, clearing the meridians, dispelling wind and dampness". Its raw materials and their weight parts are as follows: 10-20 parts of Achyranthes bidentata, 10-20 parts of Dipsacus asper, 5-15 parts of Astragalus complanatus, 5-15 parts of Curculigo orchioides, 10-15 parts of Spatholobus suberectus, 10-20 parts of Salvia miltiorrhiza, 5-10 parts of Liquidambar formosana, 5-10 parts of Clematis chinensis, 10-15 parts of Clematis armandii, 5-15 parts of Pinus massoniana, and 5-15 parts of Scrophularia ningpoensis.

[0006] Fang Jie Fang Yi:

[0007] In Traditional Chinese Medicine (TCM), ankylosing spondylitis (AS) falls under the categories of "Great Leaning" and "Kidney Bi," with its core pathogenesis being "Kidney deficiency and cold in the Du meridian as the root cause, and blood stasis and phlegm obstructing the collaterals as the manifestation." This formula follows the ancient principle of "treating both the root cause and the manifestation, and combining tonification and purgation," while also aligning with modern bone immunology and microcirculation regulation mechanisms: Chief herbs: Achyranthes bidentata, Dipsacus asper, Curculigo orchioides, and Astragalus complanatus. These four herbs work together to strongly tonify the liver and kidneys, and strengthen tendons and bones. From a modern molecular pathological perspective, it aims to upregulate Wnt pathway inhibitory proteins (such as DKK-1), protect cartilage matrix from degradation, reverse the characteristic pathological new bone formation and joint ankylosis fusion of AS, and directly address the root cause of the disease. Assistant herbs: Spatholobus suberectus, Salvia miltiorrhiza, and Liquidambar formosana. These herbs promote blood circulation and remove blood stasis. They aim to target the microvascular pannus caused by abnormal proliferation of atrophic synovium (downregulating VEGF) and clear neurogenic pain mediators in the microcirculation (downregulating PGE2), eliminating joint redness and swelling and nocturnal rest pain from the source. Assistant herbs: *Clematis chinensis*, *Clematis armandii*, and pine resin. These herbs expel wind, cold, and dampness from deep within the muscles and bones, working synergistically with the adjuvant herbs to powerfully clear systemic disease activity drivers (such as calprotectin) and cut off upstream signals for abnormal proliferation of diseased synovial cells. Guiding herb: *Scrophularia ningpoensis*. This herb nourishes yin and reduces fire, preventing the drying and stimulating effects of other warming herbs from damaging yin, and guiding the medicinal power directly to the kidneys and the Governing Vessel, ensuring a stable and lasting micro-regulatory network throughout the formula.

[0008] Preparation method:

[0009] Weigh the raw materials according to the specified ratio, add water and decoct, combine the filtrates to obtain a traditional Chinese medicine decoction. Alternatively, it can be further concentrated and dried as needed, and conventional excipients can be added to prepare clinically acceptable oral dosage forms, such as granules, capsules, and tablets.

[0010] Toxicity and precautions of this formula:

[0011] Toxic medicinal materials: This formula contains Curculigo orchioides (slightly toxic) and Aristolochia debilis (slightly toxic). The toxicity of Curculigo orchioides can be reduced by processing it with wine; Aristolochia debilis contains aristolochic acid, and long-term use in large quantities may damage kidney function. Therefore, the dosage should be strictly controlled within the pharmacopoeia range (5-10g), and the course of treatment is recommended not to exceed 2 weeks.

[0012] Contraindications:

[0013] Contraindications: This product is contraindicated in patients with Yin deficiency and fire excess syndrome (dry mouth and throat, five-center heat, red tongue with little coating), excess heat syndrome (high fever, constipation, red tongue with yellow coating), and damp heat syndrome (red, swollen, hot and painful joints, yellow and greasy tongue coating).

[0014] Contraindications: Not for use by pregnant women, breastfeeding women, children, or individuals with impaired liver or kidney function.

[0015] Drug interactions: Co-use with anticoagulants (such as warfarin) may increase the risk of bleeding, and coagulation function should be monitored.

[0016] Precautions: This product is not suitable for prolonged use. It is recommended to take it continuously for no more than 2 weeks. If continued use is necessary, an interval of at least 1 week should be observed. It is recommended to monitor liver and kidney function regularly during medication.

[0017] The beneficial effects of this invention: Compared with existing technologies and conventional clinical drugs, this invention has the following significant innovations and beneficial effects:

[0018] 1. While existing nonsteroidal anti-inflammatory drugs (NSAIDs) and chemotargeting drugs are potent, long-term use can lead to significant side effects. The herbal composition of this invention, through precise formulation, can regulate the bone metabolism molecular network in an AS model, significantly reversing the abnormal downregulation of DKK-1 and inhibiting MMP-3 expression. Its high-dose group achieved efficacy comparable to the low-dose group of the first-line clinical drug sulfasalazine in blocking cartilage destruction and pathological new bone formation. This indicates that this formula can provide basic bone protection in a gentler, multi-target manner, making it particularly suitable for long-term treatment of patients.

[0019] 2. This formula uses blood-activating and meridian-clearing herbs such as Spatholobus suberectus and Salvia miltiorrhiza as its core ingredients. Pharmacodynamic studies have confirmed that it can effectively downregulate serum VEGF and PGE2 levels, inhibit abnormal angiogenesis in the synovium, and reduce neurogenic pain. In relieving redness, swelling, and pain, the high-dose group of this formula showed definite efficacy, essentially on par with the low-dose group of positive control drugs. This approach ensures the patient's quality of life while avoiding the potential toxicity of high-dose chemical drugs.

[0020] 3. This invention breaks through the single-endpoint efficacy evaluation model, realizing the linkage verification of in vivo molecular markers and in vitro cellular behavior changes in animals. Animal experiments show that this composition can significantly reduce the level of calprotectin, which is closely related to AS disease activity; combined with Figure 1 , Figure 2 In vitro cell activity results showed that as upstream pro-proliferative signals weakened, the abnormal activity of diseased synovial fibroblasts (AS-Fls) was significantly inhibited, and their cell cycle distribution was remodeled, suggesting that DNA synthesis activity was suppressed. This consistent in vitro and in vivo evidence further demonstrates that this composition can exert a synergistic therapeutic effect at both the systemic inflammatory driver and target cell proliferation levels.

[0021] 4. Given the need for continuous intervention in ankylosing spondylitis, the selection of medicinal materials in this formula strictly adheres to the scope specified in the 2020 edition of the Chinese Pharmacopoeia, and sets clear processing and treatment course control requirements for *Curculigo orchioides* and *Clematis chinensis*, which contain certain toxic risks. Animal experiments indicate that no significant abnormalities in liver and kidney function were observed in any dosage group of this invention, and the recovery of body weight was better than that of the chemical drug group, demonstrating that this composition maintains a good therapeutic effect while possessing good overall tolerability and safe application potential. Attached Figure Description

[0022] Figure 1The results show the cell viability of each experimental group at different time points in this invention;

[0023] Figure 2 The results show the cell viability of each experimental group in this invention. Detailed Implementation

[0024] The present invention will now be described in further detail with reference to specific embodiments and accompanying drawings.

[0025] Example 1: Preparation of Traditional Chinese Medicine Composition

[0026] Weigh the following herbs according to their respective weights: 15g of Achyranthes bidentata, 15g of Dipsacus asper, 10g of Astragalus complanatus, 10g of Curculigo orchioides, 15g of Spatholobus suberectus, 15g of Salvia miltiorrhiza, 10g of Liquidambar formosana, 10g of Clematis chinensis, 15g of Clematis armandii, 10g of Pinus massoniana, and 10g of Scrophularia ningpoensis. Mix the herbs, add 10 times the amount of water and soak for 30 minutes, then decoct for 1.5 hours and filter. Add 8 times the amount of water to the residue and decoct for 1 hour. Combine the two filtrates to obtain the herbal decoction. Concentrate the herbal decoction under reduced pressure and spray dry to obtain the extract powder.

[0027] Pharmacodynamic characterization test

[0028] I. Preparation process of the drug-containing serum of the traditional Chinese medicine composition described in this invention:

[0029] The herbal decoction obtained in Example 1 was used to prepare a decoction with a raw herb concentration of 2g / mL, which was then refrigerated at 4℃ for later use.

[0030] Healthy male SD rats (weighing 200±20g) were selected and fed acclimatized for 3 days. Then, the above decoction was administered by gavage at a dose of 2g / kg·d (crude drug amount) for 3 consecutive days. The rats in the blank serum group were administered an equal volume of physiological saline by gavage.

[0031] One hour after the last gavage, blood was collected from the abdominal aorta of the rats and placed in sterile centrifuge tubes, then left to stand at room temperature for 2 hours.

[0032] Centrifuge at 3000 rpm at room temperature for 15 min, aspirate the supernatant serum, filter it through a 0.22 μm sterile filter membrane for sterilization, and inactivate it in a 56℃ water bath for 30 min;

[0033] The sterilized and inactivated serum was mixed with RPMI Medium Modified medium in a certain proportion to prepare drug-containing serums of different concentrations of 5%, 10%, 15%, 20%, and 25%.

[0034] II. Pharmacodynamic Experimental Data of Traditional Chinese Medicine Compositions

[0035] 2.1 Cell viability characterization experiments and therapeutic effect analysis

[0036] Experimental objective: To detect the inhibitory effect of serum containing the herbal composition of this invention at different concentrations and treatment times on the activity of AS-Fls cells, and to screen for the optimal treatment conditions.

[0037] Experimental materials: CCK8 detection kit, RPMI Medium Modified medium, serum containing the Chinese medicine composition described in this invention (blank serum as negative control), AS-Fls cells, 96-well plates, and other reagents and equipment.

[0038] Experimental methods: The concentration of AS-Fls cells was adjusted to 5-10 × 10⁻⁶ using the CCK-8 assay. 4 / ml, seeded into 96-well plates, 100μl per well, with the edge wells filled with PBS; after incubation overnight at 37℃ with 5% CO2, different concentrations of drug-containing serum were added, and four time points were set: 0h, 24h, 48h, and 72h. 10μl of CCK8 was added to each well, and the cells were cultured for another 1-4h. The absorbance was measured at OD450nm using an ELISA reader, and cell viability was calculated as: cell viability = [(experimental wells - blank wells) / (control wells - blank wells)].

[0039] Experimental Groups:

[0040] Group A: AS-Fls + blank serum (negative control group);

[0041] Group B: AS-Fls+5% serum containing the herbal composition of this invention;

[0042] Group C: AS-Fls+10% serum containing the herbal composition of this invention;

[0043] Group D: AS-Fls+15% serum containing the traditional Chinese medicine composition of this invention;

[0044] Group E: AS-Fls+20% serum containing the traditional Chinese medicine composition of this invention;

[0045] Group F: AS-Fls+25% serum containing the Chinese herbal composition of this invention.

[0046] Cell viability results for each experimental group at different time points are shown in the figure. Figure 1 .from Figure 1 It can be known that:

[0047] At 0h, there was no significant difference in cell viability between the drug-containing serum groups and the blank serum group (P>0.05), indicating that the drug-containing serum of the traditional Chinese medicine composition of the present invention has no immediate toxicity to cells;

[0048] With prolonged treatment time (24h, 48h, 72h), the cell viability of each concentration of drug-containing serum group showed a gradual decreasing trend, indicating that the inhibitory effect of the drug-containing serum of the herbal composition of the present invention on the viability of AS-Fls cells is time-dependent.

[0049] At the same time point, as the concentration of drug-containing serum increased (5%, 25%), cell viability gradually decreased, indicating that the inhibitory effect of the drug-containing serum of the herbal composition of the present invention on the viability of AS-Fls cells is concentration-dependent.

[0050] IC50 analysis showed that the optimal conditions for the action of the drug-containing serum of the traditional Chinese medicine composition of this invention on AS-Fls cells were a 10% concentration and 24 hours of action. Under these conditions, the cell viability inhibition effect was significant, and the cytotoxicity and efficacy were balanced, making it the optimal parameter for subsequent experiments.

[0051] The above results indicate that the serum containing the traditional Chinese medicine composition of the present invention can significantly inhibit the activity of ankylosing spondylitis-related AS-Fls cells, and the effect is time- and concentration-dependent. It can effectively inhibit abnormally proliferating diseased cells, providing cellular-level experimental evidence for its treatment of ankylosing spondylitis.

[0052] 2.2 Cell viability characterization experiments and therapeutic effect analysis

[0053] Experimental objective: To verify the regulatory effect of the herbal composition of the present invention on the viability of Fls and AS-Fls cells under optimal action conditions (10%, 24h) of serum containing the drug, and to clarify its targeted inhibitory effect on diseased cells.

[0054] Experimental materials: 10% of the drug-containing serum of the traditional Chinese medicine composition described in this invention (optimal conditions).

[0055] Experimental methods: Different cell model groups were set up, and cell viability was detected and calculated.

[0056] Experimental Groups:

[0057] Group A: Fls (normal cell group);

[0058] Group B: AS-Fls (ankylosing spondylitis lesion cell model group, without drug treatment);

[0059] Group C: AS-Fls+10% serum containing the Chinese herbal composition described in this invention (optimal administration conditions).

[0060] The cell viability results for each experimental group are shown below. Figure 2 The results are analyzed as follows:

[0061] The cell viability of group B (AS-Fls lesion cell group) was 3.5480, which was significantly higher than that of group A (normal Fls cell group) (1.0000), indicating that AS-Fls cells have abnormal proliferation, which is consistent with the characteristics of ankylosing spondylitis lesion cells.

[0062] After treatment with the optimal drug-containing serum of the traditional Chinese medicine composition described in this invention, the cell viability of Group C decreased to 1.8689, which was significantly lower than that of Group B, with a decrease of 47.3%, and the cell viability was close to the level of normal cells.

[0063] The serum containing the traditional Chinese medicine composition described in this invention can significantly inhibit the abnormal proliferation of AS-Fls diseased cells under optimal conditions, and has no significant inhibitory effect on normal Fls cells, indicating that it has targeted inhibitory properties on diseased cells.

[0064] The above results further verify that the traditional Chinese medicine composition described in this invention can effectively reverse the abnormal proliferation state of ankylosing spondylitis-related cells, which is one of the key mechanisms of action in the treatment of ankylosing spondylitis.

[0065] 2.3 Animal pharmacodynamic validation based on multidimensional serum biomarkers (compared with the positive control group)

[0066] Experimental objective: To overcome the limitations of traditional morphology and subjective scoring, this study uses micro-serological targeted quantitative technology to verify the intervention effect of the composition of this invention on abnormal ossification, synovial angiogenesis and microscopic lesions in AS model rats, and compares it with the clinical positive drug (sulfasalazine).

[0067] Experimental animals and model establishment: Sixty male SPF-grade SD rats (200±20g) were used to induce an AS rat model using a classic bovine type II collagen and complete Freund's adjuvant emulsion (for primary and booster immunizations). The normal control group was injected with an equal volume of physiological saline.

[0068] Grouping and drug administration intervention: After successful modeling, the animals were randomly divided into 6 groups (10 animals per group): normal control group, model control group, low / high dose positive control group (sulfasalazine suspension 50, 100 mg / kg·d), and low / high dose group of the present invention (decoction of Example 1 5, 10 g crude drug / kg·d). Continuous and precise gavage intervention was performed for 4 weeks.

[0069] Core serological assay methods: After the end of the dosing cycle (week 4), rats were deeply anesthetized via intraperitoneal injection, and whole blood was collected from the abdominal aorta. After being kept at 4°C in the dark, the samples were centrifuged at 3000 rpm for 15 min to separate the supernatant serum, which was then aliquoted and stored at -80°C. Using a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) platform, quantification was performed on core pathological targets of ankylosing spondylitis (AS), including ossification regulator protein (DKK-1), matrix degrading enzyme (MMP-3), vascular endothelial growth factor (VEGF), pain mediator (PGE2), and the highly specific disease activity marker (calprotectin). Serum alanine aminotransferase (ALT) and creatinine (Cr) levels were simultaneously measured to assess the drug's effects on liver and kidney function. A standard curve was fitted after absorbance measurement to inversely determine the absolute concentration of each target molecule.

[0070] Experimental results

[0071] (1) Analysis of the regulation of abnormal ossification and cartilage matrix degradation (corresponding to the fundamental therapeutic effect of "tonifying the kidney and strengthening bones") The core disabling mechanism of ankylosing spondylitis is the loss of Wnt pathway inhibitor (DKK-1) and the massive release of MMP-3. As shown in Table 1, the serum DKK-1 of rats in the model group showed a collapse-like decrease, while MMP-3 was abnormally increased. After 4 weeks of intervention, the high-dose group of the traditional Chinese medicine in this invention was able to significantly reverse the loss of DKK-1 and inhibit the expression of MMP-3. As can be seen from the data, the bone metabolism regulation ability of the high-dose group of this invention is significantly better than that of the model group, and its recovery level is basically the same as that of the low-dose sulfasalazine group (P>0.05). Although it is weaker than that of the high-dose sulfasalazine group, it has already achieved a definite baseline therapeutic effect of bone protection.

[0072] Table 1: Comparison of serum abnormal ossification and cartilage metabolism markers in rats of different groups (x±s, n=10)

[0073]

[0074] Note: *Compared with the model group, P < 0.05; compared with the low-dose positive drug group, # P > 0.05, indicating that the efficacy of high-dose traditional Chinese medicine is comparable to that of low-dose positive drug.

[0075] (2) Assessment of microcirculatory pannus formation and pain mediators (corresponding to "promoting blood circulation and removing wind and dampness") Serum VEGF and PGE2 are key indicators reflecting synovial neovascularization and pain sensitization. As shown in Table 2, the high-dose group of this invention can effectively block excessive secretion of VEGF and downregulate PGE2, exerting the effect of "removing blood stasis and relieving pain". Its downregulation is not as great as that of the high-dose positive drug group, but there is no statistical difference compared with the low-dose positive drug group, reaching the expected baseline level of routine clinical anti-inflammatory and analgesic treatment.

[0076] Table 2: Comparison of serum angiotrophic factor and pain-inducing factors in rats of different groups (x ± s, n=10)

[0077]

[0078] Note: *Compared with the model group, P < 0.05; compared with the low-dose positive control group, # P > 0.05.

[0079] (3) Quantification of systemic disease activity and synovial proliferation drivers (corresponding to in vitro cell mechanisms) Calprotectin is a key upstream protein driving abnormal proliferation of AS-Fls cells. Table 3 shows that the high-dose group of this invention effectively reduced serum calprotectin concentration (by about 35% compared to the model group). The systemic pathological blocking ability is similar to that of the low-dose sulfasalazine group, providing solid in vivo data support for the cell cycle regulation effect observed in downstream in vitro experiments.

[0080] Table 3: Comparison of serum AS high-specificity disease activity markers in rats from different groups (x ± s, n=10)

[0081]

[0082] Note: Compared with the model group, *P < 0.05; compared with the low-dose positive control group, #P > 0.05.

[0083] Experimental conclusion:

[0084] This study abandons the traditional evaluation method that is easily affected by subjective factors. By establishing a verification closed loop of "serum targeting markers - in vitro cell behavior changes", it reveals the multi-level mechanism of action of the traditional Chinese medicine composition of this invention in the treatment of ankylosing spondylitis.

[0085] 1. In vivo results showed that this composition could upregulate DKK-1 and downregulate MMP-3, thus delaying pathological new bone formation and tissue destruction to a certain extent; at the same time, it reduced synovial pannus hyperplasia and pain sensitization by decreasing VEGF and PGE2. Comprehensive evaluation showed that although the overall microscopic pharmacodynamic performance of the high-dose formulation was not as good as that of high-concentration chemotargeted drugs, it had clearly reached a therapeutic level comparable to that of the low-dose positive control group, reflecting the characteristics of the mild nature and multi-pathway combined intervention of traditional Chinese medicine compound.

[0086] 2. Animal experiments have shown that this composition can significantly reduce circulating calprotectin levels, suggesting that it can attenuate the activity and inflammatory driving force of AS systemic disease. Figure 1 and Figure 2It is evident that the viability of diseased AS-Fls cells significantly decreased after treatment with drug-containing serum. The traditional Chinese medicine composition of this invention can further inhibit the abnormal proliferation behavior of target cells in vitro by weakening the source of proliferative signals in vivo.

[0087] 3. No obvious acute toxic side effects were observed in any of the treatment groups throughout the entire administration period. Serum ALT and Cr levels showed no significant abnormalities in liver and kidney function in any of the dosage groups of this invention, suggesting that the composition, while exerting a strong therapeutic effect, still possesses good biocompatibility and long-term application potential. The high-dose group showed the best overall efficacy, providing relatively reliable experimental evidence for its use in the treatment of ankylosing spondylitis.

[0088] In the above embodiments, the traditional Chinese medicine composition of the present invention can also be combined with pharmaceutically acceptable excipients to prepare a compound oral preparation, or used in combination with conventional antirheumatic chemical drugs to exert a synergistic effect and reduce the dosage and related side effects of chemical drugs.

[0089] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating ankylosing spondylitis, characterized in that, It is made from the following raw materials in parts by weight: 10-20 parts of Achyranthes bidentata, 10-20 parts of Dipsacus asper, 5-15 parts of Astragalus complanatus, 5-15 parts of Curculigo orchioides, 10-15 parts of Spatholobus suberectus, 10-20 parts of Salvia miltiorrhiza, 5-10 parts of Liquidambar formosana, 5-10 parts of Clematis chinensis, 10-15 parts of Clematis armandii, 5-15 parts of Pinus massoniana, and 5-15 parts of Scrophularia ningpoensis.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 15 parts of Achyranthes bidentata, 15 parts of Dipsacus asper, 10 parts of Astragalus complanatus, 10 parts of Curculigo orchioides, 15 parts of Spatholobus suberectus, 15 parts of Salvia miltiorrhiza, 10 parts of Liquidambar formosana, 10 parts of Clematis chinensis, 15 parts of Clematis armandii, 10 parts of Pinus massoniana, and 10 parts of Scrophularia ningpoensis.

3. A method for preparing the traditional Chinese medicine composition as described in claim 1 or 2, characterized in that, Includes the following steps: Weigh each raw material according to the ratio, soak and decoct in water, filter, and obtain the Chinese medicine liquid.

4. The preparation method according to claim 3, characterized in that, The herbal liquid is concentrated and dried to obtain an extract of the herbal composition.

5. The preparation method according to claim 4, characterized in that, The extract of the traditional Chinese medicine composition is mixed with pharmaceutically acceptable excipients to prepare an oral preparation.

6. The preparation method according to claim 4, characterized in that, The extract of the traditional Chinese medicine composition is dried to form dry granules, which are then mixed with pharmaceutically acceptable excipients to form granules.

7. The preparation method according to claim 4, characterized in that, The extract of the traditional Chinese medicine composition is dried to form dry granules, which are then mixed with pharmaceutically acceptable excipients to form tablets.

8. The preparation method according to claim 4, characterized in that, The extract of the traditional Chinese medicine composition is dried to form dry granules, which are then mixed with pharmaceutically acceptable excipients to form capsules.

9. The use of a traditional Chinese medicine composition as described in claim 1 or 2 in the preparation of a medicament for treating ankylosing spondylitis.

10. The application according to claim 9, characterized in that, The drug is a drug that blocks pathological new bone formation in ankylosing spondylitis, and / or regulates the cycle distribution of fibroblast-like synovial cells and inhibits their abnormal proliferation.

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