CN117838779A

CN117838779A - Traditional Chinese medicine composition, oral liquid and preparation method and application thereof

Info

Publication number: CN117838779A
Application number: CN202311838846.8A
Authority: CN
Inventors: 孙平; 李菲; 王秋月; 张佳彦; 徐苏洋; 李凤前
Original assignee: SHANGHAI EIGHTH PEOPLE'S HOSPITAL
Current assignee: SHANGHAI EIGHTH PEOPLE'S HOSPITAL
Priority date: 2023-12-28
Filing date: 2023-12-28
Publication date: 2024-04-09

Abstract

The invention discloses a traditional Chinese medicine composition, an oral liquid, and a preparation method and application thereof. The traditional Chinese medicine composition comprises the following components in parts by weight: 8-17 parts of dipsacus root, 10-21 parts of malaytea scurfpea fruit, 5-9 parts of drynaria rhizome, 10-21 parts of curculigo rhizome, 10-21 parts of Chinese angelica, 10-21 parts of epimedium, 10-21 parts of prepared rehmannia root, 5-14 parts of pilose asiabell root and 5-10 parts of bupleurum root. The traditional Chinese medicine composition and the oral liquid have the effects of treating osteoporosis and promoting fracture healing, can also improve clinical manifestations of cold feeling, joint ache, limb flaccidity, listlessness and the like of patients, and achieve the effects of warming and invigorating spleen and kidney, tonifying qi, nourishing blood, activating blood and regulating visceral qi movement.

Description

Traditional Chinese medicine composition, oral liquid and preparation method and application thereof

Technical Field

The invention relates to a traditional Chinese medicine composition, an oral liquid and a preparation method and application thereof, in particular to a traditional Chinese medicine composition for treating fracture or osteoporosis, an oral liquid and a preparation method and application thereof.

Background

Osteoporosis is one of the common systemic bone diseases of middle-aged and elderly patients, and the current people suffering from osteoporosis are mainly postmenopausal women and elderly people. Along with the change of self bone metabolism and unreasonable eating habit, the incidence rate of osteoporosis and fracture rate are higher and higher. Joint pain, vertebral compression fracture and the like caused by osteoporosis bring great influence to daily life of elderly patients, particularly elderly patients who cannot independently move due to fracture, lie in bed for a long time, seriously reduce life quality of patients and increase medical burden.

Osteoporosis belongs to the category of 'bone flaccidity' and 'bone withered' in traditional Chinese medicine. The kidney is closely related to the occurrence of bone atrophy. The kidney governs bone marrow production, kidney essence deficiency, dysfunction and marrow depletion. In addition, the occurrence of osteoporosis is closely related to spleen, liver, lung and gall bladder. Spleen and stomach are the acquired sources of qi and blood, spleen invigorating qi and blood, and kidney qi nourishing, bone strengthening. In Su Wen & flaccidity theory, lung heat with scorched leaves means that the skin and hair is weak and thin, and the skin and hair is flaccid . Zhangjing Yue says that gallbladder disease loses rigidity, so it is associated with bone, and bone must be soft when it is frightened to damage gallbladder. Therefore, osteoporosis is closely related to spleen, kidney, lung and gall, and the traditional Chinese medicine prescription for clinically treating osteoporosis or promoting fracture healing is not few, but the prescription for combining the two and regulating qi-flowing is less.

Disclosure of Invention

The invention aims to overcome the defects of the prior art that the prescription for treating osteoporosis or promoting fracture healing and treating spleen-kidney yang deficiency and regulating qi movement is lack clinically, and provides a traditional Chinese medicine composition, an oral liquid and a preparation method and application thereof. The traditional Chinese medicine composition and the oral liquid have the effects of treating osteoporosis and promoting fracture healing, can also improve clinical manifestations of cold feeling, joint ache, limb flaccidity, listlessness and the like of patients, and achieve the effects of warming and invigorating spleen and kidney, tonifying qi, nourishing blood, activating blood and regulating visceral qi movement.

The invention solves the technical problems by the following technical scheme:

the invention provides a traditional Chinese medicine composition which comprises the following components in parts by weight: 8-17 parts of dipsacus root, 10-21 parts of malaytea scurfpea fruit, 5-9 parts of drynaria rhizome, 10-21 parts of curculigo rhizome, 10-21 parts of Chinese angelica, 10-21 parts of epimedium, 10-21 parts of prepared rehmannia root, 5-14 parts of pilose asiabell root and 5-10 parts of bupleurum root.

In the invention, dipsacus root, curculigo rhizome, epimedium and psoralea fruit are monarch drugs, and the invention has the advantages of large and special dosage and strengthening the effects of tonifying liver and kidney, warming kidney and supporting yang. All four principal drugs are warm and dry and consume qi to hurt yin, so the prepared rehmannia root is used for enriching blood and nourishing yin and replenishing essence and marrow, on one hand, the effect of nourishing yin is used for restricting the warm and dry property of the principal drugs, on the other hand, the principal drugs are in the middle energizer and are in the middle energizer. Bone and marrow can better promote the healing of fracture.

In the invention, the drynaria rhizome has the pharmacological effects of promoting blood circulation, relieving pain, tonifying kidney, strengthening bone, resisting bone injury, resisting osteoporosis and the like, and can promote the absorption of calcium by bone and promote the healing of fracture. Dang Gui is sweet in flavor and can tonify and moisten, pungent in flavor and warm in property, promote blood circulation, regulate menstruation and alleviate pain, and dispel cold, so it is indicated for blood deficiency and blood stasis with cold.

In the invention, the dipsacus root not only nourishes liver and kidney, but also moves blood vessels and also continues bones and muscles, is an essential medicine for treating fracture in traumatology, and has various pharmacological effects of stopping bleeding, easing pain, promoting tissue regeneration, promoting bone injury healing and the like. Fructus Psoraleae has effects of invigorating kidney, supporting yang, stopping nocturnal emission, reducing urination, and relieving asthma, and can be used for treating sexual impotence due to kidney deficiency and asthma due to kidney deficiency. The invention can achieve the pharmacological actions of enhancing immunity, promoting osteoblast proliferation and the like by using the two drugs together.

In the invention, the kidney of the Xian Mao Shanwen is yang-strengthening, can strengthen tendons and bones, dispel cold and remove dampness, and treat cold-dampness long-term arthralgia. Herba Epimedii Xin Sangan has effects of invigorating and warming dryness, entering liver and kidney channels, and has strong actions of tonifying kidney yang to strengthen tendons and bones, dispelling pathogenic wind and removing dampness to relieve arthralgia, and is commonly used for kidney deficiency, impotence and rheumatalgia. The invention can exert the effect of dispelling pathogenic wind-cold and dampness by using the two components together.

Preferably, the dipsacus root is 10-17 parts, more preferably 15-17 parts, for example 17 parts.

Preferably, the fructus Psoraleae is 15-21 parts, more preferably 18-21 parts, for example 21 parts.

Preferably, the drynaria rhizome is 6-9 parts, more preferably 8-9 parts, for example 9 parts.

Preferably, the curculigo rhizome is 15-21 parts, more preferably 18-21 parts, for example 21 parts.

Preferably, the angelica is 15-21 parts, more preferably 18-21 parts, for example 21 parts.

Preferably, the herba Epimedii is 15-21 parts, more preferably 18-21 parts, for example 21 parts.

Preferably, the rehmannia glutinosa is 15-21 parts, more preferably 18-21 parts, for example 21 parts.

Preferably, the radix Codonopsis is 10-14 parts, for example 14 parts.

Preferably, the bupleurum root is 10 parts.

Preferably, the Chinese medicinal composition further comprises 10-21 parts of poria cocos, more preferably 18-21 parts, for example 21 parts.

Preferably, the Chinese medicinal composition further comprises 5-14 parts of bighead atractylodes rhizome, more preferably 10-14 parts, for example 14 parts.

Preferably, the Chinese medicinal composition further comprises 5-10 parts of green tangerine peel, for example 5 parts or 10 parts.

Preferably, the Chinese medicinal composition further comprises 5-10 parts of dried orange peel, for example 5 parts or 10 parts.

Preferably, the Chinese medicinal composition further comprises 2-5 parts of liquorice, for example 2 parts or 5 parts.

In the invention, bighead atractylodes rhizome, poria cocos and codonopsis pilosula are added to strengthen the spleen and replenish qi and promote the generation of qi and blood. The codonopsis pilosula is sweet and tonic and calm, and has the effects of promoting fluid production and nourishing blood. Bai Zhu is sweet in tonifying, excreting and promoting diuresis, bitter in flavor and warm in nature and dry in nature, and is good at tonifying qi and strengthening spleen, drying dampness and promoting diuresis, so it is indicated for qi deficiency of spleen and stomach. Poria excretes dampness and promotes diuresis to eliminate water retention, and invigorates spleen to promote water damp transportation and transformation. Atractylodis rhizoma, poria and radix Codonopsis can be used for treating water dampness and stopping drinking, both cold and heat and spleen deficiency, and can be used in combination with other medicines for invigorating spleen and qi, eliminating phlegm dampness, regulating qi movement, and assisting principal drug in activating qi and blood.

In the invention, if the liver and kidney of a patient are deficient, spleen and qi are deficient, tonifying drugs are excessive, and spleen and stomach functions are blocked, green tangerine orange peel, dried orange peel and radix bupleuri are taken as adjuvant drugs, xin Xianghang powder, bitter dryness and warmth are dispersed, radix bupleuri is lifted and lowered to reach the upper part, the middle part and the lower part, so that stasis is removed, stagnation is removed, and qi and blood are both alive.

In some preferred embodiments of the present invention, the traditional Chinese medicine composition comprises the following components: the traditional Chinese medicine composition comprises, by weight, 10-17 parts of dipsacus root, 15-21 parts of fructus psoraleae, 6-9 parts of rhizoma drynariae, 10-21 parts of poria cocos, 5-14 parts of bighead atractylodes rhizome, 15-21 parts of curculigo rhizome, 15-21 parts of Chinese angelica, 15-21 parts of herba epimedii, 15-21 parts of prepared rehmannia root, 5-10 parts of green tangerine peel, 10-14 parts of radix codonopsis, 5-10 parts of dried orange peel and 5-10 parts of radix bupleuri.

In some preferred embodiments of the present invention, the traditional Chinese medicine composition comprises the following components: the traditional Chinese medicine composition comprises, by weight, 10-17 parts of dipsacus root, 15-21 parts of fructus psoraleae, 6-9 parts of rhizoma drynariae, 10-21 parts of poria cocos, 5-14 parts of bighead atractylodes rhizome, 15-21 parts of curculigo rhizome, 15-21 parts of Chinese angelica, 15-21 parts of herba epimedii, 15-21 parts of prepared rehmannia root, 5-10 parts of green tangerine peel, 10-14 parts of radix codonopsis, 5-10 parts of dried orange peel, 5-10 parts of radix bupleuri and 2-5 parts of liquorice.

In a specific embodiment of the invention, the traditional Chinese medicine composition comprises the following components: 17 parts of dipsacus root, 21 parts of malaytea scurfpea fruit, 9 parts of drynaria rhizome, 21 parts of poria cocos, 14 parts of bighead atractylodes rhizome, 21 parts of curculigo rhizome, 21 parts of Chinese angelica, 21 parts of epimedium, 21 parts of prepared rhizome of rehmannia, 10 parts of green tangerine peel, 14 parts of pilose asiabell root, 10 parts of dried orange peel, 10 parts of Chinese thorowax root and 5 parts of liquorice.

The invention also provides a preparation method of the oral liquid, which adopts the traditional Chinese medicine composition as raw materials and comprises the following steps:

s1, decocting the traditional Chinese medicine composition in water to obtain primary concentrated solution;

s2, mixing the primary concentrated solution with an ethanol water solution, and concentrating under reduced pressure to obtain a secondary concentrated solution;

in step S1, the operation of the decoction may be conventional in the art. Preferably, the decoction is carried out twice for 2 hours each time, and the filtrate is combined to obtain the primary concentrated solution.

Preferably, in step S2, the volume fraction of ethanol in the aqueous ethanol solution is 50% to 80%, for example 65%.

Preferably, in step S2, the aqueous ethanol solution is prepared using 95% ethanol.

Preferably, in step S2, the volume ratio of the primary concentrated solution to the aqueous ethanol solution is 1: (5-20), for example, 1:10.

preferably, in step S2, the primary concentrated solution is left at room temperature and then mixed with the aqueous ethanol solution.

Preferably, in step S2, after the primary concentrated solution is mixed with the aqueous ethanol solution, the method further comprises the steps of standing and refrigerating; wherein the temperature of the refrigeration is preferably 2-10 ℃; wherein the time of refrigeration is preferably 48 hours.

Preferably, after step S2, step S3 is further included, where step S3 is to mix the secondary concentrated solution with distilled water, filter, and collect filtrate;

when step S3 is further included after step S2, preferably, after mixing the secondary concentrated solution with distilled water, a step of refrigerating is further included, and the temperature of the refrigerating is preferably 2-10 ℃; the time of the refrigeration is preferably 48 hours;

when step S2 is further followed by step S3, preferably, the step of collecting the filtrate is further followed by a step of sterilization, preferably boiling;

when step S3 is further included after step S2, preferably, after the step of collecting the filtrate, an auxiliary material and/or water is further added to the filtrate, and filtering is performed;

wherein the auxiliary material is a sweetener and/or a preservative, the sweetener is preferably white granulated sugar, and the amount of the sweetener is preferably 15-30 parts, for example 30 parts; the preservative is preferably sodium benzoate; the preservative is preferably used in an amount of 1 to 3 parts, for example 2.5 parts; the water is preferably purified water. Purified water is added for volume, for example to 1000mL.

In the present invention, the reduced pressure concentration may be performed by a procedure conventional in the art, and the reduced pressure concentration is performed until the concentrated solution does not contain ethanol.

In the present invention, the filtration, mixing, boiling, etc. may be performed by using a conventional procedure in the art.

In the present invention, the normal temperature is a condition conventional in the art, for example, 15 to 40 ℃.

The invention also provides an oral liquid, which is prepared by adopting the preparation method of the oral liquid.

In the invention, the specification of the oral liquid can be 10 mL/branch.

The invention also provides application of the pharmaceutical composition or the oral liquid in medicines for treating fracture or osteoporosis.

On the basis of conforming to the common knowledge in the field, the above preferred conditions can be arbitrarily combined to obtain the preferred examples of the invention.

The reagents and materials used in the present invention are commercially available.

The invention has the positive progress effects that:

(1) The traditional Chinese medicine composition and the oral liquid can not only effectively treat osteoporosis and promote fracture healing, but also improve clinical manifestations of cold feeling, joint ache, limb flaccidity, listlessness and the like of patients, and achieve the effects of warming and invigorating spleen and kidney, tonifying qi and nourishing blood and activating blood and regulating viscera qi movement.

(2) The Chinese medicinal composition and the oral liquid have the effects of treating osteoporosis and fracture, the total cure rate reaches 90%, and the osteoporosis and the fracture can be obviously improved.

(3) Animal experiments of treating osteoporosis and fracture by using the traditional Chinese medicine composition are carried out, and the results show that the traditional Chinese medicine composition and the oral liquid can obviously reduce the BGP and TRAP contents (P < 0.05) of rats and increase the femur density (P < 0.05) of rats.

Detailed Description

The invention is further illustrated by means of the following examples, which are not intended to limit the scope of the invention. The experimental methods, in which specific conditions are not noted in the following examples, were selected according to conventional methods and conditions, or according to the commercial specifications.

Example 1

The traditional Chinese medicine composition comprises the following components in parts by weight: 17 parts of dipsacus root, 21 parts of malaytea scurfpea fruit, 9 parts of drynaria rhizome, 21 parts of poria cocos, 14 parts of bighead atractylodes rhizome, 21 parts of curculigo rhizome, 21 parts of Chinese angelica, 21 parts of epimedium, 21 parts of prepared rhizome of rehmannia, 10 parts of green tangerine orange peel, 14 parts of pilose asiabell root, 10 parts of dried orange peel, 10 parts of bupleurum and 5 parts of liquorice.

The oral liquid for treating fracture or osteoporosis is prepared by taking the traditional Chinese medicine composition as a raw material, and specifically comprises the following steps:

decocting the Chinese medicinal composition with water twice for 2 hr each time, and mixing filtrates to obtain primary concentrated solution; placing the primary concentrated solution at normal temperature, preparing ethanol aqueous solution with volume fraction of 65% by using 95% ethanol, adding the ethanol aqueous solution into the primary concentrated solution, refrigerating at 2-10deg.C for 48 hr, concentrating under reduced pressure until the concentrated solution does not contain ethanol, and obtaining secondary concentrated solution; adding distilled water into the secondary concentrated solution, precipitating with water, refrigerating at 2-10deg.C for 48 hr, filtering, collecting filtrate, adding 30 parts white sugar and 2.5 parts sodium benzoate, purifying to 1000ml, stirring, filtering, boiling, and sterilizing to obtain oral liquid for treating fracture or osteoporosis.

Example 2

The traditional Chinese medicine composition comprises the following components in parts by weight: 17 parts of dipsacus root, 18 parts of malaytea scurfpea fruit, 9 parts of drynaria rhizome, 21 parts of poria cocos, 14 parts of bighead atractylodes rhizome, 18 parts of curculigo rhizome, 21 parts of Chinese angelica, 18 parts of epimedium, 18 parts of prepared rhizome of rehmannia, 10 parts of green tangerine orange peel, 14 parts of pilose asiabell root, 10 parts of dried orange peel, 10 parts of bupleurum and 5 parts of liquorice.

The preparation method of the oral liquid by taking the traditional Chinese medicine composition as a raw material is the same as that of example 1.

Example 3

The traditional Chinese medicine composition comprises the following components in parts by weight: 10 parts of dipsacus root, 21 parts of malaytea scurfpea fruit, 9 parts of drynaria rhizome, 21 parts of poria cocos, 14 parts of bighead atractylodes rhizome, 10 parts of curculigo rhizome, 21 parts of Chinese angelica, 10 parts of epimedium, 18 parts of prepared rhizome of rehmannia, 10 parts of green tangerine orange peel, 14 parts of pilose asiabell root, 10 parts of dried orange peel, 10 parts of bupleurum and 5 parts of liquorice.

Example 4

The traditional Chinese medicine composition comprises the following components in parts by weight: 17 parts of dipsacus root, 18 parts of malaytea scurfpea fruit, 9 parts of drynaria rhizome, 21 parts of poria cocos, 14 parts of bighead atractylodes rhizome, 15 parts of curculigo rhizome, 21 parts of Chinese angelica, 15 parts of epimedium, 18 parts of prepared rhizome of rehmannia, 10 parts of green tangerine orange peel, 14 parts of pilose asiabell root, 10 parts of dried orange peel, 10 parts of bupleurum and 5 parts of liquorice.

Example 5

The traditional Chinese medicine composition comprises the following components in parts by weight: 17 parts of dipsacus root, 21 parts of malaytea scurfpea fruit, 9 parts of drynaria rhizome, 21 parts of poria cocos, 14 parts of bighead atractylodes rhizome, 21 parts of curculigo rhizome, 18 parts of Chinese angelica, 21 parts of epimedium, 21 parts of prepared rhizome of rehmannia, 5 parts of green tangerine orange peel, 14 parts of pilose asiabell root, 5 parts of dried orange peel, 10 parts of bupleurum and 2 parts of liquorice.

Example 6

The traditional Chinese medicine composition comprises the following components in parts by weight: 17 parts of dipsacus root, 21 parts of malaytea scurfpea fruit, 9 parts of drynaria rhizome, 21 parts of poria cocos, 14 parts of bighead atractylodes rhizome, 10 parts of curculigo rhizome, 21 parts of Chinese angelica, 10 parts of epimedium, 21 parts of prepared rhizome of rehmannia, 5 parts of green tangerine orange peel, 14 parts of pilose asiabell root, 5 parts of dried orange peel, 10 parts of bupleurum and 2 parts of liquorice.

Example 7

The traditional Chinese medicine composition comprises the following components in parts by weight: 17 parts of dipsacus root, 21 parts of malaytea scurfpea fruit, 9 parts of drynaria rhizome, 21 parts of poria cocos, 14 parts of bighead atractylodes rhizome, 10 parts of curculigo rhizome, 18 parts of Chinese angelica, 15 parts of epimedium, 21 parts of prepared rhizome of rehmannia, 10 parts of green tangerine orange peel, 14 parts of pilose asiabell root, 5 parts of dried orange peel, 10 parts of bupleurum and 2 parts of liquorice.

Example 8

The traditional Chinese medicine composition comprises the following components in parts by weight: 15 parts of dipsacus root, 21 parts of malaytea scurfpea fruit, 9 parts of drynaria rhizome, 18 parts of poria cocos, 8 parts of bighead atractylodes rhizome, 21 parts of curculigo rhizome, 15 parts of Chinese angelica, 21 parts of epimedium, 21 parts of prepared rhizome of rehmannia, 10 parts of green tangerine orange peel, 10 parts of pilose asiabell root, 10 parts of dried orange peel, 10 parts of bupleurum and 2 parts of liquorice.

Example 9

The traditional Chinese medicine composition comprises the following components in parts by weight: 17 parts of dipsacus root, 18 parts of malaytea scurfpea fruit, 8 parts of drynaria rhizome, 18 parts of poria cocos, 10 parts of bighead atractylodes rhizome, 18 parts of curculigo rhizome, 21 parts of Chinese angelica, 18 parts of epimedium, 18 parts of prepared rhizome of rehmannia, 10 parts of green tangerine orange peel, 14 parts of pilose asiabell root, 10 parts of dried orange peel, 5 parts of bupleurum and 2 parts of liquorice.

Example 10

The traditional Chinese medicine composition comprises the following components in parts by weight: 15 parts of dipsacus root, 18 parts of malaytea scurfpea fruit, 9 parts of drynaria rhizome, 15 parts of poria cocos, 10 parts of bighead atractylodes rhizome, 15 parts of curculigo rhizome, 21 parts of Chinese angelica, 15 parts of epimedium, 15 parts of prepared rhizome of rehmannia, 10 parts of green tangerine orange peel, 10 parts of pilose asiabell root, 10 parts of dried orange peel, 10 parts of bupleurum and 2 parts of liquorice.

Example 11

The traditional Chinese medicine composition comprises the following components in parts by weight: 10 parts of dipsacus root, 15 parts of malaytea scurfpea fruit, 6 parts of drynaria rhizome, 10 parts of poria cocos, 10 parts of bighead atractylodes rhizome, 15 parts of curculigo rhizome, 15 parts of Chinese angelica, 15 parts of epimedium, 15 parts of prepared rhizome of rehmannia, 5 parts of green tangerine orange peel, 5 parts of pilose asiabell root, 5 parts of dried orange peel, 5 parts of bupleurum and 2 parts of liquorice.

Example 12

The traditional Chinese medicine composition comprises the following components in parts by weight: 8 parts of dipsacus root, 10 parts of malaytea scurfpea fruit, 5 parts of drynaria rhizome, 5 parts of poria cocos, 5 parts of bighead atractylodes rhizome, 10 parts of curculigo rhizome, 10 parts of Chinese angelica, 10 parts of epimedium, 10 parts of prepared rhizome of rehmannia, 5 parts of green tangerine orange peel, 5 parts of pilose asiabell root, 5 parts of dried orange peel, 5 parts of bupleurum and 2 parts of liquorice.

Effect example 1

(1) Clinical trial

(1) Clinical manifestation score:

patients with osteoporosis with spleen-kidney yang deficiency were enrolled out of the clinic for 100 cases, scored according to the pain scale according to the above examples: based on the VAS score (the greater the score, representing pain), cold, debilitating and osteoporosis conditions are referenced in Table 1.

TABLE 1 clinical manifestation scoring

(2) The curative effect is as follows:

the effective rate was calculated from the clinical manifestation score = (pre-treatment pain score-post-treatment pain score)/(pre-treatment pain score) ×100%. According to the calculated effective rate corresponding to the curative effect, wherein the effective rate is less than or equal to 25 percent and is invalid, the effective rate is greater than 25 percent and is less than 50 percent, the effective rate is greater than or equal to 50 percent and is less than 75 percent, and the effective rate is greater than or equal to 75 percent and is healed.

TABLE 2 curative effect

Curative effect	People number (human)
		Invalidation of	10
Effective and effective	16
		Has obvious effect	54
Healing of the wound	20

(3) Typical cases:

case 1, female, 85 years old, compression fracture of the T12 vertebral body, heavy pain in the waist and back, slight fatigue and moderate cold feeling. The decoction prepared in the example 1 is taken orally, 1 dose is taken each time a day, pain is light after 4 weeks, cold feeling and fatigue discomfort are avoided, and moderate activity is realized after 6 weeks.

Case 2, male, 56 years old. The hawk-bone fracture pain on the right side is treated by fixing for 2 weeks, local pain, bruise and purple, and the decoction prepared in the example 2 is taken orally, 1 dose a day, and the pain is light after 2 weeks, the bruise and purple is absorbed, the pain is basically free from cold, and the affected part is basically healed after 4 weeks.

Case 3, male, 71 years old. The decoction prepared in the example 3 is taken orally, 1 dose a day in the morning and at night, and the pain is obviously relieved after 3 weeks, and the decoction has no obvious cold feeling.

Case 4, female, 58 years old. Postmenopausal osteoporosis, soreness of waist and back, slight cold and weakness, and oral administration of the decoction prepared in example 4, 1 dose a day, each time in the morning and evening, pain relief after 2 weeks, and no discomfort of weakness and cold.

Case 5, male, 66 years old. The 3 rd to 5 th rib fracture on the left side, chest and back pain on the left side, aversion to cold and fatigue, and the decoction prepared in the example 5 is taken orally, 1 dose a day, each time in the morning and evening, pain is relieved after 1 week, and an affected part is basically healed after 3 weeks and can moderately move.

Case 6, female, age 48. The bone fracture of the 1 st phalange of the left foot heals slowly, the decoction prepared in the example 6 is taken orally, 1 dose a day, each time in the morning and evening, and the affected part heals basically after 2 weeks, so that walking can be tried.

Case 7, female, age 78. Severe osteoporosis, soreness of waist, back and left lower limbs, slight debilitation, oral administration of the decoction prepared in example 7, 1 dose a day, once a day in the morning and evening, pain relief after 2 weeks, and obvious improvement of 4 weeks pain.

Case 8, male, 75 years old. The oral liquid prepared in the example 8 is 1 dose per day, and the pain is relieved after 4 weeks, and the oral liquid is slightly afraid of cold, and is thinner than the common people.

Case 9, male, 54 years old. Right side 6, 7 rib fracture, right chest back pain, listlessness. The decoction prepared in example 9 is taken 1 dose a day, each time in the morning and evening, pain is relieved after 2 weeks, and the affected part is basically healed after 3 weeks.

Case 10, male, 68 years old. L1 has compression fracture, pain, no debilitation and cold feeling, and the decoction prepared in the example 10 is taken 1 dose a day, and the pain is relieved after 4 weeks and can be slightly moved.

Case 11, female, 64 years old. The decoction prepared in example 11 is administered once a day, 1 dose a day and 3 weeks later, and the fatigue is free from obvious joint soreness, and the walking weakness of the two lower limbs is obviously improved, so that the cold feeling is avoided.

Case 12, male, 63 years old. The lower limb tibia on the right is ache, moderate osteoporosis, slight cold feeling, slight fatigue and hypodynamia, the decoction prepared in the example 12 is orally taken, 1 dose a day, once a day in the morning and at night, the pain is obviously relieved after 4 weeks, and no obvious cold feeling and hypodynamia are caused.

(2) Animal experiment

Healthy female SD rats of 3 months of age were kept in indoor animal houses kept at 22-26℃under the same lighting conditions and humidity conditions. After 1 week of adaptive feeding, 24 SD rats were collected and the rats were grouped according to the random number table method, and the SD rats were divided into 3 groups according to the experimental plan, namely, a normal group, a model group and a drug group.

The experiment adopts a dexamethasone intervention method to establish a rat model. The method is that the rats in the model group and the drug group are subcutaneously injected with dexamethasone 0.75mg/kg, 2 times per week for 12 weeks.

After successful molding, the oral liquid of the embodiment 1 of the invention is administrated by the drug group rats by gastric lavage, the concentration is 20g crude drug per kg respectively, and the gastric lavage is carried out once a day for 6 weeks according to 10 mL/kg. The model group and the normal control group were perfused with 1 mL/dose of physiological saline once daily for 6 weeks.

Anesthetizing the rat, placing under a dual-energy X-ray bone densitometer, and detecting femur density; and the abdominal aorta blood is extracted, the content of osteocalcin (BGP) and tartaric acid phosphatase (TRAP) in serum is measured, the data obtained by the study are processed by SPSS21.0 statistical software, the measurement data result is expressed by mean ± standard deviation (x- + -s), the comparison among multiple groups adopts single factor variance analysis, and the difference of P <0.05 is statistically significant.

As shown in table 3, the results show that compared with the normal group and the drug group, the BGP and TRAP contents of the rats in the model group are obviously increased (P < 0.05), and the femur densities of the rats in the model group are obviously reduced (P < 0.05); there was no significant difference in statistics between the drug group compared to the normal group.

TABLE 3 bone metabolism related index and bone Density conditions in serum of rats of each group

Note that: superscript Σ indicates P <0.05.

Claims

1. The traditional Chinese medicine composition is characterized by comprising the following components in parts by weight: 8-17 parts of dipsacus root, 10-21 parts of malaytea scurfpea fruit, 5-9 parts of drynaria rhizome, 10-21 parts of curculigo rhizome, 10-21 parts of Chinese angelica, 10-21 parts of epimedium, 10-21 parts of prepared rehmannia root, 5-14 parts of pilose asiabell root and 5-10 parts of bupleurum root.

2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition satisfies one or more of the following conditions a-n:

a. the dipsacus root is 10-17 parts, preferably 15-17 parts, for example 17 parts;

b. 15-21 parts, preferably 18-21 parts, for example 21 parts, of fructus Psoraleae;

c. the drynaria rhizome is 6-9 parts, preferably 8-9 parts, for example 9 parts;

d. 15-21 parts, preferably 18-21 parts, for example 21 parts, of curculigo rhizome;

e. 15-21 parts, preferably 18-21 parts, for example 21 parts, of angelica sinensis;

f. 15-21 parts, preferably 18-21 parts, for example 21 parts, of epimedium;

g. 15-21 parts of rehmannia glutinosa, preferably 18-21 parts, for example 21 parts;

h. the radix Codonopsis is 10-14 parts, such as 14 parts;

i. 10 parts of bupleurum;

j. the Chinese medicinal composition further comprises 10-21 parts of poria cocos, preferably 18-21 parts, for example 21 parts;

k. the Chinese medicinal composition also comprises 5-14 parts of bighead atractylodes rhizome, preferably 10-14 parts, for example 14 parts;

l the traditional Chinese medicine composition further comprises 5-10 parts of green tangerine peel, for example 5 parts or 10 parts;

m, the traditional Chinese medicine composition also comprises 5-10 parts of dried orange peel, for example 5 parts or 10 parts;

n, the Chinese medicinal composition further comprises 2-5 parts of liquorice, for example 2 parts or 5 parts.

3. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition comprises the following components: 10-17 parts of dipsacus root, 15-21 parts of fructus psoraleae, 6-9 parts of rhizoma drynariae, 10-21 parts of poria cocos, 5-14 parts of bighead atractylodes rhizome, 15-21 parts of curculigo rhizome, 15-21 parts of Chinese angelica, 15-21 parts of herba epimedii, 15-21 parts of prepared rehmannia root, 5-10 parts of green tangerine peel, 10-14 parts of radix codonopsis, 5-10 parts of dried orange peel and 5-10 parts of radix bupleuri;

or, according to parts by weight, 10-17 parts of dipsacus root, 15-21 parts of fructus psoraleae, 6-9 parts of rhizoma drynariae, 10-21 parts of poria cocos, 5-14 parts of bighead atractylodes rhizome, 15-21 parts of curculigo rhizome, 15-21 parts of Chinese angelica, 15-21 parts of epimedium herb, 15-21 parts of rehmannia glutinosa, 5-10 parts of green tangerine peel, 10-14 parts of radix codonopsis pilosulae, 5-10 parts of dried orange peel, 5-10 parts of radix bupleuri and 2-5 parts of liquorice.

4. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition comprises the following components: 17 parts of dipsacus root, 21 parts of malaytea scurfpea fruit, 9 parts of drynaria rhizome, 21 parts of poria cocos, 14 parts of bighead atractylodes rhizome, 21 parts of curculigo rhizome, 21 parts of Chinese angelica, 21 parts of epimedium, 21 parts of prepared rhizome of rehmannia, 10 parts of green tangerine peel, 14 parts of pilose asiabell root, 10 parts of dried orange peel, 10 parts of Chinese thorowax root and 5 parts of liquorice.

5. A method for preparing an oral liquid, which is characterized in that the oral liquid adopts the traditional Chinese medicine composition as defined in any one of claims 1-4 as raw materials, and comprises the following steps:

s2, mixing the primary concentrated solution with an ethanol water solution, and concentrating under reduced pressure to obtain a secondary concentrated solution.

6. The method according to claim 5, wherein in step S1, the number of times of decoction is two, each time for 2 hours, and the filtrates are combined to obtain the primary concentrated solution;

and/or, in step S2, the volume fraction of ethanol in the aqueous ethanol solution is 50% to 80%, for example 65%;

and/or, in the step S2, preparing the ethanol water solution by using 95% ethanol;

and/or, in step S2, the volume ratio of the primary concentrated solution to the ethanol aqueous solution is 1: (5-20), for example, 1:10;

and/or, in the step S2, the reduced pressure concentration is performed until the concentrated solution does not contain ethanol.

7. The method according to claim 5, wherein in step S2, the primary concentrated solution is mixed with the aqueous ethanol solution after being left at room temperature;

and/or, after mixing the primary concentrated solution with the ethanol water solution, the method further comprises the steps of standing and refrigerating;

wherein the temperature of the refrigeration is preferably 2-10 ℃;

wherein the time of refrigeration is preferably 48 hours;

and/or, after the step S2, the method further comprises a step S3, wherein the step S3 is to mix the secondary concentrated solution with distilled water, filter, and collect filtrate.

8. The method according to claim 7, wherein when step S3 is further included after step S2, the step of refrigerating is further included after mixing the secondary concentrated solution with distilled water;

wherein the temperature of the refrigeration is preferably 2-10 ℃;

wherein the time of refrigeration is preferably 48 hours;

and/or, after the step of collecting the filtrate, a step of sterilizing;

preferably, the sterilization mode is boiling;

and/or, after the step of collecting the filtrate, adding auxiliary materials and/or water into the filtrate, and filtering;

wherein the auxiliary materials are sweetening agents and/or preservatives;

preferably, the sweetener is white granulated sugar;

preferably, the sweetener is used in an amount of 15-30 parts, for example 30 parts;

preferably, the preservative is sodium benzoate;

preferably, the preservative is used in an amount of 1-3 parts, for example 2.5 parts;

preferably, the water is purified water.

9. An oral liquid, characterized in that the oral liquid is prepared by the preparation method of the oral liquid in any one of claims 5-8.

10. Use of a traditional Chinese medicine composition according to any one of claims 1-4 or an oral liquid according to claim 9 for the preparation of a medicament for the treatment of bone fractures or osteoporosis.