CN115212251A

CN115212251A - Medicine for treating cervical spondylosis by using caulis sinomenii extract and preparation method thereof

Info

Publication number: CN115212251A
Application number: CN202210768436.XA
Authority: CN
Inventors: 丁宇; 王蕊蕊; 刘凤乐; 陈忻宇; 孙冉; 罗成斌; 段晋; 李发丽; 董必文; 李妍; 赵春梅; 王静; 杨美怡; 刘颖; 杨字花; 李晓龙; 杨赵松; 张梅
Original assignee: Dali Bai Autonomous Prefecture Hospital Of Traditional Chinese Medicine
Current assignee: Dali Bai Autonomous Prefecture Hospital Of Traditional Chinese Medicine
Priority date: 2022-06-30
Filing date: 2022-06-30
Publication date: 2022-10-21

Abstract

The invention discloses a medicine for treating cervical spondylosis by using a caulis sinomenii extract and a preparation method thereof, wherein the medicine comprises the following medicinal components: concentrated liquid medicine, PEG6000, PEG4000 and Tween-80, wherein the concentrated liquid medicine is a mixed extracting solution of caulis sinomenii and dactylicapnos root. Mixing caulis sinomenii with the dactylicapnos root 1, decocting with water to obtain concentrated liquid medicine, mixing the concentrated liquid medicine, PEG6000, PEG4000 and Tween-80, putting the mixture into a water bath at 80 ℃ for heat preservation until the mixture is completely dissolved, coating light paraffin oil in the mold, pouring the two solutions into the mold, standing the mold at normal temperature for about 3 hours, putting the mold into the water bath for about 30 seconds to melt the paraffin oil, and removing the medicine from the mold. The invention can greatly reduce the economic cost and lighten the economic burden of patients through the purified and concentrated caulis sinomenii extract and the treatment effect of cervical spondylosis.

Description

Medicine for treating cervical spondylosis by using caulis sinomenii extract and preparation method thereof

Technical Field

The invention relates to the technical field of medicines, and in particular relates to a medicine for treating cervical spondylosis by using a caulis sinomenii extract and a preparation method thereof.

Background

With the development of modern society, the popularization of computers and smart phones leads to changes of office environments, and the working posture of the desk is kept for a long time, so that the muscles of the back of the neck are often in a tense state without proper rest, ischemia is caused, soft tissue spasm even leads to local soft tissue adhesion or aseptic inflammation, a series of symptoms or physical signs such as plate stagnation, pain and discomfort of the back of the neck are further caused, the cervical spondylosis is clinically called as cervical spondylosis, and the cervical spondylosis mainly involves the muscle group of the back of the neck. Epidemiological investigation shows that the prevalence rate of cervical spondylosis in China is 9.57%, the diagnosis rate of the cervical spondylosis is gradually increased in recent years, and the onset age has an obvious aging trend. Research shows that cervical spondylosis can cause extensive tenderness and muscle stiffness and stagnation in the neck and back region of a patient clinically, and seriously affects the daily life and work of the patient.

The treatment methods of cervical spondylosis are various, and physical therapy, motion therapy, drug therapy and acupuncture and massage therapy methods are mainly adopted. Commonly used physical therapies include: TDP irradiation, extracorporeal shock wave therapy, ultrashort wave therapy, and the like. The commonly used drug therapy mainly comprises non-steroidal anti-inflammatory analgesic drugs, local drug injection, external plaster ointment, ozone therapy, oral administration of traditional Chinese medicines and the like.

In clinical departments of traditional Chinese medicine, on the basis of a percutaneous iontophoresis technology, the characteristics of channels and collaterals and a meridian-tendon system are combined, and the effect of the therapy is further enhanced. The Chinese medicine iontophoresis through meridian points has unique advantages in the aspects of detumescence, pain relief, adhesion elimination and the like, so the Chinese medicine percutaneous iontophoresis technology is widely applied to soft tissue injury. Currently, the most common clinical medicine is zhengqing fengtongning injection, however, the zhengqing fengtongning injection is used for iontophoresis, and is high in price, so that the economic burden of patients is increased.

Disclosure of Invention

The invention aims to provide a medicine for treating cervical spondylosis by using a caulis sinomenii extract and a preparation method thereof.

The technical purpose of the invention is realized by the following technical scheme:

a medicine of caulis Sinomenii extract for treating cervical syndrome comprises the following medicinal components: concentrated liquid medicine, PEG6000, PEG4000 and Tween-80, wherein the concentrated liquid medicine is a mixed extracting solution of caulis sinomenii and dactylicapnos root.

Preferably, the concentrated liquid medicine is prepared by mixing and extracting the caulis sinomenii and the dactylicapnos root 1.

Further preferably, the pharmaceutical composition comprises: 1-1.5 parts of concentrated liquid medicine, 0.5-4.5 parts of PEG6000, 0.5-4 parts of PEG4000 and 0.2-0.3 part of Tween-80.

Further preferably, the pharmaceutical composition comprises: 1.01 parts of concentrated liquid medicine, 4.04 parts of PEG6000, 1.01 parts of PEG4000 and 0.25 part of Tween-80.

Further preferably, the pharmaceutical composition comprises: 1.01 parts of concentrated liquid medicine, 0.5 parts of PEG6000, 3.5 parts of PEG4000 and 0.25 part of Tween-80.

The invention also discloses a preparation method of the medicine for treating cervical spondylosis by using the caulis sinomenii extract, which comprises the steps of mixing caulis sinomenii with the dactylicapnos 1 by adopting water decoction to extract concentrated liquid medicine, mixing the concentrated liquid medicine, PEG6000, PEG4000 and Tween-80, putting the mixture into a water bath at 80 ℃ for heat preservation until the concentrated liquid medicine is completely dissolved, coating light paraffin oil in a mold, pouring the solution into the mold, standing the mold at normal temperature for about 3 hours, putting the mold into the water bath for about 30 seconds to melt the paraffin oil, and removing the medicine from the mold.

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

firstly, the purified and concentrated caulis sinomenii extract has good treatment effect on cervical spondylosis, and the treatment effect on the cervical spondylosis and the effect of relieving the pain of the cervical spondylosis are both superior to those of Zhengqing Fengtongning, so that the economic cost can be greatly reduced, and the economic burden of a patient can be alleviated;

secondly, PEG6000 and PEG4000 are water-soluble matrixes and are used in medicines, so that the polymerization degree and the melting point of the medicines are improved;

and thirdly, the Tween-80 is used in the medicine, so that the hydrophilicity of the water-soluble matrix is increased, and the solubilization effect is realized.

Detailed Description

In order to make the technical solutions of the present invention better understood, the present invention is further described in detail with reference to the following examples. It will be appreciated by those skilled in the art that the following examples are illustrative of the invention only and should not be taken as limiting the scope of the invention.

Example 1

A medicine of caulis sinomenii extract for treating cervical spondylosis comprises the following medicinal components: 1.01g of concentrated liquid medicine, 4.04g of PEG6000, 4000.01 g of PEG, and 0.25g of Tween-80, wherein the concentrated liquid medicine is a mixed extracting solution of caulis sinomenii and dactylicapnos root, and the concentrated liquid medicine is prepared by mixing and extracting the caulis sinomenii and the dactylicapnos root 1.

A preparation method of a medicine for treating cervical spondylosis by using a caulis sinomenii extract comprises the steps of mixing caulis sinomenii with the dactylicapnos scandens 1. The medicine is cylindrical, and the size of the medicine is 10mm in diameter and 34mm in length.

Example 2

A medicine of caulis Sinomenii extract for treating cervical syndrome comprises the following medicinal components: 1.01g of concentrated liquid medicine, 0.5g of PEG6000, 4000.5 g of PEG and 0.25g of Tween-80, wherein the concentrated liquid medicine is a mixed extracting solution of caulis sinomenii and dactylicapnos root, and the concentrated liquid medicine is prepared by mixing and extracting the caulis sinomenii and the dactylicapnos root 1.

A preparation method of a medicine for treating cervical spondylosis by using a caulis sinomenii extract comprises the steps of mixing caulis sinomenii with the dactylicapnos scandens 1. The medicine is cylindrical, and the size of the medicine is 10mm in diameter and 39mm in length.

Clinical trial

1. Source of cases

The patients with cervical spondylotic radiculopathy are treated by an outpatient clinic of acupuncture and moxibustion.

2. Instrumentation apparatus

Chinese medicine ion introduction therapeutic equipment (2 tables).

Clinical trial criteria

1. Diagnostic standard of traditional Chinese medicine

The method is formulated according to the standard of curative effect of diagnosis of traditional Chinese medicine symptoms:

(1) Has medical history of long-term strain, trauma and the like.

(2) The disease is more common to middle-aged people, and the disease is chronic when the people work for a long time and watch TV.

(3) Has three main symptoms of pain, numbness and dizziness.

(4) The neck has limited movement function, and the neck and the scapula are often painful or touch cord-like induration.

2. Standard of Western diagnosis

(1) Has more typical root symptoms such as numbness and pain, the range of pain and numbness is consistent with the area dominated by cervical and spinal nerves, and the symptoms of vertebral artery blood supply insufficiency such as headache, dizziness, tinnitus, amnesia, blurred vision and the like are accompanied.

(2) Sensory decline of the area of the skin where the compressed nerve root is located, weakened tendon reflex, weakened muscle strength, muscular atrophy, positive cervical rotation test, and positive indenter test or brachial plexus traction test.

(3) Imaging examination: the X-ray positive plate can cause the hyperplasia of the uncinate vertebra joint, the lateral position shows that the physiological curvature of the cervical vertebra becomes straight, the intervertebral space is narrow and is formed by hyperplasia or calcification, and the oblique plate can show that the intervertebral foramen becomes small. CT or MRI examination may reveal an asymmetry in the size of the left and right transverse foramen, with one side being relatively narrow or diseased.

(4) For vertebral artery angiography or digital subtraction vertebral artery angiography (DSA), which has been altered by vertebral artery thinning, tortuosity or complete obstruction, TCD shows that the vertebral-basal arterial blood flow velocity is slowed.

3. Test inclusion criteria

(1) Meets the above Western and Chinese medicine diagnosis standards, and has complete relevant clinical data and auxiliary examination data.

(2) The age is 20-70 years old, and can be treated by the treatment group or the control group and can adhere to the patients according to the planned treatment course.

(3) Complete consent and acceptance of relevant requirements of the clinical study, and consent to sign an informed consent form.

4. Test exclusion criteria

(1) Those who do not meet the inclusion criteria for cervical spondylotic radiculopathy.

(2) Combined with other serious cardiopulmonary diseases, malignant tumor, mental nerve, cerebrovascular diseases, etc., and allergic constitution.

(3) The affected part of the skin is infected or the deep part is swollen.

(4) Those with history of cervical spine surgery and congenital malformation.

(5) Severe skin lesions or skin diseases in the neck.

(6) Hemophilia or thrombocytopenic purple paralysis or those prone to bleeding.

(7) Other systemic diseases in the acute phase, accompanied by abnormal hemogram or fever.

(8) The compliance is poor, and the study staff can not be matched.

5. Rejection and shedding criteria

(1) Those who fail to meet the inclusion criteria are mistakenly included.

(2) Although the standard of inclusion is met, the patients have not been treated according to the test protocol.

(3) In the test process, the compliance of the test subject is poor, and the effectiveness evaluator is influenced.

(4) Severe adverse events, complications and specific physiological changes occurred, and subjects were not eligible for continued exposure.

(5) Cases that were withdrawn from the trial, missed visits or died due to other various reasons.

(6) Incomplete data will affect the validity judgment.

(7) The person who quits is required by self or relatives in the test process.

Experimental method

1. Case grouping

The experiment adopts a small sample amount, and 36 samples are taken in each group, and the total number is 108. The test adopts completely random design, 108 patients are randomly and evenly divided into three groups, the groups are numbered according to the treatment sequence of the patients, and the groups are randomly divided into a caulis sinomenii extract group (experimental group), a Zhengqing Fengtongning group (control group) and a 0.9% physiological saline group (blank group) by utilizing a random number table. Before treatment, the gender, age, disease course, symptom score and sign score of the treatment group, the control group and the blank group are subjected to statistical analysis.

2. Method of treatment

Three groups all adopt an acupuncture-moxibustion one-department percutaneous medicine ion introduction instrument, an experimental group adopts medicine penetrating of the caulis sinomenii extract, 4ml of liquid medicine is soaked in two electrode gauze pads, two electrodes are respectively placed at Tianzong and Quyuan acupoints on two sides, and bandages are fixed. The time is 20 min/time, and the intensity is determined by the pain sensation which can be endured by the patient. The control group is the same as the experimental group, and the medicine adopts 4ml of Zhengqing Fengtongning injection. The blank group is the same as the experimental group, and 4ml of 0.9% sodium chloride injection is adopted as the medicine. The treatment course of the scheme is as follows: the preparation is administered once daily, 10 times as a treatment course, and 2 treatment courses are total.

3. Criteria for efficacy assessment

3.1 according to the reference symptom grading quantization table, the judgment standard of Jingjijiu cervical radiculopathy treatment achievement in Tianzhong and the 11-point pain degree digital grade scale (NRS-11), the cervical spondylosis symptom and sign score are formulated. All symptoms and signs of the patients are observed, and the symptom score and the sign score of the same patient before and after treatment are recorded respectively. The treatment method, the treatment course and the change of the curative effect of the patient are carefully observed and recorded.

(1) Symptom score standard (score 25)

Neck-shoulder upper limb pain:

and (3) severe degree: severe pain, severe impact on learning and daily life, counted 10 points

Severe pain, inability to take care of oneself, severe impact on work, study and daily life, 7-9 points

Medium: moderate pain, affecting work but being able to live for 4-6 points

Mild: mild pain still can be treated with normal activities by 1-3 points, 0 point is painless

Numbness of upper limbs:

and (3) severe degree: the feeling of numbness, persistent unabated or unabated is counted for 3 points

Medium: numbness is intermittent, usually occurs during sleep or early morning, and can be relieved by 2 points

Mild: even with numb, quickly relieved by 1 point and no numbness by 0 point

Vertigo:

(1) characterised by the degree of division

And (3) severe degree: severe vertigo, almost unbearable vertigo, and 4 minutes in bed, severe vertigo, extreme difficulty, difficulty in walking, and 3 minutes in supporting or sitting

Medium: moderate vertigo, discomfort and walkability 2 points

Mild: mild vertigo, standing, normal walking with score of 1 and no symptom at score of 0

(2) Characterised by the frequency

And (3) severe degree: the weight is 4 points for 1 time per day and 3 points for 1 time per day

Medium: 2 points are counted 1 time per week

Mild: the number of the medicine is 1 point about 1 time per month, and 0 point is asymptomatic

(3) Characterised by the duration

And (3) severe degree: 4 minutes for 1 day or more and 3 minutes for several hours

Medium: from a few minutes to 1 hour and 2 minutes

Mild: from a few seconds to several minutes, 1 point, 0 point is asymptomatic

(2) Sign integration standard (15 points)

Tenderness of neck

And (2) the severity: tenderness with withdrawal 3 points

Medium: the expression meter for 2 points of tenderness accompanied with pain

Mild: the tenderness meter is 1 point, and the tenderness meter is 0 point, i.e. no tenderness

Sensory disturbance of upper limbs, 0 is no, 1 is mild decline, and 2 is obvious decline

Upper limb muscle strength: 0 is no obvious abnormality (muscle strength V grade), 1 is mild weakening (muscle strength IV grade),

2 is divided into obvious weakening (muscle strength 0-III)

Tendon reflex: 0 is no obvious abnormality, 1 is weakened, 2 is disappeared

Brachial plexus traction test: 0 is negative, 2 is positive

Foramen intervertebrale compression test: 0 is negative, 2 is positive

And (3) a posture vertigo test: 0 is negative; 2 is classified as positive

3.2 pain intensity Scoring referring to Visual Analog Scale (VAS) scoring method (instant Scale method) under the supervision of the pain society of the Chinese medical society, two ends (0-10) of a scale with a length of 10cm are used, each 1cm represents 1 point, 0 point represents no pain, 10 points represents severe pain, and the best point and the worst point respectively are represented. The patient faced the non-graduated side, indicated the site most representative of the pain level at that time, and the doctor faced the graduated side, recorded the pain level, and read the score.

(0 is no pain, 1 to 3 are mild pain, 4 to 7 are moderate pain, and 8 to 10 are severe pain.

And (3) normal: VAS is 0, no pain occurs in rest and activity, and the score is 0;

mild: VAS is 1-3, no pain is caused when the patient is at rest, and slight pain is caused during daily activities, which is 1 point;

medium: VAS is 4-7, pain is slight when resting, and pain is aggravated when daily activities, which is 2 points;

and (3) severe degree: VAS is 8-10, and pain is severe in rest or daily activities, 3 points.

3.3 Objective Observation index

The changes in imaging and TCD before and after treatment of two groups of patients were observed and the changes in imaging and TCD were evaluated

Auxiliary means for treating diseases.

3.4 evaluation of clinical efficacy

According to the efficacy assessment method of 'the standard of efficacy of diagnosis of traditional Chinese medicine diseases' published by the State administration of traditional Chinese medicine in 1995, the traditional Chinese medicine is divided into four grades of clinical cure, obvious effect, effectiveness and ineffectiveness.

Calculating the curative effect index of each item of pain, symptom and physical sign according to a nimodipine grading method: [ (pre-treatment score-post-treatment score)/pre-treatment score ] × 100%. The average of these three terms was then evaluated for overall efficacy to assess clinical efficacy:

and (3) clinical recovery: the symptoms disappear completely, the functional activities return to normal, and the score is improved by 96 to 100 percent;

the effect is shown: the main symptoms are relieved or disappeared, the functional activities are basically recovered, the normal work can be participated, and the score is improved by 75 to 95 percent;

the method has the following advantages: the main symptoms are partially relieved or disappeared, the functional activities are improved, the light work can be participated, and the score is improved by 30-74 percent;

and (4) invalidation: score improvement was less than 30% compared to pre-treatment.

4. Evaluation of safety

Safety can be divided into four levels depending on adverse events that occur during treatment

First-stage: safe and has no adverse reaction.

And (2) second stage: is safe, has mild adverse reaction, and can continue treatment without any treatment.

Third-stage: has safety problem and mild adverse reaction, and the adverse reaction can disappear after stopping treatment.

And (4) fourth stage: unsafe, stopping treatment due to serious adverse reaction.

Clinical efficacy observation data

All data were analyzed using SPSS21.0 statistical software, and rank-sum testing was used for non-normal distribution metrology data and grade data. The difference was statistically significant at the test level α =0.05, p < 0.05.

1. Evaluation of clinical efficacy

TABLE 1 comparison between the post-treatment clinical efficacy evaluation groups of the three groups

Note: * The differences were statistically significant when compared between the three groups after treatment, with P < 0.05.

TABLE 2 comparison between clinical efficacy evaluation groups of Zhengqingfeng group and caulis Sinomenii group after treatment

Note: compared between the two groups after treatment, P is more than 0.05, and the difference is not statistically significant.

Referring to tables 1-2, the research results show that the clinical efficacy of the three groups after treatment is different, and the clinical efficacy of the positive-blowing wind group and the caulis sinomenii group is obviously higher than that of the blank group; and the caulis sinomenii group has the best effect, so that the effect of the caulis sinomenii extract on treating cervical spondylosis is better than that of zheng qing feng tongning.

2. Pain intensity score

TABLE 3 Pre-and post-treatment VAS pain score comparison in groups of three groups

Note: * The three groups were compared in the pre-and post-treatment groups, with P <0.05, and the differences were statistically significant.

TABLE 4 comparison between VAS pain intensity score groups after treatment of the three groups

TABLE 5 comparison between VAS pain intensity score groups of Zhengqingfeng group and Sinomenium acutum group after treatment

Referring to tables 3-5, the results of the study show that three groups all have pain relief compared before and after treatment; pain scores among three groups are different after treatment, pain relief of the positive-blowing wind group and the caulis sinomenii group is obviously higher than that of the blank group, and the pain relief effect of the caulis sinomenii group is the best; therefore, the effect of the caulis sinomenii extract on relieving the pain of the cervical spondylosis is better than that of Zhengqingfengtongning.

The present embodiment is only for explaining the present invention, and it is not limited to the present invention, and those skilled in the art can make modifications of the present embodiment without inventive contribution as needed after reading the present specification, but all of them are protected by patent law within the scope of the claims of the present invention.

Claims

1. A medicine for treating cervical spondylosis by using a caulis sinomenii extract is characterized by comprising the following medicinal components: concentrated liquid medicine, PEG6000, PEG4000 and Tween-80, wherein the concentrated liquid medicine is a mixed extracting solution of caulis sinomenii and dactylicapnos root.

2. The medicine of the caulis sinomenii extract for treating cervical spondylosis as claimed in claim 1, wherein the medicine comprises: the concentrated liquid medicine is prepared by mixing and extracting the caulis sinomenii and the dactylicapnos root 1.

3. The medicine of claim 2, wherein the medicinal components of the caulis sinomenii extract for treating cervical spondylosis comprise: 1-1.5 parts of concentrated liquid medicine, 1-1.5 parts of PEG60000.5-4.5 parts of PEG40000.5-4 parts of tween-800.2-0.3 part of concentrated liquid medicine.

4. The medicine of claim 3, wherein the medicinal components of the caulis Sinomenii extract for treating cervical spondylosis comprise: 1.01 parts of concentrated liquid medicine, 1.01 parts of PEG60004.04 parts, 01.01 parts of PEG400, and 800.25 parts of Tween-A.

5. The medicine of claim 3, wherein the ingredients of the Sinomenium acutum extract for treating cervical spondylosis comprise: 1.01 parts of concentrated liquid medicine, 1.5 parts of PEG60000.5 parts, 03.5 parts of PEG400, and 800.25 parts of Tween-A.

6. The method for preparing a medicine for treating cervical spondylosis by using the caulis sinomenii extract as claimed in any one of claims 1 to 5, wherein caulis sinomenii is mixed with the radix dactylicapni 1 and is decocted and extracted by water to obtain a concentrated liquid medicine, the concentrated liquid medicine, PEG6000, PEG4000 and Tween-80 are mixed and then are placed in a water bath at 80 ℃ for heat preservation until the concentrated liquid medicine is completely dissolved, light paraffin oil is coated in the mold, the solution is poured into the mold and is placed for about 3 hours at normal temperature, then the solution is placed in the water bath for about 30 seconds to melt the paraffin oil, and the medicine can be extracted from the mold.