CN103340942B - Traditional Chinese medicine composition for treating cervical spondylosis and lumbar spondylosis and preparation method thereof - Google Patents

Abstract

The invention discloses a traditional Chinese medicine composition for treating cervical spondylosis and lumbar spondylosis and a preparation method thereof. Combination of Chinese herbal medicine, Shenjincao and Corydalis Corydalis. The combination of these medicines makes each medicine produce a synergistic effect, so that it can more effectively activate blood and tonify kidney, nourish blood and soften liver, relax muscles and dredge collaterals, and achieve the purpose of treating cervical spondylosis and lumbar spondylosis. The traditional Chinese medicine composition of the invention has definite curative effect, no toxic and side effects, the total effective rate is over 91.4%, and has significant clinical popularization value.

Description

A traditional Chinese medicine composition for treating cervical spondylosis and lumbar spondylosis and preparation method thereof

technical field

The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for treating cervical spondylosis and lumbar spondylosis and a preparation method thereof.

Background technique

Cervical spondylosis refers to the degeneration of cervical intervertebral disc, hypertrophy and hyperplasia of cervical spine, and cervical injury, which cause cervical bone hyperplasia, or intervertebral disc prolapse, ligament thickening, stimulation or compression of cervical spinal cord, cervical nerves, and blood vessels, resulting in a series of clinical symptoms. Syndrome, is a common clinical disease, frequently-occurring disease, more common in adults over the age of 40. Clinically, the main manifestations are headache, dizziness, neck and shoulder pain that can radiate to the headrest and upper limbs, neck stiffness, limited movement, heaviness on one side of the shoulder and back, weakness of upper limbs, numbness of fingers, and loss of skin sensation in limbs.

The most basic cause of lumbar spondylosis is the degenerative changes of the lumbar intervertebral disc. Adults may rupture the annulus fibrosus under the circumstances of excessive strain, weight bearing, sudden changes in body position or improper force. Because the annulus fibrosus is thick in the front and thin in the back, the nucleus pulposus tends to protrude backward or posteriorly, compressing the spinal cord or spinal nerve roots, resulting in lumbar pain. Leg pain, lower extremity numbness, cold sensation and other symptoms.

At present, the treatment of cervical spondylosis and lumbar spondylosis mainly includes surgical treatment and non-surgical treatment. Surgical treatment has the disadvantages of high risk, high cost, and easy recurrence, so it is not an ideal treatment method. Non-surgical treatment includes acupuncture, massage, physical therapy, traction and other methods. Although these methods are useful, their onset of action is slow, their curative effect is not good, and the patients are miserable. At present, there is an urgent need for a traditional Chinese medicine composition for treating cervical spondylosis and lumbar spondylosis with definite curative effect and no side effects.

Contents of the invention

The purpose of the present invention is to provide a Chinese medicine composition for treating cervical spondylosis and lumbar spondylosis with quick onset, good curative effect and no side effects.

Another object of the present invention is to provide a preparation method of the above-mentioned traditional Chinese medicine composition.

The object of the present invention is achieved by the following measures:

A traditional Chinese medicine composition for treating cervical spondylosis and lumbar spondylosis. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-30 parts of Caulis Spatholobus, 10-30 parts of Dipsacus, 10-40 parts of Pueraria Radix, and 10-30 parts of Angelica Sinensis. 30 parts, astragalus 8-25 parts, Chuanxiong 8-25 parts, red peony root 10-30 parts, salvia miltiorrhiza 10-30 parts, ground beetle 2-10 parts, myrrh 8-25 parts, Shenjincao 10-25 parts, Corydalis 10-30 parts.

The above-mentioned traditional Chinese medicine composition is preferably prepared from the following raw materials in parts by weight: 12-20 parts of Caulis Spatholobus, 12-20 parts of Dipsacus, 20-30 parts of Pueraria Radix, 12-20 parts of Angelica, 10-20 parts of Astragalus, and 10-20 parts of Rhizoma Chuanxiong. 20 parts, 12-18 parts of Radix Paeoniae Rubra, 12-18 parts of Salvia Miltiorrhiza, 3-7 parts of Wood Beetle, 12-18 parts of Myrrh, 12-20 parts of Shenjincao, 12-20 parts of Corydalis Corydalis.

The traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials are prepared into granules, capsules, tablets, oral liquids, pills or powders.

The preparation method of the above-mentioned traditional Chinese medicine composition for treating cervical spondylosis and lumbar spondylosis comprises the following steps: extract volatile oil after mixing the three herbs of Angelica sinensis, Chuanxiong and Myrrha, extract Corydalis Corydalis with ethanol at a concentration of 60% to 90% under reflux, and recover ethanol , to obtain the alcohol extract; the dregs of the four medicinal materials extracted from Angelica, Chuanxiong, Myrrh, and Corydalis and the rest of the medicinal materials are extracted with water to obtain a water extract, and the water extract is extracted with Angelica, Chuanxiong, and Myrrh. The obtained extracts are combined, then combined with the corydalis ethanol extract, added with volatile oil, mixed evenly, and prepared into a traditional Chinese medicine composition.

Alternatively, the method comprises the steps of: extracting volatile oil after mixing the three medicinal materials of Angelica sinensis, Chuanxiong and Myrrha, and extracting Corydalis Corydalis with ethanol at a concentration of 60% to 90% under reflux, concentrating the obtained alcohol extract into a thick paste, and extracting Angelica sinensis, Chuanxiong , Myrrha, Corydalis 4 herb extracts and the rest of the medicinal materials are extracted by heating with water to obtain a water extract, and the water extract is combined with the extract obtained after extracting volatile oil from Angelica, Chuanxiong, and Myrrh, and concentrated into a clear The paste is combined with the thickening paste of corydalone, mixed evenly, dried, made into granules, added with volatile oil, mixed evenly, and made into a traditional Chinese medicine composition.

Alternatively, the method comprises the following steps: extracting the volatile oil after mixing the three medicinal materials of Angelica sinensis, Chuanxiong and Myrrha, and carrying out inclusion inclusion of the volatile oil, and extracting Corydalis Corydalis with ethanol at a concentration of 60% to 90% under reflux, and then concentrating the obtained ethanol extract into a thick As an ointment, extract the dregs of Angelica sinensis, Chuanxiong, Myrrha, and Corydalis Corydalis and the rest of the medicinal herbs by heating and extracting to obtain a water extract, and extract the water extract with the volatile oils of Angelica, Chuanxiong, and Myrrh. The liquids are combined, concentrated into a clear paste, then combined with the thickening paste of corydalone, mixed evenly, dried, made into granules, added with volatile oil clathrate, mixed evenly, and made into a traditional Chinese medicine composition. The inclusion inclusion can be performed by using β-cyclodextrin and water.

The above-mentioned volatile oil can be extracted by steam distillation, and the extraction time is 2 to 5 hours.

The Corydalis Corydalis is extracted 1-2 times with an ethanol solution with a concentration of 60%-90%, and the extraction time is 1-2 hours each time.

Mix the dregs obtained from the extraction of Angelica, Chuanxiong, Myrrh, and Corydalis with the rest of the medicinal materials, then heat and extract them with water for 2 to 3 times, each time for 1 to 2 hours, and the amount of water used is 6-6% of the total weight of the medicinal materials. 10 times the amount.

The property of medicine of each raw material that the present invention adopts is as follows:

Spatholobus Spatholobus: bitter in the mouth, slightly sweet, warm in nature, returns liver meridian, this product promotes the circulation of blood and nourishes blood, relaxes tendons and activates collaterals, is the commonly used medicine for the treatment of meridian blockage, disharmony of collaterals.

Dipsacus: the taste is warm and enters the Liver and Kidney Meridian. It not only has the functions of warming and tonifying kidney yang, strengthening muscles and bones, benefiting deficiency and damage, but also promoting blood circulation, reducing swelling and relieving pain.

Radix Puerariae: Spicy, sweet, cool in nature, it has the effect of relieving muscle, activating blood and relieving pain, good at treating stiff neck and back pain, and can produce body fluid, moisten and nourish tendons, relax its spasm, and is an important medicine for treating cervical spondylosis pain. Yangjieji, clearing and unblocking the qi of the governor meridian, good at treating the back of the nape meridian and acupoints, and leading the medicine to go up to the disease center, which is effective in improving symptoms such as headache, dizziness, numbness, and numbness of the limbs.

Angelica sinensis: sweet in taste, pungent, warm in nature, returns to the liver, heart, and spleen meridian, good at nourishing blood, promoting blood circulation and relieving pain, and is good at promoting blood circulation, and removing blood stasis without hurting blood.

Radix Astragali: sweet, slightly warm. Return through: return lung, spleen, liver, kidney meridian, invigorate the qi of spleen and lung, with the source of the biochemistry of qi and blood.

Rhizoma Chuanxiong: Spicy in taste, warm in nature, returns to the liver, gallbladder, and pericardium meridians, has the effect of promoting qi and blood circulation, expelling wind and relieving pain, is a qi medicine in the blood, and has the function of promoting qi and blood; Radix Paeoniae Rubra is bitter in taste, slightly cold in nature, Liver meridian, clearing heat and cooling blood, dispelling blood stasis and relieving pain.

Danshen: bitter, slightly cold. GUIXIN, Liver Meridian, blood circulation, dispelling blood stasis to relieve pain.

Ground Beetle: salty cold enters the blood, mainly enters the liver meridian, is good at walking, can promote blood circulation, reduce swelling and relieve pain, and is a commonly used medicine for traumatology.

Myrrha: pungent, dissipating and warming, enters the liver meridian, can activate blood, promote qi and relieve pain, and can dissipate blood stasis and stretch muscles and numbness.

Shenjincao: Bitter in the mouth, pungent, warm in nature, can dispel wind-damp arthralgia, enter the liver and are especially good at dredging the meridians, relaxing muscles and tendons and activating collaterals.

Corydalis Corydalis: pungent in taste, bitter, warm in nature, Guixin, Liver, Spleen meridians, promoting blood circulation, promoting qi and relieving pain.

The ground beetle in the prescription of the traditional Chinese medicine composition of the present invention has a very important influence on the clinical curative effect. Traditional medicine believes that the ground beetle is slightly poisonous, which will cause unsafe factors in the long-term use of patients. However, the inventor has undergone a large number of clinical verifications, and the drug combination without the ground beetle is far less effective in analgesic and stiffness improvement. Add the prescription medicine of wood beetle. After a lot of creative work, the inventor has adopted a specific combination to obtain the traditional Chinese medicine composition containing wood beetle of the present invention, and no obvious toxic and side effects have been found in long-term use. The invention notably reduces the toxic and side effects of the ground beetle on the basis of the obvious effect of treating cervical spondylosis and lumbar spondylosis.

Corydalis Corydalis in the prescription of the traditional Chinese medicine composition of the present invention has important influence on clinical curative effect. Corydalis is a commonly used drug for pain relief. When determining its dosage, our prescription has also been compared, and a number of dosages with different ratios have been set up for clinical use. The test results show that the use of Corydalis has a direct relationship with the improvement of patients' neck, shoulder and lumbar pain. . However, after reaching a certain dosage, increasing the dosage cannot enhance the analgesic effect. The dosage of Corydalis Corydalis with the best effect is selected for the traditional Chinese medicine composition of the present invention.

Myrrha in the prescription of the pharmaceutical composition of the present invention also plays a very important role in the clinical onset process. Myrrha, Xin San Wen Tong, its volatile oil has shown a strong pharmacological effect of promoting blood circulation and relieving pain, and the minimum limit standard for its volatile oil content has also been set in the standards of medicinal materials. The present invention adopts the volatile oil inclusion technology to reduce the dissipation of volatile components to the greatest extent. Myrrh has an irreplaceable effect on the improvement of clinical symptoms such as numbness and stiffness of patients.

Usually the drug combination for treating cervical spondylosis has no obvious therapeutic effect on treating lumbar spondylosis, but the present invention not only has good curative effect on cervical spondylosis, but also has miraculous effects on treating lumbar spondylosis. Although the Radix Paeoniae Rubra, Angelica, and Chuanxiong used in the prescription of the Chinese medicine composition of the present invention are common blood-activating and stasis-removing drugs, the present invention combines these three with Caulis Spatholobus, Dipsacus, Pueraria Radix, Radix Astragali, Salvia Miltiorrhiza, and Wood Beetle. Combination of herbs, stretching tendons, and Corydalis Corydalis has a strong therapeutic effect on improving the symptoms of lumbar and cervical spine diseases such as wind-cold dampness, numbness, pain, etc. Without any one, the effect of promoting blood circulation, removing blood stasis, dredging collaterals and relieving pain will be inferior a lot of.

Detailed ways

The present invention is further illustrated below by specific examples. However, the specific details of the embodiments are only used to explain the present invention, and should not be construed as limiting the general technical solution of the present invention.

Example 1:

15 parts by weight of Caulis Spatholobus, 15 parts by weight of Dipsacus, 25 parts by weight of Pueraria Radix, 15 parts by weight of Angelica sinensis, 15 parts by weight of Radix Astragali, 10 parts by weight of Rhizoma Chuanxiong, 15 parts by weight of Radix Paeoniae Rubra, 15 parts by weight of Salvia miltiorrhiza, 5 parts by weight of ground beetle, 12 parts by weight of Myrrha, 15 parts by weight of Herba Sinensis, and 15 parts by weight of Corydalis Corydalis.

Preparation of decoction:

Weigh 15 parts by weight of Angelica sinensis, 10 parts by weight of Rhizoma Chuanxiong and 12 parts by weight of Myrrha, extract the volatile oil by steam distillation at 95-100°C for 3 hours, weigh 15 parts by weight of Corydalis Corydalis, add 80% ethanol solution Heat and reflux extraction once, the extraction time is 1.5 hours, the amount of ethanol solution is 8 times the weight of the medicinal material dosage of Corydalis Corydalis, reclaim the ethanol to obtain the alcohol extract, get the dregs after the extraction of the above-mentioned 4 medicinal materials and 15 parts by weight of Spatholobus Spatholobus, 15 Parts by weight Dipsacus, 25 parts by weight Pueraria Radix, 15 parts by weight Radix Astragali, 15 parts by weight Radix Paeoniae Rubra, 15 parts by weight Salvia miltiorrhiza, 5 parts by weight wood beetle, 15 parts by weight Shenjincao, add water and decoct 3 times, the first time for 2 hours , each 1 hour for the second and third times, the amount of water used is 8 times the total weight of the medicinal materials, the water decoction and the volatile oil extract are combined, and then combined with the corydalis alcohol extract after recovering ethanol, the volatile oil is added, and mixed evenly to obtain final product.

Example 2:

30 parts by weight of Caulis Spatholobus, 10 parts by weight of Dipsacus, 40 parts by weight of Pueraria Radix, 15 parts by weight of Angelica sinensis, 10 parts by weight of Radix Astragali, 15 parts by weight of Rhizoma Chuanxiong, 25 parts by weight of Radix Paeoniae Rubra, 30 parts by weight of Salvia Miltiorrhiza, 2 parts by weight of Wood Beetle, 20 parts by weight of Myrrha, 20 parts by weight of Herba Sinensis, and 30 parts by weight of Corydalis Corydalis.

Preparation of granules

Weigh 15 parts by weight of Angelica sinensis, 15 parts by weight of Ligusticum chuanxiong and 20 parts by weight of myrrh, extract the volatile oil by steam distillation at 95-100°C for 4 hours, and use β-cyclodextrin and water to clathrate the collected volatile oil for 3 hours. Place to cool, dry at low temperature and pulverize into fine powder, take 30 parts by weight of Corydalis Corydalis, add concentration and be 90% ethanol solution, heat and reflux to extract once, each extraction time is 2 hours, and the amount of ethanol is 8 times the weight of Corydalis Corydalis medicinal material consumption, Recover ethanol, concentrate under reduced pressure to a thick paste, take the dregs after extracting the above four medicinal materials and 30 parts by weight of Caulis Spatholobus, 10 parts by weight of Dipsacus, 40 parts by weight of Radix Puerariae, 10 parts by weight of Radix Astragali, 25 parts by weight of Radix Paeoniae Rubra, 30 parts by weight of Salvia miltiorrhiza, 2 parts by weight of ground beetle, and 20 parts by weight of Grass sinensis are decocted twice, each time for 2 hours, and the amount of water used is 10 times the total weight of the medicinal materials. The combined decoction and volatile oil extract are concentrated under reduced pressure , combine the thickening paste of corydalone, mix well, dry under vacuum and reduce pressure, pulverize, add dextrin to make granules, add volatile oil clathrate, mix well, and obtain.

Example 3:

20 parts by weight of Caulis Spatholobus, 30 parts by weight of Dipsacus, 10 parts by weight of Pueraria Radix, 10 parts by weight of Angelica sinensis, 8 parts by weight of Astragalus, 25 parts by weight of Rhizoma Chuanxiong, 20 parts by weight of Radix Paeoniae Rubra, 12 parts by weight of Salvia miltiorrhiza, 6 parts by weight of ground beetle, 30 parts by weight of Myrrha, 18 parts by weight of Herba Sinensis, and 10 parts by weight of Corydalis Corydalis.

Preparation of granules

Weigh 10 parts by weight of Angelica sinensis, 25 parts by weight of Rhizoma Chuanxiong and 30 parts by weight of Myrrha, extract the volatile oil by steam distillation at 95-100°C for 5 hours, weigh 10 parts by weight of Corydalis Corydalis, add 60% ethanol solution, heat and reflux for extraction 1 time, each extraction time is 1 hour, the amount of ethanol is 6 times the weight of the medicinal material of Corydalis Corydalis, the ethanol is recovered, concentrated under reduced pressure to a thick paste, and the dregs of the above four medicinal materials extracted and 20 parts by weight of Spatholobus Spatholobus are weighed , 30 parts by weight Dipsacus, 10 parts by weight Pueraria Radix, 8 parts by weight Radix Astragali, 20 parts by weight Radix Paeoniae Rubra, 12 parts by weight Salvia miltiorrhiza, 6 parts by weight ground beetle, 18 parts by weight Shenjincao, add water and decoct 3 times, each time 2 hour, the amount of water is 10 times of the total weight of the medicinal materials, the combined decoction and volatile oil extract are concentrated under reduced pressure, combined with fumarol thickening paste, mixed evenly, and carried out boiling one-step granulation with lactose, dextrin, etc. as auxiliary materials, spraying Add volatile oil, mix well, and get it.

Example 4:

10 parts by weight of Caulis Spatholobus, 20 parts by weight of Dipsacus, 30 parts by weight of Pueraria Radix, 20 parts by weight of Angelica sinensis, 25 parts by weight of Radix Astragali, 8 parts by weight of Rhizoma Chuanxiong, 10 parts by weight of Radix Paeoniae Rubra, 10 parts by weight of Salvia Miltiorrhiza, 8 parts by weight of Wood Beetle, 15 parts by weight of Myrrha, 20 parts by weight of Herba Sinensis, and 20 parts by weight of Corydalis Corydalis.

Preparation of capsules

Weigh 20 parts by weight of Angelica sinensis, 8 parts by weight of Ligusticum chuanxiong and 15 parts by weight of myrrh, extract the volatile oil by steam distillation at 95-100°C for 4 hours, and use β-cyclodextrin and water to clathrate the collected volatile oil for 3 hours. Place to cool, dry at low temperature and pulverize into fine powder, take 20 parts by weight of Corydalis Corydalis, add concentration and be 70% ethanol solution and heat and reflux to extract twice, each extraction time is 1.5 hours, and the amount of ethanol is 6 times the weight of Corydalis Corydalis medicinal material consumption, Recover ethanol, concentrate under reduced pressure to a thick paste, take the dregs after extracting the above four medicinal materials and 10 parts by weight of Caulis Spatholobus, 20 parts by weight of Dipsacus, 30 parts by weight of Radix Puerariae, 25 parts by weight of Radix Astragali, 10 parts by weight of Radix Paeoniae Rubra, 10 parts by weight of Salvia miltiorrhiza, 8 parts by weight of ground beetle, 20 parts by weight of Grass sinensis and the dregs extracted from the above four medicinal materials, decocted with water for 3 times, each time for 1 hour, the amount of water used is 6 times the total weight of the medicinal materials, Combine the water decoction and the volatile oil extract and concentrate under reduced pressure, combine the corydal alcohol thickening cream, mix well, add dextrin and other auxiliary materials, wet granulate, dry at low temperature, sizing, add volatile oil clathrate, mix well, pack Serve in capsules.

Example 5:

15 parts by weight of Caulis Spatholobus, 20 parts by weight of Dipsacus, 20 parts by weight of Pueraria Radix, 25 parts by weight of Angelica sinensis, 15 parts by weight of Radix Astragali, 20 parts by weight of Rhizoma Chuanxiong, 20 parts by weight of Radix Paeoniae Rubra, 12 parts by weight of Salvia miltiorrhiza, 7 parts by weight of ground beetle, 8 parts by weight of Myrrha, 18 parts by weight of Herba Sinensis, and 10 parts by weight of Corydalis Corydalis

Tablet preparation

Weigh 25 parts by weight of Angelica sinensis, 20 parts by weight of Ligusticum chuanxiong and 8 parts by weight of myrrh, extract the volatile oil by steam distillation at 95-100°C for 3 hours, and use β-cyclodextrin and water to clathrate the collected volatile oil for 3 hours. Place to cool, dry at low temperature and pulverize into fine powder, weigh 10 parts by weight of Corydalis Corydalis, add 85% ethanol solution, heat and reflux to extract twice, each extraction time is 1 hour, and the amount of ethanol is 10 times the weight of the medicinal material Corydalis Corydalis , reclaim ethanol, concentrate under reduced pressure to a thick paste, get the dregs after extracting the above-mentioned 4 medicinal materials and 15 parts by weight of Caulis Spatholobus, 20 parts by weight of Dipsacus, 20 parts by weight of Radix Puerariae, 15 parts by weight of Radix Astragali, 20 parts by weight of Radix Paeoniae Rubra , 12 parts by weight of Salvia miltiorrhiza, 7 parts by weight of ground beetle, 18 parts by weight of Grass sinensis and the dregs after the extraction of the above-mentioned 4 medicinal materials, add water and decoct 2 times, each time for 2 hours, the water consumption is 8 times the amount of the total weight of the medicinal materials , combine the water decoction and volatile oil extract to concentrate under reduced pressure, combine the thickening paste of fumarol, mix well, dry under vacuum and reduce pressure, pulverize, add starch, make granules, add volatile oil clathrate, add microcrystalline cellulose, hard Magnesium fatty acid, etc. are mixed evenly, pressed into tablets, dried, and packaged.

Embodiment 6:

20 parts of Caulis Spatholobus, 20 parts by weight of Dipsacus, 15 parts by weight of Pueraria Radix, 18 parts by weight of Angelica sinensis, 12 parts by weight of Astragalus, 10 parts by weight of Rhizoma Chuanxiong, 15 parts by weight of Radix Paeoniae Rubra, 25 parts by weight of Salvia Miltiorrhiza, 7 parts by weight of Wood Beetle, no 18 parts by weight of medicine, 10 parts by weight of Shenjincao, 25 parts by weight of Corydalis Corydalis

Preparation of pills

Weigh 18 parts by weight of Angelica sinensis, 10 parts by weight of Rhizoma Chuanxiong and 18 parts by weight of Myrrha, extract the volatile oil by steam distillation at 95-100°C for 5 hours, and use the collected volatile oil to clathrate with β-cyclodextrin and water for 2 hours. Place to cool, dry at low temperature and pulverize into fine powder, weigh 25 parts by weight of Corydalis Corydalis, add 75% ethanol solution to reflux and extract once, each extraction time is 2 hours, and the amount of ethanol is 6 times the weight of Corydalis Corydalis medicinal material. Ethanol, concentrated under reduced pressure to a thick paste, extracting the dregs of the above four medicinal materials and 20 parts by weight of Caulis Spatholobus, 20 parts by weight of Dipsacus, 15 parts by weight of Pueraria Radix, 12 parts by weight of Radix Astragali, 15 parts by weight of Radix Paeoniae Rubra, 25 parts by weight of Paeoniae Rubra, 25 parts by weight of Parts by weight of Salvia miltiorrhiza, 7 parts by weight of ground beetle, 10 parts by weight of Grass sinensis and the dregs after the extraction of the above four medicinal materials, add water and decoct 3 times, 2 hours for the first time, 1 hour for the second and third times, and the water consumption is 10 times the total weight of medicinal materials, combined with water decoction and volatile oil extract, concentrated under reduced pressure, combined with corydalone thickening paste, spray-dried, added volatile oil clathrate, mixed well, added refined honey to make a pill, and the product is obtained.

Embodiment 7:

15 parts by weight of Caulis Spatholobus, 12 parts by weight of Dipsacus, 30 parts by weight of Pueraria Radix, 20 parts by weight of Angelica sinensis, 15 parts by weight of Radix Astragali, 10 parts by weight of Rhizoma Chuanxiong, 20 parts by weight of Radix Paeoniae Rubra, 20 parts by weight of Salvia Miltiorrhiza, 4 parts by weight of Wood Beetle, 12 parts by weight of Myrrha, 12-20 parts by weight of Herba Sinensis, 12 parts by weight of Corydalis Corydalis

Preparation of Oral Solution

Weigh 20 parts by weight of Angelica sinensis, 10 parts by weight of Rhizoma Chuanxiong and 12 parts by weight of Myrrha, extract the volatile oil by steam distillation at 95-100°C for 4 hours, collect the volatile oil, weigh 12 parts by weight of Corydalis Corydalis, add 80% ethanol solution Heat and reflux extraction once, each extraction time is 1 hour, the amount of ethanol is 7 times the weight of the medicinal material of Corydalis Corydalis, reclaim the ethanol, concentrate under reduced pressure to a thick paste, take the dregs after extraction of the above 4 medicinal materials and 15 parts by weight of chicken Radix Spatholobus, 12 parts by weight Dipsacus, 30 parts by weight Pueraria Radix, 15 parts by weight Radix Astragali, 20 parts by weight Radix Paeoniae Rubra, 20 parts by weight Salvia Miltiorrhiza, 4 parts by weight Wood Beetle, 16 parts by weight Shenjincao and the extracted four medicinal materials Dregs, add water and decoct 3 times, 2 hours each time, the amount of water is 8 times the total weight of the medicinal materials, combine the water decoction and volatile oil extract to concentrate under reduced pressure, combine the thickening cream of corydalone, mix well, add diluent Water, flavoring agent honey, cosolvent Tween 80, preservative sodium benzoate, add volatile oil, mix well, ultrafilter, fill, and get ready.

The pharmaceutical composition that adopts the embodiment of the present invention 1 method to prepare carries out clinical trial:

A total of 35 patients with cervical spondylosis visited the orthopedics department of a hospital, including 9 males and 26 females; the oldest was 70 years old, the youngest was 26 years old, and the average age was 47.1714±2.24974 years old.

(1) Diagnostic criteria

1) Complaints of abnormal sensations such as pain in the head, neck, and shoulders, accompanied by corresponding tenderness points, and/or limited movement of the neck and stiff neck muscles;

2) X-ray films show changes in the curvature of the cervical spine, or instability of the intervertebral joints;

3) Other neck diseases should be excluded (stiff neck, frozen shoulder, rheumatic myofibroblastitis, neurasthenia and other shoulder and neck pain caused by non-intervertebral disc degeneration)

(2) Inclusion criteria

1) Those who meet the diagnostic criteria for cervical spondylosis;

2) Between 20 and 70 years old, regardless of gender;

3) Those who have not received similar drugs and related treatments within 2 weeks before the test;

4) Informed consent, willing to be a subject, and guarantee to complete the course of treatment on time.

(3) Exclusion criteria

1) Those who do not meet the above inclusion criteria;

2) The condition has changed due to unnatural factors or therapeutic intervention;

3) Women who are breastfeeding, pregnant or preparing to become pregnant;

4) People with allergies and allergies to multiple drugs;

5) Combined, liver, kidney, hematopoietic system, endocrine system and other primary diseases and mental illness patients;

6) The condition is critical and it is difficult to make an exact evaluation of the effectiveness and safety of the drug;

7) Mentally or legally disabled persons;

8) It is suspected that there is a history of alcohol and drug abuse, or other medical history that reduces the possibility of enrollment or complicates enrollment, such as frequent changes in the working environment, which may easily lead to loss of follow-up.

(4) Elimination criteria

1) Allergic reactions, worsening conditions, or serious adverse events that may or have occurred;

2) During the course of the test, the subject has some comorbidities, complications or special physiological changes, and it is not suitable to continue to participate in the observer;

3) Subjects who voluntarily request to quit during the clinical research process;

4) Due to objective reasons, the data are incomplete or the follow-up is lost;

5) Other unforeseen circumstances occur, and clinical observers cannot be completed.

(5) Treatment groups

All 35 cases belonged to the treatment group, and the curative effect was compared before treatment and after 2 weeks of treatment, and no control group was set up.

(6) Treatment operating procedures

The decoction of the present invention prepared according to the method of Example 1 (1 gram per part by weight in Example 1, and the dosage described in the formula of Example 1 is 1 dose): decoction in water, 1 dose/day, divided into two doses , 1 week as a course of treatment, observe 2 courses of treatment. During the above treatment process, it is forbidden to work with the head down for a long time and sleep on a high pillow and other improper postures to prevent cervical spine trauma and cold.

(7) Observation indicators

1) Grading and quantitative scoring of TCM symptoms

Table 1 Symptom grading and quantification table

Tongue pulse: describe in detail, no score.

2) Improvement of quality of life (using the health questionnaire combined with the neck disability index (NDI) scoring standard)

1. Generally speaking, the health status is:

2. Health and activities of daily living: The following questions are all about activities of daily living. Does a medical condition limit these activities? What if there are restrictions?

3. pain level

4. Personal Life Cuisine

5. read

6. Headache

7. concentrate

8. Work

9. to sleep

10. Entertainment

3) Pain and X-ray improvement

Table 2 VAS Visual Analogue Scale and X-ray Recording Form

(8) Observation time point

Recorded before treatment and 2 weeks after treatment.

(9) Observation results

The observation results before treatment and after 2 weeks of treatment were recorded, and statistical software (SPSS17.0) was used to conduct statistical analysis on the results before treatment and after 2 weeks of treatment, and the results were obtained.

1) Improvement of TCM symptoms

Table 3 Distribution table of samples before and after treatment of TCM symptoms

Table 4 Comparison of scores before and after treatment of TCM symptoms

Compared with the scores of TCM symptoms, P<0.05 before and after treatment, indicating that the difference between the groups was statistically significant. Before treatment, it was 6.8286±3.01453, and after 2 weeks of treatment, it was 3.8857±2.36110. The curative effect is remarkable.

2) Improvement of quality of life

Table 5 Number of sample cases before and after quality of life treatment

Table 6 Comparison of quality of life scores before and after treatment

The quality of life was improved, P<0.05 before and after treatment, indicating statistical significance before and after treatment. Before treatment, it was 12.4571±4.68629, and after 2 weeks of treatment, it was 6.8571±3.01118, showing a significant effect.

3) Pain comparison

Table 7 Number of samples before and after treatment

Table 8 Score comparison before and after treatment

P<0.05 before and after treatment, indicating statistical significance before and after treatment. The average pain score before treatment was 4.4571, and the average pain score after 2 weeks of treatment was 2.0000, indicating that after treatment, the effect is obvious.

Efficacy evaluation

The standard refers to the "Criteria for Diagnosis and Curative Effect of Diseases and Syndromes of Traditional Chinese Medicine" formulated by the State Administration of Traditional Chinese Medicine:

(1) Recovery: the clinical symptoms disappear, the functions of the neck and limbs return to normal, and the patient can labor and work normally;

(2) Significantly effective: clinical symptoms and signs basically disappear, neck, shoulder, and back pain are only occasionally seen in cloudy and rainy days or when the body is uncomfortable, and the function is normal;

(3) Effective: Neck, shoulder, and back pains are relieved, and neck and limb functions are improved;

(4) Ineffective: no change in clinical symptoms and signs.

Table 9 curative effect statistics

For the improvement of TCM symptoms, quality of life and pain, there is a significant statistical significance before and after treatment, and the improvement after treatment is significantly better than before treatment.

After 2 weeks of treatment, 27 of the 35 cases were markedly effective, 5 cases were effective, and 32 cases were effective overall, with an effective rate of 91.4%. The therapeutic effect is remarkable.

Typical cases

Case 1. Mr. Shen, male, 49 years old. The patient suffered from neck and shoulder pain for 2 days, which then intensified until the head could not turn or turned to one side. The neck muscles were swollen and had obvious tenderness. On the X-ray film, the cervical spine curve disappeared and became straight. After taking two courses of treatment of Chinese medicine composition embodiment 1 of the present invention, neck and shoulder pain disappears, and neck can move freely. Follow up a case by regular visits to 1 year without recurrence.

Case 2. Ms. Liu, female, 51 years old. The patient had lumbar disc herniation for 1 year. Recently, her low back pain has aggravated and spread to her lower limbs. She cannot exert force and can only lie on her back. After taking Example 3 of the Chinese medicine composition of the present invention (1 gram per part by weight in Example 3, the dosage described in Example 3 is 1 dose, 1 dose/day, taken in two divided doses, and 1 week is a course of treatment), After three courses of treatment, the waist pain disappeared, and the normal life and work status returned. Follow up a case by regular visits to 1 year without recurrence.

Case 3. Ms. Ge, female, 43 years old. The patient had continuous pain in the waist for more than a month, and pain and numbness in the hind lower limbs. After taking Example 3 of the Chinese medicine composition of the present invention (in Example 3, each part by weight is 1 gram, the dosage described in Example 3 is 1 dose, 1 dose/day, taken twice, and 1 week is a course of treatment). After a course of treatment, the pain and numbness in the waist and lower limbs disappeared. Follow up a case by regular visits to 1 year without recurrence.

The therapeutic effects of the pharmaceutical compositions described in various embodiments of the present invention are the same or similar.

Claims (9)

1. A Chinese medicine composition for treating cervical spondylosis and lumbar spondylosis, characterized in that the Chinese medicine composition is made from the following raw materials in parts by weight: 12 to 20 parts of Caulis Spatholobus, 12 to 20 parts of Dipsacus, 20 to 30 parts of Radix Puerariae 12-20 parts of angelica, 10-20 parts of astragalus, 10-20 parts of Chuanxiong, 12-18 parts of red peony, 12-18 parts of salvia miltiorrhiza, 3-7 parts of ground beetle, 12-18 parts of myrrh, and Shenjincao 12 to 20 copies, 12 to 20 copies of Corydalis. 2. The Chinese medicine composition according to claim 1, characterized in that the Chinese medicine composition and pharmaceutically acceptable adjuvants are made into granules, capsules, tablets, oral liquids, pills or powders. 3. a preparation method for treating cervical spondylosis, lumbar spondylopathy according to claim 1, characterized in that the method comprises the steps of: extracting volatile oil after mixing Angelica, Rhizoma Chuanxiong and Myrrha three medicinal materials, Corydalis is extracted by heating and refluxing ethanol with a concentration of 60% to 90%, and the ethanol is recovered to obtain an alcohol extract; the dregs of the four medicinal materials extracted from Angelica, Chuanxiong, Myrrh, and Corydalis and the remaining medicinal materials are obtained by heating and extracting with water. The water extract is the combination of the water extract and the extract obtained by extracting the volatile oil from angelica, chuanxiong and myrrh, and then combined with the corydalis ethanol extract, adding the volatile oil, and mixing to prepare a traditional Chinese medicine composition. 4. a preparation method for treating cervical spondylosis, lumbar spondylosis according to claim 1, characterized in that the method comprises the steps of: extracting volatile oil after mixing Angelica, Rhizoma Chuanxiong and Myrrha three medicinal materials, Corydalis is extracted by heating and refluxing with 60% to 90% ethanol, and the obtained alcohol extract is concentrated into a thick paste, and the dregs of the four medicinal materials extracted from Angelica, Chuanxiong, Myrrh, and Corydalis are extracted by heating with water The water extract is obtained, the water extract is combined with the extract obtained by extracting the volatile oil from angelica, chuanxiong, and myrrh, concentrated into a clear paste, then combined with the thickening paste of corydalone, mixed evenly, dried, made into granules, and added with volatile oil , and mix well to make a traditional Chinese medicine composition. 5. a preparation method for treating cervical spondylosis, lumbar spondylosis according to claim 1, characterized in that the method comprises the steps of: extracting volatile oil after mixing Angelica sinensis, Rhizoma Chuanxiong and Myrrha three herbs The volatile oil is clathrated, Corydalis Corydalis is extracted with ethanol with a concentration of 60% to 90% and heated under reflux, and the obtained alcohol extract is concentrated into a thick paste. The medicinal materials are heated and extracted with water to obtain a water extract, the water extract is combined with the extract obtained by extracting the volatile oil from angelica, chuanxiong, and myrrh, concentrated into a clear paste, and then combined with the thickening paste of fumarol, mixed evenly, and dried. Make granules, add volatile oil clathrate, mix well, and make traditional Chinese medicine composition. 6. The method according to claim 3, 4 or 5, characterized in that the volatile oil is extracted by steam distillation, and the extraction time is 2 to 5 hours. 7. The method according to claim 5, characterized in that said clathrate is clathrate with β-cyclodextrin and water. 8. The method according to claim 3, 4 or 5, characterized in that Corydalis Corydalis is extracted 1 to 2 times with ethanol with a concentration of 60% to 90%, each time for 1 to 2 hours, adding 6 to 10 times the total weight of medicinal materials amount of ethanol solution. 9. The method according to claim 3, 4 or 5, characterized in that the dregs obtained after the extraction of the four medicinal materials are mixed with the remaining medicinal materials and extracted by heating water for 2 to 3 times, each time for 1 to 2 hours, The amount of water used is 6-10 times of the total weight of the medicinal materials.