CN118416184A

CN118416184A - Pharmaceutical composition for treating protrusion of intervertebral disc and complications thereof, and preparation method and application thereof

Info

Publication number: CN118416184A
Application number: CN202410569515.7A
Authority: CN
Inventors: 陈泽俊; 陈治庆; 陈亚弟; 凌兆丰; 凌奕
Original assignee: Shenzhen Meisheng Industrial Development Co ltd
Current assignee: Shenzhen Meisheng Industrial Development Co ltd
Priority date: 2024-05-09
Filing date: 2024-05-09
Publication date: 2024-08-02

Abstract

The invention provides a pharmaceutical composition for treating disc herniation and complications thereof, and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The medicine composition of the invention comprises medicinal powder and medicinal liquor; the powder comprises: musk, eucommia bark, kusnezoff monkshood root, myrrh, safflower, astragalus root, nux vomica, szechuan lovage rhizome, honeysuckle flower, dark plum fruit, dragon's blood, drynaria rhizome, mistletoe, ground beetle, earthworm, common bletilla tuber, raw pinellia tuber, common monkshood mother root, raw arisaema tuber, centipede, leech, pubescent angelica root, cortex acanthopanacis, kaempferia galangal, dahurian angelica root, chinese angelica, liquorice, turmeric, dried orange peel, chinese yam and rhizoma polygonati; the medicinal liquor comprises the following components: achyranthes root, herb of Dali, scorpion, radix clematidis, frankincense, cinnamon, fennel, dried orange peel, chinese yam and rhizoma polygonati. The invention provides a brand new effective external application treatment scheme for treating the herniated disk and complications thereof by compounding 38 medicinal materials, preparing wine by adopting a cold extraction method, physically mixing medicinal powder, and separately placing the medicinal wine and the medicinal powder for mixed use during treatment.

Description

Pharmaceutical composition for treating protrusion of intervertebral disc and complications thereof, and preparation method and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a pharmaceutical composition for treating herniated disk and complications thereof, and a preparation method and application thereof.

Background

The current medical community is divided into traditional Chinese medicine treatment and western medicine treatment for treating the herniated disc and complications thereof.

Western medicine treatment includes: 1. drug treatment: non-steroidal anti-inflammatory analgesics and muscle relaxants. 2. Physical treatment: can be used in combination with medicinal therapy, such as traction therapy, massage, physiotherapy, etc., to relieve nerve root compression and muscle spasm. 3. Surgical treatment: patients with poor conservative treatment effects or exacerbation of symptoms, including interbody fusion, laminectomy, foramen-vitrectomy, etc.

Besides the operation treatment, western medicine treatment can basically treat the root cause, only treat the exterior, relieve the pain and have the possibility of recurrence. The side effect on the body of the patient is large in the surgical treatment, the relapse prevention cannot be guaranteed, and in addition, a plurality of surgical treatments have obvious sequelae. And the time cost and the economic cost of the operation treatment are high. In elderly patients, the operation should also take into account the patient's own ability to withstand. Therefore, most patients are not always treated conservatively, and the optimal treatment stage is often delayed.

The traditional Chinese medicine treatment comprises the following steps: 1. acupuncture treatment: the patient can be treated in an acupuncture mode, and the lumbar vertebra and other pathological change positions can be stimulated to a certain extent, so that the blood circulation of the lumbar vertebra is promoted, and discomfort caused by lumbar disc herniation is gradually improved. 2. Traction treatment: if the illness state of the patient is serious, the patient needs to be relieved by traction, the pressure of the intervertebral disc is reduced, the gap is increased, and the physiological curvature is recovered. Can also relieve the irritation of the disease to nerve root and pain of patients. 3. Massage treatment: the massage treatment is carried out by the patient under the guidance of doctors, so that local muscles can be relaxed, local blood circulation can be promoted, even the pressure in the intervertebral disc can be relieved, and the dislocation of vertebrae can be corrected, thereby achieving the effect of relieving diseases. 4. The medicine is taken orally: many classical decoctions in the traditional prescription can be applied according to specific symptoms of patients. 5. The medicine for external application: the traditional meridian prescription is continuously searched and verified from the experience of treating the traumatic injury, and a plurality of meridian prescriptions can effectively treat the protrusion of the intervertebral disc and complications thereof.

However, the existing traditional Chinese medicine treatment methods have the defects that many of the traditional Chinese medicine treatment methods can effectively remove the pain of patients, but the key for treating the disease is to treat the disease without recurrence. 1, 2 and 3 of the traditional Chinese medicine medical science medical instruments can not control the root cause basically, have high requirements on the level of doctors, and need accurate and skilled knowledge and practice methods of traditional Chinese medicine, so that the traditional Chinese medicine medical science medical instruments are difficult to achieve and need to be accumulated for years and months. It is also common for patients to be negatively affected if not experienced, resulting in increased disease. As with 1, 2 of the western medicine treatments, the patient time and economic costs are high and require lengthy treatment times, essentially half a year to one year, which is not consistent for many patients. Therefore, the physical therapy of traditional Chinese medicine is not the optimal choice. 4. 5 patients are the most suitable treatment methods for most patients at present, and the treatment method has very obvious curative effects on early and middle-stage patients, and has moderate time and economic cost. However, the method of oral administration of the Chinese medicine is selective to the individuals suffering from the diseases. Because of the different physical conditions of individuals, one prescription cannot be suitable for all persons with the same etiology, and is an oral medicine after all, and the patients of the doctor can use the oral medicine with cautious usage, which is also inconvenient for oral medicine treatment.

In all traditional Chinese medicine treatment means, the 5 th calculation is the best method, does not take the patient, does not take the time, and has low economic cost. The preparation is suitable for both early, middle and late stages of the illness, and can not only relieve psychological stress of patients, but also relieve economic burden of the patients. However, the treatment efficiency of the drug based on the treatment method of item 5 is low and the effect is slow, so it is necessary to provide a safe, effective, simple and economical treatment method.

Disclosure of Invention

The invention provides a safe, effective, simple and economic pharmaceutical composition for solving the medical problems of treating the protrusion of intervertebral disc and complications thereof in traditional Chinese medicine and facing the current situation that the number of patients is sharply increased in society.

In order to achieve the above object, the present invention provides the following technical solutions:

The invention provides a pharmaceutical composition for treating herniated disk and complications thereof, wherein the pharmaceutical composition comprises medicinal powder and medicinal liquor;

The medicinal powder comprises the following raw materials in parts by mass: 0.04-0.06 part of musk, 15-25 parts of eucommia ulmoides, 15-25 parts of radix aconiti kusnezoffii, 15-25 parts of myrrh, 15-25 parts of safflower, 15-25 parts of astragalus membranaceus, 15-25 parts of nux vomica, 15-25 parts of ligusticum wallichii, 15-25 parts of honeysuckle, 15-25 parts of dark plum, 15-25 parts of dragon's blood, 15-25 parts of rhizoma drynariae, 15-25 parts of mistletoe, 15-25 parts of eupolyphaga sinensis, 15-25 parts of earthworm, 15-25 parts of bletilla striata, 15-25 parts of raw pinellia tuber, 15-25 parts of radix aconiti, 15-25 parts of raw arisaema tuber, 15-25 parts of centipede, 15-25 parts of leech, 15-25 parts of radix angelicae pubescentis, 15-25 parts of cortex acanthopanacis, 15-25 parts of kaempferia galanga, 15-25 parts of radix angelicae, 15-25 parts of angelica sinensis, 15-25 parts of liquorice, 15-25 parts of turmeric, 15-25 parts of dried orange peel, 15-25 parts of rhizoma dioscoreae and 15-25 parts of rhizoma polygonati;

the medicinal liquor comprises the following raw materials in parts by mass: 15-30 parts of achyranthes, 15-30 parts of herba clematis, 50-100 parts of scorpion, 20-40 parts of radix clematidis, 10-20 parts of frankincense, 20-40 parts of cinnamon, 15-30 parts of fennel, 15-30 parts of dried orange peel, 20-40 parts of Chinese yam, 20-40 parts of rhizoma polygonati, 50-100 parts of honey and 1000-2000 parts of white spirit.

Preferably, the medicinal powder comprises the following raw materials in parts by mass: 0.05 part of musk, 20 parts of eucommia ulmoides, 20 parts of kusnezoff monkshood root, 20 parts of myrrh, 20 parts of safflower, 20 parts of astragalus membranaceus, 20 parts of nux vomica, 20 parts of szechuan lovage rhizome, 20 parts of honeysuckle, 20 parts of dark plum fruit, 20 parts of dragon's blood, 20 parts of drynaria rhizome, 20 parts of mistletoe, 20 parts of ground beetle, 20 parts of earthworm, 20 parts of bletilla striata, 20 parts of raw pinellia tuber, 20 parts of common monkshood mother root, 20 parts of raw arisaema tuber, 20 parts of centipede, 20 parts of leech, 20 parts of radix angelicae pubescentis, 20 parts of cortex acanthopanacis, 20 parts of kaempferia galanga, 20 parts of radix angelicae, 20 parts of Chinese angelica, 20 parts of liquorice, 20 parts of turmeric, 20 parts of dried orange peel, 20 parts of Chinese yam and 20 parts of rhizoma polygonati;

The medicinal liquor comprises the following raw materials in parts by mass: 15 parts of achyranthes, 15 parts of herb of Dali, 50 parts of scorpion, 20 parts of radix clematidis, 10 parts of frankincense, 20 parts of cinnamon, 15 parts of fennel, 15 parts of dried orange peel, 20 parts of Chinese yam, 20 parts of rhizoma polygonati, 50 parts of honey and 1000 parts of white spirit.

Preferably, the degree of the white spirit is 40-45 degrees.

The invention also provides a preparation method of the pharmaceutical composition, which comprises the following steps:

(1) Pulverizing Moschus, eucommiae cortex, radix Aconiti Kusnezoffii, myrrha, carthami flos, radix astragali, semen Strychni, rhizoma Ligustici Chuanxiong, flos Lonicerae, mume fructus, sanguis Draxonis, rhizoma Drynariae, herba Taxilli, eupolyphaga Seu Steleophaga, lumbricus, rhizoma Bletillae, rhizoma Pinelliae, radix Aconiti, rhizoma arisaematis, scolopendra, hirudo, radix Angelicae Pubescentis, cortex Acanthopancis, rhizoma Kaempferiae, radix Angelicae Dahuricae, radix Angelicae sinensis, glycyrrhrizae radix, curcuma rhizome, pericarpium Citri Tangerinae, rhizoma Dioscoreae, and rhizoma Polygonati to obtain medicinal powder;

(2) Pulverizing Achyranthis radix, herba Herminii, scorpio, radix Clematidis, olibanum, cortex Cinnamomi, fructus Foeniculi, pericarpium Citri Tangerinae, rhizoma Dioscoreae, and rhizoma Polygonati, adding Mel, and soaking in Chinese liquor to obtain medicated liquor.

Preferably, the particle size after the pulverization in the step (1) is 70 to 80 mesh.

Preferably, the particle size after crushing in the step (2) is less than 10mm.

Preferably, during the soaking in the step (2), stirring is carried out 1-2 times per day.

Preferably, the soaking time in the step (2) is as follows: soaking in summer for 12-16 days and in winter for 20-30 days.

The invention also provides an application of the pharmaceutical composition or the pharmaceutical composition prepared by the preparation method in preparing medicines for treating the herniated disk and complications thereof.

The invention also provides an application of the pharmaceutical composition or the pharmaceutical composition prepared by the preparation method in preparing medicines for treating scapulohumeral periarthritis, periostitis, synovitis, meniscus injury, fasciitis, arthritis or traumatic injury.

The dried orange peel in the pharmaceutical composition is a common traditional Chinese medicinal material and belongs to a variety in a medicine-food homologous catalogue issued by the national administration of traditional Chinese medicine. Modern scientific researches show that the dried orange peel has high volatile oil content up to 1.5-2%, and is easy to be absorbed by human skin. The medicine is an external medicine, and the volatile oil in the dried orange peel can be used as a carrier to effectively bring other traditional Chinese medicine components into the human body, so that the medicine can directly reach focus more quickly. The dried orange peel is used as an external medicine for orthopaedics and is also the initiative of the recipe. In the volatile oil of the dried orange peel, the limonene occupies high proportion, and the limonene has strong antioxidation, bacteriostasis and anti-inflammatory effects, and has therapeutic effects on hyperosteogeny, degeneration of nucleus pulposus and inflammation around vertebral bodies of patients. In addition, the important point is that the limonene has strong convergence effect on the soft tissues of the human body, and the intervertebral disc is the soft tissues, so that the limonene can promote the retraction of the marrow body and promote the convergence and the recovery elasticity of the fibrous ring, thereby playing a role in treatment fundamentally. In modern times, limonene is often used for scar removal of wounds on the surface of the human body, and the principle is also its converging effect. The soft tissue of the intervertebral disc is corrected to be protruded, so that the intervertebral disc is retracted, the medical problem is precisely solved, and the combination of the dried orange peel and other traditional Chinese medicine raw materials in the recipe has the functions of a carrier and a self treatment function.

The Chinese yam in the pharmaceutical composition is a common Chinese medicinal material and belongs to a variety in a medicine-food homologous catalogue issued by the national administration of Chinese medicine. In the traditional Chinese medicine literature, japanese Chinese herbal medicine, chinese yam is explained to assist five viscera and strengthen tendons and bones. This is a major property of yam in addition to dietary supplements. The intervertebral disc is a very special tissue in human body, and the inside of the intervertebral disc is not provided with blood vessels capable of conveying nutrient substances after the human adult. The oral administration does not substantially reach the focus and is not substantially effective. Chinese yam mainly tonifies kidney in the theory of traditional Chinese medicine. The traditional Chinese medicine considers that the kidney governs bones, the liver governs tendons, and the waist is the house of the kidney. So as to tonify kidney and strengthen waist bones. The Chinese yam is added as the theoretical basis of the traditional Chinese medicine of the formula. In addition, according to the research of modern pharmacology, the Chinese yam is rich in polysaccharide, total flavone and Chinese yam enol, and has strong oxidation resistance. Has obvious delaying effect on hyperosteogeny and ligament aging caused by common vertebra aging in patients of this type, and has the effect of improving reversibility. The yam is also rich in allantoin, and the allantoin has the paralytic and analgesic effects and can alleviate the pain of patients. Studies have shown that allantoin can also promote growth of the annulus fibrosus, such as the prescribed drug allantoin aluminum flake, which is used to promote growth of bone mucosa in a morphology similar to that of the annulus fibrosus. And the degeneration and rupture of the annulus fibrosus is the most typical sign in the present case, and the repair and regeneration of the annulus fibrosus is also a medical problem at present. There are no specific drugs other than surgery. However, yam has special repairing and growth promoting functions on intervertebral discs, marrow bodies and annulus fibrosus.

The rhizoma polygonati in the pharmaceutical composition is a common traditional Chinese medicinal material and belongs to a variety in a medicine-food homologous catalogue issued by the national administration of traditional Chinese medicine. In traditional Chinese medicine, it is mainly used for food supplement and mainly has the effects of blackening hair and reducing three highs. But never used for external application, nor in any ancient and modern literature and any known prescription for the treatment of orthopedic disorders. The addition of Polygonatum sibiricum in the formulation is also the most important discovery and innovation of the formulation. The diseases of the intervertebral discs are difficult to treat because most of them are caused by lesions in the soft tissues of the human body. The nucleus pulposus, annulus fibrosus, cartilage end plates, ligaments, are all soft tissues. Rhizoma Polygonati contains a large amount of natural steroid saponins, and French and Soviet Union scientists research shows that the natural steroid saponins have bioactivity and can be used for treating arthritis, cartilage tissue and periosteum lesions. And there is no viable treatment for the lesions or degeneration of the cartilage end plates of the intervertebral disc. Rhizoma Polygonati, however, may be the solution because of the significant effect in the practice of the present invention. Modern researches have also shown that rhizoma Polygonati contains polysaccharides with a total polysaccharide content of about 11.7%. The nucleus pulposus of human body is elastic jelly material comprising chondrocyte and proteoglycan and has water content of 80-90%. With the age of human body, proteoglycan depolymerization is increased, and the polymerization state of protein molecules is converted into a monomer state, so that elasticity is lost, which is the root cause of marrow degeneration. The rhizoma polygonati can increase the proteoglycan of the marrow body, resist depolymerization and restore elasticity, thereby achieving the purpose of treatment. In intervertebral disc diseases, the problem of degeneration, aging and damage of the annulus fibrosus of the nucleus pulposus is one of the basic symptoms and is most common and difficult to treat. Modern researches show that rhizoma polygonati contains abundant anthraquinone compounds, and the compound can promote the generation of blood platelets, obviously increase fibrinogen, and the fibrinogen is the material basis for generating fibrous rings, so that the anti-attenuation and regeneration recovery activities of fibrous rings outside marrow bodies are facilitated.

The invention provides a pharmaceutical composition for treating herniated disk and complications thereof, and a preparation method and application thereof. The formula with homology of medicine and food of three ingredients of dried orange peel, chinese yam and rhizoma polygonati is added on the basis of the traditional classical prescription, so that the treatment effect is remarkable. After the curative effect is obtained in practice, a large number of analysis and research are carried out, and related theoretical basis is found, so that the final composition of the traditional Chinese medicine is determined, and 38 medicines are taken in total and are all common traditional Chinese medicine raw materials. Except for three innovative formulas of dried orange peel, chinese yam and rhizoma polygonati, other 35 medicinal materials are external application traditional Chinese medicine raw materials which are frequently used in traditional meridian formulas and modern traditional Chinese medicine prescriptions, and the safety and the curative effect are fully confirmed through countless practical verification.

The invention provides a brand new effective external application treatment scheme for treating the herniated disk and complications thereof by compounding 38 medicinal materials, preparing wine by adopting a cold extraction method, physically mixing medicinal powder, and separately placing the medicinal wine and the medicinal powder for mixed use during treatment.

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

1. the total effective rate is up to 93.5%, the cure rate is 89%, and the recurrence rate is lower than 5%.

2. The treatment is convenient, quick and simple at any time and any place.

3. Low cost and low price.

4. The traditional Chinese medicine composition has comprehensive functions and wide pertinence, is specially used for treating lumbar and cervical disc herniation, can also be used for treating a series of orthopedic diseases such as scapulohumeral periarthritis, periostitis, synovitis, meniscus injury, fasciitis, arthritis, traumatic injury and the like, and can be applied in the early, middle and late stages.

Drawings

FIG. 1 shows the results of pre-and post-treatment diagnosis of a clinical patient using the pharmaceutical composition of the present invention. Wherein, the left graph is before treatment, and the right graph is after treatment.

FIG. 2 shows the results of pre-and post-treatment diagnosis of a clinical patient using the pharmaceutical composition of the present invention. Wherein, the left graph is before treatment, and the right graph is after treatment.

FIG. 3 shows the results of pre-and post-treatment diagnosis of a clinical patient using the pharmaceutical composition of the present invention. Wherein, the left graph is before treatment, and the right graph is after treatment.

FIG. 4 shows the results of pre-and post-treatment diagnosis of a clinical patient using the pharmaceutical composition of the present invention. Wherein, the left graph is before treatment, and the right graph is after treatment.

Fig. 5 shows the results of pre-and post-treatment diagnosis of a clinical patient using the pharmaceutical composition of the present invention. Wherein, the left graph is before treatment, and the right graph is after treatment.

FIG. 6 shows the results of pre-and post-treatment diagnosis of a clinical patient using the pharmaceutical composition of the present invention. Wherein, the left graph is before treatment, and the right graph is after treatment.

FIG. 7 shows the results of pre-and post-treatment diagnosis of a clinical patient using the pharmaceutical composition of the present invention. Wherein, the left graph is before treatment, and the right graph is after treatment.

FIG. 8 shows the results of pre-and post-treatment diagnosis of a clinical patient using the pharmaceutical composition of the present invention. Wherein, the left graph is before treatment, and the right graph is after treatment.

Fig. 9 shows the results of pre-and post-treatment diagnosis of a clinical patient using the pharmaceutical composition of the present invention. Wherein, the left graph is before treatment, and the right graph is after treatment.

Fig. 10 shows the results of pre-and post-treatment diagnosis of a clinical patient using the pharmaceutical composition of the present invention. Wherein, the left graph is before treatment, and the right graph is after treatment.

Detailed Description

The technical solutions provided by the present invention are described in detail below with reference to examples, but they should not be construed as limiting the scope of the present invention.

Example 1

The embodiment provides a pharmaceutical composition for treating the protrusion of the intervertebral disc and complications thereof.

The medicine comprises the following components:

Powder: 0.05 part of musk, 20 parts of eucommia ulmoides, 20 parts of kusnezoff monkshood root, 20 parts of myrrh, 20 parts of safflower, 20 parts of astragalus membranaceus, 20 parts of nux vomica, 20 parts of szechuan lovage rhizome, 20 parts of honeysuckle, 20 parts of dark plum fruit, 20 parts of dragon's blood, 20 parts of drynaria rhizome, 20 parts of mistletoe, 20 parts of ground beetle, 20 parts of earthworm, 20 parts of bletilla striata, 20 parts of raw pinellia tuber, 20 parts of common monkshood mother root, 20 parts of raw arisaema tuber, 20 parts of centipede, 20 parts of leech, 20 parts of radix angelicae pubescentis, 20 parts of cortex acanthopanacis, 20 parts of kaempferia galanga, 20 parts of radix angelicae, 20 parts of Chinese angelica, 20 parts of liquorice, 20 parts of turmeric, 20 parts of dried orange peel, 20 parts of Chinese yam and 20 parts of rhizoma polygonati;

Medicated wine: 15 parts of achyranthes, 15 parts of herb of Dali, 50 parts of scorpion, 20 parts of radix clematidis, 10 parts of frankincense, 20 parts of cinnamon, 15 parts of fennel, 15 parts of dried orange peel, 20 parts of Chinese yam, 20 parts of rhizoma polygonati, 50 parts of honey and 1000 parts of white spirit (45 degrees).

The manufacturing method comprises the following steps: the raw materials in the medicine powder are dried in the sun, ground into powder (75 meshes), stirred uniformly, packaged and sealed by a gauze bag according to the specification of 150 g/bag. Grinding the raw materials in the medicated liquor (diameter smaller than 10 mm), adding Mel, soaking in Chinese liquor at normal temperature (15 days in summer and 25 days in winter), stirring for 1 time a day, and filtering to remove residue.

The using method comprises the following steps: the medicinal powder is packed and placed flatly, the medicinal bag is moistened by medicinal liquor, then the medicinal liquor is applied to the affected part, and the bandage is fixed. The time of day and night is 8-10 hours per day, and the time can be accumulated for each time not less than 2 hours, and can be 8-10 hours per time. The medicated bag can be repeatedly used for seven days every 150 g, and half a jin of medicated liquor is prepared. Four bags of medicinal powder per month and 2 jin of medicinal liquor are taken as a treatment course.

Comparative example 1

Arthralgia paste (traditional Chinese medicine for treating lumbar disc herniation and cervical disc herniation in traditional meridian prescription)

The medicine comprises the following components: radix aconiti 80g, radix aconiti kusnezoffii 80g, ligusticum wallichii 80g, radix clematidis 80g, scorpion 80g, eupolyphaga 80g, frankincense 80g, garden balsam stem 8 g, myrrh 80g, rheum officinale 80g, eucommia ulmoides 80g, dipsacus root 80g, stiff silkworm 80g, radix angelicae 80g, radix salviae miltiorrhizae 80g, rhizoma drynariae 80g, polygala tenuifolia 80g, borneol 80g, radix scutellariae 80g, phellodendron 80g, turmeric 80g, earthworm 80g, rhizoma kaempferiae 80g, radix sophorae flavescentis 80g, dried ginger 80g, radix stephaniae tetrandrae 80g and liquorice 80 g.

The preparation process comprises the following steps: the raw material medicines are ground into very fine powder, 2% (w/w) of 72-6 transdermal agent is added, and the hydrogel arthralgia medicine patch is prepared by adopting a hydrogel technology.

The using method comprises the following steps: is applied to the affected part for 1 patch/48 hr for 20 days/1 course of treatment.

Comparative example 2

Dogskin plaster (classical prescription in traditional pharmacopoeia, used for treating various kinds of waist soreness and back pain, most commonly used for patients suffering from lumbar and cervical vertebra diseases)

The medicine comprises the following components: 80g of raw radix aconiti, 40g of raw radix aconiti kusnezoffii, 20g of notopterygium root, 20g of radix angelicae pubescentis, 30g of cortex acanthopanacis, 30g of caulis sinomenii, 30g of radix saposhnikoviae, 30g of radix clematidis, 20g of rhizoma atractylodis, 20g of fructus cnidii, 30g of ephedra, 20g of fennel, 10 g of cinnamon, 20g of angelica sinensis, 30g of radix paeoniae rubra, 30g of pawpaw, 30g of sappan wood, 30g of ligusticum wallichii, 30g of radix angelicae, 60 g of breast milk, 15 g of clove, 10 g of rhizoma galangae, 15 g of borneol and 30g of camphor; fine material: 60 g of Rufei, 15 g of clove, 10 g of cinnamon, 10 g of galangal, 15 g of borneol and 30g of camphor, and grinding into fine powder.

The manufacturing method comprises the following steps: grinding radix Rumicis, flos Caryophylli, cortex Cinnamomi, rhizoma Alpiniae Officinarum, borneolum Syntheticum, and Camphora into fine powder; soaking the rest raw materials in 1750 g of oleum Sesami (spring and autumn 5 days, summer 4 days, winter 10 days), decocting with strong fire, decocting with slow fire, removing residues, adding 350 g of Plumbum Preparatium, dripping water, beading, adding fine powder, stirring, and spreading on paper.

The using method comprises the following steps: the composition can be applied to affected parts by oven drying.

Comparative example 3

Bone-reinforcing powder (modern traditional Chinese medicine general prescription, external application for treating various diseases of herniated disk)

The medicine comprises the following components: 10 g of radix aconiti, 10 g of radix aconiti kusnezoffii, 12 g of rhizoma arisaematis, 6 g of rhizoma drynariae, 10 g of rosin, 12 g of raw pinellia tuber, 10 g of Chinese angelica, 10 g of safflower, 10 g of radix clematidis, 5g of asarum, 10 g of notopterygium root, 10 g of radix angelicae pubescentis, 3 g of borneol, 10 g of camphor, 12 g of rheum officinale, 10 g of peach seed and 5g of white mustard seed.

The manufacturing method comprises the following steps: the above medicines are ground into powder (medicinal powder is commonly used in the prior art to maintain the fragrance of the medicine). A gauze bag was prepared, which was about 20cm long and about 15cm wide. Mixing the above medicinal powder with vinegar, making into paste, parching in a pan (should not be too hot, should be kept in mind), and packaging into gauze bag.

The using method comprises the following steps: the plaster is applied by ironing with the pain point of waist as the center, each time for half an hour, 2 times a day. The medicine can be repeatedly used for 1 week.

Comparative example 4

Novel black plaster

The medicine comprises the following components:

Group A: 45 g of ephedra herb, 50g of common jasminorange herb, 50g of kadsura pepper stem, 50g of notopterygium root, 35 g of cassia twig, 30g of raw nux vomica, 10 g of pseudo-ginseng, 15g of raw dragon bone, 15g of prepared beetle, 30g of rhizoma typhonii, 20 g of frankincense, 20 g of myrrh, 30g of fructus piperis longi, 20 g of kadsura longepedunculata, 25 g of radix scrophulariae, 40 g of angelica sinensis, 35 g of schizonepeta, 30g of honeysuckle flower, 40 g of pericarpium zanthoxyli, 45 g of dried ginger, 30g of semen cassiae, 45 g of pawpaw, 40 g of szechuan lovage rhizome, 50g of achyranthes root, 50g of eucommia bark, 40 g of raw radix aconiti, 40 g of raw arisaema tuber, 40 g of raw pinellia tuber, 50g of gleditsia sinensis lam and 50g of Yunnan one-branch of tart;

Group B: 12 g of flos caryophylli and dragon's blood respectively, 20 g of ground beetle, stir-fried semen mesonae chinensis, calcined native copper, safflower, dipsacus root, centipede, gallnut, buffalo horn powder respectively, 6g of frankincense and myrrh respectively, and grinding into medicinal powder.

The manufacturing method comprises the following steps: decocting the medicine in the formula A with water for three times, filtering the decoction in the first two times for three hours, filtering the decoction in the third time for two hours, and mixing the three filtrates to obtain fluid extract; 1000 g of medical pressure-sensitive thermosol is put into a pot for heating and melting, the medicine powder of the group B is slowly added into the pot for uniform stirring, then the fluid extract and 50 ml of azone are added, stirring is continued, and then the plaster is spread.

The using method comprises the following steps: is applied to the affected part for more than 12 hours per day after heating.

Experimental example 1

In 2004-2009, in 400 clinical cases, the treatment was performed with the drugs of comparative examples 1-4 in crossover. In 2015-2023, the pharmaceutical composition of example 1 was used for treatment in 3335 clinical cases (partial case information is shown in fig. 1-10).

The screening criteria and treatment criteria for clinical cases are as follows:

Diagnostic criteria (including patients for whom one or more are suitable for the present therapy): imaging medical examination results show that the intervertebral disc herniation bulges or slips, the intervertebral space narrows, the medullary body is atrophic, the annulus fibrosus is damaged, the annulus fibrosus breaks, the physiological curvature straightens, the vertebral degeneration, the ligament aging, the ligament hyperplasia, the yellow zone thickening, the vertebral bone hyperplasia, the medullary body compression, the intracavity effusion, the spinal canal stenosis and the isthmus fracture. Clinically, patients have obvious pain and tingling sensation in parts, local movement is inconvenient or impossible, and one or more postures of sitting, lying and standing cannot be sustained.

Treatment criteria: effective-the sensation of ache and numbness is reduced or eliminated, and the local recovery action is free.

Cure-complete disappearance of symptoms, free recovery action, and image review shows disappearance of original focus or benign recovery.

Ineffective-no change in symptoms.

Recurrence-recurrence of symptoms within 5 years.

The therapeutic effects are shown in table 1.

Table 1 therapeutic effects of each group of drugs

In 400 cases from 2004 to 2009, the traditional prescription drugs of comparative examples 1 to 4 were used, and the total effective rate was found to be low. Moreover, the effective rate of the comparative example 1 for treating the early and middle lumbar disc herniation is about 40%, and the effect on patients with narrow intervertebral space and ligament aging is not obvious; the effective rate of the cervical disc herniation in the middle period is about 35%, but has no obvious effect on scapulohumeral periarthritis caused by cervical vertebra problems; for advanced patients, the efficacy drops below 25%; the effective period of the treatment is generally 2-3 years, and the recurrence rate is about 65%. Comparative example 2 mainly has the effects of easing pain and diminishing inflammation, has obvious analgesic effect, and is used for the conservation treatment of most patients, but the symptoms and the root causes are not treated; pain relieving and inflammation diminishing often recurs in a few weeks; in the application process, the ephedra and the camphor in the prescription are allergic traditional Chinese medicines, so that a lot of patients can easily react to stop the application after applying the medicine for 3-5 days, the curative effect is poor, and the application range is small. Comparative example 3 treatment of vertebral hyperosteogeny, aging of the edges of the vertebral bodies was effective, but it was basically ineffective against cartilage endplate degeneration, herniated disc, and ligament aging lesions. Comparative example 4 has good effect on treating cervical and lumbar disc herniation, hyperosteogeny and ligament aging, and the effective rate is 60%; however, the medicine has no curative effect on soft tissue aging symptoms such as broken annulus fibrosus, degeneration of marrow and the like, and is difficult to radically cure without recurrence.

After 2009, formula adjustment is carried out, and the combination of the 38 formulas is finally determined, wherein the total effective rate is 88% and the total cure rate of treatment reaches 75% and the recurrence rate is 3.8% in more than 1600 patients in 2009-2015.

In terms of manufacturing methods, practice of about six years from 2009 to 20015 has been growed for 1600 cases of clinical applications. Firstly, traditional Chinese medicinal materials are changed into normal-temperature purified water for soaking and naturally evaporating, and the rest solid dregs are taken and then added with medicinal liquor to be mixed into ointment. It is gradually found that the traditional Chinese medicine raw materials are directly soaked in wine and mixed into paste. Finally, the method that part of traditional Chinese medicine materials and medicinal liquor are separately placed without adopting an ointment mode and are mixed when in use is found, so that the medicinal effect can be reflected to the greatest extent, and the use is convenient. The external application therapy with the brand new formula is finally invented, and comprises two parts of medicinal liquor infused by a cold extraction method and a natural medicinal powder package. 2015 to 2023, in 3335 clinical cases, the method was adopted. The total effective rate is 93.5%, the cure rate is 89%, and the recurrence rate (defined as recurrence within 5 years) is 4%.

The patient diseases treated by the method are shown in, for example, fig. 1 to 10, wherein the left graph is the diagnosis result before treatment, and the right graph is the diagnosis result after treatment.

Fig. 1 shows, prior to treatment: lumbar swelling and sacral cyst are present in lumbar region 2/3, lumbar region 3/4, lumbar region 4/5, lumbar region 5/sacral region 1. The right patellar ankle bone is damaged, the intracavitary effusion, and the anterior and posterior horn of the lateral meniscus are degenerated. Lumbago, leg numbness, and difficulty in going up and down stairs. The lumbar and right knees were each applied for 45 days. After treatment: the symptoms disappeared and the patient had no pain sensation (except for the anterior meniscus degeneration) and was free to move.

Fig. 2 shows, prior to treatment: lumbar vertebra straightens, lumbar vertebra 4/5, lumbar vertebra 5/sacrum 1 herniated disk, walks for a long distance, and runs all have ache. The medicine is applied to the waist for 30 days. After treatment: the symptoms disappear, and the patient has no pain and moves freely.

Fig. 3 shows, prior to treatment: herniated disk of neck 2-7, compression of marrow of neck 2-6, poor curvature of cervical vertebra and hyperplasia of posterior longitudinal ligament. Dizziness, hypertension and head movement obstruction of patients are serious. The medicine is applied to the neck for 60 days. After treatment: the symptoms disappear, and the patient has no pain and moves freely.

Fig. 4 shows, prior to treatment: lumbar hyperosteogeny, 4/5 of lumbar, 5/1 of lumbar intervertebral disc herniation, and the pain and tingling of the buttocks and the legs of the patient can not go far. The medicine is applied to the waist for 30 days. After treatment: the symptoms disappear, and the patient has no pain and moves freely.

Fig. 5 shows, prior to treatment: the cervical vertebra 5/6, the cervical vertebra 6/7 and the intervertebral disc are obviously protruded, and the curvature of the cervical vertebra is straightened. Stiffness in the neck, with tingling, pain, difficulty in head movement, dizziness. The medicine is applied to the neck for 45 days. After treatment: the neck 6/7 is slightly protruded, no pain is felt, other symptoms disappear, and the head moves freely.

Fig. 6 shows, prior to treatment: lumbar vertebra L5 slipping, lumbar vertebral arch isthmus cracking, 4/5 lumbar vertebra, 1 lumbar vertebra gap narrowing, unstable walking of patients and lumbar pain. The medicine is applied to the waist for 45 days. After treatment: the symptoms disappear, the waist of the patient has no pain, and the patient walks freely.

Fig. 7 shows, prior to treatment: lumbar vertebra hyperostosis, multiple end plate inflammation of vertebral body, 4/5 of lumbar, 5/1 of lumbar and 1 of sacral space narrowing, pain and soreness of the waist of patients. The medicine is applied to the waist for 30 days. After treatment: the symptoms disappear, and the patient has no pain.

Fig. 8 shows, prior to treatment: lumbar 4/5 disc herniation, lumbar 5/sacral 1 disc herniation, degeneration. The patient has obvious pain feeling on buttocks and thighs, local tingling and difficult walking. The medicine is applied to the waist for 30 days. After treatment: only the 4/5 lumbar intervertebral disc is slightly protruded, the rest symptoms disappear, no pain is felt, and the movement is free.

Fig. 9 shows, prior to treatment: the curvature of cervical vertebra becomes straight, cervical vertebra 2/3,3/4,5/6 intervertebral disc herniation, marrow body compression, calcification of C4/5, C5/6 anterior longitudinal ligament, and stiffness of the neck of the patient with dizziness, dim eyesight and shoulder pain. The medicine is applied to the neck for 60 days. After treatment: the symptoms disappear, and the pain feeling of the shoulder disappears. The symptoms of the front and rear edges of the C3-7 vertebral body are obviously improved.

Fig. 10 shows, prior to treatment: lumbar 4/5, lumbar 5/sacral 1 herniated disk, dural sac compression, spinal stenosis, lumbar degeneration. Lumbar 3-5 vertebrae hyperosteogeny. The medicine is applied to the waist for 35 days. After treatment: the symptoms disappear, and only the lumbar 3 vertebral body has hyperplasia symptoms. The pain disappears and the movement is free.

Conclusion: the invention is an external traditional Chinese medicine treatment method, has innovative and reasonable formula, has the basis of the traditional meridian formula and the modern scientific demonstration, has environment-friendly preparation process, and has the advantages of easily obtained and economical raw materials and no toxic or side effect. The finished product has the advantages of reasonable price, simple and convenient use, high cure rate up to 89%, high popularization value and great practical significance, and is an effective means for treating the herniated disk and complications thereof.

The foregoing is merely a preferred embodiment of the present invention and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the present invention, which are intended to be comprehended within the scope of the present invention.

Claims

1. A pharmaceutical composition for treating herniated disk and complications thereof, which is characterized in that the pharmaceutical composition comprises medicinal powder and medicinal liquor;

2. The pharmaceutical composition according to claim 1, wherein the medicinal powder comprises the following raw materials in parts by mass: 0.05 part of musk, 20 parts of eucommia ulmoides, 20 parts of kusnezoff monkshood root, 20 parts of myrrh, 20 parts of safflower, 20 parts of astragalus membranaceus, 20 parts of nux vomica, 20 parts of szechuan lovage rhizome, 20 parts of honeysuckle, 20 parts of dark plum fruit, 20 parts of dragon's blood, 20 parts of drynaria rhizome, 20 parts of mistletoe, 20 parts of ground beetle, 20 parts of earthworm, 20 parts of bletilla striata, 20 parts of raw pinellia tuber, 20 parts of common monkshood mother root, 20 parts of raw arisaema tuber, 20 parts of centipede, 20 parts of leech, 20 parts of radix angelicae pubescentis, 20 parts of cortex acanthopanacis, 20 parts of kaempferia galanga, 20 parts of radix angelicae, 20 parts of Chinese angelica, 20 parts of liquorice, 20 parts of turmeric, 20 parts of dried orange peel, 20 parts of Chinese yam and 20 parts of rhizoma polygonati;

3. The pharmaceutical composition according to claim 1 or 2, wherein the degree of white spirit is 40-45 degrees.

4. A process for the preparation of a pharmaceutical composition according to any one of claims 1 to 3, comprising the steps of:

5. The method according to claim 4, wherein the particle size after pulverization in the step (1) is 70 to 80 mesh.

6. The method according to claim 4, wherein the particle size after pulverization in the step (2) is less than 10mm.

7. The method according to claim 4, wherein the soaking in step (2) is performed with stirring 1 to 2 times per day.

8. The method according to claim 4, wherein the soaking time in step (2) is: soaking in summer for 12-16 days and in winter for 20-30 days.

9. Use of a pharmaceutical composition according to any one of claims 1 to 3 or a pharmaceutical composition prepared by a method according to any one of claims 4 to 8 for the manufacture of a medicament for the treatment of herniated disc and complications thereof.

10. Use of a pharmaceutical composition according to any one of claims 1 to 3 or a pharmaceutical composition prepared by a method according to any one of claims 4 to 8 in the manufacture of a medicament for the treatment of scapulohumeral periarthritis, periostitis, synovitis, meniscus injury, fasciitis, arthritis or traumatic injury.