Pharmaceutical composition used in cooperation with rehabilitation pillow and used for treating cervical spondylosis and preparation method of pharmaceutical composition

Abstract

The invention discloses a pharmaceutical composition used in cooperation with a rehabilitation pillow and used for treating cervical spondylosis and a preparation method thereof.The pharmaceutical composition is prepared from 24-36 parts of raw radix paeoniae alba, 5-7 parts of honey-fried licorice roots, 12-18 parts of radix rehmanniae preparata, 12-18 parts of angelica sinensis and 13-19 parts of spasmolysis components, and the spasmolysis components are selected from at least one of the root of kudzu vine and cassia twigs. The pharmaceutical composition is reasonable in matching, simple in component and low in sensitization, has good anti-inflammatory and analgesic effects, can be used for treating cervical spondylosis, and has a better treatment effect on cervical spondylosis when being matched with a rehabilitation pillow for use.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a medicinal composition for treating cervical spondylosis in cooperation with a rehabilitation pillow and a preparation method thereof. BACKGROUND

[0002] According to authoritative data statistics, the number of cervical spondylosis patients in China has exceeded 200 million, the incidence rate is as high as 17.3%, and there is a significant trend of youth. The 30-60 year-old job seekers have become a high-risk group of cervical spondylosis due to long-term desk work and high-frequency use of electronic equipment. The disease not only seriously affects the quality of life of patients, but also causes huge loss of social productivity and medical burden.

[0003] The existing Chinese medicine formula for treating cervical spondylosis is complex and has a high risk of sensitization. For example, the external use black plaster for treating cervical spondylosis disclosed in CN 116196354 B has 13 kinds of Chinese medicine ingredients such as Huangqi, Danggui and Chuanxiong and a matrix such as beeswax. In the allergic reaction evaluation test, 4 / 60 people have mild erythema, and 2 / 60 people have moderate erythema. Therefore, it is a technical problem to be solved in the field to develop a Chinese medicine formula for treating cervical spondylosis with a simple formula and a low risk of sensitization. SUMMARY

[0004] In view of the deficiencies in the prior art, a medicinal composition for treating cervical spondylosis in cooperation with a rehabilitation pillow and a preparation method thereof are provided. The medicinal composition has reasonable cooperation, simple components, low sensitization, and good anti-inflammatory and analgesic effects, and can be used for treating cervical spondylosis and has better therapeutic effect on cervical spondylosis when used in cooperation with a rehabilitation pillow.

[0005] The purpose of the application is to provide a medicinal composition for treating cervical spondylosis, which is prepared from the following raw materials in parts by weight: raw white peony root 24-36 parts, fried licorice 5-7 parts, prepared rehmannia 12-18 parts, angelica 12-18 parts, and spasmolytic component 13-19 parts.

[0006] The spasmolytic component is selected from at least one of radix puerariae and cassia twig.

[0007] Many chronic cervical spondylosis is caused by liver blood deficiency and muscle and tendon deficiency. Liver governs the muscles, and the neck is the place where the muscles and tendons of the whole body converge. If the liver blood is deficient, the muscles and tendons will be dry and hard, causing stiffness, rigidity, difficulty in turning, pain and even shoulder and arm pain.

[0008] Raw white peony root can penetrate into liver meridian, soothe liver and relieve depression, and relax the tightness of muscles and tendons caused by liver blood deficiency. Fried licorice root can stabilize the middle jiao, help qi and blood to be transformed, and enhance the power of relieving acute spasm pain. The combination of the two can not only relieve the acute spasm pain of neck muscles (palliative treatment), but also improve the nutritional status of muscles and tendons by nourishing liver blood (root treatment). At the same time, the sweet and mild nature of fried licorice root can neutralize the cold and astringent nature of raw white peony root. The combination of the two in a certain range can make the overall prescription mild, which is beneficial to reduce the sensitization.

[0009] Rehmannia glutinosa can enter liver and kidney and tonify yin blood, which can fundamentally fill the loss of liver blood and provide sufficient material source for the nourishment of muscles and tendons. Angelica sinensis can help Rehmannia glutinosa to tonify blood. The “activating blood” nature of Angelica sinensis can improve the microcirculation of the neck caused by blood deficiency, and the “acrid-warm” nature of Angelica sinensis can dredge collaterals and directly act on muscles and tendons, so as to restore the flexibility of muscles and tendons and effectively relieve the spasm pain and stiffness of the neck.

[0010] The medicinal power of Pueraria lobata can directly reach the neck and back area, effectively relieve the local muscle and tendon spasm, stiffness and pulling sensation caused by wind-cold constraint or blood stasis, and Cinnamomum cassia can remove the cold-damp evil in meridians. The acrid-warm property of Cinnamomum cassia can promote the circulation of blood and nourish muscles and tendons. Both of them can dredge collaterals and blood, and relieve the tight and spastic muscles of the neck.

[0011] In some embodiments of the present application, the spasm-relieving component is Pueraria lobata and Cinnamomum cassia in a weight ratio of 5-12:5-12.

[0012] In some embodiments of the present application, the spasm-relieving component is Pueraria lobata and Cinnamomum cassia in a weight ratio of 8-12:5-7.

[0013] By using Pueraria lobata and Cinnamomum cassia as the spasm-relieving component, the ascending nature of Cinnamomum cassia can guide the medicinal power of Pueraria lobata and other drugs to the neck, back and upper limbs, so that the treatment force can accurately act on the diseased part, and the anti-inflammatory effect is more effective.

[0014] A second object of the present application is to provide a preparation method of the above-mentioned pharmaceutical composition, which comprises the following steps:

[0015] Raw white peony root, fried licorice root, Rehmannia glutinosa, Angelica sinensis and optionally Pueraria lobata are weighed by weight parts, crushed into coarse powder, decocted with 40wt%-60wt% ethanol aqueous solution, filtered to obtain a filtrate;

[0016] Optionally, Cinnamomum cassia is weighed by weight parts, crushed into coarse powder, extracted with supercritical carbon dioxide to obtain an extract;

[0017] The filtrate and optionally the extract are mixed to obtain the pharmaceutical composition.

[0018] In some embodiments of the present application, the preparation method further comprises a step of concentrating after filtration.

[0019] In some embodiments of the present application, the weight of the aqueous ethanol solution is 3-12 times the weight of the coarse powder.

[0020] In some embodiments of the present application, the decocting temperature is 50-80℃.

[0021] In some embodiments of the present application, the decocting time is 1-5h.

[0022] In some embodiments of the present application, the decocting times is 1-3 times.

[0023] In some embodiments of the present application, the extraction pressure is 10-40MPa.

[0024] In some embodiments of the present application, the extraction CO2 flow is 20-40L / h.

[0025] In some embodiments of the present application, the extraction temperature is 25-50℃.

[0026] In some embodiments of the present application, the extraction time is 1-5h.

[0027] A third object of the present application is to provide a traditional Chinese medicine preparation for treating cervical spondylosis, the preparation raw materials of which comprise the above-mentioned pharmaceutical composition and pharmaceutically acceptable excipients.

[0028] In some embodiments of the present application, the pharmaceutically acceptable excipients comprise at least one of diluents, wetting agents, binders, disintegrants, preservatives, lubricants, surfactants, and penetration enhancers.

[0029] In some embodiments of the present application, the dosage form of the traditional Chinese medicine preparation is paste, cream or gel.

[0030] A fourth object of the present application is to provide a use method of the above-mentioned pharmaceutical composition, which comprises the following steps:

[0031] Mixing the above-mentioned pharmaceutical composition or the pharmaceutical composition obtained by the above-mentioned preparation method with a pillow core auxiliary material and performing low-temperature drying to obtain a mixture; packing the mixture into a gauze bag, and then contacting the cervical vertebrae with the gauze bag. As shown in Figure 1 the gauze bag can be placed at the black line frame shown in the pillow in the figure, and the cervical vertebrae of the cervical spondylosis patient contacts this part again, which can achieve the purpose of treatment while lying down.

[0032] In some embodiments of the present application, the pillow core auxiliary material comprises at least one of cassia seed powder, buckwheat shell powder and chrysanthemum powder.

[0033] The fifth objective of this invention is to provide a method of using the aforementioned traditional Chinese medicine preparation, comprising the following steps: applying the traditional Chinese medicine preparation directly to the cervical spine; or applying the traditional Chinese medicine preparation to the surface of a wooden, stone, or plastic pillow, with the cervical spine then in contact with the medicated surface, such as... Figure 1 As shown, the above-mentioned traditional Chinese medicine preparation can be applied to the area indicated by the black line frame on the pillow in the picture. When the cervical spine of the patient with cervical spondylosis comes into contact with this area, the purpose of treatment can be achieved by lying flat.

[0034] Compared with the prior art, the present invention has the following beneficial effects:

[0035] 1) The pharmaceutical composition of the present invention is reasonably formulated, has simple components, low allergenicity, and has been verified to have good anti-inflammatory and analgesic effects. It can be used to treat cervical spondylosis, and has a better therapeutic effect on cervical spondylosis when used in conjunction with a rehabilitation pillow.

[0036] 2) In the pharmaceutical composition of the present invention, raw white peony root and prepared licorice root have the effects of nourishing yin with sour and sweet flavors and relieving pain; prepared rehmannia root and angelica root have the effects of nourishing liver blood and nourishing blood and softening tendons; kudzu root and cinnamon twig can relieve spasms in the neck and back and warm and unblock the meridians. When used together, they can achieve the effects of treating both the symptoms and the root cause.

[0037] 3) The pharmaceutical composition of the present invention can be prepared as an ointment, emulsion or gel for application, and can also be compounded with pillow core materials for use as a functional pillow. Attached Figure Description

[0038] Figure 1 This is a rehabilitation pillow that can be used in conjunction with the pharmaceutical composition and traditional Chinese medicine preparation of the present invention. Detailed Implementation

[0039] To enable those skilled in the art to better understand the technical solutions of this invention, the technical solutions of this invention will be clearly and completely described below in conjunction with the embodiments of this invention. Obviously, the described embodiments are only some embodiments of this invention, and not all embodiments. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of this invention.

[0040] Unless otherwise specified, all raw materials used in this invention are commercially available.

[0041] Preparation Example 1

[0042] This preparation example provides a pharmaceutical composition, the raw materials of which, by weight, are 30 parts of raw white peony root, 6 parts of prepared licorice root, 10 parts of kudzu root, 6 parts of cinnamon twig, 15 parts of prepared rehmannia root, and 15 parts of angelica root. The preparation method is as follows:

[0043] Weigh out the above-mentioned raw white peony root, prepared licorice root, prepared rehmannia root, angelica root, and kudzu root according to the weight parts, crush them into coarse powder, decoct them in 5 times their weight of 50wt% ethanol aqueous solution at 60℃ for 4 hours, filter, collect the liquid and concentrate it to a density of 1.1±0.02 to obtain the filtrate.

[0044] Weigh out the cinnamon twigs according to the weight, crush them into coarse powder, and extract them with supercritical carbon dioxide at a pressure of 20 MPa for 2 h at a temperature of 40℃ and a CO2 flow rate of 30 L / h to obtain the extract.

[0045] The filtrate is mixed with the extract to obtain the pharmaceutical composition.

[0046] Preparation Example 2

[0047] This preparation example provides a pharmaceutical composition, the raw materials of which, by weight, are 24 parts of raw white peony root, 7 parts of prepared licorice root, 12 parts of kudzu root, 5 parts of cinnamon twig, 12 parts of prepared rehmannia root, and 18 parts of angelica root. The preparation method is as follows:

[0048] Weigh out the above-mentioned raw white peony root, prepared licorice root, prepared rehmannia root, angelica root, and kudzu root according to the weight parts, crush them into coarse powder, decoct them in 8 times their weight of 40wt% ethanol aqueous solution at 80℃ for 4 hours, filter, collect the liquid and concentrate it to a density of 1.1±0.02 to obtain the filtrate.

[0049] Weigh out the cinnamon twigs according to the weight, crush them into coarse powder, and extract them with supercritical carbon dioxide at a pressure of 15 MPa for 3 h at a temperature of 40℃ and a CO2 flow rate of 30 L / h to obtain the extract.

[0050] The filtrate is mixed with the extract to form the pharmaceutical composition.

[0051] Preparation Example 3

[0052] This preparation example provides a pharmaceutical composition, the raw materials of which, by weight, are 36 parts of raw white peony root, 6 parts of prepared licorice root, 8 parts of kudzu root, 7 parts of cinnamon twig, 18 parts of prepared rehmannia root, and 12 parts of angelica root. The preparation method is as follows:

[0053] Weigh out the above-mentioned raw white peony root, prepared licorice root, prepared rehmannia root, angelica root, and kudzu root according to the weight parts, crush them into coarse powder, decoct them in 12 times their weight of 60wt% ethanol aqueous solution at 50℃ for 4 hours, filter, collect the liquid and concentrate it to a density of 1.1±0.02 to obtain the filtrate.

[0054] Weigh out the cinnamon twigs according to the weight, crush them into coarse powder, and extract them with supercritical carbon dioxide at a pressure of 25 MPa for 3 h at a temperature of 30℃ and a CO2 flow rate of 30 L / h to obtain the extract.

[0055] The filtrate is mixed with the extract to form the pharmaceutical composition.

[0056] Preparation Example 4

[0057] This preparation example provides a pharmaceutical composition, the raw materials of which, by weight, are 30 parts of raw white peony root, 6 parts of prepared licorice root, 16 parts of kudzu root, 15 parts of prepared rehmannia root, and 15 parts of angelica root. The preparation method is as follows:

[0058] Weigh out the above-mentioned raw white peony root, prepared licorice root, prepared rehmannia root, angelica root, and kudzu root according to the weight parts, crush them into coarse powder, decoct them in 5 times their weight of 50wt% ethanol solution at 60℃ for 4 hours, filter, collect the liquid with a concentrated density of 1.1±0.02, and obtain the filtrate, which is the drug composition.

[0059] Preparation Example 5

[0060] This preparation example provides a pharmaceutical composition, the raw materials of which, by weight, are 30 parts of raw white peony root, 6 parts of prepared licorice root, 16 parts of cinnamon twig, 15 parts of prepared rehmannia root, and 15 parts of angelica root. The preparation method is as follows:

[0061] Weigh out the above-mentioned raw white peony root, prepared licorice root, prepared rehmannia root, and angelica root according to the weight parts, crush them into coarse powder, decoct them in 5 times their weight of 50wt% ethanol aqueous solution at 60℃ for 4 hours, filter, collect the liquid with a concentrated density of 1.1±0.02, and obtain the filtrate.

[0062] Weigh out the cinnamon twigs according to the weight, crush them into coarse powder, and extract them with supercritical carbon dioxide at a pressure of 20 MPa for 2 h at a temperature of 40℃ and a CO2 flow rate of 30 L / h to obtain the extract.

[0063] The filtrate is mixed with the extract to obtain the pharmaceutical composition.

[0064] Preparation Example 6

[0065] This preparation example provides a pharmaceutical composition, the raw materials of which, by weight, are 30 parts of raw white peony root, 6 parts of prepared licorice root, 6 parts of kudzu root, 10 parts of cinnamon twig, 15 parts of prepared rehmannia root, and 15 parts of angelica root. The preparation method is as follows:

[0066] Weigh out the above-mentioned raw white peony root, prepared licorice root, prepared rehmannia root, angelica root, and kudzu root according to the weight parts, crush them into coarse powder, decoct them in 5 times their weight of 50wt% ethanol aqueous solution at 60℃ for 4 hours, filter, collect the liquid with a concentrated density of 1.1±0.02, and obtain the filtrate.

[0067] Weigh out the cinnamon twigs according to the weight, crush them into coarse powder, and extract them with supercritical carbon dioxide at a pressure of 20 MPa for 2 h at a temperature of 40℃ and a CO2 flow rate of 30 L / h to obtain the extract.

[0068] The filtrate is mixed with the extract to obtain the pharmaceutical composition.

[0069] Comparative Preparation Example 1

[0070] This comparative preparation example provides a pharmaceutical composition, the raw materials of which, by weight, are 20 parts of raw white peony root, 16 parts of prepared licorice root, 10 parts of kudzu root, 6 parts of cinnamon twig, 15 parts of prepared rehmannia root, and 15 parts of angelica root. The preparation method is as follows:

[0071] Weigh out the above-mentioned raw white peony root, prepared licorice root, prepared rehmannia root, angelica root, and kudzu root according to the weight parts, crush them into coarse powder, decoct them in 5 times their weight of 50wt% ethanol aqueous solution at 60℃ for 4 hours, filter, collect the liquid with a concentrated density of 1.1±0.02, and obtain the filtrate.

[0072] Weigh out the cinnamon twigs according to the weight, crush them into coarse powder, and extract them with supercritical carbon dioxide at a pressure of 20 MPa for 2 h at a temperature of 40℃ and a CO2 flow rate of 30 L / h to obtain the extract.

[0073] The filtrate is mixed with the extract to obtain the pharmaceutical composition.

[0074] Example 1

[0075] This embodiment provides a traditional Chinese medicine preparation, the raw materials of which are 30wt% of the drug composition obtained in Preparation Example 1, 1wt% of carbomer 934, 10wt% of glycerol, 1wt% of TW-80 and the balance of water. The preparation method is as follows: after dissolving carbomer 934 in water, add TW-80, heat to 50°C and stir evenly, cool to 30°C and then add the drug composition obtained in Preparation Example 1 and glycerol, stir and homogenize to obtain the traditional Chinese medicine preparation.

[0076] Examples 2-6 and Comparative Example 1

[0077] This embodiment / comparative example provides a traditional Chinese medicine preparation, which differs from Example 1 only in that the drug compositions obtained in Preparation Examples 2-6 and Comparative Preparation Example 1 are used instead of the drug composition obtained in Preparation Example 1. Everything else remains the same as in Example 1.

[0078] Performance testing

[0079] 1. Sensitization: h-CLAT detection

[0080] a. Experimental reagents:

[0081] Experimental group: The traditional Chinese medicine preparations obtained in Examples 1-6 and Comparative Example 1 were prepared into working solutions with a concentration of 100 μg / mL or 50 μg / mL and 0.1% DMSO in RPMI 1640 medium containing 10% FBS.

[0082] Negative control group: RPMI 1640 medium containing 0.1% DMSO;

[0083] Positive control group: NiSO4 at a concentration of 1 mmol / L was prepared in RPMI 1640 medium containing 10% volume FBS;

[0084] b. Experimental procedure:

[0085] With a standard density of 1×10 6 THP-1 cells were seeded into 24-well plates at 1 mL / well (RPMI 1640 + 10% FBS). After pre-culturing for 24 hours, the cells were centrifuged, the supernatant discarded, and washed with PBS. Experimental reagents for the experimental group, negative control group, and positive control group were added to each well (3 replicates). Cells were cultured for another 24 hours, collected, centrifuged, and washed twice with PBS. Fluorescently labeled antibodies (5 μL anti-human CD86-FITC, 5 μL anti-human CD54-PE) were added, and the cells were incubated on ice for 30 min in the dark. The cells were washed twice with PBS, and then resuspended in 300 μL PBS. The fluorescence intensity of the emitted green (FITC-CD86) and red (PE-CD54) cells was detected by flow cytometry. The relative fluorescence intensity (RFI) was calculated as (average fluorescence intensity of the positive control group or experimental group / average fluorescence intensity of the negative control group) × 100%. The results are shown in Table 1.

[0086] Wherein, P indicates positive (based on the increase in RFI value with the increase in concentration, "RFI (CD86) ≥ 150% and RFI (CD54) ≥ 200%", or "RFI (CD86) ≥ 200% and RFI (CD54) ≥ 150%"); N indicates negative.

[0087] Table 1:

[0088]

[0089] 2. Pharmacological efficacy research

[0090] 2.1 Hot plate test for pain in mice

[0091] Healthy female mice weighing 18-22g and with an initial pain threshold of 5-20s were selected and randomly divided into 9 groups of 6 mice each. The mice in each group were treated as follows:

[0092] Blank control group: Distilled water was applied to the right hind limb of mice once a day for 3 consecutive days;

[0093] Positive control group: Apply 0.4g of diclofenac sodium to the right hind limb of mice and massage for 30 seconds to promote absorption. Administer once daily for 3 consecutive days.

[0094] Examples 1-6: 0.4g of the traditional Chinese medicine preparations from Examples 1-6 were applied to the right hind limb of mice and massaged for 30 seconds to promote absorption. The medication was administered once a day for 3 consecutive days.

[0095] Comparative Example 1: 0.4g of the traditional Chinese medicine preparation of Comparative Example 1 was applied to the right hind limb of mice and massaged for 30s to promote absorption. The medication was administered once a day for 3 consecutive days.

[0096] After the last application, the pain threshold of mice on a smart hot plate at 55℃ was recorded at 30 min, 60 min, 90 min, 120 min, 150 min, and 180 min (the pain threshold was measured by the licking response of the mouse's hind paw, and the average of the three measurements was taken, with the unit being seconds, and the maximum being 60 seconds). The pain threshold improvement rate was calculated as (pain threshold of the positive control group or experimental group - pain threshold of the blank control group / pain threshold of the blank control group) × 100%. The results are shown in Table 2.

[0097] Table 2:

[0098]

[0099] * indicates a comparison with the blank control group, P < 0.05.

[0100] 2.2 Xylene-induced ear swelling experiment in mice

[0101] Healthy male mice weighing 18-22g were selected and randomly divided into 9 groups of 6 mice each. The mice in each group were treated as follows:

[0102] Negative control group: Distilled water was applied to both sides of the right ear of mice once a day for 3 consecutive days;

[0103] Positive control group: Apply 0.2g of diclofenac sodium to both sides of the right ear of mice and massage for 30 seconds to promote absorption. Apply once a day for 3 consecutive days.

[0104] Examples 1-6: 0.2g of the traditional Chinese medicine preparations from Examples 1-6 were applied to the front and back of the right ear of mice and massaged for 30 seconds to promote absorption. The application was repeated once a day for 3 consecutive days.

[0105] Comparative Example 1: Apply 0.2g of the traditional Chinese medicine preparation of Comparative Example 1 to both sides of the right ear of mice and massage for 30 seconds to promote absorption. Apply once a day for 3 consecutive days.

[0106] One hour after the last application, 0.2 mL of xylene was applied to both sides of the right ear of the mice, with the left ear serving as a blank control. The degree of swelling in the right ear of each group of mice was observed visually. After 30 minutes, the mice were euthanized by cervical dislocation, and circular ear pieces were punched at the same position in both ears using an 8 mm diameter punch. The weight of the left and right ear pieces was measured, and the swelling rate and swelling inhibition rate were calculated as follows. The results are shown in Table 3.

[0107] Swelling rate = (Weight of right earpiece - Weight of left earpiece) / Weight of left earpiece × 100%;

[0108] Swelling inhibition rate = (Swelling rate of negative control group - Swelling rate of treatment group) / Swelling rate of negative control group × 100%.

[0109] Table 3:

[0110]

[0111] * indicates that compared with the negative control group, P < 0.05.

[0112] 2.3 Experiment on a rabbit cervical spondylosis model

[0113] Healthy male New Zealand White rabbits aged 6 months with a weight of 2.5 ± 0.5 kg were selected. After a week of acclimatization before the experiment, they were randomly divided into 4 groups of 6 rabbits each. The rabbits in each group were treated as follows:

[0114] Blank control group: During the modeling period, the group was placed in a fixed box and allowed free neck movement; at other times, it was kept at room temperature of 25±2℃ and fed normally, with free movement and diet.

[0115] Modeling groups (negative control group, positive control group, and example group): Cervical spondylosis modeling was performed according to the method described in "Establishment of non-invasive rabbit cervical spondylosis animal model, Zhang Xin et al., 2015". The modeling was performed twice a day for 2 hours each time, for a total of 4 weeks. At other times, the rabbits were kept at room temperature of 25±2℃ and allowed to move and eat freely.

[0116] Subsequently, distilled water was applied to the necks of rabbits in the blank control group and negative control group, 0.5g of diclofenac sodium was applied to the necks of rabbits in the positive control group and massaged for 30 seconds to promote absorption, and 0.5g of the drug preparation of Example 1 was applied to the necks of rabbits in the example group and massaged for 30 seconds to promote absorption. The application was done once in the morning and once in the evening for 4 consecutive weeks.

[0117] On the morning of the second day after the last application, blood was collected from the marginal ear vein of all rabbits and collected in blood collection tubes. The tubes were centrifuged at 3000 r / s for 30 min at 4℃, and the supernatant was collected. The expression levels of inflammatory factors IL-6, TNF-α and IL-1β were measured using an ELISA kit. The results are shown in Table 4.

[0118] Table 4:

[0119]

[0120] *: Compared with the negative control group, P < 0.05.

[0121] As shown in Table 1, the traditional Chinese medicine preparations obtained in Examples 1-6 of this invention have low allergenicity. Furthermore, as shown in Tables 2-4, the preparations of this invention have good anti-inflammatory and analgesic effects, and exhibit good therapeutic effects when used in a rabbit cervical spondylosis model. In particular, the anti-inflammatory and analgesic effects are even better when combined with a certain mass ratio of kudzu root and cinnamon twig. In contrast, the relative weight ratio of raw white peony root to prepared licorice root in Comparative Example 1 is too large. The cold and astringent properties of raw white peony root cannot be effectively neutralized by the sweet and mild properties of prepared licorice root, resulting in a certain degree of allergenicity in the system.

[0122] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit it. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that after reading this application specification, they can still modify or make equivalent substitutions to the specific implementation of the present invention, but these modifications or changes do not depart from the protection scope of the pending claims of the present invention.

Claims

1. A pharmaceutical composition for treating cervical spondylosis, characterized in that, The raw materials for its preparation include, by weight: 24-36 parts of raw white peony root, 5-7 parts of prepared licorice root, 12-18 parts of prepared rehmannia root, 12-18 parts of angelica root, and 13-19 parts of antispasmodic components. The antispasmodic component is selected from at least one of kudzu root and cinnamon twig.

2. The pharmaceutical composition according to claim 1, characterized in that, The antispasmodic components are kudzu root and cinnamon twig in a weight ratio of 5~12:5~12.

3. The pharmaceutical composition according to claim 1, characterized in that, The antispasmodic component consists of kudzu root and cinnamon twig in a weight ratio of 8-12:5-7.

4. The method for preparing the pharmaceutical composition according to any one of claims 1 to 3, characterized in that, Includes the following steps: Weigh out raw white peony root, prepared licorice root, prepared rehmannia root, angelica root, and optionally kudzu root according to the weight percentages, crush them into coarse powder, decoct them with a 40wt%~60wt% ethanol aqueous solution, filter them, and obtain the filtrate. Optionally, weigh out cinnamon twigs by weight, crush them into coarse powder, and extract them with supercritical carbon dioxide to obtain an extract. The filtrate is mixed with the extract, optionally, to obtain the pharmaceutical composition.

5. The preparation method according to claim 4, characterized in that, It also includes a step of concentration after filtration.

6. A traditional Chinese medicine preparation for treating cervical spondylosis, characterized in that, Its raw materials include: The pharmaceutical composition according to any one of claims 1 to 3, and a pharmaceutically acceptable excipient.

7. The traditional Chinese medicine preparation according to claim 6, characterized in that, Its dosage form is paste, emulsion or gel.

8. A method of using a pharmaceutical composition for treating cervical spondylosis, characterized in that, Includes the following steps: The pharmaceutical composition according to any one of claims 1 to 3 or the pharmaceutical composition obtained by the preparation method according to any one of claims 4 to 5 is mixed with pillow core excipients and then dried at low temperature to obtain a mixture. The mixture is placed in a gauze bag, and the cervical spine is then brought into contact with the gauze bag.

9. The method of use according to claim 8, characterized in that, The pillow filling material includes at least one of cassia seed powder, buckwheat hull powder, and chrysanthemum powder.

10. A method of using a traditional Chinese medicine preparation for treating cervical spondylosis, characterized in that, Includes the following steps: The traditional Chinese medicine preparation described in claim 6 is applied directly to the cervical spine. Alternatively, the traditional Chinese medicine preparation described in claim 6 can be applied to the surface of a wooden, stone, or plastic pillow, and the cervical spine can then come into contact with the medicated surface.

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