阅读说明：本技术 一种治疗颈椎病的药物组合物及其制备方法和应用 (Pharmaceutical composition for treating cervical spondylosis and preparation method and application thereof ) 是由 刘杰 张亚欣 郝红慧 陈克欣 江玉娟 许敏 高超 潘瑞雪 王莉 于 2020-08-06 设计创作，主要内容包括：本发明提供一种治疗颈椎病的药物组合物及其制备方法和应用,属于医药技术领域。所述药物组合物的活性成分包括如下两部分：(1)中药活性成分：按重量份计,由三七1-15份；川芎3-20份；延胡索2-15份；白芍3-20份；威灵仙4-25份；葛根3-20份；羌活4-25份的中药材制备而成；(2)西药活性成分：由重量比为1:1～4的左乙拉西坦和双氯芬酸钠组成。本发明是在中国专利CN1228071C的基础上开发的一种中西医结合药物,其对治疗颈椎病具有独特的疗效,且制备工艺简单,疗效显著,起效时间短,服用方便,无毒副作用,安全有效。(The invention provides a pharmaceutical composition for treating cervical spondylosis and a preparation method and application thereof, belonging to the technical field of medicines. The active ingredients of the pharmaceutical composition comprise the following two parts: (1) the active ingredients of the traditional Chinese medicine are as follows: 1-15 parts of pseudo-ginseng; 3-20 parts of ligusticum wallichii; 2-15 parts of corydalis tuber; 3-20 parts of white peony root; 4-25 parts of clematis root; 3-20 parts of kudzu roots; 4-25 parts of notopterygium root; (2) active ingredients of western medicines: the composition consists of levetiracetam and diclofenac sodium in a weight ratio of 1: 1-4. The invention is a Chinese and western medicine combined medicine developed on the basis of Chinese patent CN1228071C, has unique curative effect on treating cervical spondylosis, and has the advantages of simple preparation process, obvious curative effect, short acting time, convenient administration, no toxic or side effect, safety and effectiveness.)

1. The pharmaceutical composition for treating cervical spondylosis is characterized in that active ingredients of the pharmaceutical composition comprise the following two parts: (1) the active ingredients of the traditional Chinese medicine are as follows: 1-15 parts of pseudo-ginseng; 3-20 parts of ligusticum wallichii; 2-15 parts of corydalis tuber; 3-20 parts of white peony root; 4-25 parts of clematis root; 3-20 parts of kudzu roots; 4-25 parts of notopterygium root; (2) active ingredients of western medicines: the composition consists of levetiracetam and diclofenac sodium in a weight ratio of 1: 1-4.

2. The pharmaceutical composition for treating cervical spondylosis as set forth in claim 1,

the traditional Chinese medicine comprises the following components: based on the weight portion, the weight portion of the material,

2-10 parts of pseudo-ginseng, 5-15 parts of ligusticum wallichii, 3-10 parts of corydalis tuber

5-15 parts of white peony root, 8-20 parts of clematis root, 5-15 parts of kudzu vine root

8-20 parts of notopterygium root;

active ingredients of western medicines: the composition consists of levetiracetam and diclofenac sodium in a weight ratio of 1: 2-4.

3. The pharmaceutical composition for treating cervical spondylosis as set forth in claim 1,

the traditional Chinese medicine comprises the following components: based on the weight portion, the weight portion of the material,

2-3 parts of pseudo-ginseng, 7-8 parts of ligusticum wallichii, 5-6 parts of corydalis tuber

7-8 parts of radix paeoniae alba, 10-11 parts of radix clematidis, 7-8 parts of radix puerariae

10-11 parts of notopterygium root;

active ingredients of western medicines: the composition consists of levetiracetam and diclofenac sodium in a weight ratio of 1: 3-4.

4. The pharmaceutical composition for treating cervical spondylosis as set forth in claim 1,

the traditional Chinese medicine comprises the following components: based on the weight portion, the weight portion of the material,

2.5 parts of pseudo-ginseng, 7.5 parts of szechuan lovage rhizome and 5 parts of corydalis tuber

White peony root 7.5 parts clematis root 10 parts kudzuvine root 7.5 parts

10 parts of notopterygium root;

active ingredients of western medicines: consists of levetiracetam and diclofenac sodium in a weight ratio of 1: 3.

5. The method of preparing a pharmaceutical composition for the treatment of cervical spondylosis as claimed in any one of claims 1 to 4, wherein the method comprises the preparation of active ingredients of the Chinese herbal medicine, specifically:

(1) pulverizing Notoginseng radix into 100-120 mesh fine powder;

(2) extracting volatile oil from Notopterygii rhizoma and radix Clematidis, collecting the distilled water solution in another container, decocting the residue with water for 1 hr, and filtering to obtain filtrate;

(3) decocting radix Puerariae and radix Paeoniae alba with water twice (2 hr for the first time and 1 hr for the second time), mixing the filtrate with the above two water solutions, concentrating, precipitating with ethanol, recovering ethanol, and concentrating to obtain fluid extract with relative density of 1.25-1.30 at 50 deg.C;

(4) reflux-extracting rhizoma Ligustici Chuanxiong and rhizoma corydalis with ethanol, removing residue, recovering ethanol from the extractive solution, and concentrating to obtain fluid extract with relative density of 1.25-1.30 at 50 deg.C;

(5) mixing the above two fluid extracts, adding Notoginseng radix powder, mixing, drying, pulverizing into fine powder, adding appropriate amount of rhizoma Peucedani, mixing, and spraying the volatile oil of Notopterygii rhizoma and radix Clematidis.

6. Use of the pharmaceutical composition for the treatment of cervical spondylosis according to any one of claims 1 to 4 for the preparation of a pharmaceutical formulation for the treatment of cervical spondylosis.

7. A pharmaceutical preparation for treating cervical spondylosis, which is characterized by being prepared from the pharmaceutical composition of any one of claims 1 to 4 and pharmaceutically acceptable auxiliary materials.

8. The pharmaceutical preparation according to claim 7, wherein the pharmaceutical preparation is a decoction, a pill, a capsule, a tablet, a powder, a granule or an oral liquid.

9. The pharmaceutical formulation of claim 7, wherein the pharmaceutically acceptable excipient in the pharmaceutical formulation comprises one or more of a diluent, a filler, a disintegrant, a lubricant, a binder, a flow agent, a complex former, a plasticizer, a colorant, a sweetener, a viscosity enhancer, a preservative, or an antioxidant.

10. The pharmaceutical formulation of claim 9, wherein the diluent comprises sorbitol, mannitol, starch, lactose, powdered or microcrystalline cellulose, dicalcium phosphate, tricalcium phosphate, or sugar;

the filler comprises sodium carboxymethylcellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose or gelatinized starch;

the disintegrant comprises dry starch, crospovidone, croscarmellose sodium, sodium carboxymethyl starch or low-substituted hydroxypropyl cellulose;

the lubricant comprises magnesium stearate, sodium dodecyl sulfate or superfine silica gel powder.

Technical Field

The invention belongs to the technical field of medicines, and particularly relates to a pharmaceutical composition for treating cervical spondylosis and a preparation method and application thereof.

Background

The information in this background section is only for enhancement of understanding of the general background of the invention and is not necessarily to be construed as an admission or any form of suggestion that this information forms the prior art that is already known to a person of ordinary skill in the art.

Cervical spondylotic radiculopathy is a common and frequently encountered disease in orthopedics and traumatology, is also the most common type of cervical spondylosis, and accounts for about 60-70% of the incidence rate. The concept related to cervical spondylosis in the earliest modern medicine is mostly derived from cervical spondylotic radiculopathy, which not only has high morbidity, but also is frequently recurrent and difficult to cure, seriously affects physical and mental health of patients, brings inconvenience to work, study and daily life of the patients, and causes other series of diseases for some patients.

Cervical spondylotic radiculopathy (blood stasis, qi stagnation and venation block) is caused by mechanical compression and chemical stimulation of nerve roots to produce congestion, edema and inflammatory reaction on the basis of intervertebral foramina stenosis, and is the category of arthralgia syndrome in traditional Chinese medicine. The etiology can be: 1. injuries caused by external force, including acute injuries and chronic strains; 2. the six exogenous pathogenic factors averse qi, wind cold dampness and evil damage, which leads to the failure of qi to circulate, failure of blood to circulate, qi and blood obstruction, failure of the tendon and vessel to warm, qi stagnation and blood stasis; 3. deficiency of the liver and kidney, congenital deficiency, the kidney governing bones, the liver governing tendons, and deficiency of the liver and kidney, the development of bones will generate deformation and abnormality of internal structure, and slight fatigue and injury will cause stagnation of qi and blood and pain. Clinically, the pain, stiffness or scurrying and scurrying of the neck, the shoulder and the upper limb are manifested as pain, fixed pain, tenderness of the pain, great pain for patients, and urgent treatment to relieve the pain as soon as possible.

The applicant filed and granted 'a medicament for treating cervical spondylosis and a preparation method thereof' (CN1228071C) in the previous period, and discloses a medicament for treating cervical spondylosis, which comprises the following components in parts by weight: 1-15 parts of pseudo-ginseng; 3-20 parts of ligusticum wallichii; 2-15 parts of corydalis tuber; 3-20 parts of white peony root; 4-25 parts of clematis root; 3-20 parts of kudzu roots; 4-25 parts of notopterygium root, for treating cervical spondylosis due to blood stasis, qi stagnation and obstruction of vessels. Products based on the patent technology are already on the market and named as 'neck pain granules' and other series products. Through clinical verification for many years, the traditional Chinese medicine composition has good curative effect on various cervical spondylosis such as nerve root type cervical spondylosis, vertebral artery type cervical spondylosis, spinal cord type cervical spondylosis, sympathetic type cervical spondylosis and mixed type cervical spondylosis, and particularly has outstanding curative effect on the nerve root type cervical spondylosis, so the traditional Chinese medicine composition is popular to patients. However, the traditional Chinese medicine compound has the problems of slow effect, long treatment course and the like in the treatment of cervical spondylosis, and western medicines have strong dependence and are often accompanied by strong toxic and side effects, so that the research of a traditional Chinese medicine and western medicine combined medicine for treating cervical spondylosis becomes one of important subjects of people research.

Disclosure of Invention

Aiming at the defects of the prior art, the invention provides a pharmaceutical composition for treating cervical spondylosis and a preparation method and application thereof. The invention is a Chinese and western medicine combined medicine developed on the basis of Chinese patent CN1228071C, has unique curative effect on treating cervical spondylosis, and has the advantages of simple preparation process, obvious curative effect, short acting time, convenient administration, no toxic or side effect, safety and effectiveness.

In order to achieve the purpose, the invention relates to the following technical scheme:

in a first aspect of the present invention, there is provided a pharmaceutical composition for treating cervical spondylosis, wherein the active ingredients of the pharmaceutical composition comprise the following two parts:

(1) the active ingredients of the traditional Chinese medicine are as follows: in parts by weight, is prepared from

1-15 parts of pseudo-ginseng, 3-20 parts of ligusticum wallichii, 2-15 parts of corydalis tuber

3-20 parts of radix paeoniae alba, 4-25 parts of radix clematidis, 3-20 parts of radix puerariae

4-25 parts of notopterygium root.

(2) Active ingredients of western medicines: the composition consists of levetiracetam and diclofenac sodium in a weight ratio of 1: 1-4.

In a second aspect of the present invention, there is provided a method for preparing the above pharmaceutical composition for treating cervical spondylosis, the method comprising preparing active ingredients of traditional Chinese medicines, specifically:

(1) pulverizing Notoginseng radix into 100-120 mesh fine powder;

(2) extracting volatile oil from Notopterygii rhizoma and radix Clematidis, collecting the distilled water solution in another container, decocting the residue with water for 1 hr, and filtering to obtain filtrate;

(3) decocting radix Puerariae and radix Paeoniae alba with water twice (2 hr for the first time and 1 hr for the second time), mixing the filtrate with the above two water solutions, concentrating, precipitating with ethanol, recovering ethanol, and concentrating to obtain fluid extract with relative density of 1.25-1.30 at 50 deg.C;

(4) reflux-extracting rhizoma Ligustici Chuanxiong and rhizoma corydalis with ethanol, removing residue, recovering ethanol from the extractive solution, and concentrating to obtain fluid extract with relative density of 1.25-1.30 at 50 deg.C;

(5) mixing the above two fluid extracts, adding Notoginseng radix powder, mixing, drying, pulverizing into fine powder, adding appropriate amount of rhizoma Peucedani, mixing, and spraying the volatile oil of Notopterygii rhizoma and radix Clematidis.

In a third aspect of the present invention, an application of the above pharmaceutical composition for treating cervical spondylosis in preparing a pharmaceutical preparation for treating cervical spondylosis is provided.

In a fourth aspect of the invention, a pharmaceutical preparation for treating cervical spondylosis is provided, which is prepared from the pharmaceutical composition and pharmaceutically acceptable auxiliary materials.

The medicinal preparation can be prepared into various medicinal dosage forms, such as decoction, pills, capsules, tablets, powder, granules or oral liquid.

The beneficial technical effects of one or more technical schemes are as follows:

the technical scheme is a Chinese and western medicine combined medicine developed on the basis of Chinese patent CN1228071C, which overcomes the defect of slow effect of the traditional Chinese medicine composition, overcomes the toxic and side effects of western medicine components, is convenient to take, safe and effective, and has good values of practical application and popularization.

Detailed Description

It is to be understood that the following detailed description is exemplary and is intended to provide further explanation of the invention as claimed. 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.

It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of exemplary embodiments according to the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof, unless the context clearly indicates otherwise. It is to be understood that the scope of the invention is not to be limited to the specific embodiments described below; it is also to be understood that the terminology used in the examples is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention.

As mentioned above, the traditional Chinese medicine compound has the problems of slow effect, long treatment course and the like in the treatment of cervical spondylosis, and the western medicine has strong dependence and is often accompanied by strong toxic and side effects, so that the research of the traditional Chinese medicine and western medicine combined medicine for treating cervical spondylosis becomes one of the important subjects of people research.

In view of the above, in one embodiment of the present invention, a pharmaceutical composition for treating cervical spondylosis is provided, wherein the active ingredients of the pharmaceutical composition comprise the following two parts:

(1) the active ingredients of the traditional Chinese medicine are as follows: in parts by weight, is prepared from

1-15 parts of pseudo-ginseng, 3-20 parts of ligusticum wallichii, 2-15 parts of corydalis tuber

3-20 parts of radix paeoniae alba, 4-25 parts of radix clematidis, 3-20 parts of radix puerariae

4-25 parts of notopterygium root.

Wherein Notoginseng radix, rhizoma Ligustici Chuanxiong, and rhizoma corydalis have effects of promoting blood circulation, activating qi-flowing, removing blood stasis, and dredging collaterals; notopterygii rhizoma, radix Clematidis and radix Puerariae have effects of dispelling pathogenic wind, cold and dampness, and relieving neck rigidity; white peony root, radix Paeoniae alba, with its main effects of nourishing blood, softening yin, nourishing tendons and vessels, promoting blood circulation, removing blood stasis, promoting the circulation of qi and relieving pain.

(2) Active ingredients of western medicines: the composition consists of levetiracetam and diclofenac sodium in a weight ratio of 1: 1-4.

The levetiracetam is chemically named as (S) -alpha-ethyl-2-oxo-1-pyrrolidine acetamide, is a selective 5-hydroxytryptamine reabsorption inhibitor, is mainly used as an antiepileptic drug at present, and is used for the additional treatment of partial seizures of adult and children over 4 years old epileptics.

Diclofenac sodium is chemically named as 2- (2, 6-dichlorophenyl) aminophenylsodium acetate, is currently used as an anti-inflammatory analgesic, and mainly achieves the anti-inflammatory analgesic effect by inhibiting cyclooxygenase to reduce synthesis of prostaglandin. It can be used for acute joint inflammation and gout attack, chronic joint inflammation, rheumatoid arthritis, other inflammatory rheumatic diseases of ankylosing spine joint and spine, pain related to degenerative diseases of joint and spine, soft tissue rheumatism, swelling pain or inflammation after trauma or surgery, treating dysmenorrhea and postoperative pain and inflammation caused by plastic, dental surgery or other minor surgical operations.

A large amount of experimental researches discover that when diclofenac sodium and the traditional Chinese medicine active ingredient of the application are jointly used, the effect is faster, the treatment effect is also improved, but the cardiovascular toxicity effect can be increased when the diclofenac sodium and the traditional Chinese medicine active ingredient are jointly used, levetiracetam is not used alone, the effect of treating cervical spondylosis is obviously achieved, when the levetiracetam is jointly used with the traditional Chinese medicine active ingredient and the diclofenac sodium, the cardiovascular toxicity effect generated by the medicine can be inhibited, meanwhile, the treatment effect of the cervical spondylosis is also improved to a certain extent, and the traditional Chinese medicine and western medicine combined medicine of the application has good treatment effect and safety on the cervical spondylosis.

In yet another embodiment of the present invention,

the traditional Chinese medicine comprises the following components: based on the weight portion, the weight portion of the material,

2-10 parts of pseudo-ginseng, 5-15 parts of ligusticum wallichii, 3-10 parts of corydalis tuber

5-15 parts of white peony root, 8-20 parts of clematis root, 5-15 parts of kudzu vine root

And 8-20 parts of notopterygium root.

Active ingredients of western medicines: the composition consists of levetiracetam and diclofenac sodium in a weight ratio of 1: 2-4.

In yet another embodiment of the present invention,

the traditional Chinese medicine comprises the following components: based on the weight portion, the weight portion of the material,

2-3 parts of pseudo-ginseng, 7-8 parts of ligusticum wallichii, 5-6 parts of corydalis tuber

7-8 parts of radix paeoniae alba, 10-11 parts of radix clematidis, 7-8 parts of radix puerariae

10-11 parts of notopterygium root.

Active ingredients of western medicines: the composition consists of levetiracetam and diclofenac sodium in a weight ratio of 1: 3-4.

In yet another embodiment of the present invention,

the traditional Chinese medicine comprises the following components: based on the weight portion, the weight portion of the material,

2.5 parts of pseudo-ginseng, 7.5 parts of szechuan lovage rhizome and 5 parts of corydalis tuber

White peony root 7.5 parts clematis root 10 parts kudzuvine root 7.5 parts

10 parts of notopterygium root;

active ingredients of western medicines: consists of levetiracetam and diclofenac sodium in a weight ratio of 1: 3.

In another embodiment of the present invention, a method for preparing the pharmaceutical composition for treating cervical spondylosis is provided, wherein the method comprises the steps of preparing active ingredients of traditional Chinese medicines, specifically:

(1) pulverizing Notoginseng radix into 100-120 mesh fine powder;

(2) extracting volatile oil from Notopterygii rhizoma and radix Clematidis, collecting the distilled water solution in another container, decocting the residue with water for 1 hr, and filtering to obtain filtrate;

(3) decocting radix Puerariae and radix Paeoniae alba with water twice (2 hr for the first time and 1 hr for the second time), mixing the filtrate with the above two water solutions, concentrating, precipitating with ethanol, recovering ethanol, and concentrating to obtain fluid extract with relative density of 1.25-1.30 at 50 deg.C;

(4) reflux-extracting rhizoma Ligustici Chuanxiong and rhizoma corydalis with ethanol, removing residue, recovering ethanol from the extractive solution, and concentrating to obtain fluid extract with relative density of 1.25-1.30 at 50 deg.C;

(5) mixing the above two fluid extracts, adding Notoginseng radix powder, mixing, drying, pulverizing into fine powder, adding appropriate amount of rhizoma Peucedani, mixing, and spraying the volatile oil of Notopterygii rhizoma and radix Clematidis.

In another embodiment of the present invention, the present invention provides an application of the pharmaceutical composition for treating cervical spondylosis in preparing a pharmaceutical preparation for treating cervical spondylosis.

In another embodiment of the present invention, a pharmaceutical preparation for treating cervical spondylosis is provided, which is prepared from the pharmaceutical composition and pharmaceutically acceptable excipients.

The medicinal preparation can be prepared into various medicinal dosage forms, such as decoction, pills, capsules, tablets, powder, granules or oral liquid.

Pharmaceutically acceptable excipients in the pharmaceutical formulation include, but are not limited to: diluents include, but are not limited to, sorbitol, mannitol, starch, lactose, powdered or microcrystalline cellulose, dicalcium phosphate, tricalcium phosphate, sugars, and the like; filling agent: sodium carboxymethylcellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose, gelatinized starch, and the like; disintegrating agent: dry starch, crospovidone, croscarmellose sodium, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, and the like; lubricant: magnesium stearate, sodium lauryl sulfate or aerosil; other adjuvants include one or more of binding agent, flowing agent, composite forming agent, plasticizer, colorant, sweetener, viscosity enhancer, preservative or antioxidant.

The invention is further illustrated by the following examples, which are not to be construed as limiting the invention thereto. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention.