A detumescent and analgesic composition for promoting callus growth and preparation method thereof

Abstract

The invention discloses a detumescent and analgesic composition for promoting callus growth and a preparation method thereof, and belongs to the technical field of preparation of drugs for treating fractures. The detumescent and analgesic composition for promoting callus growth disclosed by the invention is prepared from the following raw materials by weight: 10-15 parts of frankincense, 12-16 parts of dragon's blood, 3-8 parts of ramie root, 8-10 parts of cyathula, 8-10 parts of chuanxiong, 100-150 parts of angelica, 5-10 parts of hippocampus powder, 3-8 parts of amber, 0.5-1.2 parts of borneol, 0.1 parts of artificial musk, 20-50 parts of radix scutellariae and 10-20 parts of cockroach powder. The composition can improve the recovery speed of fractures by promoting blood circulation, detumescence and analgesia and promoting callus growth, and has the characteristics of significant curative effect.

Description

Technical Field

[0001] The invention belongs to the technical field of preparation of fracture treatment drugs, and in particular relates to a swelling-reducing and analgesic composition for promoting callus growth and a preparation method thereof. Background Art

[0002] Fracture refers to the complete or partial break of the continuity of bone structure. It is more common in children and the elderly, and sometimes in young and middle-aged people. Patients often have a fracture in one part, and a few have multiple fractures. There are three main reasons for fractures: 1. Direct violence: Violence directly acts on a certain part of the bone, causing the fracture of that part, resulting in fractures in the injured part, often accompanied by varying degrees of soft tissue damage. For example, when a wheel hits the calf, a fracture of the tibia and fibula occurs at the impact site. 2. Indirect violence: When indirect violence acts, fractures occur at a distance through longitudinal conduction, leverage or torsion. For example, when a person falls from a height and lands on his feet, the trunk bends forward sharply due to gravity, and the vertebrae at the junction of the thoracic and lumbar spine suffer compression or burst fractures. 3. Accumulated strain: Long-term, repeated, and mild direct or indirect injuries can cause fractures in a specific part of the limbs, also known as fatigue fractures. For example, long-distance walking can easily cause fractures in the second and third metatarsal bones and the lower 1 / 3 of the fibula. Fracture patients generally have symptoms such as pain, hematoma, deformity of the injured limb, difficulty in movement, and severe patients may also go into shock.

[0003] In modern medicine, surgical treatment methods are usually used to treat fractures, such as open reduction, internal fixation, plaster fixation, and functional exercise, but this method either has a long treatment period and the defects of insignificant treatment effect, or has the defects of increased pain and swelling that cannot be dissipated. The existing Chinese medicine formula has a variety of traumatic plasters, which have certain therapeutic effects, but the therapeutic effect is not obvious. And the main effect of these ointments is to reduce swelling and relieve pain, that is, to eliminate inflammation during the hematoma organization stage. It can quickly reduce inflammation and relieve pain, but it cannot quickly generate bone callus to increase the rate of fracture healing. Summary of the invention

[0004] In order to solve the above problems mentioned in the background technology, the present invention provides a detumescent and analgesic composition for promoting callus growth and a preparation method thereof, which can ensure the basic function of the drug in detumescent and analgesic, and promote the rapid growth of callus, improve the treatment effect of fracture and accelerate the healing time.

[0005] In a first aspect, the present invention provides a detumescent and analgesic composition for promoting callus growth, which is prepared from the following raw materials in parts by weight:

[0006] 10-15 parts of frankincense, 12-16 parts of dragon's blood, 3-8 parts of ramie roots, 8-10 parts of achyranthes bidentata, 8-10 parts of chuanxiong, 100-150 parts of angelica sinensis, 5-10 parts of hippocampus powder, 3-8 parts of amber, 0.5-1.2 parts of borneol, 0.1 part of artificial musk, 20-50 parts of radix speranskiae and 10-20 parts of cockroach powder.

[0007] Further, it is made from the following raw materials in parts by weight:

[0008] 10-11 parts of frankincense, 15-16 parts of dragon's blood, 4-6 parts of ramie roots, 9-10 parts of Achyranthes bidentata, 9-10 parts of Chuanxiong, 120-130 parts of angelica, 5-10 parts of hippocampus powder, 5 parts of amber, 0.8-1.0 parts of borneol, 0.1 parts of artificial musk, 30-35 parts of radix speranskiae, and 10-20 parts of cockroach powder.

[0009] Further, it is made from the following raw materials in parts by weight:

[0010] 10 parts of frankincense, 15 parts of dragon's blood, 5 parts of ramie roots, 10 parts of cyathula, 10 parts of ligusticum chuanxiong, 130 parts of angelica, 8 parts of hippocampus powder, 5 parts of amber, 1 part of borneol, 0.1 parts of artificial musk, 30 parts of radix speranskiae, and 20 parts of cockroach powder.

[0011] Furthermore, the mass ratio of the seahorse powder to the cockroach powder is 5~10:10~20, and the mass ratio of the ramie root to the amber is 1:1.

[0012] In a second aspect, the present invention provides a method for preparing the detumescent and analgesic composition for promoting callus growth as described in any one of the first aspects, comprising the following steps:

[0013] Weigh all raw materials except cockroach powder and borneol according to weight, soak for 1 to 5 hours, boil, and filter to obtain the first medicinal juice;

[0014] Add water to the filter residue and boil it again, filter to obtain a second medicinal juice, and mix the first medicinal juice and the second medicinal juice in a mass ratio of 1 to 3:5 to obtain a Chinese medicine extract;

[0015] Add ethanol to the cockroach powder, soak it and boil it for 3 to 5 times, take the filtrate after each boiling, mix it, centrifuge it and take the supernatant;

[0016] The supernatant is mixed with the Chinese medicine extract, purified, and concentrated to a relative density of 1.1 to 1.2 to obtain a thick paste;

[0017] The thick extract, borneol and pharmaceutically acceptable auxiliary materials are mixed evenly to obtain an ointment.

[0018] Furthermore, all raw materials except cockroach powder and borneol are soaked in cold water with a temperature of 5-20° C., and the boiling time after soaking in cold water is 30-60 minutes.

[0019] Furthermore, in the step of preparing the second medicinal juice, the mass ratio of the filter residue to water is 10:20-30, and the boiling time again is 10-20 minutes.

[0020] Furthermore, the mass ratio of the cockroach powder to the ethanol is 1:3-10, and the immersion is heated in a water bath, the temperature of the water bath is 90-100° C., and the water bath time is 20-40 minutes.

[0021] Furthermore, in the decoction step after the cockroach powder is soaked in ethanol, the decoction time is 10 to 20 minutes, and after taking the filtrate each time, ethanol is added and decocted again under the same conditions.

[0022] Furthermore, the purification comprises the following steps: adding chitosan acetic acid solution to the mixed solution formed by the supernatant and the traditional Chinese medicine extract, stirring in a water bath, taking out, standing and filtering.

[0023] Furthermore, the volume ratio of the mixed solution to the chitosan acetic acid solution is 10-20:100, the concentration of the chitosan acetic acid solution is 1-2 wt.%, the water bath temperature is 50-55°C, the water bath time is 10-20 minutes, and the standing time is not less than 24 hours.

[0024] Furthermore, chitosan acetic acid solution was prepared by the following method: 5.00 g chitosan powder was taken, 500 mL of 1% acetic acid solution was added, the mixture was stirred at a uniform speed, and allowed to stand for swelling for 24 h to prepare a 1% chitosan acetic acid aqueous solution for later use.

[0025] The above technical solution provided by the embodiment of the present application has at least the following advantages compared with the prior art:

[0026] 1. The detumescent and analgesic composition for promoting callus growth disclosed in the present invention is formulated with traditional Chinese medicine and is prepared into an external medicine for promoting fracture healing through a simple processing technology. The components work together to achieve the purpose and efficacy of clearing heat and cooling blood, detumescent and analgesic, activating blood circulation and removing blood stasis, and promoting rapid growth of callus.

[0027] 2. The formula of the present invention is reasonable. Blatta and Herba Spermatorrhizae are used as the main medicines. In the early stage, they play the effects of dispelling wind and dampness, dispersing blood stasis and reducing swelling. In the mid-term, they play the effect of promoting the increase of callus fibroblasts and reducing osteoclasts. In the later stage, they play the effect of stretching tendons and penetrating bones and promoting osteocyte differentiation. With Sanguisorba officinalis, Radix Angelicae Sinensis, Hippocampus Powder and Radix Achyranthis Bidentatae as the ministerial medicines, they have the auxiliary curative effects of dispersing blood and removing blood stasis, reducing swelling and relieving pain, and can also detoxify, continue injuries and relieve pain. Wherein Achyranthes Bidentatae mainly plays the effect of removing blood stasis, dredge meridians, strengthening tendons and bones and guiding blood downward.

[0028] Frankincense, myrrh, ramie root, and Chuanxiong are used as adjuvants. Frankincense can invigorate blood circulation, dispel wind, relax muscles and relieve pain. Myrrh has the effects of dispersing blood and removing blood stasis, reducing swelling and relieving pain. As the first adjuvant, the two can play the role of invigorating blood circulation. Ramie root can treat traumatic injuries when applied externally. Chuanxiong can replenish the five labors, strengthen muscles and bones, regulate all meridians, break up old blood, and nourish new blood. As the second adjuvant, the two can play the role of invigorating blood circulation and strengthening bones.

[0029] Artificial musk and borneol are used as adjuvants to open the orifices and relieve blockages, improve microcirculation, and at the same time play the role of antibacterial, anti-inflammatory, swelling and pain relief. After the above drugs are made into external medicines, they are blended and applied externally, and absorbed through the skin at the fracture ends to achieve the effects of swelling and pain relief, blood circulation and blood stasis removal, and promoting the growth of bone callus. DETAILED DESCRIPTION

[0030] In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application is clearly and completely described below. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0031] Unless otherwise specified, various raw materials, reagents, instruments and equipment used in this application can be purchased from the market or prepared by existing methods.

[0032] In a first aspect, the present application provides a detumescent and analgesic composition for promoting callus growth, which is made of the following raw materials in parts by weight:

[0033] 10-15 parts of frankincense, 12-16 parts of dragon's blood, 3-8 parts of ramie roots, 8-10 parts of achyranthes bidentata, 8-10 parts of chuanxiong, 100-150 parts of angelica sinensis, 5-10 parts of hippocampus powder, 3-8 parts of amber, 0.5-1.2 parts of borneol, 0.1 part of artificial musk, 20-50 parts of radix speranskiae and 10-20 parts of cockroach powder.

[0034] Achyranthes bidentata: It has the functions of removing blood stasis and promoting menstruation, nourishing the liver and kidney, strengthening tendons and bones, promoting diuresis and relieving stranguria, and guiding blood downward. It is used for amenorrhea, dysmenorrhea, sore waist and knees, weakness of tendons and bones, stranguria, edema, headache, dizziness, toothache, sun sores, hematemesis, and epistaxis.

[0035] Amber: Its functions and indications are to calm the nerves and soothe the mind, dissipate blood stasis and stop bleeding, and promote diuresis and relieve stranguria. It can treat convulsions, epilepsy, palpitations and insomnia, blood in the urine, urinary obstruction, amenorrhea, abdominal pain caused by blood stasis after childbirth, carbuncle, sore, and trauma.

[0036] Radix Pseudostellariae: It has the effects of dispelling wind and dampness, relaxing muscles and activating blood circulation, dispersing blood stasis and reducing swelling, detoxifying and relieving pain. It is mainly used to treat rheumatic arthralgia, muscle and bone contracture, cold and damp beriberi, waist sprain, paralysis, amenorrhea, scrotal eczema, sores, boils and swelling.

[0037] Ramie root: cools blood and stops bleeding, stabilizes pregnancy, clears away heat and detoxifies. Commonly used for colds and fever, measles and high fever, urinary tract infection, nephritis and edema, abdominal pain in pregnant women, fetal movement disorder, and threatened abortion. External use for traumatic injuries.

[0038] Frankincense: It has the effects of promoting blood circulation, relieving pain, reducing swelling and promoting tissue regeneration. It is used for chest pain, heart pain, stomach pain, dysmenorrhea, amenorrhea, postpartum blood stasis, abdominal pain due to abdominal masses, rheumatic pain, muscle spasm, traumatic injury, carbuncle, ulcer.

[0039] Chuanxiong: It can promote qi circulation and relieve depression, dispel wind and dampness, promote blood circulation and relieve pain. It can treat headache and dizziness caused by wind and cold, pain in the ribs and abdomen, cold arthralgia and muscle spasm, amenorrhea, dystocia, postpartum blood stasis and pain, carbuncle and ulcer. It can be used for irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain caused by masses, stabbing pain in the chest and ribs, swelling and pain caused by falls, headache, and rheumatic pain.

[0040] Dracaena: It is made from the resin exuded from the fruit of the palm plant, the genus Qilinjie. It has the effects of promoting blood circulation and relieving pain, removing blood stasis and stopping bleeding, promoting tissue regeneration and healing sores. It is used for traumatic injuries, heart and abdominal pain, bleeding from trauma, and sores that do not heal.

[0041] Angelica: It has the effects of nourishing blood and activating blood circulation, regulating menstruation and relieving pain, and moistening the intestines and relieving constipation. It is often used for blood deficiency and sallow complexion, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, rheumatism and pain, injuries from falls, carbuncle, ulcers, and constipation caused by dry intestines. Wine Angelica activates blood circulation and regulates menstruation. It is used for amenorrhea and dysmenorrhea, rheumatism and pain, and injuries from falls.

[0042] Seahorse powder: Seahorse tastes sweet and salty, has a slow nature, and enters the liver and kidney meridians. It has the functions of nourishing the liver and kidney, strengthening yang and calming the mind, regulating qi, promoting blood circulation and removing blood stasis, relaxing muscles and tendons, and relieving asthma and asthma.

[0043] Borneol: It has the effects of invigorating the mind, clearing away heat and relieving pain. It is used for symptoms such as coma due to febrile disease, convulsions, and sore throat.

[0044] Artificial musk: It has the effects of invigorating the mind, promoting blood circulation and menstruation, reducing swelling and relieving pain. It is mainly used to treat closed syndrome, coma, sores, swelling and poison, scrofula, phlegm, sore throat, blood stasis and amenorrhea, abdominal mass, sudden pain in the heart and abdomen, headache, traumatic injury, wind-cold-dampness arthralgia, dystocia, stillbirth, and retained placenta.

[0045] Cockroach powder: Functions and indications: promoting blood circulation and dispersing blood stasis, detoxifying and eliminating malnutrition, diuresis and swelling. Used for accumulation of masses, malnutrition in children, beriberi edema, furuncle, swelling and poison, and insect and snake bites.

[0046] Further, it is made from the following raw materials in parts by weight:

[0047] 10-11 parts of frankincense, 15-16 parts of dragon's blood, 4-6 parts of ramie roots, 9-10 parts of Achyranthes bidentata, 9-10 parts of Chuanxiong, 120-130 parts of angelica, 5-10 parts of hippocampus powder, 5 parts of amber, 0.8-1.0 parts of borneol, 0.1 parts of artificial musk, 30-35 parts of radix speranskiae, and 10-20 parts of cockroach powder.

[0048] Further, it is made from the following raw materials in parts by weight:

[0049] 10 parts of frankincense, 15 parts of dragon's blood, 5 parts of ramie roots, 10 parts of cyathula, 10 parts of ligusticum chuanxiong, 130 parts of angelica, 8 parts of hippocampus powder, 5 parts of amber, 1 part of borneol, 0.1 parts of artificial musk, 30 parts of radix speranskiae, and 20 parts of cockroach powder.

[0050] In the present invention, the weight parts of frankincense can be 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, etc.

[0051] In the present invention, the weight parts of Dragon's Blood can be 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, etc.

[0052] In the present invention, the weight parts of ramie roots can be 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, etc.

[0053] In the present invention, the weight parts of Achyranthes bidentata can be 8 parts, 8.5 parts, 9 parts, 9.5 parts, 10 parts, etc.

[0054] In the present invention, the weight parts of Chuanxiong can be 8 parts, 8.5 parts, 9 parts, 9.5 parts and 10 parts.

[0055] When the weight portions of Achyranthes bidentata and Rhizoma Chuanxiong are the same, the effect is best.

[0056] In the present invention, the weight parts of Angelica sinensis can be 100 parts, 102 parts, 105 parts, 110 parts, 112 parts, 113 parts, 115 parts, 120 parts, 122 parts, 125 parts, 128 parts, 130 parts, 133 parts, 135 parts, 140 parts, 142 parts, 143 parts, 145 parts, 146 parts, 148 parts and 150 parts, etc.

[0057] In the present invention, the weight proportions of seahorse powder can be 5 parts, 5.5 parts, 6 parts, 6.5 parts, 6.6 parts, 7 parts, 7.2 parts, 8 parts, 8.5 parts, 9 parts, 9.2 parts, 9.8 parts and 10 parts, etc.

[0058] In the present invention, the weight proportion of amber can be 3 parts, 4 parts, 5 parts, 6 parts, 7 parts and 8 parts, etc. When the weight ratio of ramie root to amber in the present invention is 1:1, the medicinal effect is optimal.

[0059] In the present invention, the weight proportion of borneol can be 0.5 parts, 0.6 parts, 0.65 parts, 0.7 parts, 0.75 parts, 0.8 parts, 0.85 parts, 0.9 parts, 0.95 parts, 1.0 parts, 1.02 parts, 1.05 parts, 1.1 parts, 1.2 parts, etc.

[0060] In the present invention, only 0.1 parts by weight of artificial musk is needed to achieve the requirements of the formulation of the present invention, and it is not advisable to use more than that.

[0061] In the present invention, the weight parts of Herba Spermatorrhizae uralensis can be 20 parts, 22 parts, 25 parts, 28 parts, 30 parts, 32 parts, 35 parts, 36 parts, 40 parts, 42 parts, 45 parts, 48 ​​parts and 50 parts, etc.

[0062] In the present invention, the weight parts of cockroach powder can be 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts and 20 parts, etc.

[0063] Furthermore, the mass ratio of the seahorse powder to the cockroach powder is 5~10:10~20, and the mass ratio of the ramie root to the amber is 1:1.

[0064] In a second aspect, the present invention provides a method for preparing the detumescent and analgesic composition for promoting callus growth as described in any one of the first aspects, comprising the following steps:

[0065] Weigh all raw materials except cockroach powder and borneol according to weight, soak in cold water at 5-20°C for 1-5 hours, boil for 30-60 minutes, and filter to obtain the first medicinal juice;

[0066] Add 2 to 3 times the weight of water to the filter residue and boil it again for 10 to 20 minutes, filter to obtain the second medicinal juice, and mix the first medicinal juice and the second medicinal juice in a mass ratio of 1 to 3:5 to obtain a Chinese medicine extract;

[0067] After adding 3-10 parts by weight of ethanol to the cockroach powder, soaking it, heating it in a water bath to improve the soaking effect, and then decocting it for 3-5 times, mixing the filtrate after each decoction, taking the supernatant after centrifugation, the water bath temperature is 90-100°C, the water bath time is 20-40 minutes, and the decoction time is 10-20 minutes each time. After taking the filtrate after each decoction, add ethanol and decoct it again under the same conditions;

[0068] The supernatant is mixed with the Chinese medicine extract, purified, and concentrated to a thick paste with a relative density of 1.1 to 1.2;

[0069] The concentrated thick paste is added with borneol and pharmaceutically acceptable auxiliary materials and mixed evenly to obtain an ointment.

[0070] The purification comprises the following steps: adding chitosan acetic acid solution to the mixed solution formed by the supernatant and the traditional Chinese medicine extract, stirring in a water bath, taking out, standing and filtering.

[0071] The volume ratio of the mixed solution to the chitosan acetic acid solution is 10-20:100, the concentration of the chitosan acetic acid solution is 1-2wt.%, the temperature of the water bath is 50-55°C, the water bath time is 10-20min, and the standing time is not less than 24h.

[0072] The pharmaceutically acceptable excipients are a matrix, a tackifier and a softener. In the present invention, rubber is preferably used as the matrix, glycerol rosin ester, hydrogenated rosin, β-pinene, etc. are used as the tackifier, and vaseline, lanolin, liquid paraffin, vegetable oil, dibutyl phthalate, dioctyl phthalate, etc. are used as the softener. The composition of the present invention is mixed with the tackifier and the softener and then coated on the rubber for use.

[0073] The principles and features of the present invention are described below in conjunction with the examples, which are only used to explain the present invention and are not intended to limit the scope of the present invention. If no specific conditions are specified in the examples, the conditions are carried out according to conventional conditions or the conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments is not specified, they are all conventional products that can be purchased commercially.

[0074] The chitosan acetic acid solution used in the embodiment of the present invention is prepared by the following method: 5.00 g of chitosan powder is added to 500 mL of 1% acetic acid solution, stirred at a uniform speed, and allowed to stand for swelling for 24 hours to prepare a 1% chitosan acetic acid aqueous solution for use.

[0075] The matrix used in the embodiments of the present invention is rubber, the tackifier is glycerol rosin ester, the softener is vaseline, and the dosage is the same. It is a conventional ointment preparation method, which will not be repeated or limited here.

[0076] Example 1

[0077] This embodiment discloses a detumescent and analgesic composition for promoting callus growth, which is composed of the following raw materials in parts by weight:

[0078] 10 parts of frankincense, 15 parts of dragon's blood, 5 parts of ramie roots, 10 parts of cyathula, 10 parts of ligusticum chuanxiong, 130 parts of angelica, 8 parts of hippocampus powder, 5 parts of amber, 1 part of borneol, 0.1 parts of artificial musk, 30 parts of radix speranskiae, and 20 parts of cockroach powder.

[0079] The detumescence and analgesia composition is prepared by the following method:

[0080] Weigh all the raw materials except cockroach powder and borneol according to weight, soak them in 5°C cold water for 3 hours, boil them for 30 minutes, and filter them to obtain the first medicine juice;

[0081] Add 3 times the weight of water to the filter residue and boil it again for 10 minutes, filter to obtain the second medicinal juice, mix the first medicinal juice and the second medicinal juice in a mass ratio of 2:5 to obtain a Chinese medicine extract;

[0082] After soaking the cockroach powder in 5 parts by weight of ethanol, the mixture was heated in a water bath to improve the soaking effect, and then decocted for 5 times. The filtrate after each decoction was mixed and centrifuged to obtain the supernatant. The water bath temperature was 90° C., the water bath time was 20 min, and the decoction time was 20 min each time. After taking the filtrate after each decoction, ethanol was added and decocted again under the same conditions.

[0083] The supernatant was mixed with the Chinese medicine extract to obtain a mixed solution, chitosan acetic acid solution (volume ratio of 1:10) was added to the mixed solution, and the mixture was stirred in a water bath at 50°C for 10 minutes, then taken out and allowed to stand for more than 24 hours, filtered and purified, and concentrated to a relative density of 1.2;

[0084] The concentrated product is added with pharmaceutically acceptable auxiliary materials and borneol, and the mixture is mixed evenly to obtain an ointment.

[0085] The volume ratio of the mixed solution to the chitosan acetic acid solution is 10:100, the temperature of the water bath is 50° C., the water bath time is 10 minutes, and the standing time is not less than 24 hours.

[0086] Example 2

[0087] This embodiment discloses a detumescent and analgesic composition for promoting callus growth, which is composed of the following raw materials in parts by weight:

[0088] 15 parts of frankincense, 16 parts of dragon's blood, 8 parts of ramie roots, 10 parts of cyathula, 10 parts of ligusticum chuanxiong, 150 parts of angelica, 10 parts of hippocampus powder, 8 parts of amber, 1.2 parts of borneol, 0.1 parts of artificial musk, 50 parts of scutellaria baicalensis, and 20 parts of cockroach powder.

[0089] The preparation method of this embodiment is the same as that of embodiment 1.

[0090] Example 3

[0091] This embodiment discloses a detumescent and analgesic composition for promoting callus growth, which is composed of the following raw materials in parts by weight:

[0092] 10 parts of frankincense, 16 parts of dragon's blood, 3 parts of ramie roots, 10 parts of achyranthes bidentata, 8 parts of chuanxiong, 150 parts of angelica sinensis, 5 parts of hippocampus powder, 8 parts of amber, 0.5 parts of borneol, 0.1 parts of artificial musk, 20 parts of radix speranskiae, and 20 parts of cockroach powder.

[0093] The preparation method of this embodiment is the same as that of embodiment 1.

[0094] Example 4

[0095] This embodiment discloses a detumescent and analgesic composition for promoting callus growth, which is composed of the following raw materials in parts by weight:

[0096] 15 parts of frankincense, 12 parts of dragon's blood, 5 parts of ramie roots, 8 parts of achyranthes bidentata, 8 parts of chuanxiong, 100 parts of angelica sinensis, 10 parts of hippocampus powder, 8 parts of amber, 0.5 parts of borneol, 0.1 parts of artificial musk, 50 parts of radix speranskiae, and 10 parts of cockroach powder.

[0097] The preparation method of this embodiment is the same as that of embodiment 1.

[0098] Example 5

[0099] This embodiment discloses a detumescent and analgesic composition for promoting callus growth, which is composed of the following raw materials in parts by weight:

[0100] 10 parts of frankincense, 10 parts of dragon's blood, 3 parts of ramie roots, 8 parts of achyranthes bidentata, 8 parts of chuanxiong, 100 parts of angelica sinensis, 5 parts of hippocampus powder, 3 parts of amber, 0.5 parts of borneol, 0.1 parts of artificial musk, 20 parts of radix speranskiae, and 20 parts of cockroach powder.

[0101] The preparation method of this embodiment is the same as that of embodiment 1.

[0102] Example 6

[0103] The components and proportions of the detumescent and analgesic composition for promoting callus growth in this embodiment are the same as those in Example 1, and the preparation method of the composition comprises the following steps:

[0104] Weigh all the raw materials except cockroach powder and borneol according to weight, soak them in 5°C cold water for 5 hours, boil them for 60 minutes, and filter them to obtain the first medicine juice;

[0105] Add 3 times the weight of water to the filter residue and boil it again for 20 minutes, filter to obtain the second medicinal juice, mix the first medicinal juice and the second medicinal juice in a mass ratio of 3:5 to obtain a Chinese medicine extract;

[0106] After adding 10 parts by weight of ethanol to the cockroach powder and soaking it, the mixture was heated in a water bath to improve the soaking effect, and then decocted for 3 times. The filtrate after each decoction was mixed and centrifuged to obtain the supernatant. The water bath temperature was 100° C., the water bath time was 40 minutes, and the decoction time was 20 minutes each time. After taking the filtrate after each decoction, ethanol was added and decocted again under the same conditions.

[0107] The supernatant and the Chinese medicine extract are mixed and then chitosan solution is added, stirred in a water bath, taken out, allowed to stand, filtered, and concentrated to a relative density of 1.1 to obtain a thick paste;

[0108] The concentrated thick paste is added with pharmaceutically acceptable auxiliary materials and borneol, and the mixture is mixed evenly to obtain an ointment.

[0109] The volume ratio of the mixed solution to the chitosan acetic acid solution is 10:100, the temperature of the water bath is 55° C., the water bath time is 20 minutes, and the standing time is not less than 24 hours.

[0110] Example 7

[0111] The components and proportions of the detumescent and analgesic composition for promoting callus growth in this embodiment are the same as those in Example 1, and the preparation method of the composition comprises the following steps:

[0112] Weigh all the raw materials except cockroach powder and borneol according to weight, soak them in cold water at 20°C for 1 hour, boil them for 45 minutes, and filter them to obtain the first medicine juice;

[0113] Add twice the weight of water to the filter residue and boil again for 20 minutes, filter to obtain the second medicinal juice, mix the first medicinal juice and the second medicinal juice in a mass ratio of 3:5 to obtain a Chinese medicine extract;

[0114] After adding 10 parts by weight of ethanol to the cockroach powder and soaking it, the mixture was heated in a water bath to improve the soaking effect, and then decocted for 3 times, the filtrate after each decoction was mixed, and the supernatant was taken after centrifugation. The temperature of the water bath was 100° C., the water bath time was 30 minutes, and the decoction time was 15 minutes each time. After taking the filtrate after each decoction, ethanol was added and decocted again under the same conditions;

[0115] The supernatant and the Chinese medicine extract are mixed, and then chitosan acetic acid solution is added, stirred in a water bath, taken out, allowed to stand, filtered, and concentrated to a relative density of 1.2 to obtain a thick paste;

[0116] The concentrated thick paste is added with pharmaceutically acceptable auxiliary materials and borneol, and the mixture is mixed evenly to obtain an ointment.

[0117] The volume ratio of the mixed solution to the chitosan acetic acid solution is 20:100, the temperature of the water bath is 55° C., the water bath time is 15 minutes, and the standing time is not less than 24 hours.

[0118] Example 8

[0119] The components and proportions of the detumescent and analgesic composition for promoting callus growth in this embodiment are the same as those in Example 1, and the preparation method of the composition comprises the following steps:

[0120] Weigh all raw materials except cockroach powder and borneol according to weight, soak in 10°C cold water for 2 hours, boil for 40 minutes, and filter to obtain the first medicine juice;

[0121] Add 3 times the weight of water to the filter residue and boil it again for 15 minutes, filter to obtain the second medicinal juice, mix the first medicinal juice and the second medicinal juice in a mass ratio of 2:5 to obtain a Chinese medicine extract;

[0122] After soaking the cockroach powder in 8 times the weight of ethanol, the mixture was heated in a water bath to improve the soaking effect, and then decocted for 5 times. The filtrate after each decoction was mixed and centrifuged to obtain the supernatant. The water bath temperature was 95°C, the water bath time was 20 minutes, and the decoction time was 10 minutes each time. After taking the filtrate after each decoction, ethanol was added and decocted again under the same conditions.

[0123] The supernatant and the Chinese medicine extract are mixed, and then chitosan acetic acid solution is added, stirred in a water bath, taken out, allowed to stand, filtered, and concentrated to a relative density of 1.2 to obtain a thick paste;

[0124] The concentrated thick paste is added with pharmaceutically acceptable auxiliary materials and borneol, and the mixture is mixed evenly to obtain an ointment.

[0125] The volume ratio of the mixed solution to the chitosan acetic acid solution is 15:100, the temperature of the water bath is 52° C., the water bath time is 15 minutes, and the standing time is not less than 24 hours.

[0126] Comparative Example 1

[0127] The difference between this comparative example and Example 1 is that the cockroach powder is not included.

[0128] Comparative Example 2

[0129] The difference between this comparative example and Example 1 is that Herba Spermatophyllae is not included.

[0130] Comparative Example 3

[0131] The difference between this comparative example and Example 1 is that ramie roots are not included.

[0132] Comparative Example 4

[0133] The difference between this comparative example and Example 1 is that the weight portion of ramie root is 3 parts and the weight portion of amber is 8 parts.

[0134] Comparative Example 5

[0135] The difference between this comparative example and Example 1 is that the weight portion of ramie root is 8 parts and the weight portion of amber is 3 parts.

[0136] Comparative Example 6

[0137] The difference between this comparative example and Example 1 is that the weight portion of the artificial musk is 0.05 parts.

[0138] Comparative Example 7

[0139] The difference between this comparative example and Example 1 is that the weight portion of the artificial musk is 1.0 part.

[0140] Comparative Example 8

[0141] The difference between this comparative example and Example 1 is that the cockroach powder is not used to prepare the medicinal juice separately, but is directly boiled and filtered together with the raw materials, and then purified and concentrated in sequence, and auxiliary materials are added to prepare the ointment.

[0142] Comparative Example 9

[0143] The difference between this comparative example and Example 1 is that the cockroach powder is not heated during soaking.

[0144] The components prepared in Example 1 and Comparative Examples 1-9 were analyzed experimentally, as follows:

[0145] 1. Animal skin irritation safety test

[0146] The rabbit back spine was trimmed and the skin was prepared on both sides, with an area of ​​about 5 cm × 8 cm. During the test, the paste of the present invention was directly and evenly applied on one side of the test skin at a thickness of 0.5 cm, and then bandaged with an impermeable bandage. The opposite side was used as a control. The dressing was changed every 3 days for 14 consecutive days. The test skin was observed every day for the formation of erythema and edema, the reaction degree was recorded and scored, and the total score and irritation index were calculated.

[0147] Test results: The total score and the highest irritation index of the multiple skin application test are both "0". According to the multiple skin irritation intensity grading standard in DB61-267-1998 "Health Products Safety Toxicology Evaluation Procedures and Test Methods", the multiple skin irritation intensity of the composition of the present invention is non-irritating.

[0148] 2. Clinical Data

[0149] A total of 100 patients with fractures were randomly selected from the outpatient clinic, most of whom were fractures caused by external forces. Among them, there were 64 males and 36 females, aged 16-68 years old, with an average age of 40 years old.

[0150] Diagnostic criteria: The diagnosis can be confirmed based on clinical manifestations and imaging examinations.

[0151] Treatment method: Use the medicine of Example 1 of the present invention, apply it to the affected area in a group of 50 g, bandage it with a medical bandage, and change the dressing every 2 days.

[0152] Efficacy criteria:

[0153] Cure: Based on X-ray images, the fracture line is blurred, there is continuous callus passing through the fracture line, the swelling and pain disappear, and the patient can move freely and normally.

[0154] Improvement: Callus formation is obvious, surrounding the fracture ends, swelling and pain disappear, and the patient can move locally.

[0155] Ineffective: No callus formation or a small amount of callus formation, with obvious swelling and pain.

[0156] Treatment results: See Table 1.

[0157] Table 1. Clinical treatment effects

[0158]

[0159] It can be seen from the above results that the composition prepared by the present invention has a high efficacy and a short treatment course in treating fracture patients, and can greatly alleviate the pain of patients.

[0160] 3. Plantar swelling and joint tissue pathological scores before and after mouse modeling

[0161] Experimental subjects: 110 SD rats of the same age, half male and half female.

[0162] Experimental method: 10 rats were randomly selected from 110 SD rats as the normal control group, and the remaining 100 rats were used as the experimental group and the control group, with 10 rats in each group. The first group was the experimental group, and the remaining groups were given drugs in corresponding proportions 1-9, respectively, as control groups 1-9.

[0163] Freund's 、 s complete adjuvant 0.15mL induced RA rat model. Before modeling, the normal volume of the right hind foot of each rat was measured by a plantar volume meter. After measurement, 10 rats in the normal control group were subcutaneously injected with 0.15mL of normal saline in the same way. On the 10th day after modeling, the right hind foot volume of each rat was measured in the same way as above, and the plantar swelling degree before drug administration on the 10th day of modeling was calculated (plantar swelling degree before drug administration on the 10th day of modeling = right hind foot volume on the 10th day of modeling - right hind foot normal volume before modeling).

[0164] The experimental group and the control groups 1-9 were all given external application, and the normal control group was not treated. The dosage was 0.5 g, and the dressing was changed every two days for 20 consecutive days. The results are shown in Table 2.

[0165] Table 2 Comparison of plantar swelling and joint tissue pathology scores in rats before and after modeling

[0166]

[0167] 4. Actual case:

[0168] (1) Mr. Li, male, 28 years old, injured his left calf when playing ball. He suffered from pain in his calf and could not move. X-ray results showed a comminuted fracture (with displacement) on the left side. After applying the drug of Example 1 of the present invention for 4 days, the redness and swelling completely disappeared, and there was only slight pain when pressing. After 10 days of application, the pain and redness disappeared, and after another 10 days of use, he could move freely.

[0169] (2) Wu, male, 67 years old, fell down the stairs accidentally. He felt persistent severe pain in his right hip, limited mobility, and could not stand or walk. X-ray examination showed a fracture of the right femoral neck. After applying the drug of the present invention for 3 months, the patient recovered.

[0170] (3) Han, female, 45 years old, suffered a tibia fracture in a car accident. Three months after the plate internal fixation surgery, X-ray examination found that the callus was not healed enough and her movement was still impaired. After applying the drug of the present invention for 15 days, the callus grew rapidly and she could move slowly. After continuing to use it for 15 days, she could walk with big strides and move without hindrance.

[0171] (4) Wang, female, 41 years old, fell into a ditch while riding a bicycle and suffered closed fractures of the left ulna and radius. After external application of the drug of the present invention, the pain disappeared after 5 days of medication, and she could move slowly after 12 days; after 20 days, the redness and swelling completely disappeared, and her motor function gradually recovered.

[0172] (5) Luo, female, 66 years old, had pain in the right knee joint when going up and down stairs, and the pain was particularly obvious when going up stairs or climbing stairs. After examination in the hospital, it was diagnosed as senile osteoarthritis and effusion in the knee joint. After external application of the drug of the present invention, the pain disappeared significantly after 1 month, and there was some difficulty and soreness when going up stairs. After taking the drug for 5 months, there was no pain symptom except climbing multiple flights of stairs continuously. After taking the drug for another 3 months, there was no joint pain phenomenon.

[0173] (6) Hong, male, 18 years old. The patient fell while running and injured his right knee. The hospital diagnosed him with a right tibia proximal fracture and performed plaster fixation. After the plaster was removed, his right leg was swollen and stiff and could not be stretched freely. After applying the drug of the present invention externally, he recovered in 20 days and could walk and stretch normally.

[0174] (7) Li, female, 24 years old, was hit by an electric tricycle on the way to work. After the injury, she felt continuous severe pain in her right elbow, no radiation, and limited movement. After being sent to the hospital for treatment, X-ray examination confirmed that she had a comminuted fracture of the lower end of the right humerus. After external application of the drug of the present invention, the pain was greatly reduced after 1 month, and the local swelling basically disappeared. After continuing to use the drug of the present invention for 2 months, the patient's activities were like normal people.

[0175] Various embodiments of the present application may be presented in the form of a range; it should be understood that the description in the form of a range is only for convenience and brevity, and should not be understood as a rigid limitation on the scope of the present application; therefore, the range description should be considered to have specifically disclosed all possible sub-ranges and single numerical values ​​within the range. For example, the range description from 1 to 6 should be considered to have specifically disclosed sub-ranges, such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as single numbers within the range, such as 1, 2, 3, 4, 5 and 6, which apply regardless of the range. In addition, whenever a numerical range is indicated herein, it is meant to include any cited number (fractional or integer) within the indicated range.

[0176] The above description is only a specific implementation of the present application, so that those skilled in the art can understand or implement the present application. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present application. Therefore, the present application will not be limited to the embodiments shown herein, but will conform to the widest range consistent with the principles and novel features applied for herein.

Claims

1. A detumescent and analgesic composition for promoting callus growth, characterized in that: In parts by weight, it is made from the following raw materials: 10-15 parts of frankincense, 12-16 parts of dragon's blood, 3-8 parts of ramie roots, 8-10 parts of achyranthes bidentata, 8-10 parts of chuanxiong, 100-150 parts of angelica sinensis, 5-10 parts of hippocampus powder, 3-8 parts of amber, 0.5-1.2 parts of borneol, 0.1 part of artificial musk, 20-50 parts of radix speranskiae and 10-20 parts of cockroach powder.

2. The detumescent and analgesic composition for promoting callus growth according to claim 1, characterized in that: In parts by weight, it is made from the following raw materials: 10-11 parts of frankincense, 15-16 parts of dragon's blood, 4-6 parts of ramie roots, 9-10 parts of Achyranthes bidentata, 9-10 parts of Chuanxiong, 120-130 parts of angelica, 5-10 parts of hippocampus powder, 5 parts of amber, 0.8-1.0 parts of borneol, 0.1 parts of artificial musk, 30-35 parts of radix speranskiae, and 10-20 parts of cockroach powder.

3. The detumescent and analgesic composition for promoting callus growth according to claim 2, characterized in that: In parts by weight, it is made from the following raw materials: 10 parts of frankincense, 15 parts of dragon's blood, 5 parts of ramie roots, 10 parts of cyathula, 10 parts of ligusticum chuanxiong, 130 parts of angelica, 8 parts of hippocampus powder, 5 parts of amber, 1 part of borneol, 0.1 parts of artificial musk, 30 parts of radix speranskiae, and 20 parts of cockroach powder.

4. The detumescent and analgesic composition for promoting callus growth according to claim 1, characterized in that: The mass ratio of the seahorse powder to the cockroach powder is 5-10:10-20, and the mass ratio of the ramie root to the amber is 1:

1.

5. The method for preparing the detumescent and analgesic composition for promoting callus growth according to any one of claims 1 to 4, characterized in that: The following steps are involved: Weigh all raw materials except cockroach powder and borneol according to weight, soak for 1 to 5 hours, boil, and filter to obtain the first medicinal juice; Add water to the filter residue and boil it again, filter to obtain a second medicinal juice, mix the first medicinal juice and the second medicinal juice to obtain a Chinese medicine extract; Add ethanol to the cockroach powder, soak it and boil it for 3 to 5 times, take the filtrate after each boiling, mix it, centrifuge it and take the supernatant; After the supernatant is mixed with the Chinese medicine extract, it is purified and concentrated to a relative density of 1.1 to 1.2 to obtain a thick extract; The thick extract, borneol and pharmaceutically acceptable excipients are mixed evenly to prepare an ointment; The purification comprises the following steps: adding chitosan acetic acid solution to the mixed solution formed by the supernatant and the traditional Chinese medicine extract, stirring in a water bath, taking out, standing and filtering.

6. The method for preparing the detumescent and analgesic composition for promoting callus growth according to claim 5, characterized in that: All raw materials except cockroach powder and borneol are soaked in cold water with a temperature of 5-20° C. and the boiling time after soaking in cold water is 30-60 minutes.

7. The method for preparing the detumescent and analgesic composition for promoting callus growth according to claim 5, characterized in that: In the step of preparing the second medicinal juice, the mass ratio of the filter residue to water is 10:20-30, and the re-boiling time is 10-20 minutes.

8. The method for preparing the detumescent and analgesic composition for promoting callus growth according to claim 5, characterized in that: The mass ratio of the cockroach powder to the ethanol is 1:3-10. The immersion is heated in a water bath with a temperature of 90-100° C. and a water bath time of 20-40 minutes.

9. The method for preparing the detumescent and analgesic composition for promoting callus growth according to claim 5, characterized in that: In the decoction step after the cockroach powder is soaked in ethanol, the decoction time is 10 to 20 minutes. After taking the filtrate each time, ethanol is added and decocted again under the same conditions.

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