阅读说明：本技术 中药薜荔在制备椎间盘突出药物中的应用 (Application of traditional Chinese medicine Ficus pumila in preparation of medicament for treating intervertebral disc protrusion ) 是由 潘旭旺 庄让笑 黄劲松 刘寿荣 琚立萍 潘金明 姜晓杰 孙晶晶 童芬美 包剑锋 于 2021-11-22 设计创作，主要内容包括：本发明涉及中药技术领域,具体涉及中药薜荔在制备椎间盘突出药物中的应用。通过以中药薜荔作为治疗椎间盘突出等疾病的内服或外用制剂,能够有效利用薜荔不同部位的有效成分,对椎间盘突出等疾病的患者具有很好的疗效,且治疗非常快速,一般在作为内服制剂服用20天左右疼痛就能够得到大幅度的减轻,甚至消除。(The invention relates to the technical field of traditional Chinese medicines, in particular to application of a traditional Chinese medicine Ficus pumila in preparation of a medicament for treating herniated disk. The Ficus pumila can be used as an oral preparation or an external preparation for treating diseases such as intervertebral disc protrusion, can effectively utilize effective components of different parts of the Ficus pumila, has good curative effect on patients with diseases such as intervertebral disc protrusion, is very quick to treat, and can greatly relieve or even eliminate pain after being taken as the oral preparation for about 20 days.)

1. Application of Ficus pumila in preparing medicine for treating intervertebral disc prolapse is provided.

2. The application of the traditional Chinese medicine Ficus pumila in preparing the medicament for treating the intervertebral disc protrusion according to claim 1, wherein the intervertebral disc protrusion is the protrusion of cervical, thoracic or lumbar intervertebral discs.

3. The medicament for treating the herniated disk is characterized in that the effective component of the medicament for treating the herniated disk is Ficus pumila.

4. The medicament for treating disc herniation according to claim 3, wherein the disc herniation is cervical disc, thoracic disc or lumbar disc herniation.

5. The medicament for treating intervertebral disc herniation according to claim 3, wherein the Ficus pumila is one or a mixture of Ficus pumila fruits, Ficus pumila leaves, Ficus pumila stems and Ficus pumila roots.

6. The medicament for treating the intervertebral disc protrusion according to claim 3, further comprising an auxiliary material.

7. The medicament for treating the herniated disk, according to claim 6, wherein the auxiliary material is selected from one or more of a flavoring agent, a bacteriostatic agent, a plasticizer, a thickening agent, and a sweetening agent.

8. The medicament for treating the intervertebral disc protrusion according to claim 3, wherein the medicament for treating the intervertebral disc protrusion comprises an internal preparation and/or an external preparation.

9. The medicament for treating the intervertebral disc protrusion according to claim 8, wherein the oral preparation is a tablet, a pill, a capsule, a granule or a liquid preparation; the external preparation is a hot compress agent, a liniment, a film agent, a plaster or a spray.

10. A method of preparing a medicament for the treatment of a disc herniation as claimed in any one of claims 3-9, comprising:

freeze-drying Ficus pumila at low temperature, and pulverizing into powder to obtain medicine for treating prolapse of intervertebral disc; or the like, or, alternatively,

extracting Ficus pumila with solvent to obtain extractive solution, and further processing to obtain medicine for treating prolapse of intervertebral disc.

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to application of a traditional Chinese medicine Ficus pumila in preparation of a medicament for treating herniated disk.

Background

Ficus pumila (Ficus pumila) is a evergreen climbing or creeping plant of Ficus of Moraceae, also called Manglietia prostrata, Liangfen vine, Mesona chinensis, Gekko Swinhonis, Shilongteng, Shipinteng, Buxue king, cowherb seed and the like, is widely distributed in China and Japan, and is mainly distributed in provinces (regions) such as Hunan, Sichuan, Jiangxi, Guangxi, Guangdong, Hainan and the like in China.

The climbing fig is a plant used as both medicine and food, the root, stem, vine, leaf and fruit of the climbing fig can be used as medicine, the nature is flat, the taste is light, sour and slightly bitter, the climbing fig can enter liver, spleen and large intestine channels, the climbing fig has the efficacies of dispelling wind and removing dampness, promoting blood circulation and removing obstruction in channels, detoxifying and reducing swelling, tonifying kidney and securing essence, promoting blood circulation, promoting lactation and the like, and is mainly used for treating rheumatic arthralgia, sciatica, diarrhea, edema, urinary stranguria, amenorrhea, postpartum abdominal pain due to blood stasis, traumatic injury, sore throat, carbuncle sore and swollen sore, spermatorrhea, impotence, galactostasis and the like. The Ficus pumila as a medicinal plant is widely used in folks of China and has good effect. The inflorescence support (the lean fruit) can be processed into bean jelly for eating, and is a folk traditional good product for relieving summer heat.

Prolapse of intervertebral disc is one of the more common diseases of the spine in clinic. Mainly because each component of the intervertebral disc (nucleus pulposus, annulus fibrosus and cartilage plate), especially nucleus pulposus, is degenerated to different degrees, under the action of external factors, the annulus fibrosus of the intervertebral disc is ruptured, and nucleus pulposus tissues protrude (or are separated) from the ruptured part to the rear (side) side or vertebral canal, so that adjacent tissues such as spinal nerve root and spinal cord are stimulated or pressed, and a series of clinical symptoms such as neck, shoulder, waist and leg pain, numbness and the like are generated. The disease parts are divided into cervical intervertebral disc protrusion, thoracic intervertebral disc protrusion and lumbar intervertebral disc protrusion.

Wherein the lumbar intervertebral disc protrusion is a common clinical disease and frequently encountered disease, and seriously harms the physical and psychological health of patients. Relevant studies at home and abroad show that the incidence rate of the lumbar intervertebral disc protrusion is about 2-3%, while the incidence rate of men above 35 years old is about 4.8%, and women are about 2.5%. Common causes include degenerative changes, injuries, congenital abnormalities of the lumbosacral, genetic factors, and the like. The pathogenesis and mechanism of the lumbar intervertebral disc protrusion are very complex, each pathological stage can be the result of the combined action of one or more factors, and different factors can mutually deteriorate in different stages to aggravate the lumbar intervertebral disc protrusion, and the main pathogenesis of the lumbar intervertebral disc protrusion comprises intervertebral disc degeneration, mechanical stress injury, immune inflammation, extracellular matrix metabolic imbalance and the like.

The lumbar intervertebral disc protrusion is a common and frequently encountered orthopedic disease, the statistics of the incidence rate of the lumbar intervertebral disc protrusion is closely related to the age and the sex, the lumbar intervertebral disc protrusion is more likely to occur in people of 16-55 years old, and the proportion of men to women is about 2: 1. 95% of lumbar disc herniations occur at the levels of L4-L5 and L5-S1. Diagnosis, treatment and prevention of lumbar intervertebral disc protrusion are hot spots of domestic and foreign orthopedics field researches.

The main treatment methods of the lumbar intervertebral disc protrusion comprise general treatment, medicament treatment, minimally invasive treatment, surgical treatment, physical treatment and the like. The non-steroidal anti-inflammatory drugs are recommended in the first line of clinic, and comprise ibuprofen, celecoxib, etoricoxib and the like. The non-steroidal anti-inflammatory drugs mainly achieve the effects of diminishing inflammation and relieving pain, and can effectively relieve symptoms, but have obvious side effects, such as adverse reactions of digestive tracts, renal function damage and the like, and especially have potential cardiovascular and digestive tract bleeding risks after long-term use. Therefore, there is a need for a safe and effective drug for treating prolapse of intervertebral disc.

The Ficus pumila can be taken as an edible medicine and has high safety, however, based on the compatibility principle of traditional Chinese medicines, the Ficus pumila is mostly used by combining a plurality of traditional Chinese medicine components in clinic, and basically a single use mode is not adopted, and the application of the Ficus pumila in treating the intervertebral disc protrusion, especially the lumbar intervertebral disc protrusion, is not researched at present.

Disclosure of Invention

The invention aims to provide application of Ficus pumila in preparation of a medicament for treating intervertebral disc protrusion, and the single traditional Chinese medicine Ficus pumila is used as an internal or external preparation for treating the intervertebral disc protrusion.

In one technical scheme of the invention, the application of the ficus pumila in preparing the medicament for treating the herniated disk is disclosed.

Further, the disc herniation is cervical disc herniation, thoracic disc herniation or lumbar disc herniation.

According to the second technical scheme, the medicine for treating the intervertebral disc herniation comprises the effective component of the single traditional Chinese medicine Ficus pumila and does not contain other medicinal components.

Further, the disc herniation is cervical disc herniation, thoracic disc herniation or lumbar disc herniation.

Further, the Ficus pumila is one or more of Ficus pumila fruit, Ficus pumila leaf, Ficus pumila rattan and Ficus pumila root.

Further, the medicament for treating the intervertebral disc protrusion also comprises auxiliary materials.

Further, the auxiliary materials are selected from one or more of flavoring agents, bacteriostats, plasticizers, thickening agents and sweetening agents.

Further, the medicament for treating the intervertebral disc protrusion comprises an internal preparation and/or an external preparation.

Further, the oral preparation is a tablet, a pill, a capsule, a granule or a liquid preparation; the external preparation is a hot compress agent, a liniment, a film agent, a plaster or a spray.

In a third technical scheme of the present invention, the preparation method of the drug for treating the herniated disk comprises:

drying Ficus pumila at low temperature, and pulverizing into powder to obtain medicine for treating prolapse of intervertebral disc; or the like, or, alternatively,

extracting Ficus pumila with solvent to obtain extractive solution, and directly administering or further processing to obtain medicine for treating prolapse of intervertebral disc.

Further, the solvent is one or more of water, ethanol, ethyl acetate and n-butanol, and the extraction material-liquid ratio is 1 g: (5-20) mL.

Further, the method comprises the following steps:

(1) drying and crushing the climbing fig raw material, adding water or ethanol, heating, refluxing, extracting, filtering, repeatedly extracting for 1-5 times, and combining filtrates to obtain an extracting solution a;

(2) adding ethyl acetate and/or n-butanol into the extracting solution a, extracting and separating to obtain extracting solution b;

(3) rotary evaporation and concentration are carried out on the extract a and the extract b to obtain an extract a and an extract b;

(4) and (3) preparing the medicament for treating the intervertebral disc protrusion by using the extract a or the extract b as a raw material.

Furthermore, in the step (1), the ratio of the materials to the liquid is 1 g: (10-20) adding water into mL, soaking for 10-120min, and heating and extracting under reflux at 50-100 deg.C for 0.5-5 h;

further, in the step (2), adding ethyl acetate and/or n-butanol solvent, shaking, standing for layering, separating, repeating the above operation for 1-3 times, and mixing the extractive solutions.

Compared with the prior art, the invention has the beneficial effects that:

the traditional Chinese medicine Ficus pumila is taken as an oral or external preparation for treating diseases such as intervertebral disc herniation, the effective components of different parts of the Ficus pumila can be effectively utilized, the preparation has good curative effect on patients with the diseases such as intervertebral disc herniation, the treatment is very quick, the pain can be greatly relieved or even eliminated after the Ficus pumila is taken as the oral preparation for about 20 days generally, and the application of the Ficus pumila in treating the intervertebral disc herniation does not exist at present, so the preparation is a new application and has good prospect. Furthermore, the application of the ficus pumila alone in treating the herniated disk does not exist at present. The inventor finds that the single medicine of the Ficus pumila can play a good role in treating the herniated disk, which is different from the traditional Chinese medicine classic decoction such as aconite decoction, radix angelicae pubescentis parasitic decoction and other traditional Chinese medicine compound decoctions.

The traditional Chinese medicine Ficus pumila of the invention has good repairing effect on the protrusion of intervertebral disc, can quickly relieve various pain symptoms caused by the protrusion of intervertebral disc, has quite long-term effect, can have good treatment effect on the protrusion of intervertebral disc, especially on the protrusion of lumbar intervertebral disc, and has little side effect.

In the preferred preparation method of the medicine for treating the herniated disk, the raw materials are dried, crushed and then leached, so that the effective substance components in the Ficus pumila are fully released in the subsequent extraction process on the premise of fully retaining the effective substance components, in the leaching process, water or ethanol is firstly used as a solvent to extract the water-soluble raw materials in the Ficus pumila, and then different solvents are selected to further extract the leaching solution, so that the effective components of the Ficus pumila are fully dissolved, the drug effect is stronger, and the treatment effect on the herniated disk is better.

Detailed Description

Reference will now be made in detail to various exemplary embodiments of the invention, the detailed description should not be construed as limiting the invention but as a more detailed description of certain aspects, features and embodiments of the invention.

It is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. Further, for numerical ranges in this disclosure, it is understood that each intervening value, between the upper and lower limit of that range, is also specifically disclosed. Every smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in a stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although only preferred methods and materials are described herein, any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. All documents mentioned in this specification are incorporated by reference herein for the purpose of disclosing and describing the methods and/or materials associated with the documents. In case of conflict with any incorporated document, the present specification will control.

It will be apparent to those skilled in the art that various modifications and variations can be made in the specific embodiments of the present disclosure without departing from the scope or spirit of the disclosure. Other embodiments will be apparent to those skilled in the art from consideration of the specification. The description and examples are intended to be illustrative only.

As used herein, the terms "comprising," "including," "having," "containing," and the like are open-ended terms that mean including, but not limited to.

The fruits, leaves, stems and roots of the ficus pumila used in the embodiment of the invention are all traditional Chinese medicine decoction pieces supplied in the market. The purchased fruits, leaves, stems and roots of the Ficus pumila are respectively crushed to be below 800 meshes to obtain Ficus pumila fruit powder, Ficus pumila leaf powder, Ficus pumila stem powder and Ficus pumila root powder.

Example 1

15 parts of climbing fig fruit powder, 35 parts of climbing fig leaf powder, 32 parts of climbing fig stem powder and 18 parts of climbing fig root powder; the medicine powder for treating the intervertebral disc protrusion is prepared by uniformly mixing the raw materials, and is prepared into an external liniment by blending the medicine powder for treating the intervertebral disc protrusion with soybean oil.

Example 2

(1) Weighing the following raw materials in parts by mass: 15 parts of climbing fig fruit powder, 35 parts of climbing fig leaf powder, 32 parts of climbing fig stem powder and 18 parts of climbing fig root powder, and mixing to obtain mixed powder;

(2) mixing the powder and water in a ratio of 1 g: uniformly mixing 20mL of material-liquid ratio, heating and refluxing for extraction for 1.5h at 100 ℃, and filtering to obtain an extracting solution a;

(3) extracting the extract a with ethyl acetate for 3 times, separating and combining to obtain extract b;

(4) and (3) carrying out rotary evaporation and concentration on the extract liquid b to obtain an extract b, freeze-drying the extract b, and crushing to obtain the medicinal powder for treating the protrusion of the intervertebral disc, and blending the medicinal powder for treating the protrusion of the intervertebral disc with soybean oil to prepare the externally-used liniment.

Example 3

Using climbing fig stem powder and water, mixing the powder with water in a ratio of 1 g: mixing 20mL of the materials and the solution uniformly, heating and refluxing for extraction for 1.5h at 100 ℃, filtering to obtain an extracting solution a, and preparing the filtrate a into an oral liquid preparation or an external liniment.

Example 4

The difference from the example 2 is that the climbing fig vine stem powder is used as the raw material to prepare the medicament powder for treating the intervertebral disc protrusion;

example 5

The difference from example 2 is that the ficus pumila leaf powder is used as the raw material to prepare the medicinal powder for treating the herniated disk.

Example 6

The difference from the example 2 is that the stem powder of the climbing fig stem and the leaf powder of the climbing fig are mixed according to the mass ratio of 1:1 to prepare the medicament powder for treating the intervertebral disc protrusion.

Example 7

An oral liquid preparation or an external liniment is prepared by using only the ficus pumila fruit powder as a raw material by the method of example 3.

Example 8

An oral liquid preparation or an external liniment is prepared by using the ficus pumila leaf powder as a raw material and using the method in example 3.

Example 9

The stem powder of the climbing fig and the leaf powder of the climbing fig are mixed according to the mass ratio of 1:1 to be used as raw materials, and the method of the embodiment 3 is utilized to prepare the oral liquid preparation or the external liniment.

Example of Effect verification

Selecting 200 patients aged 50-65 years old with lumbar disc herniation in a clinical traditional Chinese medicine hospital, dividing into 10 groups, and treating 20 patients in each group according to the table 1; treatment was continued for 6 weeks.

Observation indexes are as follows: scoring is carried out. Two groups of patients were compared for post-treatment using Visual Analogue Scoring (VAS), with higher scores indicating more severe. ② grading lumbago. The lumbago changes before and after treatment were evaluated in two groups of patients using the Japanese Orthopaedic Association (JOA) lumbago rating scale, with higher scores indicating less lumbago symptoms. And thirdly, scoring the quality of life. Quality of life before and after treatment was assessed in both groups of patients using a concise health survey scale (SF-36), with higher scores indicating higher quality of life. Fourthly, the clinical curative effect.

The treatment effect evaluation standard is as follows: the pain in waist and lower extremities and positive signs disappear, the function returns to normal, and normal life and sleep can be realized; the effect is shown: the pain symptom is obviously relieved, the function is basically recovered to be normal, and the life and the sleep are slightly influenced; the method has the following advantages: the pain symptom is relieved, the function is improved, and the living sleep is influenced moderately; and (4) invalidation: the pain symptoms and physical signs do not obviously change before and after treatment, and the life and the sleep are seriously influenced. Total effective rate is (number of cure cases + number of significant cases + number of effective cases)/total number of cases × 100%.

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Data were processed using SPSS19.0 statistical software. The measurement data is expressed by mean number standard deviation (X gauss s) and a t test is adopted; the data of counts are expressed in cases (%) as X²And (6) checking. P<A difference of 0.05 is statistically significant.

TABLE 1 methods of treatment

As a result, the comparison of pain, lumbago and quality of life scores of the patients before treatment has no statistical significance (P is more than 0.05). The pain scores of the patients in each group after treatment were lower than those before treatment, wherein the differences between the groups 3, 4, 6 and 9 compared with the groups before treatment were statistically significant (P < 0.05), and the differences between the groups 3 and 4 compared with the control group were statistically significant (P < 0.05); the lumbago and the quality of life scores of the patients in each group are higher than those before treatment (P is less than 0.05), wherein the lumbago scores of the 3, 4, 6 and 9 groups have statistical significance (P is less than 0.05) compared with those before treatment, the quality of life scores of the 3 and 4 groups have statistical significance (P is less than 0.05) compared with those before treatment, and the lumbago and the quality of life scores of the 3 and 4 groups have statistical significance (P is less than 0.05) compared with those of the control group, and the results are shown in a table 2.

Compared with clinical curative effects, the total effective rates of the treatment group 3 and the treatment group 4 are respectively 95% (19/20) and 90% (18/20), which are both obviously higher than 60% (12/20) of the control group, the difference has statistical significance (P is less than 0.05), and the results are shown in Table 3.

The results show that the ficus pumila, particularly the rattan, for treating the lumbar intervertebral disc protrusion can obviously improve the pain, and the curative effect is obvious.

TABLE 2 comparison of treatment sessions and posttreatment sessions for two groups of patients with prolapse of lumbar intervertebral disc

Note: compared with the group before treatment,^*p is less than 0.05; compared with the control group after the treatment,^#P＜0.05。

TABLE 3 comparison of clinical curative effects of two groups of patients with prolapse of lumbar intervertebral disc

Note: compared with the control group, the compound of the formula,^#P＜0.05。

the above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention are intended to be included therein.