A traditional Chinese medicine composition for treating post-fracture soreness and fatigue and application thereof

Abstract

The present application relates to a kind of traditional Chinese medicine composition for treating post-fracture soreness, fatigue, it is made from the following weight parts of raw medicinal materials: flying cinnabar 250-350 parts, top blood 250-350 parts, natural copper 250-350 parts, upper sandalwood 130-170 parts, water fly realgar 130-170 parts, big mei piece 40-80 parts.The present application also provides the use of the above-mentioned drug.Its advantages are that: the traditional Chinese medicine composition of the present application meets the compatibility of monarch, minister, and assistant, with natural copper dispersing blood stasis, stopping pain, and continuing tendon and bone as monarch drug;Bone fracture supplement treating injury, pain relief, kidney and bone strengthening;Realgar dry dampness, dispel wind, kill insects, detoxification;Big mei piece detumescence analgesic, together as minister drug;Sandalwood qi-warming analgesic, cinnabar heat-clearing and detoxifying as assistant drug.

Description

[Technical Field]

[0001] This invention relates to a traditional Chinese medicine composition for treating post-fracture pain and weakness and its application, specifically a traditional Chinese medicine preparation made from Chinese herbal medicines. [Background Technology]

[0002] A fracture is a condition caused by external or internal injuries that result in the partial or complete breakage of bone. With the widespread use of transportation, traffic accidents are becoming increasingly frequent, leading to a daily increase in orthopedic trauma patients. Typical symptoms of fractures include local deformity, abnormal movement of the limb, audible crepitus when moving the limb, severe pain at the wound site, local swelling and bruising, and post-injury movement disorders. The ultimate goal of fracture treatment is to restore the injured limb to its fullest possible function.

[0003] Currently, fractures are mainly treated surgically. However, both open surgery and internal fixation or reduction and fixation can cause further damage to soft tissues, leading to risks of complications such as skin infection and necrosis, nonunion of fractures, and joint dysfunction.

[0004] Chinese patent document CN201810411959.2 discloses a plaster for treating fractures. This traditional Chinese medicine composition is made from the following key ingredients in the indicated weight ratios: 9-15 parts by weight of *Drynaria fortunei*, 9-15 parts by weight of *Salvia miltiorrhiza*, 8-12 parts by weight of *Ligusticum chuanxiong*, 9-15 parts by weight of *Angelica dahurica*, 9-15 parts by weight of *Bletilla striata*, 6-15 parts by weight of *Lycopodium clavatum*, 3-9 parts by weight of *Caesalpinia sappan*, 3-9 parts by weight of *Carthamus tinctorius*, 3-9 parts by weight of borneol, 3-9 parts by weight of *Dracaena cochinchinensis*, 3-9 parts by weight of natural copper, 200 parts by weight of *Limonium styracifolium*, and 1000 parts by weight of sesame oil. This invention, based on traditional Chinese medicine theory, uses the principle of syndrome differentiation and treatment to select the appropriate herbal formula. The formula is scientifically sound, simple to prepare, has no toxic side effects, a short treatment duration, and rapid onset of action. The overall formula has the effects of promoting blood circulation, removing blood stasis, clearing the meridians, dispelling wind, and relieving pain. Chinese patent document CN201810188609.4 discloses a plaster for treating fractures and its preparation method. This traditional Chinese medicine pill is made from the following raw materials in the indicated weight ratios: 40-50 parts Panax notoginseng, 20-30 parts Dipsacus asper, 20-30 parts Psoralea corylifolia, 5-15 parts Eupolyphaga sinensis, 10-20 parts Acanthopanax senticosus, 10-20 parts Eucommia ulmoides, 5-15 parts Carthamus tinctorius, 20-30 parts Drynaria fortunei, 10-30 parts Angelica sinensis, 10-20 parts Ligusticum chuanxiong, 20-30 parts Boswellia carterii, and 20-30 parts Commiphora myrrha. The ingredients are: 5-10 parts leech, 15-30 parts *Lycopodium clavatum*, 15-30 parts natural copper, 5-10 parts calomel, 10-30 parts dragon's blood, and 2-4 parts musk; the pharmaceutically acceptable carriers include: 2000-3000 parts sesame oil and 1000-1200 parts litharge; the plaster prepared by this invention has the effects of promoting blood circulation and removing blood stasis, regulating qi and relieving pain, reducing swelling and promoting tissue regeneration, and promoting tendon and bone healing. It has a significant therapeutic effect on fractures, with rapid onset of action, short healing time, safety and reliability, no toxic side effects, low cost, convenient use, and simple preparation method.

[0005] There are many traditional Chinese medicine compositions for treating fractures, but they all have more or less drawbacks, such as too many ingredients, difficulty in sourcing materials, high prices, and unclear efficacy and poor treatment results. Therefore, there is an urgent need for a medicine that is effective in treating post-fracture pain and fatigue, has fewer ingredients, and is easy to prepare. [Summary of the Invention]

[0006] The purpose of this invention is to address the shortcomings of existing technologies by providing a traditional Chinese medicine composition for treating post-fracture pain and weakness.

[0007] Another object of the present invention is to provide a use of the above-mentioned drug.

[0008] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0009] A traditional Chinese medicine composition for treating post-fracture pain and weakness is made from the following raw materials in parts by weight: 250-350 parts of cinnabar, 250-350 parts of dragon's blood, 250-350 parts of natural copper, 130-170 parts of sandalwood, 130-170 parts of realgar, and 40-80 parts of borneol.

[0010] More preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 300 parts of cinnabar, 300 parts of dragon's blood, 300 parts of natural copper, 150 parts of sandalwood, 150 parts of realgar, and 60 parts of borneol.

[0011] The medicine described is a plaster.

[0012] To achieve the second objective mentioned above, the technical solution adopted by the present invention is as follows:

[0013] The application of the drug in the preparation of drugs for treating fractures.

[0014] Preferably, the fracture symptoms are in the later stage of the fracture, after the clamping is removed, such as soreness and weakness.

[0015] The advantages of this invention are:

[0016] The traditional Chinese medicine composition of this invention conforms to the principle of monarch, minister, assistant, and guide. Natural copper is used as the monarch drug to disperse blood stasis, relieve pain, and promote the healing of tendons and bones; Drynaria fortunei is used to heal injuries, relieve pain, tonify the kidneys, and strengthen bones; Realgar is used to dry dampness, dispel wind, kill parasites, and detoxify; Prunus campestris is used to reduce swelling and relieve pain; Sandalwood is used to regulate qi, warm the middle jiao, and relieve pain; Cinnabar is used to clear heat and detoxify.

Detailed Implementation Methods

[0017] Example 1: Preparation of the Traditional Chinese Medicine Composition of the Present Invention (I)

[0018] 300 parts of cinnabar, 300 parts of dragon's blood, 300 parts of natural copper, 150 parts of sandalwood, 150 parts of realgar, and 60 parts of borneol.

[0019] Example 2: Preparation of the Traditional Chinese Medicine Composition of the Present Invention (II)

[0020] 300 parts of cinnabar, 250 parts of dragon's blood, 350 parts of natural copper, 150 parts of sandalwood, 130 parts of realgar, and 80 parts of borneol.

[0021] Example 3: Preparation of the Traditional Chinese Medicine Composition of the Present Invention (Part III)

[0022] 250 parts of cinnabar, 350 parts of dragon's blood, 300 parts of natural copper, 130 parts of sandalwood, 170 parts of realgar, and 60 parts of borneol.

[0023] Example 4: Preparation of the Traditional Chinese Medicine Composition of the Present Invention (Part Four)

[0024] 350 parts of cinnabar, 300 parts of dragon's blood, 250 parts of natural copper, 170 parts of sandalwood, 150 parts of realgar, and 40 parts of borneol.

[0025] Example 5: Preparation of the Traditional Chinese Medicine Composition of the Present Invention (V)

[0026] 250 parts of cinnabar, 250 parts of dragon's blood, 250 parts of natural copper, 130 parts of sandalwood, 130 parts of realgar, and 40 parts of borneol.

[0027] Example 6 Animal Experiment

[0028] 1. Experimental Materials

[0029] 1.1 Drugs

[0030] Treatment Group 1: 300 parts of cinnabar, 300 parts of dragon's blood, 300 parts of natural copper, 150 parts of sandalwood, 150 parts of realgar, and 60 parts of borneol.

[0031] Treatment Group 2: 350 parts of cinnabar, 300 parts of dragon's blood, 250 parts of natural copper, 170 parts of sandalwood, 150 parts of realgar, and 40 parts of borneol.

[0032] Control group 1: 300 parts amber, 300 parts Panax notoginseng, 300 parts natural copper, 150 parts sandalwood, 150 parts realgar, and 60 parts borneol;

[0033] Control group 2: 350 parts of cinnabar, 300 parts of cattail pollen, 250 parts of natural copper, 170 parts of sandalwood, 150 parts of Cnidium monnieri, and 40 parts of borneol.

[0034] Model group: physiological saline.

[0035] 1.2 Animals

[0036] Sixty rats, weighing 250-280g and aged 6-7 months, were purchased from Jesstech.

[0037] 1.3 Reagents and Instruments

[0038] Chloral hydrate, penicillin, and routine surgical instruments.

[0039] 2. Methods

[0040] 2.1 Modeling and Grouping for Drug Administration

[0041] After 3 days of acclimatization, rats were used for modeling. The method was as follows: Rats were anesthetized intraperitoneally with 10% chloral hydrate at 0.3 ml / 10 g. After the anesthesia took effect, the rats were fixed in a supine position on the operating table. The hair on the left hind limb was shaved and disinfected. Under aseptic conditions, a longitudinal incision was made on the medial side, and the skin and subcutaneous tissue were cut layer by layer to expose the tibia. At the junction of the middle and lower 1 / 3 of the tibia, a 3 mm wide periosteum was removed with a scalpel to expose the subperiosteal bone. A fracture was created with bone forceps, and then the layers were sutured without fixation. Postoperatively, three anti-infection treatments were given, including an intramuscular injection of penicillin 80,000 U / 100 g once.

[0042] Fifty successfully modeled rats were randomly selected and divided into five groups of ten each. Every week thereafter, the ointment was changed at the fracture sites in the treatment and control groups, while the model groups were simply wrapped with gauze until the end of the experiment.

[0043] 2.3 Collection of materials

[0044] Rats were randomly selected on postoperative days 7, 15, 21, 30, and 42. After intraperitoneal anesthesia, X-rays were taken to compare bone growth and fracture healing, and scores were assigned. Scoring criteria: 1 point: Fracture edge is blurred, periosteal reaction is mild, no bone mass is visible; 2 points: Fracture edge is blurred, periosteal reaction is faint, bone density is low, and the edge is irregular; 3 points: Fracture edge is still visible but nearly disappears, periosteal reaction is deep, bone mass is increased but does not fill the defect, density is increased, and the edge is relatively clear; 4 points: Fracture edge completely disappears, periosteal reaction density is similar to bone shadow, bone mass fills the defect, and the bone mass is of the same density as the cortical bone and interconnected.

[0045] 2.4 Statistical Methods

[0046] All statistical analyses were performed using Graphpad Prism 8 software. Results are expressed as mean ± standard deviation. Paired and unpaired data were evaluated using the Student's t-test. P < 0.05 was considered statistically significant.

[0047] 3. Results

[0048] 3.1 Post-treatment scoring results

[0049] On day 7 after modeling, the fracture edges in the treatment group were slightly constricted, and the periosteum showed a mild reaction, but no callus growth occurred. On day 15, a small amount of callus grew in the treatment group, with blurred edges, while no callus grew in the control group. On day 21, the fracture density increased, and more callus formed, with the edges still visible, while only a small amount of callus formed in the control group. On day 30, the bone density in the treatment group continued to increase, the periosteum reaction was deeper, and the amount of callus had surrounded the fracture ends, while the control group showed more callus. On day 42, the periosteum density was close to that of bone, and the fracture line basically disappeared. The fracture lines in the control group and the model group were still clear, and the amount of callus was greater. The scores are shown in Table 1.

[0050] Table 1 Comparison of rat scores after treatment

[0051]

[0052] Note: *Compared with the control group, p<0.05; #Compared with the model group (p<0.05, p<0.01).

[0053] The above description is only a preferred embodiment of the present invention. It should be noted that those skilled in the art can make several improvements and additions without departing from the method of the present invention, and these improvements and additions should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating post-fracture pain and fatigue, characterized in that, It is made from the following raw materials in parts by weight: 300 parts of cinnabar, 300 parts of dragon's blood, 300 parts of natural copper, 150 parts of sandalwood, 150 parts of realgar, and 60 parts of borneol; the dosage form of the medicine is a plaster.

2. The application of the traditional Chinese medicine composition according to claim 1 in the preparation of a medicine for treating soreness and weakness in the later stage of fracture and after the removal of clamps.

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