CN114224945B

CN114224945B - A Chinese medicinal composition with effects of strengthening tendons and bones, relieving rigidity of muscles and activating collaterals, and its preparation method

Info

Publication number: CN114224945B
Application number: CN202111555439.7A
Authority: CN
Inventors: 席桂才; 葛一蒙; 柳叶; 韩宇
Original assignee: HEILONGJIANG ZBD PHARMACEUTICAL CO Ltd
Current assignee: HEILONGJIANG ZBD PHARMACEUTICAL CO Ltd
Priority date: 2021-12-17
Filing date: 2021-12-17
Publication date: 2023-08-08
Anticipated expiration: 2041-12-17
Also published as: CN114224945A

Abstract

The invention provides a traditional Chinese medicine composition with the effects of strengthening tendons and bones and relaxing tendons and activating collaterals and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 8-14 parts of suberect spatholobus stem, 7-13 parts of white paeony root, 7-13 parts of pawpaw, 2-9 parts of Chinese angelica, 2-8 parts of himalayan teasel root, 2-8 parts of cortex acanthopanacis, 7-12 parts of lycopodium clavatum, 7-12 parts of astragalus root and 0.5-1.5 parts of liquorice. The traditional Chinese medicine composition provided by the invention is mainly used for treating bone fracture, is optimally applied to later stages of fracture, is safe and effective for treating patients with weak liver and kidney such as non-hard bones and muscles, stiff joints and unfavorable activities, has no adverse reaction and has clinical necessity.

Description

A Chinese medicinal composition with effects of strengthening tendons and bones, relieving rigidity of muscles and activating collaterals, and its preparation method

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition with the effects of strengthening tendons and bones and relaxing tendons and activating collaterals and a preparation method thereof.

Background

Bone diseases seriously endanger human health, and the traditional Chinese medicine considers that bones and muscles are most closely related to liver and kidney, liver governs tendons and bones, governs exercise and governs blood collection; the kidneys govern bones, and govern marrow generation, which is the acquired root. Nourishing liver and kidney, strengthening tendons and bones, replenishing blood and promoting blood circulation are the principle of treating orthopedic diseases.

Fracture refers to the complete or partial fracture of bone or bone structure, and belongs to the common diseases of orthopaedics, which are commonly seen in children and the elderly. The common telephone says that "the tendons and bones are injured for one hundred days" and the bones are not hard, the joints are stiff and the movement is unfavorable in the later treatment period of the fracture, and the channels and collaterals around the bones and joints are not smooth, so that the oral medicine is difficult to reach the focus, the treatment period is long, the treatment effect is small, more than three months are needed for recovery, and the work is delayed and the pain is brought to the patient.

Disclosure of Invention

The invention provides a traditional Chinese medicine composition, which is prepared from the following components in parts by weight: 8-14 parts of suberect spatholobus stem, 7-13 parts of white paeony root, 7-13 parts of pawpaw, 2-9 parts of Chinese angelica, 2-8 parts of himalayan teasel root, 2-8 parts of cortex acanthopanacis, 7-12 parts of lycopodium clavatum, 7-12 parts of astragalus root and 0.5-1.5 parts of liquorice.

In the traditional Chinese medicine composition, the caulis spatholobi has the effects of activating blood and replenishing blood; radix paeoniae alba has the effects of softening liver, nourishing liver, relieving spasm and pain, relaxing tendons and activating collaterals, and radix angelicae sinensis has the effects of replenishing blood and activating blood, and the three medicines are used as auxiliary drugs; radix dipsaci and cortex acanthopanacis have effects of tonifying liver and kidney, strengthening tendons and bones, and herba lycopodii has effects of promoting blood circulation, removing obstruction in collaterals, relaxing tendons, invigorating qi, consolidating superficial resistance, and removing toxic substances; the liquorice regulates the medicines. The medicines are combined together to play the roles of strengthening tendons and bones, relaxing tendons and activating collaterals.

According to the monarch, minister, assistant and guide of traditional Chinese medicinal materials in the formula, the proportion of the medicinal materials is optimized, and the treatment effect is improved, and the traditional Chinese medicinal composition is prepared from the following components in parts by weight: 9-14 parts of spatholobus stem, 8-12 parts of white peony root, 8-12 parts of papaya, 3-8 parts of angelica, 2-7 parts of teasel root, 2-7 parts of cortex acanthopanacis, 7-11 parts of lycopodium clavatum, 7-11 parts of astragalus root and 0.6-1.2 parts of liquorice.

In a more preferred embodiment, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-14 parts of spatholobus stem, 9-11 parts of white peony root, 9-11 parts of papaya, 4-7 parts of angelica, 2-6 parts of teasel root, 2-6 parts of cortex acanthopanacis, 7-10 parts of lycopodium clavatum, 7-10 parts of astragalus root and 0.7-1.3 parts of liquorice.

The second aim of the invention is to provide the application of the traditional Chinese medicine composition in preparing medicines with the effects of strengthening tendons and bones and relaxing tendons and activating collaterals.

In a preferred embodiment, the medicament is suitable for patients with liver and kidney weakness in the late stage of fracture, the symptoms of which include: the tendons and bones are not hard, the joints are stiff, the movement is unfavorable, etc.

The third object of the present invention is to provide a preparation method of the above Chinese medicinal composition, comprising the following steps:

extracting caulis Spatholobi, radix Paeoniae alba, fructus Chaenomelis, radix Angelicae sinensis, radix Dipsaci, cortex Acanthopancis, herba Lycopodii, radix astragali and Glycyrrhrizae radix with water to obtain water extractive solution;

concentrating the water extract to obtain the traditional Chinese medicine composition.

In some preferred embodiments, the aqueous extract is specifically: mixing caulis Spatholobi, radix Paeoniae alba, fructus Chaenomelis, radix Angelicae sinensis, radix Dipsaci, cortex Acanthopancis, herba Lycopodii, radix astragali and Glycyrrhrizae radix, adding water with weight 6-10 times of the weight of the raw materials, decocting and extracting for 2 times, each for 1-2 hours, filtering to obtain filtrate, and mixing the filtrates of the two water extractions to obtain water extractive solution.

In some preferred embodiments, the aqueous extract is concentrated to a relative density of 1.05 to 1.10 (60 ℃).

The fourth object of the invention is to provide a traditional Chinese medicine preparation, which comprises the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials.

Wherein the Chinese medicinal preparation is in the form of tablet, pill, oral solution, capsule, syrup, dripping pill or granule.

For the traditional Chinese medicine composition prepared by the preparation method, the traditional Chinese medicine composition is usually prepared into granules, and the paeoniflorin content in each 1g of granules is not less than 1.4mg.

In some preferred embodiments, the method of making the granule is as follows: adding 30% of auxiliary materials by weight of the prescription of the raw medicinal materials into the traditional Chinese medicine composition, uniformly mixing, spray drying, adding 1.5% of auxiliary materials by weight of the prescription of the raw medicinal materials, uniformly mixing, and granulating to obtain the traditional Chinese medicine composition. 3g of the medicine is taken each time, 3 times a day. Higher or lower doses may also be used in certain situations, with the appropriate dose for each patient being ultimately determined by the physician based on the mode of administration, age, weight and response of the patient.

Based on the traditional Chinese medicine theory of kidney governing bones and liver governing tendons, the invention prepares the therapeutic principle of bone diseases of nourishing liver and kidney, strengthening tendons and bones, enriching blood and activating blood and also prepares the prescription. The traditional Chinese medicine composition provided by the invention is mainly used for treating bone fracture, is optimally applied to the later stage of fracture, is used for treating patients with weak liver and kidney such as non-hard bones and muscles, stiff joints and unfavorable activities, is safe and effective, has no adverse reaction, and has clinical necessity.

In the invention, the traditional Chinese medicine composition meets the first requirement of the 2020 edition of Chinese pharmacopoeia, if no special description exists:

caulis Spatholobi is dried rattan of Spatholobus stem Spatholobus suberectus Dunn of Spatholobus stem of Leguminosae.

Radix Paeoniae alba is dry root of Pall Paeonia lactiflora of Pall of Paulliniaceae.

Papaya is a dried near-ripe fruit of Begonia sessiliflora Chaenomeles speciosa (Sweet) Nakai of Rosaceae.

Angelica sinensis is the dry root of Angelica sinensis Angelica sinensis (Oliv.) Diels, an Umbelliferae plant.

Dipsacus asperoides is dry root of Dipsacus asper wall. Ex Henry of Dipsacaceae.

Cortex Acanthopancis is the dried root bark of Acanthopanax gracilistylus Acanthopanax gracilistylus W.W.Smith.

Herba Lycopodii is dried whole herb of Pinus koraiensis Lycopodium japonicum thunder.

Astragalus root is the dried root of astragalus mongholicus Astragalus membranaceus (fischer) bge.var. Mongholicus (bge.) Hsiao or astragalus membranaceus Astragalus membranaceus (fischer) bge.

Glycyrrhrizae radix (processed with honey) is processed product of dried root and rhizome of Glycyrrhrizae radix Glycyrrhiza uralensis Fisch of Leguminosae.

Detailed Description

The following describes the embodiments of the present invention in further detail with reference to examples. The following examples are illustrative of the invention and are not intended to limit the scope of the invention. Unless otherwise indicated, the technical means used in the examples are conventional means well known to those skilled in the art, and all raw materials used are commercially available.

Example 1

The embodiment provides a traditional Chinese medicine composition with the effects of strengthening tendons and bones and relaxing tendons and activating collaterals, which is prepared from the following raw materials: 8 parts of suberect spatholobus stem, 13 parts of white paeony root, 13 parts of pawpaw, 8 parts of Chinese angelica, 5 parts of teasel root, 5 parts of cortex acanthopanacis, 10 parts of lycopodium clavatum, 10 parts of astragalus and 1.0 part of liquorice.

The preparation method comprises the following steps: decocting the above 9 materials with water twice, adding 8 times of water for the first time and 6 times of water for the second time, decocting for 1 hr each time, filtering, mixing decoctions, and concentrating the filtrate to relative density of 1.05 (60deg.C) to obtain the final product.

Adding dextrin 30% of the weight of the medicinal materials into the obtained traditional Chinese medicine composition, uniformly mixing, spray drying, adding dextrin 1.5% of the weight of the medicinal materials, uniformly mixing, granulating, and thus obtaining the granule.

Example 2

The embodiment provides a traditional Chinese medicine composition with the effects of strengthening tendons and bones and relaxing tendons and activating collaterals, which is prepared from the following raw materials: 9 parts of suberect spatholobus stem, 12 parts of white paeony root, 12 parts of pawpaw, 4 parts of Chinese angelica, 5 parts of teasel root, 5 parts of cortex acanthopanacis, 10 parts of lycopodium clavatum, 10 parts of astragalus and 1.0 part of liquorice.

The preparation method of the traditional Chinese medicine composition and the granules thereof are the same as that of the example 1.

Example 3

The embodiment provides a traditional Chinese medicine composition with the effects of strengthening tendons and bones and relaxing tendons and activating collaterals, which is prepared from the following raw materials: 10 parts of suberect spatholobus stem, 10 parts of white paeony root, 10 parts of pawpaw, 5 parts of Chinese angelica, 5 parts of teasel root, 5 parts of cortex acanthopanacis, 10 parts of lycopodium clavatum, 10 parts of astragalus and 1.0 part of liquorice.

Example 4

The embodiment provides a traditional Chinese medicine composition with the effects of strengthening tendons and bones and relaxing tendons and activating collaterals, which is prepared from the following raw materials: 12 parts of suberect spatholobus stem, 10 parts of white paeony root, 10 parts of pawpaw, 6 parts of Chinese angelica, 4 parts of teasel root, 4 parts of cortex acanthopanacis, 8 parts of lycopodium clavatum, 8 parts of astragalus and 1.0 part of liquorice.

Comparative example 1

Comparative example 1 provides a traditional Chinese medicine composition with the effects of strengthening tendons and bones and relaxing tendons and activating collaterals, which is prepared from the following raw materials: 5 parts of suberect spatholobus stem, 15 parts of white paeony root, 15 parts of pawpaw, 10 parts of Chinese angelica, 5 parts of teasel root, 5 parts of cortex acanthopanacis, 5 parts of lycopodium clavatum, 5 parts of astragalus and 1.0 part of liquorice.

Comparative example 2

Comparative example 2 provides a traditional Chinese medicine composition with the effects of strengthening tendons and bones and relaxing tendons and activating collaterals, which is prepared from the following raw materials: 15 parts of suberect spatholobus stem, 5 parts of white paeony root, 5 parts of pawpaw, 5 parts of Chinese angelica, 5 parts of teasel root, 5 parts of cortex acanthopanacis, 15 parts of lycopodium clavatum, 15 parts of astragalus and 1.0 part of liquorice.

Animal test

SPF-grade healthy male SD rats 90, quality 240-280g,90 rats were anesthetized by injecting 3% sodium pentobarbital solution into abdominal cavity according to weight 0.2ml/100g, fixed in supine position, left tibia outside skin preparation, incision, separating muscle group and tibia, shearing tibia middle section by bone scissors, retrograde internal fixation of bone marrow cavity by Rong Kirschner wire, suture incision, not binding. 84 rats with better selection status are intramuscular injected with 80 ten thousand U/ml penicillin sodium solution 0.1 ml/rat for 3 consecutive days on the next day after operation. And randomly dividing the weight into models, and preparing the model according to the weight of each of the groups of examples 1-4 and the comparative examples 1-2, wherein each group comprises 12. Starting to perform gastric lavage administration on the same day, and performing gastric lavage administration on the corresponding medicine according to the volume of 1ml/100g of body weight once a day to obtain 1g/kg of medicine; the administration was for 4 weeks.

The three-point bending biomechanical test primary incision reveals the femoral shaft and is taken out, soft tissue residues such as surface muscles, fascia and the like are scraped off, and the Kirschner wire is extracted. In the intensity measuring room of the mechanical college, the microcomputer controlled full-digital electronic universal biological material tester is adopted to carry out three-point bending test on the free femur of the rat. The femur specimen is placed on the test support, the femur ruler faces downwards, the fracture line with the span L=19mm is centered, the T-shaped head is right over the fracture line, and the femur specimen descends at a constant speed of 2mm/min until the specimen breaks. And measuring the inner diameter and the outer diameter of the center of the backbone, converting the load and the radius, drawing a stress-strain curve, and reading and calculating the maximum load and the maximum deflection from the curve.

Table 1 biomechanical index results for fracture healing in rats (x±s, n=12)

Group of	Maximum load (N)	Maximum deflection (mm)
			Model group	51.32±4.97	1.19±0.55
Example 1 group	89.64±3.26 ^*	4.86±0.43 ^*
			Example 2 group	93.15±6.23 ^*	4.92±0.29 ^*
Example 3 group	95.22±3.54 ^*	5.19±0.38 ^*
			Example 4 group	99.78±5.55 ^*	5.68±0.40 ^*
Comparative example 1 group	53.52±4.27	2.23±0.49
			Comparative example 2 group	55.10±5.91	2.07±0.21

Note that: in comparison with the set of models, ^* P<0.05

and calculating the maximum load and the maximum deflection through a load-displacement curve. The results are shown in table 1, with the 4 th week example group having significantly higher maximum load and maximum deflection than the model group (P < 0.05).

Clinical trial

1. Test method

1.1 subjects

100 outpatients all accord with the diagnosis standard of Western fracture and the diagnosis standard of traditional Chinese medicine liver and kidney deficiency syndrome type. After informed consent, the treatment group and the control group were randomized into 50 cases. 29 men and 21 women in the control group, ages 33-73 years old; 30 men and 20 women in the treatment group, with ages 36-66 years. The gender, age and course of disease of the two groups of patients were statistically analyzed, and the differences were not statistically significant (P > 0.05).

All the patients after treatment are treated after fracture reduction fixation treatment. 50 patients with fracture in the control group take eplerenone orally, wherein each time of the eplerenone is taken by l tablets, 3 times a day, and meanwhile, the Long Liji calcium tablets are taken by chewing, and 3 tablets are taken each time; patients in the treatment group were given the example 3 granule treatment 3 at the convalescence of fracture, 3 times daily, 3g each time. 3 months is a treatment course. And (5) comparing and evaluating the two groups of clinical treatment effects after the treatment is finished.

1.2 diagnostic criteria

The method is determined by referring to the clinical observation guiding principle of treating traumatic fracture by using new traditional Chinese medicine: (1) a history of trauma with direct or indirect violence; (2) the systemic symptoms are not obvious or serious, and the simple fracture without vascular and nerve injury complications is caused; (3) the local symptoms include pain and tenderness, swelling, dysfunction, deformity, etc.; (4) x-ray examination can clearly determine the fracture type, the manual reduction and the external fixation of the splint. The disease course is 30 days.

Traditional Chinese medicine syndrome waiting diagnosis standard: deficiency of liver and kidney. Main symptoms are as follows: the bone is not hard, the waist and knee are ache, and the limb swelling is not completely eliminated. Secondary symptoms: lassitude, pale or dark red tongue, thin and white or thin and yellow coating, thin and wiry pulse.

1.3 therapeutic efficacy criterion

Preferably: the fracture dissection is aligned, the function is recovered to be normal, pain and muscle atrophy are avoided, and the joint can stretch freely, so that the fracture dissection device can work in the past.

Good: the fracture function is close to normal, no pain, slight muscular atrophy, slightly bad activity and can still work in the past.

The method comprises the following steps: fracture alignment is not ideal, pain exists, muscle atrophy is slight, and movement is slightly limited.

The difference is: the above criteria cannot be met.

1.4 statistical methods

The data were processed with SPSS21.0 software, counting (chi-square test), metering (t-test), and P <0.05 indicated that there was a large difference in the comparison data.

2. Therapeutic results

The comparison of the two therapeutic effects is shown in Table 2. The total effective rate of the treatment group is 90%, and the total effective rate of the control group is 74%. The two groups of treatment effects are obviously different compared (P < 0.05), which shows that the treatment effect of the treatment group is better than that of the control group.

Table 2 comparison of the two therapeutic effects

Note that: after treatment, the clinical curative effect reaches the best and good, and the statistics is the total effective rate.

While the invention has been described in detail in the foregoing general description, embodiments and experiments, it will be apparent to those skilled in the art that modifications and improvements can be made thereto. Accordingly, such modifications or improvements may be made without departing from the spirit of the invention and are intended to be within the scope of the invention as claimed.

Claims

1. The traditional Chinese medicine composition for the patients with the deficiency of the liver and kidney in the later stage of fracture is characterized by being prepared from the following components in parts by weight: 8-14 parts of suberect spatholobus stem, 7-13 parts of white paeony root, 7-13 parts of papaya, 2-9 parts of Chinese angelica, 2-8 parts of teasel root, 2-8 parts of cortex acanthopanacis, 7-12 parts of lycopodium clavatum, 7-12 parts of astragalus mongholicus and 0.5-1.5 parts of liquorice.

2. The traditional Chinese medicine composition according to claim 1, which is characterized by being prepared from the following components in parts by weight: 9-14 parts of suberect spatholobus stem, 8-12 parts of white paeony root, 8-12 parts of pawpaw, 3-8 parts of Chinese angelica, 2-7 parts of teasel root, 2-7 parts of cortex acanthopanacis, 7-11 parts of lycopodium clavatum, 7-11 parts of astragalus mongholicus and 0.6-1.2 parts of liquorice.

3. The traditional Chinese medicine composition according to claim 1 or 2, which is characterized by being prepared from the following components in parts by weight: 10-14 parts of suberect spatholobus stem, 9-11 parts of white paeony root, 9-11 parts of pawpaw, 4-7 parts of Chinese angelica, 2-6 parts of teasel root, 2-6 parts of cortex acanthopanacis, 7-10 parts of lycopodium clavatum, 7-10 parts of astragalus mongholicus and 0.7-1.3 parts of liquorice.

4. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in preparing medicines with effects of strengthening tendons and bones and relaxing tendons and activating collaterals.

5. The use according to claim 4, wherein the medicament is suitable for patients with liver and kidney weakness in the late stage of fracture.

6. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 3, which is characterized by comprising the following steps:

7. The preparation method according to claim 6, wherein the water extraction is specifically: mixing caulis Spatholobi, radix Paeoniae alba, fructus Chaenomelis, radix Angelicae sinensis, radix Dipsaci, cortex Acanthopancis, herba Lycopodii, radix astragali and Glycyrrhrizae radix, adding water with weight 6-10 times of that of the raw materials, decocting and extracting for 2 times, each for 1-2 hours, filtering to obtain filtrate, and mixing the filtrates of the two water extractions to obtain water extractive solution.

8. The method according to claim 6 or 7, wherein the aqueous extract is concentrated to a relative density of 1.05-1.10 at 60 ℃.

9. A Chinese medicinal preparation, which is characterized by comprising the Chinese medicinal composition according to any one of claims 1-3 and pharmaceutically acceptable auxiliary materials.

10. The Chinese medicinal preparation according to claim 9, wherein the dosage form is a tablet, a pill, an oral solution, a capsule, a syrup, a drop pill or a granule.

11. The Chinese medicinal preparation according to claim 10, wherein the dosage form is granule, and the paeoniflorin content in each 1g granule is not less than 1.4mg.