CN107929646B

CN107929646B - Traditional Chinese medicine composition and pill for treating syringomyelia and preparation method thereof

Info

Publication number: CN107929646B
Application number: CN201711366722.9A
Authority: CN
Inventors: 郭永昌; 宫顺国; 宜娟娟; 石文忠; 林辉; 陈熙; 刘红月
Original assignee: ZHENGZHOU TRADITIONAL CHINESE HOSPITAL OF ORTHOPAEDICS
Current assignee: ZHENGZHOU TRADITIONAL CHINESE HOSPITAL OF ORTHOPAEDICS
Priority date: 2017-12-18
Filing date: 2017-12-18
Publication date: 2021-03-26
Anticipated expiration: 2037-12-18
Also published as: CN107929646A

Abstract

The invention discloses a traditional Chinese medicine composition for treating syringomyelia, a pill and a preparation method thereof, wherein the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 232-248 parts of astragalus membranaceus, 232-248 g of semen coicis, 114-126 g of prepared rehmannia root, 114-126 g of parasitic loranthus, 90-100 g of rhizoma cibotii, 32-40 g of cinnamon, 44-52 g of fructus amomi, 44-52 g of pericarpium citri reticulatae and 69-75 g of lumbricus. The traditional Chinese medicine composition for treating syringomyelia of the invention utilizes the action advantages and mutual synergistic action of the raw materials of the traditional Chinese medicines, mainly strengthens spleen and kidney, benefits essence and fills marrow, and aims at correcting limb numbness, pain and warmness, muscle atrophy, paralysis and weakness, soreness and weakness of waist and knees, chilly sensation and cold limbs of flaccidity caused by spleen and kidney deficiency. The Chinese medicinal composition has reasonable composition, and is suitable for patients to take without discomfort.

Description

Traditional Chinese medicine composition and pill for treating syringomyelia and preparation method thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicine compounds, and in particular relates to a traditional Chinese medicine composition and a traditional Chinese medicine pill for treating syringomyelia and a preparation method thereof.

Background

Syringomyelia is a chronic progressive degenerative disease of the spinal cord, which is clinically characterized by discrete sensory disturbances (pain sensation, disappearance of temperature sensation, presence of touch), muscular atrophy and dystrophies appearing in the affected segment. The pathological changes are mostly in the lower neck marrow and the upper chest marrow, and can also progress upwards to bulbar, which is called bulbar cavernosis, also called globoid cavernosis; and may progress down to the lower thoracic and even lumbosacral medulla.

Syringomyelia belongs to the category of flaccidity syndrome, consumptive disease and other diseases of traditional Chinese medicine. The spleen and kidney deficiency syndrome at the late stage of flaccidity syndrome is manifested by numbness of limbs, pain and warmth, muscular atrophy, paralysis, weakness, soreness of waist and knees, aversion to cold, cold limbs, abdominal distention, loose stool, pale tongue, swollen body with teeth marks, thin and white fur, and deep and thready pulse. Many people lose their ability to do work due to the lingering course of the disease and recurrent attacks. Thus, a great burden is imposed on the patient and the society.

Disclosure of Invention

In view of the above, the present invention provides a new traditional Chinese medicine composition for treating syringomyelia, a new pill and a new preparation method thereof.

One embodiment of the invention provides a traditional Chinese medicine composition for treating syringomyelia, which comprises the following raw materials in parts by weight: 232-248 parts of astragalus membranaceus, 232-248 parts of semen coicis, 114-126 parts of prepared rehmannia root, 114-126 parts of parasitic loranthus, 90-100 parts of rhizoma cibotii, 32-40 parts of cinnamon, 44-52 parts of fructus amomi, 44-52 parts of pericarpium citri reticulatae and 69-75 parts of lumbricus.

In the above traditional Chinese medicine composition for treating syringomyelia: 235-245 parts of astragalus; 235 to 245 portions of coix seed.

In the above traditional Chinese medicine composition for treating syringomyelia: 117-123 parts of prepared rehmannia root; 117-123 parts of parasitic loranthus; 94-98 parts of rhizoma cibotii; 34-38 parts of cinnamon.

In the above traditional Chinese medicine composition for treating syringomyelia: 46-50 parts of fructus amomi; 46-50 parts of dried orange peel; 70-73 parts of earthworm.

In the above traditional Chinese medicine composition for treating syringomyelia: 240 parts of astragalus; 240 parts of coix seeds; prepared rehmannia root 120 parts; 120 portions of loranthus parasiticus; 96 parts of rhizoma cibotii; 36 parts of cinnamon; 48 parts of fructus amomi; 48 parts of dried orange peel; 72 parts of earthworm.

Another embodiment of the present invention provides a pill for treating syringomyelia, which comprises the above-mentioned Chinese medicinal composition.

In the above-mentioned pill for treating syringomyelia: every 100 parts of the traditional Chinese medicine composition is also added with 1-3 parts of starch, 0.1-0.2 part of microcrystalline cellulose and 10-20 parts of honey.

In another embodiment of the present invention, there is provided a method for preparing a pill for the treatment of syringomyelia, the pill comprising the above-mentioned Chinese medicinal composition for the treatment of syringomyelia; the preparation method comprises the following steps: and crushing the raw materials and uniformly mixing to obtain powder.

In the above method for preparing a pill for the treatment of syringomyelia: mixing and stirring 100 parts of the powder, 1-3 parts of starch, 0.1-0.2 part of microcrystalline cellulose, 10-20 parts of honey and 25-45 parts of pure water, and then preparing wet pills.

In the above method for preparing a pill for the treatment of syringomyelia: drying the wet pills to a moisture content of less than 5% (by weight) to obtain plain pills, coating the plain pills with activated carbon and polishing with talcum powder, wherein 0.45-0.55 part of activated carbon and 0.45-0.55 part of talcum powder are used per 100 parts of plain pills.

The Chinese medicinal composition for treating syringomyelia selects pure natural Chinese medicinal raw materials, takes astragalus and coix seeds as monarch medicaments, takes prepared rehmannia root, parasitic loranthus, east Asian tree fern rhizome and cassia bark as ministerial medicaments, takes amomum fruit and dried orange peel as adjuvant medicaments, takes earthworm as a conductant medicament, comprehensively utilizes the action advantages and mutual synergistic action of the Chinese medicinal raw materials, mainly strengthens the spleen and tonifies the kidney, benefits the essence and fills the marrow, and aims at correcting limb numbness, pain and warmth, muscle atrophy, paralysis and weakness, soreness and weakness of waist and knees, intolerance of cold and cold limbs caused by deficiency of spleen and kidney. The prescription has reasonable composition, no discomfort feeling during the taking of patients and is beneficial to the taking of patients.

In addition, compared with western medicines, the traditional Chinese medicine composition for treating syringomyelia has low cost, is safe to use, and has no pain and toxic or side effect.

In order to make the aforementioned and other objects, features and advantages of the invention more comprehensible, preferred embodiments accompanied with figures are described in detail below.

Detailed Description

In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention.

This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.

When an amount, concentration, or other value or parameter is expressed as a range, preferred range, or as a range of upper preferable values and lower preferable values, this is to be understood as specifically disclosing all ranges formed from any pair of any upper range limit or preferred value and any lower range limit or preferred value, regardless of whether ranges are separately disclosed. For example, when the range "1 ~ 5" is disclosed, the ranges described should be construed to include the ranges "1 ~ 4", "1 ~ 3", "1 ~ 2 and 4 ~ 5", "1 ~ 3 and 5", and the like. When a range of values is described herein, unless otherwise stated, the range is intended to include the endpoints thereof and all integers and fractions within the range.

One embodiment of the invention provides a traditional Chinese medicine composition for treating syringomyelia, which comprises the following raw materials in parts by weight:

232-248 parts of astragalus root such as 234 parts, 236 parts, 238 parts, 240 parts, 242 parts, 244 parts or 246 parts. The astragalus is preferably 235 to 245 parts, and more preferably 240 parts.

232-248 parts of coix seed such as 234 parts, 236 parts, 238 parts, 240 parts, 242 parts, 244 parts or 246 parts. The coix seed is preferably 235-245 parts, and more preferably 240 parts.

Prepared rehmannia root 114-126 parts such as 116 parts, 118 parts, 120 parts, 122 parts or 124 parts. The prepared rehmannia root is preferably 117-123 parts; more preferably 120 parts.

114-126 parts of parasitic loranthus, such as 116 parts, 118 parts, 120 parts, 122 parts or 124 parts. The preferable proportion of the parasitic loranthus is 117-123 parts; more preferably 120 parts.

90-100 parts of rhizoma cibotii such as 92 parts, 94 parts, 96 parts or 98 parts. The rhizoma cibotii is preferably 94-98 parts; more preferably 96 parts.

32-40 parts of cinnamon, such as 33 parts, 34 parts, 35 parts, 36 parts, 37 parts, 38 parts or 39 parts. The cinnamon is preferably 34-38 parts; more preferably 36 parts.

44-52 parts of fructus amomi, such as 45 parts, 46 parts, 47 parts, 48 parts, 49 parts, 50 parts or 51 parts and the like. The optimized part of fructus amomi is 46-50 parts; more preferably 48 parts.

44-52 parts of dried orange peel, such as 45 parts, 46 parts, 47 parts, 48 parts, 49 parts, 50 parts or 51 parts. The preferable proportion of the dried orange peel is 46-50 parts; more preferably 48 parts.

69 to 75 portions of earthworm such as 70 portions, 71 portions, 72 portions, 73 portions or 74 portions. The earthworm is preferably 70-73 parts; more preferably 72 parts.

Radix astragali and semen Coicis are used as principal drugs. Huang Qi is sweet and warm, entering lung and spleen meridians. Has the effects of invigorating qi, invigorating yang, consolidating superficial resistance, arresting sweating, inducing diuresis, relieving swelling, promoting fluid production, nourishing blood, removing stagnation, relieving arthralgia, removing toxic substance, expelling pus, healing sore, and promoting granulation. Can be used for treating deficiency of vital energy, asthenia, anorexia, loose stool, collapse of middle-warmer energy, chronic diarrhea, rectocele, hematochezia, spontaneous perspiration due to exterior deficiency, edema due to qi deficiency, internal heat, diabetes, blood deficiency, hemiplegia, arthralgia, numbness, carbuncle, cellulitis, and intractable ulcer. Rihuazi: astragalus root, radix astragali helps qi and strengthen the muscles and bones, and grows flesh and enriches blood. The records of the Western Zhongzhao nationality: "it is good at treating impotence.

Yi ren is sweet, bland and cool, and enters spleen, stomach and lung meridians. Has effects of promoting diuresis, eliminating dampness, invigorating spleen, relieving diarrhea, eliminating arthralgia, expelling pus, removing toxic substance, and resolving hard mass. Can be used for treating edema, loempe, dysuria, spleen deficiency, diarrhea, damp arthralgia, spasm, pulmonary abscess, intestinal abscess, wart, and cancer. The book Jing: the main tendons are spasm and unable to bend and stretch. Compendium (compendium): yi ren can invigorate spleen and nourish stomach. For the diseases of tendons and bones, it is indicated for yang-yin, so it is indicated for spasm, wind-arthralgia. According to the ancient prescription, the Xiao Xie Tang annotates the cloud: for spasm of tendons and muscles due to apoplexy and wiry pulse due to late speech, Coicis semen can be added. Also strengthen the spleen and inhibit liver.

The astragalus and the coix seed are combined to strengthen the spleen and replenish qi, strengthen the muscles and bones, promote tissue regeneration and promote the growth of flesh, which are monarch drugs. The spleen and stomach are healthy and healthy to transport and transform qi and blood, so called to nourish the acquired origin of the spleen and stomach, and the spleen and stomach are vigorous, so the tendons and vessels in the four extremities are nourished and the functional prescription is restored, i.e. treating atrophy and solely taking yangming, the book Su Wen and Yang atrophy theory notes that the yang brightness, the sea of the five zang-organs and six fu-organs, mainly moisten the tendons and the tendons mainly restrain the bones and benefit the joints.

Prepared rehmannia root, Chinese taxillus twig, east Asian tree fern rhizome and cassia bark are taken as ministerial drugs. Shu Di Huang is sweet and warm, entering liver and kidney meridians. Has effects in replenishing blood, nourishing eyesight, replenishing essence, and replenishing marrow. Can be used for treating blood deficiency, sallow complexion, cardiopalmus, menoxenia, metrorrhagia, metrostaxis, deficiency-type liver-yin and kidney-yin, soreness of waist and knees, hectic fever due to yin deficiency, night sweat, nocturnal emission, internal heat, diabetes, giddiness, tinnitus, and early white beard and hair. The book Jing: "bone marrow filling, muscle growth".

Sang Ji Sheng is bitter, sweet and neutral, enters liver and kidney meridians. Has effects of dispelling pathogenic wind and removing dampness, nourishing liver and kidney, strengthening tendons and bones, and calming fetus. Can be used for treating rheumatalgia, soreness of waist and knees, weakness of bones and muscles, metrorrhagia, metrostaxis, pregnant hemorrhage, threatened abortion, and dizziness. The Chinese materia medica Chong Yuan (original Chinese materia Medica): parasitic branches and joints, which are affected by parasitic wind, grow without time and without artificial soil, and take the spirit of the transformation from heaven to earth. For lumbago, the lumbar region is the external symptom of kidney, and men can store essence, women can tie uterus, and Loranthus can obtain the qi of sang Jing and deficiency can cause generation, so it is indicated for lumbago. The herbal Zhenzhen: "sang Ji Sheng is an essential herb for tonifying kidney and blood, which governs bone by kidney, gives out blood and gives priority to kidney, so kidney can tonify tendons and bones without soreness and pain caused by flaccidity and arthralgia . Sweet and blood tonifying, blood tonifying is induced by the herbs to be absorbed by the herbs without withering and falling . Therefore, it is not indicated for lumbago due to internal injury, bone and muscle diseases, abortion, external incised wound, and rheumatism of skin.

Ci Yao is bitter and sweet, warm and enters liver and kidney meridians. Has effects of dispelling pathogenic wind and removing dampness, nourishing liver and kidney, and strengthening waist and knee. Can be used for treating rheumatalgia, soreness of waist and knees, and weakness of lower limbs. The book Jing: "strong waist and back, slow and urgent shutdown, peripheral arthralgia, cold-dampness and knee pain". The bibliography: "treat male's leg weakness lumbago, strengthen the spine and facilitate pitching". Jade mountain ash Yao Jie (Yao Jie): the medicine has the effects of treating flaccidity, relieving pain, removing dampness of kidney and liver, dredging collaterals, benefiting orifices, strengthening bones and muscles, and treating lumbago, gonalgia, swelling of feet and weak legs. Ben Cao Jing Shu (the book of materia Medica Prime and Dredging): the bitter dog-bone can dry dampness, sweet dog-bone can nourish blood, warm and nourish qi, so it is also a herb for tonifying and moving. Kidney deficiency can lead to strong waist and back, and mild and urgent diseases. for deficiency of the lumbar and back manifested as unrelieved sensation and unsmooth sensation in the organ due to nourishing yin and replenishing qi and blood.

Cinnamon bark, pungent and sweet in flavor, with large heat, enters kidney, spleen, heart and liver meridians. Has the effects of tonifying fire, supporting yang, guiding fire to the origin, dispelling cold, relieving pain, and warming and dredging channels and collaterals. Can be used for treating sexual impotence, cold womb, lumbago, gonalgia, deficiency-type asthma, deficiency-type yang floating upward, giddiness, conjunctival congestion, heart orifice psychroalgia, asthenia cold vomiting and diarrhea, cold pain, abdominal pain, dysmenorrhea, and amenorrhea. The book Jing: benefiting joints, invigorating spleen and replenishing qi. The book of identity records, which governs warming the middle energizer, strengthens the joints of bones and promotes blood circulation, is widely used in the fields of medicine, health care and medicine. Rihuazi: "Bu Wulaoqi Qishang, Tong Jiu Qiao, Li Jie, Yi Jing Ming, Warm waist and knee, Xiao Xue Pi and Zheng Mass, Xiao Xue, treat wind arthralgia with bone contracture, reunite the muscles and bones, and promote tissue regeneration". Des-join materia Medica: nourishing the ministerial fire of the Mingmen, connecting the upper and lower yin nodes, ascending yang qi to cross the middle energizer, opening orifices to produce yin turbidity, entering the liver from shaoyang qi reception, calming the liver to strengthen spleen earth, all of which are suitable for treating deficiency-cold. The materia Medica (materia Medica essence): gui Xin enters two or three segments of yin tonics, which can promote the stagnation of rehmannia to tonify kidney, while its pungent flavor belongs to lung to promote generation of kidney water, warm in nature to promote blood circulation to remove stagnation, and can tonify kidney to remove blood stagnation .

The prepared rehmannia root, the mulberry mistletoe, the cibotium rhizome and the cinnamon are compatible, the liver and kidney are benefited, the essence is benefited, the marrow is filled, the bones and muscles are strengthened, the waist and the spine are strengthened, and the prepared rehmannia root, the mulberry mistletoe, the cibotium rhizome and the cinnamon are used as ministerial drugs. Tonifying the liver and kidney can supplement the innate essence and blood. Rou Gui warms and tonifies spleen and kidney, induces fire to return to original, and tonifies Di Huang without stagnation.

Fructus amomi and dried orange peel are used as adjuvant drugs. Sha ren is pungent and warm in property, and enters spleen, stomach and kidney meridians. Has effects of eliminating dampness, promoting appetite, warming spleen, relieving diarrhea, regulating qi-flowing, and preventing miscarriage. Can be used for treating damp turbidity obstruction in middle energizer, abdominal distention, inappetence, deficiency-cold of spleen and stomach, emesis, diarrhea, vomiting, and threatened abortion. Compendium (compendium): tonifying lung and spleen, nourishing stomach and tonifying kidney, regulating primordial qi and activating qi. Press Han 25035: the kidney is pungent and moist, while the pungent and pungent flavor of Sha ren can moisten the kidney and dry it. And cloud: since the shrinked sand belongs to earth and has the effect of activating spleen, the drugs are led to the Yundao, so that the drugs can flee with fragrance and combine with the qi of five internal organs, for example, the earth is used as the qi of five internal organs, so the kidney-tonifying drugs are steamed with the rehmannia pills, and the drugs are taken to achieve the aim of descending. The definition of the drug substance (Yi Xue): sha ren, pungent with its action of dispersing bitter and descending, is thick in smell. To remove stagnation, move qi and descend qi, take the fragrance of herbs to harmonize five zang organs, and pass all meridians along with the introduced herbs.

Tangerine peel, pericarpium Citri Tangerinae, bitter and pungent in flavor and warm in nature, enters lung and spleen meridians. Has the effects of regulating qi, strengthening spleen, eliminating dampness and phlegm. Can be used for treating abdominal distention, anorexia, vomiting, diarrhea, cough, and excessive phlegm.

The amomum fruit and the dried orange peel are matched and used as adjuvant drugs for strengthening the spleen and regulating the flow of qi. Fructus Amomi is combined with radix rehmanniae Preparata to prevent the deficiency of nourishing and greasing.

Earthworm is used as a guiding drug. Di Long is salty and cold, and enters liver, spleen and gluteal meridians. Has effects of clearing heat, arresting convulsion, dredging collaterals, relieving asthma, and promoting urination. Can be used for treating hyperpyrexia, unconsciousness, convulsive epilepsy, convulsion, arthralgia, numbness of limbs, hemiplegia, cough and asthma due to lung heat, edema, and oliguria. Earthworm, Lumbricus promotes blood circulation and unblocks collaterals, is a guiding drug.

The traditional Chinese medicine composition for treating syringomyelia takes astragalus and coix seeds as monarch drugs, takes prepared rehmannia root, loranthus parasiticus, rhizoma cibotii and cinnamon as ministerial drugs, fructus amomi and dried orange peel as adjuvant drugs and earthworm as conductant drug, comprehensively utilizes the action advantages and mutual synergistic action of the raw materials of the traditional Chinese medicines, takes spleen strengthening and kidney tonifying, essence boosting and marrow filling as main drugs, and aims at correcting limb numbness, pain and warmness, muscle atrophy, paralysis and weakness, waist and knee soreness, intolerance of cold and cold limb symptoms caused by flaccidity due to spleen and kidney deficiency. The prescription has reasonable composition, no discomfort feeling during the taking of patients and is beneficial to the taking of patients.

Another embodiment of the invention provides a pill for treating syringomyelia, which comprises the above traditional Chinese medicine composition. Every 100 parts of the traditional Chinese medicine composition is also added with 1-3 parts of starch, 0.1-0.2 part of microcrystalline cellulose and 10-20 parts of honey.

In another embodiment of the present invention, there is provided a method for preparing a pill for the treatment of syringomyelia, the pill comprising the above-mentioned Chinese medicinal composition for the treatment of syringomyelia; the preparation method comprises the following steps: and crushing the raw materials and uniformly mixing to obtain powder. 100 parts of the powder, 1-3 parts of starch, 0.1-0.2 part of microcrystalline cellulose, 10-20 parts of honey and 25-45 parts of pure water are mixed and stirred to prepare wet pills. Drying the wet pellets to a moisture content of 5% (by weight) or less (preferably 3% or less) to obtain plain pellets, and coating the plain pellets with activated carbon and polishing with talc, wherein 0.45-0.55 part of activated carbon and 0.45-0.55 part of talc are used per 100 parts of the plain pellets.

The traditional Chinese medicine composition and the pill thereof are safe to use and have no toxic or side effect. The pill is simple to prepare, easy to take and convenient to carry, does not need or needs few auxiliary materials during preparation, is low in cost and suitable for mass production, and therefore the dosage form is preferably the pill. Of course, other formulations such as tablets, capsules, granules and the like may be prepared as required. A specific example of the manufacture of the pill is given below.

The equipment for pulverizing the raw materials into powder can be, for example, a model TF300B two-stage pulverizer (Tianjin Chinese medicine machinery factory). The powder yield of the medicinal materials can reach 94.9 percent, and the production requirement is met. The powder mixing equipment may be, for example, GH-200 type high-efficiency three-dimensional motion mixer (Harbin pharmaceutical chemical engineering equipment Co., Ltd.), and 20.26Kg of the essence-filled and marrow-producing pellet powder may be mixed in a mixer for 40 minutes.

Weighing bone essence-replenishing marrow-producing pill powder, starch and microcrystalline cellulose according to the above formula, placing in a tank type mixer (such as CHJ-200 tank type mixer of Gansu Tianshuihua pharmaceutical equipment science and technology Co., Ltd.) and stirring for 10 min, adding Mel and purified water, and stirring for about 20 min to obtain soft material.

The soft material is placed in an intelligent efficient full-automatic pill making machine (for example, YUJ-17B type intelligent efficient full-automatic pill making machine of Gansu Tianshuihua pharmaceutical equipment science and technology Limited) to be subjected to bracing and pill rolling to obtain round, uniform and uniform wet pills with consistent appearance, and the diameter of the wet pills can be 4.0-4.3 mm.

Placing 29.03Kg wet pills in a microwave drying and sterilizing box (for example, HWL15-1 microwave drying and sterilizing box of Gansu Tianshuihua David pharmaceutical equipment science and technology Co., Ltd.) with hot air at 50 ℃ and drying at the temperature of 80 ℃ in the box for 50-60 minutes. The water content of the dried pill is controlled below 5%, preferably below 3%.

Placing the vegetarian pill in a sugar-coating pan (such as TG-1000 sugar-coating pan of Gansu Tianshuihua pharmaceutical equipment science and technology Co., Ltd.) and polishing with active carbon and pulvis Talci 0.5Kg each per 100Kg vegetarian pill.

In order to facilitate understanding of the present invention, the technical solutions of the present invention will be further described below with reference to examples and specific cases.

Example 1

The traditional Chinese medicine composition for treating syringomyelia comprises the following components: 240 parts of astragalus; 240 parts of coix seeds; 120 parts of prepared rehmannia root; 120 parts of parasitic loranthus; 96 parts of rhizoma cibotii; 36 parts of cinnamon; 48 parts of fructus amomi; 48 parts of dried orange peel; 72 parts of earthworm.

The Chinese medicinal raw materials are prepared according to the specific example for preparing the pill.

Example 2

The traditional Chinese medicine composition for treating syringomyelia comprises the following components: 232 parts of astragalus; 248 parts of coix seeds; 114 parts of prepared rehmannia root; 124 parts of parasitic loranthus; 100 parts of rhizoma cibotii; 38 parts of cinnamon; 44 parts of fructus amomi; 50 parts of dried orange peel; earthworm (74 parts).

The traditional Chinese medicine raw materials are prepared into pills according to the method.

Example 3

The traditional Chinese medicine composition for treating syringomyelia comprises the following components: 248 parts of astragalus; 232 parts of coix seeds; 126 parts of prepared rehmannia root; 114 parts of parasitic loranthus; 92 parts of rhizoma cibotii; 34 parts of cinnamon; 50 parts of fructus amomi; 46 parts of dried orange peel; 70 parts of earthworm.

Example 4

The traditional Chinese medicine composition for treating syringomyelia comprises the following components: 234 parts of astragalus; 246 parts of coix seeds; 118 parts of prepared rehmannia root; 122 parts of parasitic loranthus; 94 parts of rhizoma cibotii; 35 parts of cinnamon; 46 parts of fructus amomi; 52 parts of dried orange peel; 72 parts of earthworm.

Example 5

The traditional Chinese medicine composition for treating syringomyelia comprises the following components: 232 parts of astragalus; 232 parts of coix seeds; 126 parts of prepared rehmannia root; 126 parts of parasitic loranthus; 100 parts of rhizoma cibotii; 40 parts of cinnamon; 52 parts of fructus amomi; 52 parts of dried orange peel; 75 parts of earthworm.

Comparative example 1

Different from the embodiment 1, the dosage of the astragalus root is 100 parts and the coix seed is 100 parts, and other components and the preparation method are the same as the embodiment 1.

Comparative example 2

Except for example 1, rehmanniae radix preparata and Taxillus chinensis were used in amounts of 50 parts each, and other ingredients and preparation methods were the same as in example 1.

Comparative example 3

Different from the example 1, the usage amount of the rhizoma cibotii is 30 parts, the usage amount of the cinnamon is 15 parts, and other components and the preparation method are the same as the example 1.

Comparative example 4

Different from the example 1, 20 parts of each of the amomum fruit and the tangerine peel are used, and other components and the preparation method are the same as the example 1.

Comparative example 5

Different from the example 1, 30 parts of earthworm is used, and other components and the preparation method are the same as the example 1.

The effect was verified using the pill of example 1, and 250 patients with syringomyelia (age 40-65 years) were randomly divided into 5 groups of 50 patients, and the pill of example 1-5 was administered to each patient, and the treatment was performed according to the above-mentioned method. The administration method comprises the following steps: the preparation is administered once 9g, three times a day, 10 days as a treatment course, and 5 treatment courses.

And (3) judging the curative effect:

and (3) curing: the signs of symptoms have substantially disappeared.

The method has the following advantages: the signs of symptoms were relieved.

And (4) invalidation: signs of symptoms were not improved prior to treatment.

After the traditional Chinese medicine granules are prepared, the statistical results are as follows:

examples	Total number of people	Cure of disease	Is effective	Invalidation	Cure rate	High efficiency
							1	50	46	3	1	92％	98％
2	50	44	2	3	88％	92％
							3	50	40	3	7	80％	86％
4	50	43	1	6	86％	88％
							5	50	39	3	8	78％	84％

As shown in the table, the traditional Chinese medicine composition has good effect after treatment, the effective rate is above 84%, and the cure rate is above 78%. In addition, the effect of example 1 is the best in terms of the combination of cure rate and efficacy.

In addition, the inventors also treated 5 groups of patients (10 per group) separately using the pills prepared in comparative examples 1-5, with comparative example 1 being effective in one case and ineffective in nine cases; comparative examples 2 and 3 were effective for four and six cases were not; comparative example 4 is valid for five, none; comparative example 5 was effective for six cases and ineffective for four cases. Compared with the technical scheme of the invention, the treatment effect is obviously poor.

The following is a list of relevant animal tests performed using the protocol of the present invention.

Experiment 1 Effect of pill for replenishing essence and producing marrow on Experimental rat denervation muscular atrophy

1 materials of the experiment

1.1 test drugs: essence-replenishing and marrow-regenerating pills (pills prepared according to example 1)

The test sample is prepared into a proper concentration by 0.1 percent CMC-Na at the time of clinical application.

1.2 Positive drugs: 1g/10 pills of Zhenbao pill, a lot number of 060921, a national medicine standard character Z21020292 and Fuxin Mongolian medicine, which are produced by Limited responsibility company and are prepared into 0.06g/ml suspension by 0.1 percent of CMC-Na during experiments.

1.3 animals: SD rats with the weight of 200-.

1.4 reagent: acetic acid, produced by chemical reagent works in Luoyang.

2 method of experiment

2.1 Experimental groups

2.1.1 model control (n ═ 10): 0.1% CMC-Na, 10 ml/kg;

2.1.2 positive drug control group (n ═ 10): 0.6g/kg of Zhenbao pill;

2.1.3 pills for replenishing essence and generating marrow 3.1g finished medicine/kg (31 percent, which is equivalent to 12 times of clinical daily dose);

2.1.4 pills for replenishing essence and generating marrow 1.55g finished medicine/kg (15.5 percent, which is equivalent to 6 times of clinical daily dose);

2.1.5 pill for replenishing essence and generating marrow 0.775g patent drug/kg (7.75%, equivalent to 3 times of clinical daily dose).

2.2 Experimental procedures

2.2.1 intraperitoneal injection and anesthesia are carried out with 30mg/kg sodium pentobarbital, sciatic nerves are exposed in the middle of the posterior lateral aseptic operation of the right thigh, sciatic nerves are cut off at a position 5mm away from the lower edge of piriformis, the sciatic nerves are sutured by a micro suture, and the incision is closed layer by layer.

2.2.2 postoperative animals were raised in cages. The administration was once daily for 8 weeks.

2.2.3 animals were sacrificed 24 hours after the last administration by intraperitoneal injection with a lethal dose of sodium pentobarbital, gastrocnemius muscles were isolated and excised and immediately weighed on an analytical balance.

2.3 statistical methods: comparison between groups, t-test.

3 results of the experiment

The gastrocnemius muscle of the large-dose group of the essence-replenishing and marrow-generating pills is full and elastic, and has glossy appearance; the gastrocnemius muscle of the control group had a small and dull appearance. The wet weight of gastrocnemius is higher than that of a control group of the model, and the difference has significance. It is suggested that the product has the effect of improving the denervation muscular atrophy (Table 1).

TABLE 1 Effect of pill for replenishing essence and marrow on writhing response in mice

Note: p <0.05 compared to model control group.

4 conclusion

The experimental result shows that the pill for replenishing essence and generating marrow has the function of improving the denervation muscular atrophy of the rats with the denervation muscular atrophy.

Experiment 2 Effect of pill for replenishing essence and producing marrow on muscle strength of myasthenia mouse

1 materials of the experiment

1.1 test drugs: essence-replenishing and marrow-regenerating pills (pills prepared according to example 1). The test sample is prepared into a proper concentration by 0.5 percent CMC-Na at the time of clinical application.

1.2 Positive drugs: the Zhenbao pill, 1g/10 pills, is produced by Fuxin Mongolian medicine, Limited liability company, and is prepared into 0.06g/ml suspension by 0.1 percent CMC-Na during the experiment.

1.3 acetylcholine receptor (AChR) (Sigma Co., USA); complete Freund's adjuvant (FCA) (product of sigma company, USA)

1.4 animals: the weight of a Kunming mouse with the age of 10-12 weeks is 25-30g, and the male and female are half each, and are provided by the experimental animal center in Henan province.

2 method of experiment

2.1 Experimental groups

2.1.1 model control (n ═ 10): 0.1% CMC-Na, 20 ml/kg;

2.1.2 normal drug control group (n ═ 10): 0.1% CMC-Na, 20 ml/kg;

2.1.3 positive drug control group (n ═ 10): 0.6g/kg of Zhenbao pill;

2.1.3 pill for replenishing essence and generating marrow 6.2g finished medicine/kg (31%, equivalent to 24 times of clinical daily dose);

2.1.4 pills for replenishing essence and generating marrow 3.1g finished medicine/kg (15.5 percent, which is equivalent to 12 times of clinical daily dose);

2.1.5 pill for replenishing essence and generating marrow 1.55g patent medicine/kg (7.75%, corresponding to 6 times of clinical daily dose).

2.2 Experimental procedures

2.2.1 mixing AChR and Freund's adjuvant 1:2, immunizing mouse, initially sensitizing, preparing AChR into 75 μ g/mL antigen emulsion, and performing intradermal inoculation on multiple parts of back, limbs and tail base.

2.2.24 weeks later, the cells were sensitized again with an emulsion containing 150. mu.g/mL antigen. Adjuvant control groups were immunized with equal amounts of freund's adjuvant.

2.2.3 determination of the model 14 days after the last immunization, the criteria are: the EAMG mice have the symptoms of myasthenia of different degrees, such as dry hair, hump back, food intake reduction, activity reduction, lameness and the like; swimming tests show that the swimming time of the EAMG model mice is obviously shorter than that of the adjuvant control group and the normal control group.

2.2.4 after the model is established, each group of mice is continuously administered by gavage for 4 weeks, once a day, and 20mL/kg of body weight (20 mL0.1% CMC-Na/kg of body weight of a model control group, a normal control group and a Freund's adjuvant control group).

2.2.5 after 24 hours of the last administration, suspending the hind limbs of the mouse, enabling the forepaws to grasp a metal thin rod with the diameter of 0.5cm for 20 times, and recording the times of successfully holding the metal thin rod by each animal; then, the mice were placed in a water tank for 2 minutes (water depth 20cm, water temperature 25 ℃ C.), and the number of animals that were able to swim normally for 2 minutes was observed and recorded.

2.3 statistical methods: comparison between groups, t-test.

3 results of the experiment

The number of normal swimming animals and the successful grasping times of the large-dosage group of the essence-replenishing and marrow-regenerating pills are higher than those of the control group of the model, and the difference has significance. It is suggested that this herb has the action of improving muscle strength (Table 2).

TABLE 2 Effect of essence-replenishing and marrow-producing pills on the grasping and swimming abilities of myasthenia mice

Note: p <0.05 compared to model control.

4 conclusion

The experimental result shows that the pill for replenishing essence and generating marrow has the function of improving muscle force of the EAMG model mouse.

Experiment 3 acute toxicity test of pill for replenishing essence and producing marrow

The pill for replenishing essence and nourishing marrow is administered to mice 3 times a day according to the maximum concentration and the maximum gavage capacity, and then observed for two weeks. The animals have no death, normal weight change, no abnormality in hair, activity, mental state, diet and the like. Not measured LD₅₀Therefore, the maximum dose of the essence-replenishing and marrow-producing pill administered by gastric administration to mice was determined to be 58.32g of the patent drug/kg. d (corresponding to 226.80 times of the clinical dose).

1 purpose: the mice were observed for toxicity and mortality after administration of the bolus to the mice at maximum concentration and maximum gavage capacity.

2, materials:

2.1 test drugs: essence-replenishing and marrow-regenerating pills (pills prepared according to example 1). In the experiment, 48.6% of suspension is prepared by 0.1% of CMC-Na.

2.2 Experimental animals: 20 Kunming mice with the weight of 18-22g and half male and female are provided by the experimental animal center of Henan province.

3 method

20 Kunming mice for experiment are used, half of the mice are female and male, after fasting for 12h, the mice are gavaged according to the maximum concentration of 48.6 percent, the volume is 0.4ml/10g, the mice are gavaged for 3 times (the interval is 8h) in one day, the total dosage reaches 58.32g patent drugs/kg, and the mice are fed conventionally after the drug administration and observed for two weeks.

4 results

After administration, mice were active normally; the hair, mental state and diet of the patient are not abnormal; body weight changes were normal, see table 1; within two weeks the mice did not die. Since LD50 was not detected, the maximum dose of the essence-replenishing and marrow-producing pill was 58.32 g/kg. d, which is 226.80 times the clinical dose.

TABLE 3 weight changes of mice before and after gavage with pill for replenishing essence and producing marrow: (

g)

Experiment 4 Long-term toxicity experiment of pill for replenishing essence and producing marrow

The long-term repeated administration of the bolus for replenishing essence and producing marrow to rats was observed for the possible cumulative toxicity and delayed toxic response.

1 materials of the experiment

During the experiment, three suspensions with the concentrations of 48.6%, 45.39% and 42.17% are respectively prepared by using 0.1% CMC-Na.

1.2 Experimental animals: wistar rats, half male and female, weighing 85-100g, were provided by the Experimental animals center of Henan province.

1.3 kits

1) Alanine amino group converting enzyme (rate method): shanghai province, California chinensis diagnostic products.

2) Aspartate aminotransferase (rate method): shanghai province, California chinensis diagnostic products.

3) Alkaline phosphatase (rate method): shanghai province, California chinensis diagnostic products.

4) r-glutamyl transpeptidase (rate method): shanghai province, California chinensis diagnostic products.

5) Total protein (end-point): shanghai province, California chinensis diagnostic products.

6) Albumin (end-point method): shanghai province, California chinensis diagnostic products.

7) Total cholesterol (end-point method): shanghai province, California chinensis diagnostic products.

8) Triglyceride (end-point method): shanghai province, California chinensis diagnostic products.

9) Blood glucose (end-point method): shanghai province, California chinensis diagnostic products.

10) Urea nitrogen (end point method): shanghai province, California chinensis diagnostic products.

11) Creatinine (end-point method): shanghai province, California chinensis diagnostic products.

12) Total bilirubin (end-point method): shanghai province, California chinensis diagnostic products.

1.4 instruments

1) ECG-11B model electrocardiograph, Guangdong.

2) MS9-5 blood cell analyzer, France.

3) Au-400 full-automatic biochemical analyzer, japan.

2 method of experiment

2.1 animal groups and administrations: the experimental Wistar rats, 80 in each half, were randomly divided into 4 groups. The feed is provided by experimental animal center in Henan province, room temperature is 23 + -2 deg.C, humidity is 50-70%, natural lighting is provided, ventilation is performed at regular time every day, group culture is performed, male and female parts are separated, 5 animals are placed in each cage, and observation is performed for 3 days before experiment. The administration is carried out by gavage 2 times a day, each time 20ml/kg, and continuously for three months.

(ii) placebo (n ═ 20): 0.1% CMC-Na, 20 ml/kg.d;

② high dose group of pills for replenishing essence and generating marrow (n is 20): 19.44g finished medicine/kg.d, which is equal to 75.60 times of clinical medicine dosage;

③ replenishing essence and generating marrow pill middle dose group (n is 20): 18.15g finished medicine/kg.d, which is equal to 70.60 times of clinical medicine dosage;

(iv) low dose group of essence-replenishing and marrow-producing pills (n is 20): 16.87g finished medicine/kg.d, which is equivalent to 65.60 times of clinical medicine dosage.

2.2 Observation index

1) General condition and body weight: the behavior and activity of animals, the amount of water taken, the excretion of feces, and the death of animals were observed daily, the amount of food taken was measured daily, the body weight was weighed once a week, and the dose was adjusted according to the change in body weight.

2) Blood cell analysis: on day 90 of dosing and 14 days after discontinuation of dosing (fasting for 12h without water), 10 animals per group were sacrificed each time, and in each half of males and females, blood was taken from the decapitated end for blood cell analysis, including red blood cell count (RBC), hemoglobin content (Hb), white blood cell count (WBC) and white blood cell classification (LY, MO, GR), platelet count (BPC).

3) Biochemical determination of blood: including alanine amino transferase (ALT), aspartate amino transferase (AST), alkaline phosphatase (ALP), r-glutamyl transpeptidase (GGT), Total Protein (TP), Albumin (ALB), Total Bilirubin (TBI), total Cholesterol (CHO), Triglyceride (TG), blood Glucose (GLU), myoliver (CR), and urea nitrogen (BUN).

4) Visceral index and histopathological examination: after blood is taken, weighing each main organ (brain, heart, liver, spleen, lung, kidney, adrenal gland, thymus, testis epididymis and uterus ovary), observing with naked eyes and calculating the index of the organ; the sections were fixed in 10% formalin, paraffin embedded, and stained for histopathological examination.

2.3 statistical methods: results a comparison t-test between groups was performed.

3 results of the experiment

3.1 general conditions: during the administration period of the pill and after the pill is stopped, the behavior and the activity of animals, the water intake, the excrement discharge and the like are not abnormal.

3.2 weight and food intake: during the administration period of the pill and after the pill is stopped, the weight gain of the animals has no significant difference compared with the control group. See tables 4 and 5.

3.3 blood cell examination: the pill has no obvious influence on blood cells after being administrated for three months and 2 weeks after stopping administration, and each index has no significant difference compared with a control group. See tables 6 and 7.

3.4 Biochemical examination of blood: the pill has statistical difference between individual biochemical indexes and control group, but has no biological significance in normal range. See tables 8 and 9.

3.5 organ coefficients: the pill has no obvious influence on the index of main organs after being taken for three months and 2 weeks after stopping taking the pill. See tables 10 and 11.

3.6 histopathological examination: the shape of the main organs of each group of animals can be seen by naked eyes, the main organs are regular and elastic, the capsule is smooth and complete, the texture is soft, and no tissue protrusion or retraction is seen on the section. No pathological changes such as cell degeneration, turbidity, liquefaction, necrosis and the like appear under the microscope, the structures of cell membranes and cell nucleuses are clear, the tissue structures are compact, the cells are arranged orderly, and the layers are distinct.

4 small knot

The pill for replenishing essence and generating marrow is continuously administrated to rats by gavage for 3 months and stopping taking the medicine for 2 weeks at three doses of 19.44g/kg of body weight, 18.15g/kg of body weight and 16.87g/kg of body weight (respectively equal to 75.61 times, 70.60 times and 65.60 times of clinical medicine dosage), has no obvious influence on the weight increase, the food intake, the electrocardiogram, the blood cells, the blood biochemistry, the main organ index and the histopathology examination of the rats, and has no obvious difference compared with a blank control group. The pill shows that the pill has no obvious accumulative toxicity and delayed toxicity reaction to rats.

Table 4 effect of the pill on body weight of male rats (unit: g,

)

table 5 effect of the pill on body weight of female rats (unit: g,

)

TABLE 6 Effect of pill for replenishing essence and marrow (administered for 3 months) on hematological indices of rats

TABLE 7 Effect of pill for replenishing essence and marrow (3 months after administration and 14 days after withdrawal of the drug) on the hematological index of rats

TABLE 8 Biochemical Effect of pill for replenishing essence and generating marrow (administered for 3 months) on blood of rats

TABLE 8 Effect of pill for replenishing essence and marrow (3 months of administration) on blood biochemistry of rat

TABLE 9 Biochemical Effect of pill for replenishing essence and marrow (3 months after administration and 14 days after withdrawal of the drug) on blood of rats

TABLE 9 Effect of pill for replenishing essence and marrow (3 months after administration and 14 days after discontinuation) on blood biochemistry of rats

TABLE 10 Effect of pill for replenishing essence and marrow (administered for 3 months) on rat organ index: (

Unit:%)

TABLE 11 influence of pill for replenishing essence and marrow (administered for 3 months, stopped for 14 days) on the organ index of rats: (

Unit:%)

Clinical cases

Leaf of a certain species, female, age 44, prefecture of Shannan province, Shanshui county. Pain in the waist and hip, discomfort of acid and cold, aggravation in cold, no relief of rest and inability to sit for a long time and stand for a long time after 2015 fatigue of patients. 2017.9.25 the treatment of pain of waist and hip is admitted to our hospital.

Admission symptoms are as follows: the patient can walk, squat, pain in waist and hip, no limitation of lumbar movement, stiff and painful neck, clear spirit, poor sleep, sticky stool, dark tongue with white fur and wiry and smooth pulse.

Physical examination: stiffness of the lumbar region, rightward lateral bending of the lumbar vertebrae, shallow physiological curvature, 3-4 lumbar regions, 5 lumbar regions, and tenderness between spinous processes and beside the vertebrae. Stiffness of neck and shoulder, shallow physiological curvature of cervical vertebra, tenderness of 2-6 spinous processes and paravertebral processes of left side neck, tenderness of 3-7 spinous processes and paravertebral processes of right side neck, tenderness of supraspinatus, infraspinatus and greater and lesser teres, slight leftward curvature of thoracic vertebra, tenderness of 1-10 spinous processes and both sides of chest.

Auxiliary inspection: cervical vertebra positive side position, two oblique positions, open mouth position, thoracic vertebra, lumbar vertebrae positive side position, pelvis positive position piece: 1. considering cervical spondylosis; 2. slight degeneration of thoracic vertebra and lumbar vertebra; 3. lateral curvature of thoracic vertebra and lumbar vertebra. The physiological curvature of the cervical vertebra is shallow, the hook is suddenly pointed, the bone structure at the edge of the vertebral body is pointed, the axis of the thoracic vertebra bends towards the left side, the axis of the lumbar vertebra bends towards the right side, the position of the pelvis is correct, and the bone structures, the density and the joint gaps of the pelvis are not obviously abnormal. Lumbar vertebra CT: 1. lumbar degeneration 2, L3/4, L4/5 disc bulging, L5/S1 disc left-posterior protrusion. Cervical vertebra MR: 1. 3-4, 4-5, 5-6 and 6-7 bulging of the cervical disc; 2. cervical spinal cord cavity; 3. hyperosteogeny of cervical vertebra.

The diagnosis is as follows: 1. lumbar intervertebral disc prolapse; 2. cervical spondylosis; 3. scoliosis; 4. syringomyelia. The medicine of the invention in the embodiment 1 is taken with warm boiled water for 3 times a day at 9g each time. The pain of waist and hip of the patient is relieved after 1 month, the mobility of lumbar vertebrae is proper, the stiffness and pain of neck and shoulder are relieved, the rest discomfort is not complained, the condition is stable, and the patient is discharged. When the medicine is taken continuously after discharge, 2017.11.22 has no obvious pain in neck, shoulder and lumbosacral part.

The above description is only a preferred embodiment of the present invention, and is not intended to limit the present invention, and it will be apparent to those skilled in the art that various modifications and variations can be made in the formulation and preparation process of the present invention. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. The pill for treating syringomyelia is characterized by comprising a traditional Chinese medicine composition for treating syringomyelia, wherein the traditional Chinese medicine composition for treating syringomyelia is prepared from the following raw materials in parts by weight: 232-248 parts of astragalus membranaceus, 232-248 parts of semen coicis, 114-126 parts of prepared rehmannia root, 114-126 parts of parasitic loranthus, 90-100 parts of rhizoma cibotii, 32-40 parts of cinnamon, 44-52 parts of fructus amomi, 44-52 parts of pericarpium citri reticulatae and 69-75 parts of lumbricus;

every 100 parts of the traditional Chinese medicine composition is also added with 1-3 parts of starch, 0.1-0.2 part of microcrystalline cellulose and 10-20 parts of honey.

2. The traditional Chinese medicine composition for treating syringomyelia according to claim 1, which is characterized in that: 235-245 parts of astragalus; 235 to 245 portions of coix seed.

3. The traditional Chinese medicine composition for treating syringomyelia according to claim 1, which is characterized in that: 117-123 parts of prepared rehmannia root; 117-123 parts of parasitic loranthus; 94-98 parts of rhizoma cibotii; 34-38 parts of cinnamon.

4. The traditional Chinese medicine composition for treating syringomyelia according to claim 1, which is characterized in that: 46-50 parts of fructus amomi; 46-50 parts of dried orange peel; 70-73 parts of earthworm.

5. The traditional Chinese medicine composition for treating syringomyelia according to claim 1, which is characterized in that: 240 parts of astragalus; 240 parts of coix seeds; prepared rehmannia root 120 parts; 120 portions of loranthus parasiticus; 96 parts of rhizoma cibotii; 36 parts of cinnamon; 48 parts of fructus amomi; 48 parts of dried orange peel; 72 parts of earthworm.

6. A preparation method of a pill for treating syringomyelia is characterized by comprising the following steps: the pill comprising the traditional Chinese medicine composition for treating syringomyelia according to any one of claims 1-5; the preparation method comprises the following steps: and crushing the raw materials and uniformly mixing to obtain powder.

7. The method for preparing a pill for the treatment of syringomyelia according to claim 6, wherein: mixing and stirring 100 parts of the powder, 1-3 parts of starch, 0.1-0.2 part of microcrystalline cellulose, 10-20 parts of honey and 25-45 parts of pure water, and then preparing wet pills.

8. The method for preparing a pill for the treatment of syringomyelia according to claim 7, wherein: drying the wet pills to a moisture content of less than 5% (by weight) to obtain plain pills, coating the plain pills with activated carbon and polishing with talcum powder, wherein 0.45-0.55 part of activated carbon and 0.45-0.55 part of talcum powder are used per 100 parts of plain pills.