Sodium hyaluronate composition and application thereof in preparation of medicine for preventing and treating knee osteoarthritis

Abstract

The invention discloses a sodium hyaluronate composition and application of the sodium hyaluronate composition in preparation of medicines for preventing and treating knee osteoarthritis, and belongs to the field of medicines. The composition is an oral preparation, and the oral preparation is prepared from sodium hyaluronate, cortex acanthopanacis, caulis polygoni multiflori, radix achyranthis bidentatae, pawpaw, radix astragali and pharmaceutically acceptable auxiliary materials. Sodium hyaluronate is combined with'arthralgia-removing powder 'to treat knee osteoarthritis, and results of clinical tests show that by combining the two medicines, knee joint pain can be effectively relieved for a long time, knee joint activity can be improved, swelling can be eliminated, comprehensive functions of knee joints can be improved, patients do not relapse after drug withdrawal, and existing treatment effects can still be maintained.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of medicine, and in particular, relates to a traditional Chinese medicine and western medicine composition, and more particularly to a composition containing sodium hyaluronate and traditional Chinese medicine and the use thereof in the preparation of a medicine for preventing and treating knee osteoarthritis. BACKGROUND

[0002] Osteoarthritis is a chronic, high-incidence, degenerative joint disease caused by multiple factors. The main features of the disease are progressive degeneration of articular cartilage and secondary paroxysmal synovitis and bone remodeling. The clinical manifestations are joint pain, swelling, stiffness, joint dysfunction, and even deformity, which seriously affect the quality of life of patients. Osteoarthritis is a highly heterogeneous disease that affects all synovial joints, including the knee, hand, hip, and spine. Domestic epidemiological studies show that the prevalence of knee osteoarthritis is about 18% (Wang B, et al. Systematic review of epidemiology and disease burden of knee osteoarthritis in China [J]. Chinese Journal of Evidence-Based Medicine, 2018, 18(2): 134-142.), and the prevalence of knee osteoarthritis in people over 45 years old has increased to 16%. The probability of diagnosing osteoarthritis in people over 65 years old with knee pain is more than 50%, and the probability of diagnosing osteoarthritis in people over 75 years old with knee pain is more than 80% (Xiao JW. Osteoarthritis diagnosis and treatment guidelines for traditional Chinese medicine and western medicine [J]. Rheumatism and Arthritis, 2023, 12(6): 70-80.).

[0003] Currently, western medicine mainly adopts anti-inflammatory analgesic and other symptomatic treatment for knee osteoarthritis, and there is no treatment method that can reverse the progression of the disease (Chinese Medical Doctor Association Rheumatology Branch Osteoarthritis Group, Zhang ZY, Zeng XF, et al. Chinese expert consensus on clinical drug treatment for knee osteoarthritis (2023) [J]. Chinese Journal of Internal Medicine, 2024, 63(6): 560-578.). The main treatment method of western medicine is sodium hyaluronate intra-articular injection, which can reduce joint inflammation, lubricate the joint, improve and restore the stability of the intra-articular environment, and thus protect the knee joint function. However, the long-term effect is not ideal and is prone to recurrence. In addition, traditional Chinese medicine treatment of knee osteoarthritis can relieve pain and effectively restore joint function. Knee osteoarthritis belongs to the category of arthralgia, bone arthralgia, etc. in traditional Chinese medicine (Li CD, Huang HY, Wang YQ, et al. Chinese Diagnosis [M]. 4th ed. Beijing: China Press of Traditional Chinese Medicine, 2016.). The etiology and pathogenesis is summarized in The Guide to Diagnosis and Treatment of Knee Osteoarthritis (2020 Edition) as liver and kidney deficiency, external invasion of wind, cold and dampness, and the syndrome belongs to deficiency in origin and excess in superficiality. The treatment mainly adopts methods such as expelling wind and dampness, tonifying liver and kidney, and strengthening bones and muscles. Some drugs are also recommended in the relevant guidelines, such as Xuefuzhuyu Decoction, Juanyi Decoction, and Zuogui Pill. However, the existing traditional Chinese medicines have a slow effect, and patients need to take them for a long time, which is often difficult to adhere to.

[0004] CN112675295A discloses a blueberry powder compound solid preparation for preventing and improving osteoarthritis, which comprises 10-90 parts by weight of blueberry powder, 10-150 parts of non-denatured type II collagen, 10-100 parts of sodium hyaluronate, 10-80 parts of chaenomeles speciosa powder and 10-80 parts of loquat leaf powder. The raw material composition of the preparation is relatively complex, including proteins, polysaccharides and plant tissues. However, the raw materials from various sources obviously increase the product cost, especially the non-denatured type II collagen, which not only has high raw material cost, but also is sensitive to temperature, has harsh transportation and storage conditions, and is not conducive to large-scale industrial production. SUMMARY

[0005] In view of the slow effect of pure traditional Chinese medicine and the high cost of existing Chinese and western medicine compound preparations, the purpose of the present application is to provide a composition containing sodium hyaluronate and traditional Chinese medicine and its application in the preparation of drugs for preventing and treating knee osteoarthritis.

[0006] In order to achieve the above technical purpose, the present inventors consider that the combination of traditional Chinese and western medicine conservative treatment is the development trend of treating knee osteoarthritis in China in the future, therefore according to the pathogenesis of "bone impediment", the TCM internal treatment method of expelling wind and removing dampness, relaxing sinews and activating collaterals, and tonifying qi and blood and liver and kidney is established, starting from the whole, and the folk prescription "impediment-removing powder" is combined with sodium hyaluronate to adjust the internal environment of the human body, so as to achieve the purpose of treating the symptoms and the root cause.

[0007] Specifically, the purpose of the present application is achieved by a composition containing sodium hyaluronate and traditional Chinese medicine, which is an oral preparation prepared from sodium hyaluronate, schisandra chinensis, cusparia fruit, achyranthes bidentata, chaenomeles speciosa, astragalus and pharmaceutically acceptable excipients.

[0008] It should be noted that the pharmaceutical composition of the present application comprises "Chubi Powder" and sodium hyaluronate, and "Chubi Powder" is composed of Acanthopanax bark, Caulis Polygoni Multiflori, Radix Cyathulae, Chaenomelis Fructus and Radix Astragali; Acanthopanax bark tastes bitter and pungent, and is warm in nature, and belongs to liver and kidney channels; Acanthopanax bark has the following effects: ① dispelling wind and dampness: pungent can dispel wind, bitter can dry dampness, and warm can dispel cold, which can directly attack and expel the wind and dampness evil that stagnates in muscles, tendons and joints. ② tonifying liver and kidney and strengthening tendons and bones: this is the unique advantage of Acanthopanax bark. It not only can dispel evil, but also can support the healthy. By tonifying liver and kidney, it can fundamentally strengthen tendons and bones, so that tendons and bones are strong enough to resist external evil, which is especially suitable for the treatment of the symptoms of long-term arthralgia syndrome, such as soreness of waist and knees and weakness of walking caused by liver and kidney deficiency; Caulis Polygoni Multiflori tastes sweet, and is flat in nature, and belongs to heart and liver channels; Caulis Polygoni Multiflori has the following effects: ① nourishing blood and calming the mind: arthralgia syndrome often causes pain, especially at night, which seriously affects sleep and the mind, and it is difficult to regulate blood and qi; Caulis Polygoni Multiflori can nourish heart blood and calm the mind, help patients sleep, improve sleep, and help the recovery of healthy qi and the relief of pain; ② dredging collaterals and dispelling wind: it has a mild effect of dredging collaterals and dispelling wind, which can help the lord drug to dredge collaterals, and has a good effect on limb numbness; Radix Cyathulae tastes bitter and sour, and is flat in nature, and belongs to liver and kidney channels; Radix Cyathulae has the following effects: ① tonifying liver and kidney and strengthening tendons and bones: it is used together with Acanthopanax bark to strengthen the aspect of supporting the healthy, and aims at the "root" of pathogenesis; ② promoting blood circulation and unblocking channels: it is good at downward movement, can unblock blood vessels and guide stagnant blood downward, and has a good effect on arthralgia of lower limbs; ③ guiding drugs downward: this is an important effect of Radix Cyathulae in the prescription; arthralgia syndrome often occurs in joints below the waist and legs, and Radix Cyathulae can guide the medicinal effect of other drugs in the prescription to the lower body and directly reach the diseased part; Chaenomelis Fructus tastes sour, and is warm in nature, and belongs to liver and spleen channels; Chaenomelis Fructus has the following effects: ① relaxing tendons and activating collaterals: sour enters liver, and liver governs tendons, so Chaenomelis Fructus is a key drug for relaxing tendons and relieving tension, and has a good effect on arthralgia syndrome caused by tendon and muscle tension, joint flexion and extension, and calf cramps; ② harmonizing stomach and resolving dampness: it belongs to spleen channel, can awaken spleen and stomach, and eliminate dampness in muscles; spleen governs four limbs and muscles, so the symptoms of muscle soreness and heaviness can be eliminated after dampness is eliminated; Radix Astragali tastes sweet, and is warm in nature, and belongs to spleen and lung channels; Radix Astragali has the following effects: ① tonifying qi and consolidating the exterior: the occurrence of arthralgia syndrome is often caused by the weakness of body resistance (low immunity), so wind, cold and damp evil can easily invade; Radix Astragali can tonify spleen and lung qi, so that the body resistance is strong when qi is sufficient, which is like a "windproof wall" for the body, which can not only help dispel evil, but also prevent recurrence, which is the key to "treatment of the root"; ② promoting water and eliminating swelling: its effect of tonifying qi and promoting water can help eliminate joint swelling; ③ promoting blood circulation: qi is the leader of blood, so sufficient qi can promote blood circulation, which helps to dredge the blocked collaterals, and the saying "treatment of wind should be treatment of blood, and blood circulation can eliminate wind" is true; sodium hyaluronate (molecular weight < 500,000 daltons) can be absorbed by the intestinal tract, and through blood circulation, it is specifically distributed and enriched in joint cartilage, synovial membrane and other tissues, provides essential precursor substances for protein glycan and collagen protein synthesized by chondrocytes, directly supplements the composition of cartilage matrix, stimulates synovial B cells, and promotes the body to synthesize more and higher quality endogenous hyaluronic acid.

[0009] Further preferably, the composition containing sodium hyaluronate and Chinese medicines as described above is prepared into the oral preparation, and the raw materials are used in the following amounts: 20 parts by weight of sodium hyaluronate, 16-20 parts by weight of Acanthopanax, 30-34 parts by weight of Radix Polygoni Multiflori, 16-20 parts by weight of Radix Rehmanniae, 16-20 parts by weight of Chaenomelis Fructus, and 30-34 parts by weight of Radix Astragali.

[0010] Still further preferably, the composition containing sodium hyaluronate and Chinese medicines as described above is prepared into the oral preparation, and the raw materials are used in the following amounts: 20 parts by weight of sodium hyaluronate, 19 parts by weight of Acanthopanax, 32 parts by weight of Radix Polygoni Multiflori, 19 parts by weight of Radix Rehmanniae, 19 parts by weight of Chaenomelis Fructus, and 32 parts by weight of Radix Astragali.

[0011] In the most preferred embodiment of the present application, the composition containing sodium hyaluronate and Chinese medicines as described above is prepared into the oral preparation in the form of capsules or pills. When the oral preparation is in the form of capsules, the pharmaceutically acceptable adjuvants are corn starch, magnesium stearate and silicon dioxide.

[0012] In addition, the present application also provides a preparation method of the composition containing sodium hyaluronate and Chinese medicines as described above, which comprises the following steps:

[0013] (1) The sodium hyaluronate, Acanthopanax, Radix Polygoni Multiflori, Radix Rehmanniae, Chaenomelis Fructus, Radix Astragali and pharmaceutically acceptable adjuvants are respectively crushed and then passed through a 40-80 mesh sieve;

[0014] (2) The weighed raw and auxiliary materials are thoroughly mixed in a mixer, and then filled into the capsule shells by using a full-automatic capsule filling machine to obtain the capsules.

[0015] Further preferably, the preparation method of the composition containing sodium hyaluronate and Chinese medicines as described above uses 1# capsule shells.

[0016] Finally, the present application also provides the use of the composition containing sodium hyaluronate and Chinese medicines as raw materials in the preparation of the oral preparation for preventing and treating knee osteoarthritis, wherein the Chinese medicine composition is composed of Acanthopanax, Radix Polygoni Multiflori, Radix Rehmanniae, Chaenomelis Fructus and Radix Astragali. Further preferably, the raw materials are used in the following amounts: 20 parts by weight of sodium hyaluronate, 16-20 parts by weight of Acanthopanax, 30-34 parts by weight of Radix Polygoni Multiflori, 16-20 parts by weight of Radix Rehmanniae, 16-20 parts by weight of Chaenomelis Fructus, and 30-34 parts by weight of Radix Astragali.

[0017] In the most preferred clinical application example of the present application, the raw materials are used in the following amounts: 20 parts by weight of sodium hyaluronate, 19 parts by weight of Acanthopanax, 32 parts by weight of Radix Polygoni Multiflori, 19 parts by weight of Radix Rehmanniae, 19 parts by weight of Chaenomelis Fructus, and 32 parts by weight of Radix Astragali.

[0018] Compared with the prior art, the present application has the following advantages and significant progress: the sodium hyaluronate can achieve certain effect, but after drug withdrawal, it is easy to appear rebound in reducing knee joint pain, improving knee joint activity, eliminating swelling and the like. The present application adopts sodium hyaluronate combined with Chubi Powder to treat knee osteoarthritis, and the results of clinical test show that the combination of the two drugs can effectively reduce knee joint pain, improve knee joint activity, eliminate swelling and improve knee joint comprehensive function for a long time, and the patients can still maintain the existing treatment effect after drug withdrawal. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 The technical route of the present application.

[0020] Figure 2 Comparison of VAS scores of each treatment group.

[0021] Figure 3 Comparison of IKDC scores of each treatment group.

[0022] Figure 4 Comparison of KSS scores of each treatment group. DETAILED DESCRIPTION

[0023] The present application will be further described in detail according to specific test examples, and the advantages and characteristics of the present application will be more clear with the description. It should be understood by those skilled in the art that the details and forms of the technical solutions can be modified or replaced without departing from the spirit of the present application, and these modifications or replacements all fall within the protection scope of the present application.

[0024] Example 1: Preparation of compound capsules

[0025] Material taking

[0026] According to the batch production instruction, the required materials are taken, and the information such as the name, batch number, weight, quantity, quality state and the like of the raw and auxiliary materials is checked.

[0027] Crushing and sieving

[0028] According to the material condition, the materials are respectively crushed and sieved through a 60-mesh sieve. Before sieving, it is checked whether the sieve is intact, and the sieved materials are respectively put into clean turnover bags, and the material labels are timely completed, for standby.

[0029] Weighing and batching

[0030] Sodium hyaluronate 2.0 kg, acanthopanax 1.9 kg, radix cuspariae 3.2 kg, radix rehmanniae 1.9 kg, chaenomeles fruit 1.9 kg, astragalus 3.2 kg, corn starch 15.3 kg, magnesium stearate 0.45 kg, and silicon dioxide 0.24 kg were weighed according to the formula, and timely material label was prepared, and the ingredients were operated, one person operated and one person checked.

[0031] Total mixing

[0032] The weighed sodium hyaluronate, acanthopanax, radix cuspariae, radix rehmanniae, chaenomeles fruit, astragalus, corn starch, magnesium stearate, and silicon dioxide were mixed in a three-dimensional motion mixer for 20 min, and then were loaded into clean packaging bags. The moisture content was controlled to be less than or equal to 9.0% during the production process, and the mixed materials were placed in the middle station for not more than one week.

[0033] Capsule filling

[0034] The mixed materials were filled into 1# capsule shells by using a full-automatic capsule filling machine. The filling amount was adjusted, and the difference in the filling amount was not more than ±7.5%. During the capsule filling process, 10 capsules were taken every 30 min for detection of the filling amount difference, to ensure that each capsule contained 20 mg of sodium hyaluronate, 19 mg of acanthopanax, 32 mg of radix cuspariae, 19 mg of radix rehmanniae, 19 mg of chaenomeles fruit, and 32 mg of astragalus. The capsules were polished.

[0035] Gold detection of foreign matter

[0036] Before production, three consecutive verification tests were performed. After the test was qualified, the product was detected by a gold detector, and the detection was performed once every hour during the process until the detection was completed. If the detection time was less than 1 h, the detection was performed once during the process. After completion, three verification tests were performed again to ensure that the entire system was operating normally.

[0037] Inner packaging

[0038] The packaging bottles should meet the requirements of YBB 0012 2002 “Oral solid pharmaceutical high-density polyethylene bottles”.

[0039] Outer packaging

[0040] Labeling, boxing, 8 bottles / box, and sampling detection after packaging.

[0041] Storage

[0042] After the product was qualified, the storage procedures were handled according to the inspection report and the storage list.

[0043] Comparative Example 1: Preparation of sodium hyaluronate capsules

[0044] The raw material only contains sodium hyaluronate, and does not contain Dui Bi San. The other steps are consistent with Example 1. Each capsule contains 20 mg of sodium hyaluronate.

[0045] Preparation of Chinese medicine capsules

[0046] The raw material only contains each Chinese medicinal material of Dui Bi San, and does not contain sodium hyaluronate. The other steps are consistent with Example 1. Each capsule contains 19 mg of Wu Jia Pi, 32 mg of Shou Wu Teng, 19 mg of Huai Niu Xi, 19 mg of Mu Gu, and 32 mg of Huang Qi.

[0047] Example 2: Clinical study on treatment of knee osteoarthritis with sodium hyaluronate combined with Dui Bi San

[0048] 1. Research object

[0049] 300 patients with knee osteoarthritis, including 150 males and 150 females.

[0050] 2. Selection of research object

[0051] 2.1 Diagnosis criteria of research object: Western medicine diagnosis refers to the clinical, laboratory and radiological criteria in the revised “Classification Criteria for Knee Osteoarthritis” of American Rheumatism Association. The TCM syndrome diagnosis criteria refer to the TCM syndrome diagnosis criteria for treating osteoarthritis in “Guiding Principles for Clinical Research on New Drugs of Traditional Chinese Medicine” (2002 revised edition).

[0052] 2.2 Case inclusion criteria: Patients who meet the above western medicine disease diagnosis criteria and TCM syndrome diagnosis criteria, and have not used other drugs and other methods of treatment in the past 1 week.

[0053] 2.3 Case exclusion criteria: (1) Those who do not meet the diagnosis criteria of knee osteoarthritis; (2) Those who have serious diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and mental illness; (3) Those with allergic constitution; (4) Those who have bone tumors, bone tuberculosis or obvious history of acute trauma causing meniscus injury, ligament rupture and vascular nerve injury, as well as non-specific inflammation patients; (5) Pregnant women and lactating women; (6) Those who cannot adhere to treatment, change treatment method in the middle, and cannot determine the efficacy or have incomplete data which affect the determination of efficacy; (7) Patients who need knee replacement.

[0054] 3. Treatment of research object

[0055] 3.1 Patients were divided into three levels according to K-L classification system 1-3 level: K-L 1 level, K-L 2 level, K-L 3 level. Kellgren-Lawrence (K-L) classification is a way to evaluate the severity of osteoarthritis by X-ray: K-L 1 level shows a small osteophyte on the edge of the joint, but the joint space is normal; K-L 2 level shows clear osteophyte formation, and may be accompanied by mild joint space narrowing; K-L 3 level shows moderate osteophyte, clear joint space narrowing and possible subchondral bone sclerosis. All selected patients were divided into group A, group B and group C, 100 cases in each group, and there was no significant difference in gender, age, K-L classification and other aspects.

[0056] 3.2 Among them, group A patients only take sodium hyaluronate, group B patients only take Chuobi powder, and group C patients take sodium hyaluronate and Chuobi powder. Specifically: group A patients take sodium hyaluronate capsules prepared by comparative example 1, group B patients take traditional Chinese medicine capsules prepared by comparative example 2, and group C patients take compound capsules prepared by example 1 (specification: 300mg / pill, provided by Shandong Jiaofen Furuida Biological Co., Ltd.). Each group of patients orally takes medicine, 1 pill at a time, 3 times a day. Continuous medication for 12 weeks, 2 weeks before treatment and during treatment, patients stop using all non-steroidal anti-inflammatory analgesics, hormone drugs and other physical therapy.

[0057] 4. Efficacy evaluation

[0058] After treatment, the patient's indicators were evaluated and compared with the pre-treatment indicators:

[0059] 4.1 Visual analogue scale (visual analogue scale, VAS);

[0060] 4.2 IKDC knee function scoring table;

[0061] 4.3 Knee function score (Knee Society scoring, KSS);

[0062] The evaluation time points were before treatment, 1 month, 3 months and 6 months after treatment.

[0063] 5. Statistical analysis

[0064] Continuous variables are expressed as mean ± standard deviation (normal distribution) or median (quartile) (skewed distribution), and categorical variables are expressed as frequency or percentage. Single factor analysis of variance (normal distribution), Kruscal Whallis H (skewed distribution) test and chi-square test (categorical variables) were used to determine the statistical differences between the means and proportions of each group. P<0.05 was considered statistically significant.

[0065] 6 Research results

[0066] As shown in Figure 2 , after 1 month and 3 months of treatment, the VAS scores of the patients in groups A and B were decreased, and the data difference was not statistically significant, and the VAS score of group C was significantly decreased (P<0.05). As shown in Figure 3 , Figure 4 , the KSS scores and IKDC scores of the patients in groups A and B were increased, and the data difference was not statistically significant, and the KSS scores and IKDC scores of the patients in group C were significantly increased (P<0.05), which indicated that the knee joint pain of the patients was relieved and the knee joint function was improved. After 6 months of treatment, the VAS, KSS and IKDC of the patients in the three groups had no significant difference compared with those before treatment, which indicated that the treatment effective period of the formula was about half a year. In summary, the results of the clinical test showed that the self-prepared Dui Bi Powder combined with sodium hyaluronate for treating osteoarthritis could relieve the joint pain of the patients and improve the joint function, and had a synergistic effect of 1+1>2 in treating knee osteoarthritis, and had a good treatment effect on knee osteoarthritis.

Claims

1. A composition containing sodium hyaluronate and traditional Chinese medicine, characterized in that, The composition is an oral preparation made from sodium hyaluronate, Acanthopanax senticosus, Polygonum multiflorum, Achyranthes bidentata, Chaenomeles speciosa, Astragalus membranaceus, and pharmaceutically acceptable excipients.

2. The composition containing sodium hyaluronate and traditional Chinese medicine according to claim 1, characterized in that, The raw materials used to prepare the oral preparation are: 20 parts by weight of sodium hyaluronate, 16-20 parts by weight of Acanthopanax senticosus, 30-34 parts by weight of Polygonum multiflorum, 16-20 parts by weight of Achyranthes bidentata, 16-20 parts by weight of Chaenomeles speciosa, and 30-34 parts by weight of Astragalus membranaceus.

3. The composition containing sodium hyaluronate and traditional Chinese medicine according to claim 2, characterized in that, The raw materials used to prepare the oral preparation are: 20 parts by weight of sodium hyaluronate, 19 parts by weight of Acanthopanax senticosus, 32 parts by weight of Polygonum multiflorum vine, 19 parts by weight of Achyranthes bidentata, 19 parts by weight of Chaenomeles speciosa, and 32 parts by weight of Astragalus membranaceus.

4. The composition containing sodium hyaluronate and traditional Chinese medicine according to any one of claims 1-3, characterized in that, The oral preparation is a capsule or pill.

5. The composition containing sodium hyaluronate and traditional Chinese medicine according to claim 4, characterized in that, When the oral formulation is a capsule, the pharmaceutically acceptable excipients are corn starch, magnesium stearate, and silicon dioxide.

6. A method for preparing a composition containing sodium hyaluronate and traditional Chinese medicine according to any one of claims 1-3, characterized in that, The method includes the following steps: (1) Sodium hyaluronate, Acanthopanax senticosus, Polygonum multiflorum vine, Achyranthes bidentata, Chaenomeles speciosa, Astragalus membranaceus and pharmaceutically acceptable excipients are pulverized and passed through a 40-80 mesh sieve; (2) Place the weighed raw and auxiliary materials into a mixer and mix them thoroughly. Then fill the capsule shells with a fully automatic capsule filling machine to obtain capsules.

7. The method for preparing the composition containing sodium hyaluronate and traditional Chinese medicine according to claim 6, characterized in that, The capsule shell is a No. 1 capsule shell.

8. The application of sodium hyaluronate and a traditional Chinese medicine composition as raw materials in the preparation of oral formulations for the prevention and treatment of knee osteoarthritis, wherein the traditional Chinese medicine composition consists of Acanthopanax senticosus, Polygonum multiflorum, Achyranthes bidentata, Chaenomeles speciosa and Astragalus membranaceus.

9. The application according to claim 8, characterized in that, The raw materials used to prepare the oral preparation are: 20 parts by weight of sodium hyaluronate, 16-20 parts by weight of Acanthopanax senticosus, 30-34 parts by weight of Polygonum multiflorum, 16-20 parts by weight of Achyranthes bidentata, 16-20 parts by weight of Chaenomeles speciosa, and 30-34 parts by weight of Astragalus membranaceus.

10. The application according to claim 8, characterized in that, The raw materials used to prepare the oral preparation are: 20 parts by weight of sodium hyaluronate, 19 parts by weight of Acanthopanax senticosus, 32 parts by weight of Polygonum multiflorum vine, 19 parts by weight of Achyranthes bidentata, 19 parts by weight of Chaenomeles speciosa, and 32 parts by weight of Astragalus membranaceus.

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