CN1709378A - Medicinal composition for promoting bone fracture healing and its preparing method - Google Patents

Medicinal composition for promoting bone fracture healing and its preparing method Download PDF

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CN1709378A
CN1709378A CN 200510040414 CN200510040414A CN1709378A CN 1709378 A CN1709378 A CN 1709378A CN 200510040414 CN200510040414 CN 200510040414 CN 200510040414 A CN200510040414 A CN 200510040414A CN 1709378 A CN1709378 A CN 1709378A
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ethanol
filtering
time
filtrate
water
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CN100344315C (en
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肖伟
戴翔翎
凌娅
李明慧
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Jiangsu Kanion Pharmaceutical Co Ltd
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Jiangsu Kanion Pharmaceutical Co Ltd
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Abstract

The present invention relates to a Chinese medicine composition for promoting union with obvious therapeutic effect. Said Chinese medicine composition is made up by using 4 Chinese medicinal materials of drynaria root, sarcandra twig and leaf, dipsacus root and astragalus root, Besides, said invention also provides its preparation method and concrete steps.

Description

pharmaceutical composition for promoting fracture healing and preparation method thereof
Technical Field
The invention relates to a pharmaceutical composition using Chinese herbal medicines as raw materials, in particular to a pharmaceutical composition for promoting fracture healing, and also relates to a preparation method of the pharmaceutical composition.
Background
The current treatment method of fracture is mainly surgical reduction and fixation, but no matter how advanced the surgical method is, the healing of the fracture also needs 3 months or more, thereby leading the fracture sufferer to lose labor capacity and even self-care ability for a long time. In addition, the fracture treatment by adopting a strong internal fixation method has obvious osteoporosis and bone atrophy due to the existence of stress shielding, and the re-fracture is easy to occur after the internal fixation is taken out; the fracture treatment by the elastic fixation method is easy to cause delayed union or nonunion of the fracture because the movement of the bone end is difficult to control. A clinical analysis of the three-flower bone-knitting powder for treating 128 cases of fracture is disclosed in 1999 journal of Ningxia medicine, volume 21 and 11. The compound traditional Chinese medicine Sanhua fracture setting powder has the effects of relieving swelling and pain and can obviously promote the healing of fracture. The three-flower bone-knitting powder is composed of 18 Chinese herbal medicines of pseudo-ginseng, saffron, dragon's blood and the like, wherein the saffron is a famous and precious medicinal material in the formula, and the powder is not suitable for patients to take. The Chinese patent application with the application number of 02109322.9 and the name of 'bone-knitting pill' discloses a medicine for treating fracture healing, which is prepared from a plurality of Chinese herbal medicine raw materials. The bone-knitting pill is prepared with 20 kinds of Chinese medicinal materials, including angelica, Chuanxiong rhizome, red peony root, etc. and has complicated recipe. At present, no Chinese patent medicine with scientific and simple formula and obvious pharmacological and pharmacodynamic effects for promoting fracture healing exists.
Disclosure of Invention
The invention aims to solve the technical problem of providing a medicine for promoting fracture healing, which has reasonable compatibility, simple formula and good treatment effect and aims at overcoming the defects of the prior art.
The invention also provides a preparation method of the medicine.
The technical problem to be solved by the present invention is achieved by the following technical means. The invention relates to a pharmaceutical composition for promoting fracture healing, which is characterized in that the pharmaceutical composition is a medicament prepared from the following raw materials in parts by weight,
1 to 20 parts of rhizoma drynariae, 1 to 20 parts of glabrous sarcandra herb,
0-20 parts of teasel roots and 0-30 parts of astragalus roots.
In the technical scheme of the invention, the teasel root and the astragalus root are optional raw materials, namely the raw materials can be prepared from 2 medicines of drynaria rhizome and glabrous sarcandra herb, can be prepared from any one of the drynaria rhizome, the glabrous sarcandra herb, the teasel root and the astragalus root, and can also be prepared from 4 medicines of the drynaria rhizome, the glabrous sarcandra herb, the teasel root and the astragalus root.
The technical problem to be solved by the present invention can also be achieved by the following technical means. The pharmaceutical composition is characterized in that the weight ratio of the raw materials is,
10 portions of rhizoma drynariae, 10 portions of glabrous sarcandra herb,
dipsacus asperoides 10 and/or Astragalus membranaceus 20.
The invention also provides a preparation method of the pharmaceutical composition for promoting fracture healing, which is characterized by comprising the following steps:
(1) soaking teasel roots in 90-95% ethanol as a solvent for 36-48 hours, percolating at the speed of 1-2ml per minute, and collecting percolate until total saponins are completely percolated out; or extracting with 85-95% ethanol under reflux for 2-4 times, wherein the dosage of the ethanol solution is more than 4 times each time, the reflux time is 1-2.5 hours each time, filtering, and combining the filtrates; decolorizing the percolate or the reflux extract by using alumina or active carbon, filtering, recovering ethanol, concentrating to obtain a thick paste, adding 1-10 times of water, precipitating by using water, carrying out degreasing treatment, adsorbing the degreased liquid by using a macroporous resin column, eluting by using an ethanol solution with the concentration of more than 40%, collecting eluent, and recovering a solvent to obtain a dipsacus asperoides extract;
(2) decocting glabrous sarcandra herb in water for 2-4 times, each time for 0.5-2 hours, adding water for 4-10 times, combining decoctions, filtering, concentrating the filtrate until the relative density is 1.5-1.35 in a thermal measurement at 70 ℃, adding ethanol for precipitation for 2 times, the alcohol content is 60-70% in the first time, the alcohol content is 75-85% in the second time, refrigerating for 24-48 hours in each time, filtering, recovering ethanol from the filtrate, concentrating until the relative density is 1.1-1.3 in the thermal measurement at 70 ℃, adding a proper amount of newly configured egg protein solution, stirring, precipitating, refrigerating for 24-48 hours, filtering, boiling the filtrate to solidify excessive egg protein, filtering, adding ethanol into the filtrate to make the ethanol content be 70-80%, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain the glabrous sarcandra herb extract;
(3) taking drynaria rhizome, adding water, decocting for 2-4 times, adding water for more than 4 times each time, 0.5-2 hours each time, filtering, concentrating until the relative density is 1.10-1.20 when measuring the temperature at 45 ℃, adding ethanol while stirring, uniformly mixing until the alcohol content of the extracting solution reaches 55% -70%, standing for 24-48 hours, filtering, recovering ethanol from the filtrate until no alcohol smell exists, adding ethanol while stirring until the alcohol content of the extracting solution reaches 75% -85%, uniformly mixing, standing for 12-48 hours, recovering ethanol until no alcohol smell exists, and obtaining a drynaria rhizome extract; decocting radix astragali in water for 2-4 times, each time for 1-1.5 hours, combining decoctions, filtering, concentrating the filtrate until each 1ml of the filtrate is equivalent to 1-2 g of the raw medicinal material, precipitating with ethanol for 1-3 times, wherein the ethanol content in the solution is 75-85% each time, refrigerating and placing for 10-24 hours each time, filtering, concentrating the filtrate until each 1ml of the filtrate is equivalent to 5-6 g of the raw medicinal material, and cooling to obtain the radix astragali extract; or taking astragalus, extracting with 85-95% ethanol under reflux for 2-4 times, wherein the dosage of the ethanol solution is more than 4 times each time, the reflux time is 1-2.5 hours each time, filtering, and combining the filtrates; recovering ethanol, concentrating to obtain a thick paste, adding 1-10 times of water, precipitating with water for 24-48 hours, filtering, concentrating to obtain 5-6 g of raw medicinal materials per 1ml, and cooling to obtain radix astragali extract; or,
(3) decocting drynaria rhizome and astragalus membranaceus in water for 2-4 times, adding more than 4 times of water for each time, 0.5-2 hours for each time, filtering, concentrating until the relative density is 1.10-1.20 in a thermal test at 45 ℃, adding ethanol while stirring, uniformly mixing until the alcohol content of an extracting solution reaches 55% -70%, standing for 24-48 hours, filtering, recovering ethanol from a filtrate until no alcohol smell exists, adding ethanol while stirring until the alcohol content of the extracting solution reaches 75% -85%, uniformly mixing, standing for 12-48 hours, recovering ethanol until no alcohol smell exists, and obtaining drynaria rhizome and astragalus membranaceus extracts;
(4) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into any dosage form of pharmacy.
The invention also provides a preparation method of another medicine composition for promoting fracture healing, which is characterized by comprising the following steps:
(1) decocting glabrous sarcandra herb in water for 2-4 times, each time for 0.5-2 hours, adding water for 4-10 times, combining decoctions, filtering, concentrating the filtrate until the relative density is 1.5-1.35 in a thermal measurement at 70 ℃, adding ethanol for precipitation for 2 times, the alcohol content is 60-70% in the first time, the alcohol content is 75-85% in the second time, refrigerating for 24-48 hours in each time, filtering, recovering ethanol from the filtrate, concentrating until the relative density is 1.1-1.3 in the thermal measurement at 70 ℃, adding a proper amount of newly configured egg protein solution, stirring, precipitating, refrigerating for 24-48 hours, filtering, boiling the filtrate to solidify excessive egg protein, filtering, adding ethanol into the filtrate to make the ethanol content be 70-80%, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain the glabrous sarcandra herb extract;
(2) taking drynaria rhizome, adding water, decocting for 2-4 times, adding water for more than 4 times each time, 0.5-2 hours each time, filtering, concentrating until the relative density is 1.10-1.20 when measuring the temperature at 45 ℃, adding ethanol while stirring, uniformly mixing until the alcohol content of the extracting solution reaches 55% -70%, standing for 24-48 hours, filtering, recovering ethanol from the filtrate until no alcohol smell exists, adding ethanol while stirring until the alcohol content of the extracting solution reaches 75% -85%, uniformly mixing, standing for 12-48 hours, recovering ethanol until no alcohol smell exists, and obtaining a drynaria rhizome extract;
(3) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into any dosage form of pharmacy.
The invention also provides a preparation method of another medicine composition for promoting fracture healing, which is characterized by comprising the following steps,
(1) soaking teasel roots in 90-95% ethanol as a solvent for 36-48 hours, percolating at the speed of 1-2ml per minute, and collecting percolate until total saponins are completely percolated out; or extracting with 85-95% ethanol under reflux for 2-4 times, wherein the dosage of the ethanol solution is more than 4 times each time, the reflux time is 1-2.5 hours each time, filtering, and combining the filtrates; decolorizing the percolate or the reflux extract by using alumina or active carbon, filtering, recovering ethanol, concentrating to obtain a thick paste, adding 1-10 times of water, precipitating by using water, carrying out degreasing treatment, adsorbing the degreased liquid by using a macroporous resin column, eluting by using an ethanol solution with the concentration of more than 40%, collecting eluent, and recovering a solvent to obtain a dipsacus asperoides extract;
(2) decocting glabrous sarcandra herb, rhizoma drynariae and astragalus membranaceus in water for 2-4 times, 0.5-2 hours each time, adding 4-10 times of water each time, combining decoctions, filtering, concentrating the filtrate until the relative density is 1.5-1.35 when the filtrate is subjected to thermal measurement at 70 ℃, adding ethanol for precipitation for 2 times, enabling the alcohol content to be 60-70% for the first time and 75-85% for the second time, refrigerating for 24-48 hours each time, and filtering; recovering ethanol from the filtrate, concentrating to relative density of 1.1-1.3 at 70 deg.C, adding appropriate amount of newly prepared egg protein solution, stirring, precipitating, refrigerating for 24-48 hr, filtering, boiling the filtrate to solidify excessive egg protein, and filtering; adding ethanol into the filtrate to make the ethanol content reach 70-80%, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain extracts of herba Pileae Scriptae, rhizoma Drynariae and radix astragali;
(3) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into any dosage form of pharmacy.
The invention also provides a preparation method of another medicine composition for promoting fracture healing, which is characterized by comprising the following steps,
(1) soaking teasel roots in 90-95% ethanol as a solvent for 36-48 hours, percolating at the speed of 1-2ml per minute, and collecting percolate until total saponins are completely percolated out; or extracting with 85-95% ethanol under reflux for 2-4 times, wherein the dosage of the ethanol solution is more than 4 times each time, the reflux time is 1-2.5 hours each time, filtering, and combining the filtrates; decolorizing the percolate or the reflux extract by using alumina or active carbon, filtering, recovering ethanol, concentrating to obtain a thick paste, adding 1-10 times of water, precipitating by using water, carrying out degreasing treatment, adsorbing the degreased liquid by using a macroporous resin column, eluting by using an ethanol solution with the concentration of more than 40%, collecting eluent, and recovering a solvent to obtain a dipsacus asperoides extract;
(2) decocting glabrous sarcandra herb and rhizoma drynariae in water for 2-4 times, 0.5-2 hours each time, adding 4-10 times of water each time, combining decoctions, filtering, concentrating the filtrate until the relative density is 1.5-1.35 when the filtrate is subjected to thermal measurement at 70 ℃, adding ethanol for precipitation for 2 times, enabling the alcohol content to be 60-70% for the first time and 75-85% for the second time, refrigerating for 24-48 hours each time, and filtering; recovering ethanol from the filtrate, concentrating to relative density of 1.1-1.3 at 70 deg.C, adding appropriate amount of newly prepared egg protein solution, stirring, precipitating, refrigerating for 24-48 hr, filtering, boiling the filtrate to solidify excessive egg protein, and filtering; adding ethanol into the filtrate to make the ethanol content reach 70-80%, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain glabrous sarcandra herb and rhizoma drynariae extracts;
(3) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into any dosage form of pharmacy.
The invention also provides a preparation method of another medicine composition for promoting fracture healing, which is characterized by comprising the following steps,
(1) soaking teasel roots and astragalus membranaceus in 90-95% ethanol as a solvent for 36-48 hours, percolating at the speed of 1-2ml per minute, collecting percolate until total saponins are completely percolated out, or refluxing and extracting for 2-4 times by 85-95% ethanol, wherein the dosage of the ethanol solution is more than 4 times each time, the refluxing time is 1-2.5 hours each time, filtering, and combining filtrates; decolorizing the percolate or the reflux extract by using alumina or active carbon, filtering, recovering ethanol, concentrating to obtain a thick paste, adding 1-10 times of water, precipitating by using water, carrying out degreasing treatment, adsorbing the degreased liquid by using a macroporous resin column, eluting by using an ethanol solution with the concentration of more than 40%, collecting eluent, and recovering a solvent to obtain extracts of dipsacus asperoides and astragalus membranaceus;
(2) decocting glabrous sarcandra herb and rhizoma drynariae in water for 2-4 times, 0.5-2 hours each time, adding 4-10 times of water each time, combining decoctions, filtering, concentrating the filtrate until the relative density is 1.5-1.35 when the filtrate is subjected to thermal measurement at 70 ℃, adding ethanol for precipitation for 2 times, enabling the alcohol content to be 60-70% for the first time and 75-85% for the second time, and refrigerating for 24-48 hours each time; filtering, recovering ethanol from the filtrate, concentrating to relative density of 1.1-1.3 at 70 deg.C, adding appropriate amount of newly-prepared egg protein solution, stirring, precipitating, refrigerating for 24-48 hr, filtering, boiling the filtrate to solidify excessive egg protein, and filtering; adding ethanol into the filtrate to make the ethanol content reach 70-80%, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain glabrous sarcandra herb and rhizoma drynariae extracts;
(3) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into any dosage form of pharmacy.
The invention also provides a preparation method of another medicine composition for promoting fracture healing, which is characterized by comprising the following steps,
(1) the bone drynaria rhizome is taken, water is added for decoction for 2-4 times, the amount of water is more than 4 times of that of each time, each time is 0.5-2 hours, the bone drynaria rhizome is filtered and concentrated to the relative density of 1.10-1.20 in the thermal measurement at 45 ℃, ethanol is added under stirring, the mixture is uniformly mixed until the alcohol content of the extracting solution reaches 55% -70%, the mixture is kept stand for 24-48 hours, the filtering is carried out, the ethanol is recovered from the filtrate until no alcohol smell exists, the ethanol is added under stirring until the alcohol content of the extracting solution reaches 75% -85%, the mixture is uniformly mixed, the mixture is kept stand. Adsorbing with polyamide, flushing with water or 5-25% ethanol solution, eluting with 60-95% ethanol, recovering ethanol, and concentrating to obtain rhizoma Drynariae flavone extract with rhizoma Drynariae total flavone content of not less than 50% based on dry extract;
(2) soaking teasel roots in 90-95% ethanol as a solvent for 36-48 hours, percolating at the speed of 1-2ml per minute, and collecting percolate until total saponins are completely percolated out; or extracting with 85-95% ethanol under reflux for 2-4 times, wherein the dosage of the ethanol solution is more than 4 times each time, the reflux time is 1-2.5 hours each time, filtering, and combining the filtrates; decolorizing the percolate or the reflux extracting solution by using alumina or active carbon, filtering, recovering ethanol, concentrating to obtain a thick paste, adding 1-10 times of water, precipitating by using water, carrying out degreasing treatment, adsorbing the degreased solution by using a macroporous resin column, eluting by using an ethanol solution with the concentration of more than 40%, collecting eluent, and recovering a solvent to obtain a dipsacus asperoides total saponin extract, wherein the content of the dipsacus asperoides total saponin is not less than 50% in terms of dry extract;
(3) decocting glabrous sarcandra herb in water for 2-4 times, each time for 0.5-2 hours, adding 4-10 times of water for each time, combining decoction, filtering, concentrating the filtrate until the relative density is 1.5-1.35 in a thermal measurement at 70 ℃, adding ethanol for precipitation for 2 times, firstly enabling the alcohol content to be 60-70% and the alcohol content to be 75-85%, refrigerating for 24-48 hours, filtering, recovering ethanol from the filtrate, concentrating until the relative density is 1.1-1.3 in the thermal measurement at 70 ℃, adding a proper amount of newly configured egg protein solution, stirring, enabling the precipitation to be refrigerated for 24-48 hours, filtering, boiling the filtrate, solidifying excessive egg protein, and filtering; adding ethanol into the filtrate to ensure that the ethanol content is 70-80%, standing for precipitation, filtering, and recovering ethanol from the filtrate; adsorbing with polyamide, flushing with water or 5-25% ethanol solution, eluting with 60-95% ethanol, recovering ethanol, and concentrating to obtain herba Pileae Scriptae flavone extract with total flavone content of not less than 50% based on dry extract;
(4) decocting radix astragali in water for 2-4 times, each time for 1-2.5 hours, mixing decoctions, filtering, concentrating the filtrate to 1ml, which is equivalent to 1-2 g of the original medicinal material, precipitating with ethanol for 1-3 times, wherein the ethanol content in the solution is 75-85% each time, refrigerating and standing for 10-48 hours each time, filtering, and recovering the solvent; or extracting with 85-95% ethanol under reflux for 2-4 times, wherein the dosage of the ethanol solution is more than 4 times each time, the reflux time is 1-2.5 hours each time, filtering, and combining the filtrates. Decolorizing the extract by using alumina or activated carbon, filtering, recovering ethanol, concentrating to obtain a thick paste, adding 1-10 times of water, precipitating by using water, adsorbing by using a macroporous resin column, eluting by using an ethanol solution of more than 40%, collecting eluent, and recovering a solvent to obtain an astragalus total saponin extract, wherein the content of the astragalus total saponin is not less than 50% in terms of dry extract;
(5) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into any dosage form of pharmacy.
The invention also provides a preparation method of another medicine composition for promoting fracture healing, which is characterized by comprising the following steps,
(1) soaking teasel roots in 90-95% ethanol as a solvent for 36-48 hours, percolating at the speed of 1-2ml per minute, and collecting percolate until total saponins are completely percolated out; decocting radix astragali in water for 2-4 times, each time for 1-2.5 hours, mixing decoctions, filtering, concentrating the filtrate to 1ml, which is equivalent to 1-2 g of the original medicinal material, precipitating with ethanol for 1-3 times, wherein the ethanol content in the solution is 75-85% each time, refrigerating and standing for 10-48 hours each time, filtering, and recovering the solvent; or reflux-extracting radix Dipsaci and radix astragali with 85-95% ethanol for 2-4 times, wherein the amount of ethanol solution is more than 4 times of that of ethanol solution each time, and the reflux time is 1-2.5 hours each time, filtering, and mixing filtrates; decolorizing radix Dipsaci and radix astragali extractive solution with alumina or activated carbon, filtering, recovering ethanol, concentrating into thick paste, adding 1-10 times of water, precipitating with water, defatting, adsorbing the defatting solution with macroporous resin column, eluting with 40% ethanol solution, collecting eluate, and recovering solvent to obtain radix Dipsaci and radix astragali total saponin extract with total saponin content of not less than 50% based on dry extract;
(2) decocting glabrous sarcandra herb and rhizoma drynariae in water for 2-4 times, 0.5-2 hours each time, adding 4-10 times of water each time, combining decoctions, filtering, concentrating the filtrate until the relative density is 1.5-1.35 when the filtrate is subjected to thermal measurement at 70 ℃, adding ethanol for precipitation for 2 times, enabling the alcohol content to be 60-70% for the first time and 75-85% for the second time, and refrigerating for 24-48 hours each time. Filtering, recovering ethanol from the filtrate, performing polyamide adsorption treatment, flushing a column with water or 5-25% ethanol solution, eluting with 60-95% ethanol, recovering ethanol, and concentrating to obtain glabrous sarcandra herb and rhizoma drynariae flavone extracts, wherein the content of total flavone is not lower than 50% in terms of dry extract;
(3) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into any dosage form of pharmacy.
The preparation method comprises the steps of mixing the extracts, adding more than 5-10 times of water for injection, filtering, refrigerating for 24-48 hours, adjusting the pH value of the filtrate to 7.5-9.0 by using a 20% NaOH solution, adding 0.05-0.15% of activated carbon, boiling for 5-30 minutes, filtering, ultrafiltering, adjusting the pH value to 7.5-9.0 by using a 20% NaOH solution, adding an auxiliary material for injection, and preparing into an injection or preparing into a freeze-dried powder injection by a freeze-drying process.
Because the teasel root and the astragalus root are optional raw materials in the technical scheme of the pharmaceutical composition, when the raw materials are composed of 2 medicines of drynaria rhizome and glabrous sarcandra herb or are composed of any one of the drynaria rhizome, the glabrous sarcandra herb, the teasel root and the astragalus root, the preparation method of the pharmaceutical composition can be a preparation method formed by combining preparation steps of the corresponding raw materials selected in any preparation method.
The dosage form of the pharmaceutical composition can be any one of the dosage forms of the pharmaceutical composition including oral preparations, external preparations and the like, such as granules, tablets, capsules, soft capsules, dripping pills, dispersible tablets, effervescent tablets, oral liquid and emplastrum.
Compared with the prior art, the medicine is a Chinese patent medicine with scientific and reasonable formula and obvious pharmacological action for accelerating healing after fracture and enhancing fracture resistance, and pharmacological experiments show that the medicine has the effects of promoting callus growth of experimental fracture rats, reducing fracture healing time, obviously improving bone calcium content, reducing whole blood viscosity, improving blood circulation and having strong anti-inflammatory and analgesic effects. The preparation method disclosed by the invention has the advantages of advanced process and controllable quality, and the medicine prepared by the method has high content of effective components and can further improve the curative effect of the medicine.
Detailed Description
Example 1. A Chinese medicine for promoting healing of fracture is prepared from the raw materials (gram unit)
10 portions of rhizoma drynariae, 10 portions of glabrous sarcandra herb,
dipsacus root 10, astragalus root 20. Making into oral liquid by conventional method.
Example 2. A Chinese medicine for promoting healing of fracture is prepared from the raw materials (gram unit)
10 portions of rhizoma drynariae, 10 portions of glabrous sarcandra herb,
dipsacus root 10, astragalus root 20.
The preparation method comprises the following steps:
(1) soaking radix Dipsaci in 90% alcohol for 36 hr, percolating at a speed of 1ml per minute, and collecting percolate until total saponins are completely percolated out; or reflux-extracting with 85% ethanol for 2 times, wherein the amount of ethanol solution is more than 4 times of that of ethanol solution each time, the reflux time is 1 hr each time, filtering, and mixing filtrates; decolorizing the percolate or reflux extractive solution with alumina or active carbon, filtering, recovering ethanol, concentrating to obtain soft extract, adding 1 times of water, precipitating with water, defatting, adsorbing the defatting solution with macroporous resin column, eluting with 40% ethanol solution, collecting eluate, and recovering solvent to obtain radix Dipsaci extract;
(2) decocting herba Pileae Scriptae in water for 2 times, each for 0.5 hr, adding 4 times of water, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.5 at 70 deg.C, precipitating with ethanol for 2 times, first time to obtain 60% ethanol content and second 75% ethanol content, refrigerating for 24 hr, filtering, recovering ethanol from the filtrate, concentrating to relative density of 1.1 at 70 deg.C, adding appropriate amount of newly-prepared egg protein solution, stirring, precipitating, refrigerating for 24 hr, filtering, boiling the filtrate to obtain excessive egg protein, coagulating, filtering, adding ethanol to the filtrate to obtain 70% ethanol content, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain herba Pileae Scriptae extract;
(3) decocting rhizoma Drynariae in water for 2 times (each time with water amount of more than 4 times and 0.5 hr), filtering, concentrating to relative density of 1.10 at 45 deg.C, adding ethanol under stirring, standing for 24 hr, filtering, recovering ethanol from filtrate until ethanol smell disappears, adding ethanol under stirring until ethanol content reaches 75%, mixing, standing for 12 hr, recovering ethanol until ethanol smell disappears to obtain rhizoma Drynariae extract;
decocting radix astragali in water for 2 times, each for 1 hr, mixing decoctions, filtering, concentrating the filtrate until each 1ml is equivalent to 1g of the original medicinal material, precipitating with ethanol for 1 time, each time the solution contains 75% of ethanol, cold preserving for 10 hr, filtering, concentrating the filtrate until each 1ml is equivalent to 5g of the original medicinal material, and cooling to obtain radix astragali extract; or reflux-extracting radix astragali with 85% ethanol for 2 times, wherein the amount of ethanol solution is more than 4 times each time, and the reflux time is 1 hr each time, filtering, and mixing filtrates; recovering ethanol, concentrating to obtain soft extract, adding 1 time of water, precipitating with water for 24 hr, filtering, concentrating to 1ml per 1ml corresponding to 5g of raw medicinal materials, and cooling to obtain radix astragali extract; or,
(3) decocting rhizoma Drynariae and radix astragali in water for 2 times (4 times of water each time, 0.5 hr each time), filtering, concentrating to relative density of 1.10 at 45 deg.C, adding ethanol under stirring to make ethanol content of extractive solution reach 55%, standing for 24 hr, filtering, recovering ethanol from filtrate until there is no ethanol smell, adding ethanol under stirring to make ethanol content of extractive solution reach 75%, mixing, standing for 12 hr, recovering ethanol until there is no ethanol smell, to obtain rhizoma Drynariae and radix astragali extract;
(4) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into tablet.
Example 3. A Chinese medicine for promoting healing of fracture is prepared from the raw materials (gram unit)
20 portions of rhizoma drynariae, 20 portions of glabrous sarcandra herb,
teasel root 20, astragalus root 30. The preparation method comprises the following steps:
(1) soaking radix Dipsaci in 95% ethanol for 48 hr, percolating at a speed of 2 ml/min, and collecting percolate until total saponins are completely percolated out; or reflux-extracting with 95% ethanol for 4 times, wherein the amount of ethanol solution is more than 4 times of that of ethanol solution each time, and the reflux time is 2.5 hr each time, filtering, and mixing filtrates; decolorizing the percolate or the reflux extractive solution with aluminum oxide or active carbon, filtering, recovering ethanol, concentrating to obtain soft extract, adding 10 times of water, precipitating with water, defatting, adsorbing the defatting solution with macroporous resin column, eluting with 40% ethanol solution, collecting eluate, and recovering solvent to obtain radix Dipsaci extract;
(2) decocting herba Pileae Scriptae in water for 4 times, each for 2 hr, adding 10 times of water, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.35 at 70 deg.C, precipitating with ethanol for 2 times, first time to obtain 70% ethanol content and second 85% ethanol content, refrigerating for 48 hr, filtering, recovering ethanol from the filtrate, concentrating to relative density of 1.3 at 70 deg.C, adding appropriate amount of newly-prepared egg protein solution, stirring, precipitating, refrigerating for 48 hr, filtering, boiling the filtrate to obtain excessive egg protein, coagulating, filtering, adding ethanol to the filtrate to obtain 80% ethanol content, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain herba Pileae Scriptae extract;
(3) decocting rhizoma Drynariae in water for 4 times (4 times of water each time, 2 hr each time), filtering, concentrating to relative density of 1.20 at 45 deg.C, adding ethanol under stirring to make ethanol content of extractive solution reach 70%, standing for 48 hr, filtering, recovering ethanol from filtrate until no ethanol smell exists, adding ethanol under stirring to make ethanol content of extractive solution reach 85%, mixing, standing for 48 hr, recovering ethanol to obtain rhizoma Drynariae extract;
decocting radix astragali in water for 4 times, each for 1.5 hr, mixing decoctions, filtering, concentrating the filtrate to 1ml corresponding to 2g of the raw medicinal material, precipitating with ethanol for 3 times, each time the solution contains 85% ethanol, refrigerating for 24 hr, filtering, concentrating the filtrate to 1ml corresponding to 6g of the raw medicinal material, and cooling to obtain radix astragali extract; or reflux-extracting radix astragali with 95% ethanol for 4 times (each time the amount of ethanol solution is more than 4 times and each time the reflux time is 2.5 hr), filtering, and mixing filtrates; recovering ethanol, concentrating to obtain soft extract, adding 10 times of water, precipitating with water for 48 hr, filtering, concentrating to 1ml per 1ml corresponding to 6g of raw medicinal materials, and cooling to obtain radix astragali extract; or,
(3) decocting rhizoma Drynariae and radix astragali in water for 4 times (4 times of water each time and 2 hr each time), filtering, concentrating to relative density of 1.20 at 45 deg.C, adding ethanol under stirring, standing for 48 hr, filtering, recovering ethanol from filtrate until ethanol smell disappears, adding ethanol under stirring until ethanol content reaches 85%, mixing, standing for 48 hr, recovering ethanol until ethanol smell disappears to obtain rhizoma Drynariae and radix astragali extract;
(4) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into granule.
Example 4. A Chinese medicine for promoting healing of bone fracture is prepared from the raw materials (kilogram unit)
Rhizoma drynariae 10 and glabrous sarcandra herb 10.
The preparation method comprises the following steps:
(1) decocting herba Pileae Scriptae in water for 2 times, each for 0.5 hr, adding 4 times of water, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.5 at 70 deg.C, precipitating with ethanol for 2 times, first time to obtain 60% ethanol content and second 75% ethanol content, refrigerating for 24 hr, filtering, recovering ethanol from the filtrate, concentrating to relative density of 1.1 at 70 deg.C, adding appropriate amount of newly-prepared egg protein solution, stirring, precipitating, refrigerating for 24 hr, filtering, boiling the filtrate to obtain excessive egg protein, coagulating, filtering, adding ethanol to the filtrate to obtain 70% ethanol content, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain herba Pileae Scriptae extract;
(2) decocting rhizoma Drynariae in water for 2 times (each time with water amount of more than 4 times and 0.5 hr), filtering, concentrating to relative density of 1.10 at 45 deg.C, adding ethanol under stirring, standing for 24 hr, filtering, recovering ethanol from filtrate until ethanol smell disappears, adding ethanol under stirring until ethanol content reaches 75%, mixing, standing for 12 hr, recovering ethanol until ethanol smell disappears to obtain rhizoma Drynariae extract;
(3) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into capsule.
Example 5. A Chinese medicine for promoting healing of bone fracture is prepared from the raw materials (kilogram unit)
20 parts of rhizoma drynariae and 20 parts of glabrous sarcandra herb.
The preparation method comprises the following steps:
(1) decocting herba Pileae Scriptae in water for 4 times, each for 2 hr, adding 10 times of water, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.35 at 70 deg.C, precipitating with ethanol for 2 times, first time to obtain 70% ethanol content and second 85% ethanol content, refrigerating for 48 hr, filtering, recovering ethanol from the filtrate, concentrating to relative density of 1.3 at 70 deg.C, adding appropriate amount of newly-prepared egg protein solution, stirring, precipitating, refrigerating for 48 hr, filtering, boiling the filtrate to obtain excessive egg protein, coagulating, filtering, adding ethanol to the filtrate to obtain 80% ethanol content, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain herba Pileae Scriptae extract;
(2) decocting rhizoma Drynariae in water for 4 times (4 times of water each time, 2 hr each time), filtering, concentrating to relative density of 1.20 at 45 deg.C, adding ethanol under stirring to make ethanol content of extractive solution reach 70%, standing for 48 hr, filtering, recovering ethanol from filtrate until no ethanol smell exists, adding ethanol under stirring to make ethanol content of extractive solution reach 85%, mixing, standing for 48 hr, recovering ethanol to obtain rhizoma Drynariae extract;
(3) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into soft capsule.
Example 6. A Chinese medicine for promoting healing of bone fracture is prepared from the raw materials (kilogram unit)
1 part of rhizoma drynariae, 1 part of glabrous sarcandra herb,
1 part of dipsacus root and 1 part of astragalus root.
The preparation method comprises the following steps of,
(1) soaking radix Dipsaci in 90% ethanol for 36 hr, percolating at a speed of 1ml per minute, and collecting percolate until total saponins are completely percolated out; or reflux-extracting with 85% ethanol for 2 times, wherein the amount of ethanol solution is more than 4 times of that of ethanol solution each time, the reflux time is 1 hr each time, filtering, and mixing filtrates; decolorizing the percolate or reflux extractive solution with alumina or active carbon, filtering, recovering ethanol, concentrating to obtain soft extract, adding 1 times of water, precipitating with water, defatting, adsorbing the defatting solution with macroporous resin column, eluting with 40% ethanol solution, collecting eluate, and recovering solvent to obtain radix Dipsaci extract;
(2) decocting herba Pileae Scriptae, rhizoma Drynariae, and radix astragali in water for 0.5 hr for 2 times, adding 4 times of water for each time, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.5 at 70 deg.C, precipitating with ethanol for 2 times to obtain solution with ethanol content of 60 and 75% for the first time, refrigerating for 24 hr for each time, and filtering; recovering ethanol from the filtrate, concentrating to relative density of 1.1 at 70 deg.C, adding appropriate amount of newly-prepared egg protein solution, stirring, precipitating, refrigerating for 24 hr, filtering, boiling the filtrate to solidify excessive egg protein, and filtering; adding ethanol into the filtrate to ethanol content of 70, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain extracts of herba Pileae Scriptae, rhizoma Drynariae and radix astragali;
(3) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into patch.
Example 7. A Chinese medicine for promoting healing of bone fracture is prepared from the raw materials (kilogram unit)
15 portions of rhizoma drynariae, 5 portions of glabrous sarcandra herb,
dipsacus root 5, astragalus root 15.
The preparation method comprises the following steps of,
(1) soaking radix Dipsaci in 95% ethanol for 48 hr, percolating at a speed of 2 ml/min, and collecting percolate until total saponins are completely percolated out; or reflux-extracting with 95% ethanol for 4 times, wherein the amount of ethanol solution is more than 4 times of that of ethanol solution each time, and the reflux time is 2.5 hr each time, filtering, and mixing filtrates; decolorizing the percolate or the reflux extractive solution with aluminum oxide or active carbon, filtering, recovering ethanol, concentrating to obtain soft extract, adding 10 times of water, precipitating with water, defatting, adsorbing the defatting solution with macroporous resin column, eluting with 40% ethanol solution, collecting eluate, and recovering solvent to obtain radix Dipsaci extract;
(2) decocting herba Pileae Scriptae, rhizoma Drynariae, and radix astragali in water for 4 times (2 hr each time) with 10 times of water, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.35 at 70 deg.C, precipitating with ethanol for 2 times (first time to reach ethanol content of 70% and second time to reach ethanol content of 85%, refrigerating for 48 hr each time, and filtering; recovering ethanol from the filtrate, concentrating to relative density of 1.3 at 70 deg.C, adding appropriate amount of newly-prepared egg protein solution, stirring, precipitating, refrigerating for 48 hr, filtering, boiling the filtrate to solidify excessive egg protein, and filtering; adding ethanol into the filtrate to make ethanol content reach 80%, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain extracts of herba Pileae Scriptae, rhizoma Drynariae and radix astragali;
(3) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into oral liquid.
Example 8. A Chinese medicine for promoting healing of bone fracture is prepared from the raw materials (kilogram unit)
10 parts of drynaria rhizome, 10 parts of glabrous sarcandra herb and 10 parts of teasel root.
The preparation method comprises the following steps of,
(1) soaking radix Dipsaci in 90% ethanol for 36 hr, percolating at a speed of 1ml per minute, and collecting percolate until total saponins are completely percolated out; or reflux-extracting with 85% ethanol for 2 times, wherein the amount of ethanol solution is more than 4 times of that of ethanol solution each time, the reflux time is 1 hr each time, filtering, and mixing filtrates; decolorizing the percolate or reflux extractive solution with alumina or active carbon, filtering, recovering ethanol, concentrating to obtain soft extract, adding 1 times of water, precipitating with water, defatting, adsorbing the defatting solution with macroporous resin column, eluting with 40% ethanol solution, collecting eluate, and recovering solvent to obtain radix Dipsaci extract;
(2) decocting herba Pileae Scriptae and rhizoma Drynariae in water for 2 times (0.5 hr each time) with 4 times of water, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.5 at 70 deg.C, precipitating with ethanol for 2 times (first time to obtain ethanol content of 60% and ethanol content of 75%, refrigerating for 24 hr each time, and filtering; recovering ethanol from the filtrate, concentrating to relative density of 1.1 at 70 deg.C, adding appropriate amount of newly-prepared egg protein solution, stirring, precipitating, refrigerating for 24 hr, filtering, boiling the filtrate to solidify excessive egg protein, and filtering; adding ethanol into the filtrate to make ethanol content reach 70%, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain herba Pileae Scriptae and rhizoma Drynariae extract;
(3) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into dispersible tablet.
Example 9. A Chinese medicine for promoting healing of bone fracture is prepared from the raw materials (kilogram unit)
5 parts of drynaria rhizome, 15 parts of glabrous sarcandra herb and 20 parts of teasel root.
The preparation method comprises the following steps of,
(1) soaking radix Dipsaci in 95% ethanol for 48 hr, percolating at a speed of 2 ml/min, and collecting percolate until total saponins are completely percolated out; or reflux-extracting with 95% ethanol for 4 times, wherein the amount of ethanol solution is more than 4 times of that of ethanol solution each time, and the reflux time is 2.5 hr each time, filtering, and mixing filtrates; decolorizing the percolate or the reflux extractive solution with aluminum oxide or active carbon, filtering, recovering ethanol, concentrating to obtain soft extract, adding 10 times of water, precipitating with water, defatting, adsorbing the defatting solution with macroporous resin column, eluting with 40% ethanol solution, collecting eluate, and recovering solvent to obtain radix Dipsaci extract;
(2) decocting herba Pileae Scriptae and rhizoma Drynariae in water for 4 times (2 hr each time), adding 10 times of water, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.35 at 70 deg.C, precipitating with ethanol for 2 times (first time to ethanol content of 70% and second time to ethanol content of 85%, refrigerating for 48 hr each time, and filtering; recovering ethanol from the filtrate, concentrating to relative density of 1.3 at 70 deg.C, adding appropriate amount of newly-prepared egg protein solution, stirring, precipitating, refrigerating for 48 hr, filtering, boiling the filtrate to solidify excessive egg protein, and filtering; adding ethanol into the filtrate to make ethanol content reach 80%, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain herba Pileae Scriptae and rhizoma Drynariae extract;
(3) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into injection.
Example 10. A Chinese medicine for promoting healing of bone fracture is prepared from the raw materials (kilogram unit)
8 parts of rhizoma drynariae, 18 parts of glabrous sarcandra herb,
dipsacus root 12, astragalus root 18.
The preparation method comprises the following steps of,
(1) soaking radix Dipsaci and radix astragali in 90% ethanol for 36 hr, percolating at a speed of 1ml per minute, collecting percolate until total saponins are completely percolated out, or reflux-extracting with 85% ethanol for 2 times (each time the ethanol solution amount is more than 4 times, each time the reflux time is 1 hr), filtering, and mixing filtrates; decolorizing the percolate or the reflux extractive solution with aluminum oxide or active carbon, filtering, recovering ethanol, concentrating to obtain soft extract, adding 1 times of water, precipitating with water, defatting, adsorbing the defatting solution with macroporous resin column, eluting with 40% ethanol solution, collecting eluate, and recovering solvent to obtain radix Dipsaci and radix astragali extract;
(2) decocting herba Pileae Scriptae and rhizoma Drynariae in water for 2 times (0.5 hr each time) with 4 times of water, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.5 at 70 deg.C, precipitating with ethanol for 2 times to obtain solution with ethanol content of 60% for the first time and 75% for the second time, and refrigerating for 24 hr each time; filtering, recovering ethanol from the filtrate, concentrating to relative density of 1.1 at 70 deg.C, adding appropriate amount of newly-prepared egg protein solution, stirring, precipitating, refrigerating for 24 hr, filtering, boiling the filtrate to solidify excessive egg protein, and filtering; adding ethanol into the filtrate to make ethanol content reach 70%, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain herba Pileae Scriptae and rhizoma Drynariae extract;
(3) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into dripping pill.
Example 11. A Chinese medicine for promoting healing of bone fracture is prepared from the raw materials (kilogram unit)
5 parts of rhizoma drynariae, 15 parts of glabrous sarcandra herb,
dipsacus root 5, astragalus root 25.
The preparation method comprises the following steps of,
(1) soaking radix Dipsaci and radix astragali in 95% ethanol for 48 hr, percolating at speed of 2 ml/min, collecting percolate until total saponins are completely percolated out, or reflux-extracting with 95% ethanol for 4 times (each time the ethanol solution amount is more than 4 times, each reflux time is 2.5 hr), filtering, and mixing filtrates; decolorizing the percolate or the reflux extractive solution with aluminum oxide or active carbon, filtering, recovering ethanol, concentrating to obtain soft extract, adding 10 times of water, precipitating with water, defatting, adsorbing the defatting solution with macroporous resin column, eluting with 40% ethanol solution, collecting eluate, and recovering solvent to obtain radix Dipsaci and radix astragali extract;
(2) decocting herba Pileae Scriptae and rhizoma Drynariae in water for 4 times (2 hr each time), adding 10 times of water, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.35 at 70 deg.C, precipitating with ethanol for 2 times (the first time makes ethanol content 70% and the second time makes ethanol content 85%, and refrigerating for 48 hr each time); filtering, recovering ethanol from the filtrate, concentrating to relative density of 1.3 at 70 deg.C, adding appropriate amount of newly-prepared egg protein solution, stirring, precipitating, refrigerating for 48 hr, filtering, boiling the filtrate to solidify excessive egg protein, and filtering; adding ethanol into the filtrate to make ethanol content reach 80%, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain herba Pileae Scriptae and rhizoma Drynariae extract;
(3) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into dry extract powder for oral administration.
Example 12. A Chinese medicine for promoting healing of bone fracture is prepared from the raw materials (kilogram unit)
12 parts of rhizoma drynariae, 8 parts of glabrous sarcandra herb,
dipsacus root 2, astragalus root 12.
The preparation method comprises the following steps of,
(1) decocting rhizoma Drynariae in water for 2 times (each time with water amount of more than 4 times and 0.5 hr), filtering, concentrating to relative density of 1.10 at 45 deg.C, adding ethanol under stirring, standing for 24 hr, filtering, recovering ethanol from filtrate until no alcohol smell exists, adding ethanol under stirring until ethanol content reaches 75%, mixing, standing for 12 hr, and recovering ethanol until no alcohol smell exists. Adsorbing with polyamide, eluting with water or 5% ethanol solution, eluting with 60% ethanol, recovering ethanol, and concentrating to obtain rhizoma Drynariae flavone extract with rhizoma Drynariae total flavone content of not less than 50% based on dry extract;
(2) soaking radix Dipsaci in 90% ethanol for 36 hr, percolating at a speed of 1ml per minute, and collecting percolate until total saponins are completely percolated out; or reflux-extracting with 85% ethanol for 2 times, wherein the amount of ethanol solution is more than 4 times of that of ethanol solution each time, the reflux time is 1 hr each time, filtering, and mixing filtrates; decolorizing the percolate or the reflux extractive solution with aluminum oxide or active carbon, filtering, recovering ethanol, concentrating to obtain soft extract, adding 1 time of water, precipitating with water, defatting, adsorbing the defatting solution with macroporous resin column, eluting with 40% ethanol solution, collecting eluate, and recovering solvent to obtain radix Dipsaci total saponin extract with radix Dipsaci total saponin content of not less than 50% based on dry extract;
(3) decocting herba Pileae Scriptae in water for 2 times, each time for 0.5 hr, adding 4 times of water, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.5 at 70 deg.C, precipitating with ethanol for 2 times, first time to obtain ethanol content of 60% and second time to obtain 75% ethanol content, refrigerating for 24 hr, filtering, recovering ethanol from the filtrate, concentrating to relative density of 1.1 at 70 deg.C, adding appropriate amount of newly-prepared egg protein solution, stirring, precipitating, refrigerating for 24 hr, filtering, boiling the filtrate to solidify excessive egg protein, and filtering; adding ethanol into the filtrate to make ethanol content 70%, standing for precipitation, filtering, and recovering ethanol from the filtrate; adsorbing with polyamide, eluting with water or 5% ethanol solution, eluting with 60% ethanol, recovering ethanol, and concentrating to obtain herba Pileae Scriptae flavone extract with total flavone content of not less than 50% based on dry extract;
(4) decocting radix astragali in water for 2 times, each for 1 hr, mixing decoctions, filtering, concentrating the filtrate to 1ml corresponding to 1g of the original medicinal material, precipitating with ethanol for 1 time, each time the solution contains 75% ethanol, refrigerating for 10 hr, filtering, and recovering solvent; or reflux-extracting with 85% ethanol for 2 times (more than 4 times of ethanol solution for each time, 1 hr for each time), filtering, and mixing filtrates. Decolorizing the extractive solution with alumina or activated carbon, filtering, recovering ethanol, concentrating to obtain soft extract, adding 1 time of water, precipitating with water, adsorbing with macroporous resin column, eluting with 40% ethanol solution, collecting eluate, and recovering solvent to obtain total saponins extract of radix astragali with total saponins content of not less than 50% based on dry extract;
(5) mixing the above extracts, adding more than 8 times of injectable water, filtering, refrigerating for 30 hr, adjusting pH of the filtrate to 8.0 with 20% NaOH solution, adding 0.10% active carbon, boiling for 20 min, filtering, ultrafiltering, adjusting pH to 8.0 with 20% NaOH solution, adding injectable pharmaceutical adjuvants, and making into injection.
Example 13. A Chinese medicine for promoting healing of bone fracture is prepared from the raw materials (kilogram unit)
14 parts of rhizoma drynariae, 4 parts of glabrous sarcandra herb,
dipsacus root 18, astragalus root 14.
The preparation method comprises the following steps of,
(1) decocting rhizoma Drynariae in water for 4 times (4 times of water each time, 2 hr each time), filtering, concentrating to relative density of 1.20 at 45 deg.C, adding ethanol under stirring to make ethanol content of extractive solution reach 70%, standing for 48 hr, filtering, recovering ethanol from filtrate until no alcohol smell exists, adding ethanol under stirring to make ethanol content of extractive solution reach 85%, mixing, standing for 48 hr, and recovering ethanol until no alcohol smell exists. Adsorbing with polyamide, washing with water or 25% ethanol solution, eluting with 95% ethanol, recovering ethanol, and concentrating to obtain rhizoma Drynariae flavone extract with rhizoma Drynariae total flavone content of not less than 50% based on dry extract;
(2) soaking radix Dipsaci in 95% ethanol for 48 hr, percolating at a speed of 2 ml/min, and collecting percolate until total saponins are completely percolated out; or reflux-extracting with 95% ethanol for 4 times, wherein the amount of ethanol solution is more than 4 times of that of ethanol solution each time, and the reflux time is 2.5 hr each time, filtering, and mixing filtrates; decolorizing the percolate or the reflux extractive solution with alumina or active carbon, filtering, recovering ethanol, concentrating to obtain soft extract, adding 10 times of water, precipitating with water, defatting, adsorbing the defatting solution with macroporous resin column, eluting with 40% ethanol solution, collecting eluate, and recovering solvent to obtain radix Dipsaci total saponin extract with radix Dipsaci total saponin content of not less than 50% based on dry extract;
(3) decocting herba Pileae Scriptae in water for 4 times, each for 2 hr, adding 10 times of water, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.35 at 70 deg.C, precipitating with ethanol for 2 times, first time to obtain ethanol content of 70% and second time to obtain 85% ethanol content, refrigerating for 48 hr, filtering, recovering ethanol from the filtrate, concentrating to relative density of 1.3 at 70 deg.C, adding appropriate amount of newly-prepared egg protein solution, stirring, precipitating, refrigerating for 48 hr, filtering, boiling the filtrate to solidify excessive egg protein, and filtering; adding ethanol into the filtrate to make ethanol content reach 80%, standing for precipitation, filtering, and recovering ethanol from the filtrate; adsorbing with polyamide, eluting with water or 25% ethanol solution, eluting with 95% ethanol, recovering ethanol, and concentrating to obtain herba Pileae Scriptae flavone extract with total flavone content of not less than 50% based on dry extract;
(4) decocting radix astragali in water for 4 times, each for 2.5 hr, mixing decoctions, filtering, concentrating the filtrate to 1ml corresponding to 2g of the raw medicinal material, precipitating with ethanol for 3 times, each time the ethanol content in the solution is 85%, cold preserving for 48 hr, filtering, and recovering solvent; or reflux-extracting with 95% ethanol for 4 times (each time the amount of ethanol solution is more than 4 times and each time the reflux time is 2.5 hr), filtering, and mixing filtrates. Decolorizing the extractive solution with alumina or activated carbon, filtering, recovering ethanol, concentrating to obtain soft extract, adding 10 times of water, precipitating with water, adsorbing with macroporous resin column, eluting with 40% ethanol solution, collecting eluate, and recovering solvent to obtain total saponins extract of radix astragali with total saponins content of not less than 50% based on dry extract;
(5) mixing the above extracts, adding 10 times of water for injection, filtering, refrigerating for 48 hr, adjusting pH of the filtrate to 9.0 with 20% NaOH solution, adding 0.15% active carbon, boiling for 30 min, filtering, ultrafiltering, adjusting pH to 9.0 with 20% NaOH solution, adding injectable pharmaceutical adjuvants, and making into injection.
Example 14. A Chinese medicine for promoting healing of bone fracture is prepared from the raw materials (kilogram unit)
20 parts of rhizoma drynariae, 2 parts of glabrous sarcandra herb,
dipsacus root 2, astragalus root 30.
The preparation method comprises the following steps of,
(1) soaking radix Dipsaci in 90% ethanol for 36 hr, percolating at a speed of 1ml per minute, and collecting percolate until total saponins are completely percolated out; decocting radix astragali in water for 2 times, each for 1 hr, mixing decoctions, filtering, concentrating the filtrate to 1ml corresponding to 1g of the original medicinal material, precipitating with ethanol for 1 time, each time the solution contains 75% ethanol, refrigerating for 10 hr, filtering, and recovering solvent; or reflux-extracting radix Dipsaci and radix astragali with 85% ethanol for 2 times, wherein the amount of ethanol solution is more than 4 times each time, and the reflux time is 1 hr each time, filtering, and mixing filtrates; decolorizing radix Dipsaci and radix astragali extractive solution with alumina or activated carbon, filtering, recovering ethanol, concentrating into thick paste, adding 1 times of water, precipitating with water, defatting, adsorbing the defatting solution with macroporous resin column, eluting with 40% ethanol solution, collecting eluate, and recovering solvent to obtain total saponin extract of radix Dipsaci and radix astragali with total saponin content of not less than 50% calculated on dry extract;
(2) decocting herba Pileae Scriptae and rhizoma Drynariae in water for 2 times (0.5 hr each time) with 4 times of water, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.5 at 70 deg.C, precipitating with ethanol for 2 times to obtain ethanol content of 60% for the first time and 75% for the second time, and refrigerating for 24 hr each time. Filtering, recovering ethanol from the filtrate, adsorbing with polyamide, eluting with water or 5% ethanol solution, eluting with 60% ethanol, recovering ethanol, and concentrating to obtain herba Pileae Scriptae and rhizoma Drynariae flavone extract with total flavone content of not less than 50% based on dry extract;
(3) mixing the above extracts, adding more than 5 times of water for injection, filtering, refrigerating for 24 hr, adjusting pH of the filtrate to 7.5 with 20% NaOH solution, adding 0.05% active carbon, boiling for 5min, filtering, ultrafiltering, adjusting pH to 7.5 with 20% NaOH solution, adding medicinal adjuvants for injection, and making into lyophilized powder for injection.
Example 15. A Chinese medicine for promoting healing of bone fracture is prepared from the raw materials (kilogram unit)
16 parts of rhizoma drynariae, 6 parts of glabrous sarcandra herb,
dipsacus root 16, astragalus root 26.
The preparation method comprises the following steps of,
(1) soaking radix Dipsaci in 95% ethanol for 48 hr, percolating at a speed of 2 ml/min, and collecting percolate until total saponins are completely percolated out; decocting radix astragali in water for 4 times, each for 2.5 hr, mixing decoctions, filtering, concentrating the filtrate to 1ml corresponding to 2g of the raw medicinal material, precipitating with ethanol for 3 times, each time the ethanol content in the solution is 85%, cold preserving for 48 hr, filtering, and recovering solvent; or reflux-extracting radix Dipsaci and radix astragali with 95% ethanol for 4 times (more than 4 times of ethanol solution each time, each reflux time for 2.5 hr), filtering, and mixing filtrates; decolorizing radix Dipsaci and radix astragali extractive solution with alumina or activated carbon, filtering, recovering ethanol, concentrating into soft extract, adding 10 times of water, precipitating with water, defatting, passing the defatting solution through macroporous resin column, eluting with 40% ethanol solution, collecting eluate, and recovering solvent to obtain total saponin extract of radix Dipsaci and radix astragali with total saponin content of not less than 50% calculated on dry extract;
(2) decocting herba Pileae Scriptae and rhizoma Drynariae in water for 4 times (2 hr each time), adding 10 times of water, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.35 at 70 deg.C, precipitating with ethanol for 2 times (the first time makes ethanol content 70% and the second time 85% respectively), and refrigerating for 48 hr each time. Filtering, recovering ethanol from the filtrate, adsorbing with polyamide, eluting with water or 25% ethanol solution, eluting with 95% ethanol, recovering ethanol, and concentrating to obtain herba Pileae Scriptae and rhizoma Drynariae flavone extract with total flavone content of not less than 50% based on dry extract;
(3) mixing the above extracts, adding more than 6 times of injectable water, filtering, refrigerating for 40 hr, adjusting pH of the filtrate to 8.5 with 20% NaOH solution, adding 0.15% active carbon, boiling for 25 min, filtering, ultrafiltering, adjusting pH to 8.5 with 20% NaOH solution, adding injectable pharmaceutical adjuvants, and making into injection.
Example 16. A Chinese medicine for promoting healing of bone fracture is prepared from the raw materials (kilogram unit)
10 portions of rhizoma drynariae, 10 portions of glabrous sarcandra herb,
dipsacus root 10. The effective components are extracted according to the extraction method of rhizoma drynariae, glabrous sarcandra herb and Chinese teasel root in the embodiment 13, and the capsules are prepared.
Example 17. A Chinese medicine for promoting healing of bone fracture is prepared from the raw materials (kilogram unit)
10 portions of rhizoma drynariae, 10 portions of glabrous sarcandra herb,
20 of astragalus root. The effective components are extracted according to the extraction method of rhizoma drynariae, glabrous sarcandra herb and astragalus in the example 14, and the tablets are prepared.
Example 18. A Chinese medicine for promoting healing of bone fracture is prepared from the raw materials (kilogram unit)
1 part of rhizoma drynariae and 1 part of glabrous sarcandra herb. The powder is prepared by the conventional process in the prior art.
Example 19. A Chinese medicine for promoting healing of bone fracture is prepared from the raw materials (kilogram unit)
1 part of rhizoma drynariae, 20 parts of glabrous sarcandra herb,
1 of dipsacus root. Making into tablet by conventional method.
Example 20. A Chinese medicine for promoting healing of bone fracture is prepared from the raw materials (kilogram unit)
20 parts of rhizoma drynariae, 1 part of glabrous sarcandra herb,
1, astragalus root.
Making into capsule by conventional method.
Pharmacodynamic study experiment (examples 21 to 24) of the dry paste powder prepared in example 11.
Example 21. The therapeutic effect of the dry paste powder on experimental fracture rats is tested according to the drug effect.
The experimental method comprises the following steps: taking 50 male adult rats of S D, anesthetizing with sodium pentobarbital, sterilizing the right leg of the rat with iodine and alcohol, performing transverse sawing operation to completely defect the middle section of the tibiofibula of the lower limb by 3mm, suturing an incision after the operation, not covering and binding, and performing ip penicillin infection resistance for 3 days continuously to form a rat fracture model. The model rats are randomly divided into 5 groups, and each group comprises 10 dry paste powder groups with high, medium and low dosages, a model group and a positive medicine group. The administration is performed by gavage 1 time per day for 30 days. The positive control group ig traumatology bone-setting tablet is 0.5g/kg, the model group ig distilled water is 10mL/kg, and the dry paste powder high, medium and low dosage groups are 0.25, 0.5 and 1.0g/kg respectively. After anesthetizing the rats 15 and 30 days after the drug administration, the rats of each group were photographed under the conditions of 47kV, 100m A, 06s and 90cm, and rated by the X-ray film evaluation standard of the research institute of bone fracture, Shanghai city.
The experimental results are as follows: the result shows that X-ray films of each dose group of dry paste powder are obviously changed on the 15 th day after fracture, the fracture ends of rats are fuzzy, callus is formed, mild periosteum reaction is caused, the effect is obvious in a large dose group, and the positive control group also has the same effect; the model group only shows that the fractured ends are fuzzy, slight periosteal reaction exists, individual callus is visible, but the difference is not significant through statistical test. More callus is formed at the defect part of the dry paste powder group 30 days after fracture, 7 rats in the large dose group and 1 rat in the model group have healed fracture defect parts, and the difference of the dry paste powder is obvious compared with the model group. (the statistical method adopts a rank order value method). The results are shown in Table 1.
TABLE 1 therapeutic action of dry extract powder on experimental fracture rat (X + -S)
Group of Dosage (g/kg) 15 days 30 days
+ ++ +++ ++++ + ++ +++ ++++
Model group traumatology bone plate group high dose group medium dose group low dose group -0.50.250.51.0 64445 45365 01300 00000 00000 85256 14134 117*20
Note: comparison with model group*P<0.05
Example 22. The treatment effect of the dry paste powder on experimental fracture mice is tested.
Purpose of the experiment: therapeutic effect of dry paste powder on experimental fracture mice
The experimental method comprises the following steps: 75 ICR mice are selected, and the male mice are male and have the weight of 22-25 g. The lower limb of the right leg of the mouse is folded inwards by 90 degrees by hand, and simultaneously the mouse fracture model is caused by hearing the sound of bone fracture and feeling the fracture, all the mice are not bound and fixed, the model mouse is randomly divided into 5 groups, and each group comprises 15 groups, namely dry paste powder high, medium and low dose groups, a model group and a positive medicine group. The administration is performed by gavage 1 time per day for 30 days. 1.0g/kg of positive control group ig traumatology bone-setting tablet, 20mL/kg of model group ig distilled water, 0.5g/kg of dry paste powder high, 1.0g/kg of dry paste powder medium and 2.0g/kg of dry paste powder low dose group. Each group of 5 mice was sacrificed in batches at 10, 20, and 30d after administration, the right leg, lower limb, femur, and femur of the mice were fixed with 10% formaldehyde solution, soft tissue was removed, decalcification was performed with 10% nitric acid, paraffin sections were obtained, hematoxylin-eosin staining was performed, and the histological change of callus was observed. The judgment standard of the curative effect is as follows: the ossification of the broken end chondrocytes is less than 50% (+), the ossification of the broken end chondrocytes is 50% (++), and the ossification of the broken end chondrocytes is more than 50% (++). The results of each group were compared to the model groups for rank order statistical analysis, see table 2. The result shows that the dry paste powder can promote the ossification of the chondrocytes at the broken ends of the bones of the mice and is beneficial to the healing of the fracture.
TABLE 2 therapeutic action of the dry extract powder on experimental fracture mice (X + -S)
Group of Dosage (g/kg) 10 days 20 days Day 0
+ ++ +++ + ++ +++ + ++ +++
Model set - 5 0 0 5 0 0 4 1 0
Bone-knitting tablet set for department of traumatology 1.0 1 2 2* 0 3 2** 0 1 4**
High dose group 0.5 0 2 3** 0 1 4** 0 0 5**
Middle dose group 1.0 1 3 1* 0 3 2** 0 1 4**
Low dose group 2.0 1 4 0* 0 4 1** 0 2 3**
Note: comparison with model group*P<0.05,**P<0.01
Example 23. Experiment on the influence of the dry paste powder on swelling of auricle of mice caused by croton oil.
Purpose of the experiment: and observing the influence of the dry paste powder on swelling of auricles of mice caused by croton oil.
The experimental method comprises the following steps: 50 normal ICR mice are taken, the weight of the mice is 18-22 g, and the mice are half male and half female. The mice are randomly divided into 5 groups, and each group comprises 10 mice, namely a dry paste powder high, medium and low dose group, a model group and a positive drug group. The administration is performed by gavage 1 time per day for 7 days. Positive control group ig acetylsalicylic acid 0.11g/kg, model group ig distilled water 20mL/kg, dry paste powder high, medium and low dosage groups are 0.5, 1.0, 2.0g/kg respectively. After administration for 40min on day 7, the two sides of the left ear of the mouse were smeared with 0.05ml of 2% croton oil, the mouse was sacrificed 4 hours after inflammation, the left and right ears were cut off along the base line of the auricle, round ear pieces were removed from the same portions by a punch (diameter 9mm), weighed by an electronic balance, and the difference between the weights of the left and right ear shells of the mouse was taken as the swelling degree of the ear shells, and the swelling percentage was calculated.
Figure A20051004041400291
The experimental results are as follows: the dry paste powder can relieve swelling degree of mouse ear caused by croton oil and reduce swelling rate, has significant difference (p is less than 0.05, p is less than 0.01) compared with blank group, and is similar to acetylsalicylic acid group. The dry paste powder has stronger anti-inflammatory action. The results are shown in Table 3.
Influence of pinellia ternate stomach harmonizing capsules on swelling of mouse ears caused by croton oil (X +/-S)
Group of Dosage (g/kg) Animal number (only) Swelling degree of ear shell (mg) Rate of swelling
Blank acetylsalicylic acid group high dose group medium dose group low dose group -0.110.51.02.0 1010101010 27.66±4.0317.89±6.40**18.40±7.97**19.52±3.87**21.84±6.28* 174.2±46.0105.3±55.4**108.0±56.2**116.6±43.7*129.1±42.4*
Note: in comparison to the blank set, the data is,*p<0.05,**p<0.01。
example 24. Experiment on influence of the dry paste powder on body writhing of mice caused by acetic acid.
Purpose of the experiment: and observing the influence of the dry paste powder on the body writhing of the mice caused by acetic acid.
The experimental method comprises the following steps: 100 normal ICR mice are taken, the weight of the mice is 18-22 g, and the mice are half male and half female. The mice are randomly divided into 5 groups, and each group comprises 20 mice, namely dry paste powder high, medium and low dose groups, a model group and a positive drug group. The administration is performed by gavage 1 time per day for 7 days. Positive control group ig acetylsalicylic acid 0.11g/kg, model group ig distilled water 20mL/kg, dry paste powder high, medium and low dosage groups are 0.5, 1.0, 2.0g/kg respectively. After the administration for 40min on day 7, 0.6% acetic acid 0.2 ml/mouse was intraperitoneally injected into each group of mice, and the number of writhing-responsive animals and the number of writhing-responsive times of each group of mice were observed within 15min after the injection of acetic acid.
The experimental results are as follows: the times of writhing of each group of mice with the dry paste powder are obviously lower than those of the blank group and are equivalent to those of the model group, which shows that the dry paste powder can reduce the times of pain and writhing of the mice caused by acetic acid abdominal cavity stimulation and has the function of analgesia. The results are shown in Table 4.
TABLE 4 influence of dry extract powder on pain response of mice caused by acetic acid abdominal cavity stimulation (X + -S)
Group of Dosage (g/kg) Animal number (only) Number of untwisted animals Number of times of twisting
Blank acetylsalicylic acid group high dose group medium dose group low dose group -0.110.51.02.0 2020202020 06**6**5*2 37.4±6.112.6±10.4**12.9±10.5**18.7±15.9**25.9±16.2**
Note: in comparison to the blank set, the data is,*p<0.05,**p<0.01。
experiments on pharmacodynamics of the injection solutions prepared as in example 15 (examples 25 to 28).
Example 25. Experiment of the therapeutic effect of the injection on experimental fracture rats.
Purpose of the experiment: the therapeutic effect of the injection on experimental fracture rats was observed.
The experimental method comprises the following steps: taking 50 male adult rats of S D, anesthetizing with sodium pentobarbital, sterilizing the right leg of the rat with iodine and alcohol, performing transverse sawing operation to completely defect the middle section of the tibiofibula of the lower limb by 3mm, suturing an incision after the operation, not covering and binding, and performing ip penicillin infection resistance for 3 days continuously to form a rat fracture model. The model rats are randomly divided into 5 groups of 10 rats, namely injection high, medium and low dose groups, a model group and a positive drug group. The administration is carried out by tail vein injection, 1 time per day and 30 days continuously. The positive control group compound angelica injection im is 0.5mL/kg, the model group im normal saline is 1.0mL/kg, and the high, medium and low dosage groups of the injection are respectively iv0.25, 0.5 and 1.0 mL/kg. After anesthetizing the rats 15 and 30 days after drug administration, the rats of each group were photographed under the conditions of 47kV, 100mA, 06s and 90cm, and rated by the X-ray evaluation standard of the research institute of bone fracture department in Shanghai city.
The experimental results are as follows: the result shows that X-ray films of injection dose groups on the 15 th day after fracture are obviously changed, the fracture ends of rats are fuzzy, callus is formed, mild periosteal reaction is caused, the effect is obvious in a large dose group, and the positive control group also has the same effect; the model group only shows that the fractured ends are fuzzy, slight periosteal reaction exists, individual callus is visible, but the difference is not significant through statistical test. 30d after fracture, more callus is formed at the defect part of the injection group, 7 rats at the large dose group and 1 rat at the fracture defect part of the model group are healed, and the difference between the injection group and the model group is obvious. (the statistical method adopts a rank order value method). The results are shown in Table 1.
TABLE 1 therapeutic effect of the injection on experimental fracture rats (X + -S)
Group of Dosage (g/kg) 15 days 30 days
+ ++ +++ ++++ + ++ +++ ++++
Model group positive drug group high dose group medium dose group low dose group -0.50.250.51.0 64435 45475 01200 00000 00000 85146 14244 117*20
Note: comparison with model group*P<0.05
Example 26. Experiment of the injection on the treatment effect of experimental fracture mice.
Purpose of the experiment: the injection has therapeutic effect on experimental fracture mice.
The experimental method comprises the following steps: 75 ICR mice are selected, and the male mice are male and have the weight of 22-25 g. The lower limbs of the right legs of the mouse are folded inwards by 90 degrees by hands, the mouse fracture model is caused by listening to the sound of bone fracture and feeling the fracture, the mouse fracture model is not bound and fixed, the model mouse is randomly divided into 5 groups, and each group comprises 15 groups, namely high-dosage, medium-dosage and low-dosage groups of injection, a model group and a positive medicine group. The administration is carried out by tail vein injection, 1 time per day and 30 days continuously. Positive control group compound radix Angelicae sinensis injection im1.0mL/kg, model group im normal saline 10mL/kg, injection high, middle and low dosage groups iv 0.5, 1.0, 2.0mL/kg respectively. Each group of 5 mice was sacrificed in batches at 10, 20, and 30d after administration, the right leg, lower limb, femur, and femur of the mice were fixed with 10% formaldehyde solution, soft tissue was removed, decalcification was performed with 10% nitric acid, paraffin sections were obtained, hematoxylin-eosin staining was performed, and the histological change of callus was observed. The judgment standard of the curative effect is as follows: the ossification of the broken end chondrocytes is less than 50% (+), the ossification of the broken end chondrocytes is 50% (++), and the ossification of the broken end chondrocytes is more than 50% (++). The results of each group were compared to the model groups for rank order statistical analysis, see table 2. The results show that the injection can promote the ossification of the chondrocytes at the broken ends of the bones of the mice, and is beneficial to the healing of the fractures.
TABLE 2 therapeutic Effect of the injection on experimental fracture mice (X. + -. S)
Group of Dosage (g/kg) 10 days 20 days 30 days
+ ++ +++ + ++ +++ + ++ +++
Model set - 5 0 0 5 0 0 4 1 0
Positive drug group 1.0 1 2 2* 0 3 2** 0 1 4**
Height ofDose groups 0.5 0 2 3** 0 1 4** 0 0 5**
Middle dose group 1.0 1 3 1* 0 3 2** 0 1 4**
Low dose group 2.0 1 4 0* 0 4 1** 0 2 3**
Note: comparison with model group*P<0.05, **P<0.01
Example 27. Experiment on the influence of the injection on swelling of auricle of mice caused by croton oil.
Purpose of the experiment: the effect of the injection on swelling of mouse auricle caused by croton oil was observed.
The experimental method comprises the following steps: 50 normal ICR mice are taken, the weight of the mice is 18-22 g, and the mice are half male and half female. The mice were randomly divided into 5 groups of 10 mice each, i.e., injection high, medium and low dose groups, model group and positive drug group. The administration is carried out by tail vein injection, 1 time per day, and 7 days continuously. Positive control group compound radix Angelicae sinensis injection im1.0mL/kg, model group im normal saline 10mL/kg, injection high, middle and low dosage groups im 0.5, 1.0, 2.0mL/kg respectively. After administration for 40min on day 7, the two sides of the left ear of the mouse were smeared with 0.05ml of 2% croton oil, the mouse was sacrificed 4 hours after inflammation, the left and right ears were cut off along the base line of the auricle, round ear pieces were removed from the same portions by a punch (diameter 9mm), weighed by an electronic balance, and the difference between the weights of the left and right ear shells of the mouse was taken as the swelling degree of the ear shells, and the swelling percentage was calculated.
The experimental results are as follows: the injection can reduce the ear swelling degree of mice caused by croton oil and reduce the swelling rate, has significant difference (p is less than 0.05, p is less than 0.01) compared with a blank group, and is similar to an acetylsalicylic acid group. The injection has strong anti-inflammatory effect. The results are shown in Table 3.
Influence of pinellia ternate stomach harmonizing capsules on swelling of mouse ears caused by croton oil (X +/-S)
Group of Dosage (g/kg) Animal number (only) Swelling degree of ear shell (mg) Rate of swelling
Blank group of compound angelica injection group with high dose group and medium dose group and low dose group -1.00.51.02.0 1010101010 27.66±4.0317.89±6.40**18.40±7.97**19.52±3.87**21.84±6.28* 174.2±46.0105.3±55.4**108.0±56.2**116.6±43.7*129.1±42.4*
Note: in comparison to the blank set, the data is,*p<0.05,**p<0.01。
example 28. Experiment on influence of injection on acetic acid on writhing of mice.
Purpose of the experiment: the effect of the injection on the writhing of the mice caused by acetic acid was observed.
The experimental method comprises the following steps: 100 normal ICR mice are taken, the weight of the mice is 18-22 g, and the mice are half male and half female. The mice were randomly divided into 5 groups of 20 mice each, namely injection high, medium and low dose groups, model group and positive drug group. The administration is carried out by tail vein injection, 1 time per day, and 7 days continuously. Positive control group compound radix Angelicae sinensis injection im1.0mL/kg, model group im normal saline 10mL/kg, injection high, middle and low dosage groups im 0.5, 1.0, 2.0mL/kg respectively. After the administration for 40min on day 7, 0.6% acetic acid 0.2 ml/mouse was intraperitoneally injected into each group of mice, and the number of writhing-responsive animals and the number of writhing-responsive times of each group of mice were observed within 15min after the injection of acetic acid.
The experimental results are as follows: the times of writhing of each group of mice of the injection are obviously lower than those of the blank group and are equivalent to those of the model group, which shows that the injection can reduce the times of pain and writhing of the mice caused by acetic acid abdominal cavity stimulation and has the function of analgesia. The results are shown in Table 4.
TABLE 4 Effect of injection on the pain response of mice to acetic acid intraperitoneal stimulation (X. + -. S)
Group of Dosage (g/kg) Animal number (only) Number of untwisted animals Number of times of twisting
Blank group of compound angelica injection group with high dose group and medium dose group and low dose group -1.00.51.02.0 2020202020 00532 38.9±6.718.0±14.6**20.4±11.2**23.6±10.6**30.3±6.0**
Note: in comparison to the blank set, the data is,*p<0.05,**p<0.01。

Claims (10)

1. A pharmaceutical composition for promoting fracture healing is characterized in that the pharmaceutical composition is a medicament prepared from the following raw materials in parts by weight,
1 to 20 parts of rhizoma drynariae, 1 to 20 parts of glabrous sarcandra herb,
0-20 parts of teasel roots and 0-30 parts of astragalus roots.
2. The pharmaceutical composition of claim 1, wherein the weight ratio of each raw material is,
10 portions of rhizoma drynariae, 10 portions of glabrous sarcandra herb,
dipsacus asperoides 10 and/or Astragalus membranaceus 20.
3. A preparation method of a pharmaceutical composition for promoting fracture healing is characterized by comprising the following steps:
(1) soaking teasel roots in 90-95% ethanol as a solvent for 36-48 hours, percolating at the speed of 1-2ml per minute, and collecting percolate until total saponins are completely percolated out; or extracting with 85-95% ethanol under reflux for 2-4 times, wherein the dosage of the ethanol solution is more than 4 times each time, the reflux time is 1-2.5 hours each time, filtering, and combining the filtrates; decolorizing the percolate or the reflux extract by using alumina or active carbon, filtering, recovering ethanol, concentrating to obtain a thick paste, adding 1-10 times of water, precipitating by using water, carrying out degreasing treatment, adsorbing the degreased liquid by using a macroporous resin column, eluting by using an ethanol solution with the concentration of more than 40%, collecting eluent, and recovering a solvent to obtain a dipsacus asperoides extract;
(2) decocting glabrous sarcandra herb in water for 2-4 times, each time for 0.5-2 hours, adding water for 4-10 times, combining decoctions, filtering, concentrating the filtrate until the relative density is 1.5-1.35 in a thermal measurement at 70 ℃, adding ethanol for precipitation for 2 times, the alcohol content is 60-70% in the first time, the alcohol content is 75-85% in the second time, refrigerating for 24-48 hours in each time, filtering, recovering ethanol from the filtrate, concentrating until the relative density is 1.1-1.3 in the thermal measurement at 70 ℃, adding a proper amount of newly configured egg protein solution, stirring, precipitating, refrigerating for 24-48 hours, filtering, boiling the filtrate to solidify excessive egg protein, filtering, adding ethanol into the filtrate to make the ethanol content be 70-80%, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain the glabrous sarcandra herb extract;
(3) taking drynaria rhizome, adding water, decocting for 2-4 times, adding water for more than 4 times each time, 0.5-2 hours each time, filtering, concentrating until the relative density is 1.10-1.20 when measuring the temperature at 45 ℃, adding ethanol while stirring, uniformly mixing until the alcohol content of the extracting solution reaches 55% -70%, standing for 24-48 hours, filtering, recovering ethanol from the filtrate until no alcohol smell exists, adding ethanol while stirring until the alcohol content of the extracting solution reaches 75% -85%, uniformly mixing, standing for 12-48 hours, recovering ethanol until no alcohol smell exists, and obtaining a drynaria rhizome extract;
decocting radix astragali in water for 2-4 times, each time for 1-1.5 hours, combining decoctions, filtering, concentrating the filtrate until each 1ml of the filtrate is equivalent to 1-2 g of the raw medicinal material, precipitating with ethanol for 1-3 times, wherein the ethanol content in the solution is 75-85% each time, refrigerating and placing for 10-24 hours each time, filtering, concentrating the filtrate until each 1ml of the filtrate is equivalent to 5-6 g of the raw medicinal material, and cooling to obtain the radix astragali extract; or taking astragalus, extracting with 85-95% ethanol under reflux for 2-4 times, wherein the dosage of the ethanol solution is more than 4 times each time, the reflux time is 1-2.5 hours each time, filtering, and combining the filtrates; recovering ethanol, concentrating to obtain a thick paste, adding 1-10 times of water, precipitating with water for 24-48 hours, filtering, concentrating to obtain 5-6 g of raw medicinal materials per 1ml, and cooling to obtain radix astragali extract;
or,
(3) decocting drynaria rhizome and astragalus membranaceus in water for 2-4 times, adding more than 4 times of water for each time, 0.5-2 hours for each time, filtering, concentrating until the relative density is 1.10-1.20 in a thermal test at 45 ℃, adding ethanol while stirring, uniformly mixing until the alcohol content of an extracting solution reaches 55% -70%, standing for 24-48 hours, filtering, recovering ethanol from a filtrate until no alcohol smell exists, adding ethanol while stirring until the alcohol content of the extracting solution reaches 75% -85%, uniformly mixing, standing for 12-48 hours, recovering ethanol until no alcohol smell exists, and obtaining drynaria rhizome and astragalus membranaceus extracts;
(4) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into any dosage form of pharmacy.
4. A preparation method of a pharmaceutical composition for promoting fracture healing is characterized by comprising the following steps:
(1) decocting glabrous sarcandra herb in water for 2-4 times, each time for 0.5-2 hours, adding water for 4-10 times, combining decoctions, filtering, concentrating the filtrate until the relative density is 1.5-1.35 in a thermal measurement at 70 ℃, adding ethanol for precipitation for 2 times, the alcohol content is 60-70% in the first time, the alcohol content is 75-85% in the second time, refrigerating for 24-48 hours in each time, filtering, recovering ethanol from the filtrate, concentrating until the relative density is 1.1-1.3 in the thermal measurement at 70 ℃, adding a proper amount of newly configured egg protein solution, stirring, precipitating, refrigerating for 24-48 hours, filtering, boiling the filtrate to solidify excessive egg protein, filtering, adding ethanol into the filtrate to make the ethanol content be 70-80%, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain the glabrous sarcandra herb extract;
(2) taking drynaria rhizome, adding water, decocting for 2-4 times, adding water for more than 4 times each time, 0.5-2 hours each time, filtering, concentrating until the relative density is 1.10-1.20 when measuring the temperature at 45 ℃, adding ethanol while stirring, uniformly mixing until the alcohol content of the extracting solution reaches 55% -70%, standing for 24-48 hours, filtering, recovering ethanol from the filtrate until no alcohol smell exists, adding ethanol while stirring until the alcohol content of the extracting solution reaches 75% -85%, uniformly mixing, standing for 12-48 hours, recovering ethanol until no alcohol smell exists, and obtaining a drynaria rhizome extract;
(3) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into any dosage form of pharmacy.
5. A preparation method of a pharmaceutical composition for promoting fracture healing is characterized by comprising the following steps,
(1) soaking teasel roots in 90-95% ethanol as a solvent for 36-48 hours, percolating at the speed of 1-2ml per minute, and collecting percolate until total saponins are completely percolated out; or extracting with 85-95% ethanol under reflux for 2-4 times, wherein the dosage of the ethanol solution is more than 4 times each time, the reflux time is 1-2.5 hours each time, filtering, and combining the filtrates; decolorizing the percolate or the reflux extract by using alumina or active carbon, filtering, recovering ethanol, concentrating to obtain a thick paste, adding 1-10 times of water, precipitating by using water, carrying out degreasing treatment, adsorbing the degreased liquid by using a macroporous resin column, eluting by using an ethanol solution with the concentration of more than 40%, collecting eluent, and recovering a solvent to obtain a dipsacus asperoides extract;
(2) decocting glabrous sarcandra herb, rhizoma drynariae and astragalus membranaceus in water for 2-4 times, 0.5-2 hours each time, adding 4-10 times of water each time, combining decoctions, filtering, concentrating the filtrate until the relative density is 1.5-1.35 when the filtrate is subjected to thermal measurement at 70 ℃, adding ethanol for precipitation for 2 times, enabling the alcohol content to be 60-70% for the first time and 75-85% for the second time, refrigerating for 24-48 hours each time, and filtering; recovering ethanol from the filtrate, concentrating to relative density of 1.1-1.3 at 70 deg.C, adding appropriate amount of newly prepared egg protein solution, stirring, precipitating, refrigerating for 24-48 hr, filtering, boiling the filtrate to solidify excessive egg protein, and filtering; adding ethanol into the filtrate to make the ethanol content reach 70-80%, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain extracts of herba Pileae Scriptae, rhizoma Drynariae and radix astragali;
(3) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into any dosage form of pharmacy.
6. A preparation method of a pharmaceutical composition for promoting fracture healing is characterized by comprising the following steps,
(1) soaking teasel roots in 90-95% ethanol as a solvent for 36-48 hours, percolating at the speed of 1-2ml per minute, and collecting percolate until total saponins are completely percolated out; or extracting with 85-95% ethanol under reflux for 2-4 times, wherein the dosage of the ethanol solution is more than 4 times each time, the reflux time is 1-2.5 hours each time, filtering, and combining the filtrates; decolorizing the percolate or the reflux extract by using alumina or active carbon, filtering, recovering ethanol, concentrating to obtain a thick paste, adding 1-10 times of water, precipitating by using water, carrying out degreasing treatment, adsorbing the degreased liquid by using a macroporous resin column, eluting by using an ethanol solution with the concentration of more than 40%, collecting eluent, and recovering a solvent to obtain a dipsacus asperoides extract;
(2) decocting glabrous sarcandra herb and rhizoma drynariae in water for 2-4 times, 0.5-2 hours each time, adding 4-10 times of water each time, combining decoctions, filtering, concentrating the filtrate until the relative density is 1.5-1.35 when the filtrate is subjected to thermal measurement at 70 ℃, adding ethanol for precipitation for 2 times, enabling the alcohol content to be 60-70% for the first time and 75-85% for the second time, refrigerating for 24-48 hours each time, and filtering; recovering ethanol from the filtrate, concentrating to relative density of 1.1-1.3 at 70 deg.C, adding appropriate amount of newly prepared egg protein solution, stirring, precipitating, refrigerating for 24-48 hr, filtering, boiling the filtrate to solidify excessive egg protein, and filtering; adding ethanol into the filtrate to make the ethanol content reach 70-80%, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain glabrous sarcandra herb and rhizoma drynariae extracts;
(3) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into any dosage form of pharmacy.
7. A preparation method of a pharmaceutical composition for promoting fracture healing is characterized by comprising the following steps,
(1) soaking teasel roots and astragalus membranaceus in 90-95% ethanol as a solvent for 36-48 hours, percolating at the speed of 1-2ml per minute, collecting percolate until total saponins are completely percolated out, or refluxing and extracting for 2-4 times by 85-95% ethanol, wherein the dosage of the ethanol solution is more than 4 times each time, the refluxing time is 1-2.5 hours each time, filtering, and combining filtrates; decolorizing the percolate or the reflux extract by using alumina or active carbon, filtering, recovering ethanol, concentrating to obtain a thick paste, adding 1-10 times of water, precipitating by using water, carrying out degreasing treatment, adsorbing the degreased liquid by using a macroporous resin column, eluting by using an ethanol solution with the concentration of more than 40%, collecting eluent, and recovering a solvent to obtain extracts of dipsacus asperoides and astragalus membranaceus;
(2) decocting glabrous sarcandra herb and rhizoma drynariae in water for 2-4 times, 0.5-2 hours each time, adding 4-10 times of water each time, combining decoctions, filtering, concentrating the filtrate until the relative density is 1.5-1.35 when the filtrate is subjected to thermal measurement at 70 ℃, adding ethanol for precipitation for 2 times, enabling the alcohol content to be 60-70% for the first time and 75-85% for the second time, and refrigerating for 24-48 hours each time; filtering, recovering ethanol from the filtrate, concentrating to relative density of 1.1-1.3 at 70 deg.C, adding appropriate amount of newly-prepared egg protein solution, stirring, precipitating, refrigerating for 24-48 hr, filtering, boiling the filtrate to solidify excessive egg protein, and filtering; adding ethanol into the filtrate to make the ethanol content reach 70-80%, standing for precipitation, filtering, and recovering ethanol from the filtrate to obtain glabrous sarcandra herb and rhizoma drynariae extracts;
(3) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into any dosage form of pharmacy.
8. A preparation method of a pharmaceutical composition for promoting fracture healing is characterized by comprising the following steps,
(1) the bone drynaria rhizome is taken, water is added for decoction for 2-4 times, the amount of water is more than 4 times of that of each time, each time is 0.5-2 hours, the bone drynaria rhizome is filtered and concentrated to the relative density of 1.10-1.20 in the thermal measurement at 45 ℃, ethanol is added under stirring, the mixture is uniformly mixed until the alcohol content of the extracting solution reaches 55% -70%, the mixture is kept stand for 24-48 hours, the filtering is carried out, the ethanol is recovered from the filtrate until no alcohol smell exists, the ethanol is added under stirring until the alcohol content of the extracting solution reaches 75% -85%, the mixture is uniformly mixed, the mixture is kept stand. Adsorbing with polyamide, flushing with water or 5-25% ethanol solution, eluting with 60-95% ethanol, recovering ethanol, and concentrating to obtain rhizoma Drynariae flavone extract with rhizoma Drynariae total flavone content of not less than 50% based on dry extract;
(2) soaking teasel roots in 90-95% ethanol as a solvent for 36-48 hours, percolating at the speed of 1-2ml per minute, and collecting percolate until total saponins are completely percolated out; or extracting with 85-95% ethanol under reflux for 2-4 times, wherein the dosage of the ethanol solution is more than 4 times each time, the reflux time is 1-2.5 hours each time, filtering, and combining the filtrates; decolorizing the percolate or the reflux extracting solution by using alumina or active carbon, filtering, recovering ethanol, concentrating to obtain a thick paste, adding 1-10 times of water, precipitating by using water, carrying out degreasing treatment, adsorbing the degreased solution by using a macroporous resin column, eluting by using an ethanol solution with the concentration of more than 40%, collecting eluent, and recovering a solvent to obtain a dipsacus asperoides total saponin extract, wherein the content of the dipsacus asperoides total saponin is not less than 50% in terms of dry extract;
(3) decocting glabrous sarcandra herb in water for 2-4 times, each time for 0.5-2 hours, adding 4-10 times of water for each time, combining decoction, filtering, concentrating the filtrate until the relative density is 1.5-1.35 in a thermal measurement at 70 ℃, adding ethanol for precipitation for 2 times, firstly enabling the alcohol content to be 60-70% and the alcohol content to be 75-85%, refrigerating for 24-48 hours, filtering, recovering ethanol from the filtrate, concentrating until the relative density is 1.1-1.3 in the thermal measurement at 70 ℃, adding a proper amount of newly configured egg protein solution, stirring, enabling the precipitation to be refrigerated for 24-48 hours, filtering, boiling the filtrate, solidifying excessive egg protein, and filtering; adding ethanol into the filtrate to ensure that the ethanol content is 70-80%, standing for precipitation, filtering, and recovering ethanol from the filtrate; adsorbing with polyamide, flushing with water or 5-25% ethanol solution, eluting with 60-95% ethanol, recovering ethanol, and concentrating to obtain herba Pileae Scriptae flavone extract with total flavone content of not less than 50% based on dry extract;
(4) decocting radix astragali in water for 2-4 times, each time for 1-2.5 hours, mixing decoctions, filtering, concentrating the filtrate to 1ml, which is equivalent to 1-2 g of the original medicinal material, precipitating with ethanol for 1-3 times, wherein the ethanol content in the solution is 75-85% each time, refrigerating and standing for 10-48 hours each time, filtering, and recovering the solvent; or extracting with 85-95% ethanol under reflux for 2-4 times, wherein the dosage of the ethanol solution is more than 4 times each time, the reflux time is 1-2.5 hours each time, filtering, and combining the filtrates. Decolorizing the extract by using alumina or activated carbon, filtering, recovering ethanol, concentrating to obtain a thick paste, adding 1-10 times of water, precipitating by using water, adsorbing by using a macroporous resin column, eluting by using an ethanol solution of more than 40%, collecting eluent, and recovering a solvent to obtain an astragalus total saponin extract, wherein the content of the astragalus total saponin is not less than 50% in terms of dry extract;
(5) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into any dosage form of pharmacy.
9. A preparation method of a pharmaceutical composition for promoting fracture healing is characterized by comprising the following steps,
(1) soaking teasel roots in 90-95% ethanol as a solvent for 36-48 hours, percolating at the speed of 1-2ml per minute, and collecting percolate until total saponins are completely percolated out; decocting radix astragali in water for 2-4 times, each time for 1-2.5 hours, mixing decoctions, filtering, concentrating the filtrate to 1ml, which is equivalent to 1-2 g of the original medicinal material, precipitating with ethanol for 1-3 times, wherein the ethanol content in the solution is 75-85% each time, refrigerating and standing for 10-48 hours each time, filtering, and recovering the solvent; or reflux-extracting radix Dipsaci and radix astragali with 85-95% ethanol for 2-4 times, wherein the amount of ethanol solution is more than 4 times of that of ethanol solution each time, and the reflux time is 1-2.5 hours each time, filtering, and mixing filtrates; decolorizing radix Dipsaci and radix astragali extractive solution with alumina or activated carbon, filtering, recovering ethanol, concentrating into thick paste, adding 1-10 times of water, precipitating with water, defatting, adsorbing the defatting solution with macroporous resin column, eluting with 40% ethanol solution, collecting eluate, and recovering solvent to obtain radix Dipsaci and radix astragali total saponin extract with total saponin content of not less than 50% based on dry extract;
(2) decocting glabrous sarcandra herb and rhizoma drynariae in water for 2-4 times, 0.5-2 hours each time, adding 4-10 times of water each time, combining decoctions, filtering, concentrating the filtrate until the relative density is 1.5-1.35 when the filtrate is subjected to thermal measurement at 70 ℃, adding ethanol for precipitation for 2 times, enabling the alcohol content to be 60-70% for the first time and 75-85% for the second time, and refrigerating for 24-48 hours each time. Filtering, recovering ethanol from the filtrate, performing polyamide adsorption treatment, flushing a column with water or 5-25% ethanol solution, eluting with 60-95% ethanol, recovering ethanol, and concentrating to obtain glabrous sarcandra herb and rhizoma drynariae flavone extracts, wherein the content of total flavone is not lower than 50% in terms of dry extract;
(3) mixing the above extracts, concentrating, adding medicinal adjuvants, and making into any dosage form of pharmacy.
10. The preparation method according to any one of claims 3 to 9, wherein the medicament is an injection, and the preparation method comprises mixing the extracts, adding more than 5-10 times of water for injection, filtering, refrigerating for 24-48 hours, adjusting the pH value of the filtrate to 7.5-9.0 with 20% NaOH solution, adding 0.05-0.15% of activated carbon, boiling for 5-30 minutes, filtering, ultrafiltering, adjusting the pH value to 7.5-9.0 with 20% NaOH solution, adding adjuvants for injection, and preparing into an injection, or performing a freeze-drying process to prepare a freeze-dried powder injection.
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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102743550A (en) * 2012-07-12 2012-10-24 朱崇田 Medicine composition for accelerating healing after fracture surgery, preparation method and application
CN104922192A (en) * 2015-06-12 2015-09-23 史风 Traditional Chinese medicine for treating fracture and preparation method thereof
CN108324760A (en) * 2018-05-17 2018-07-27 黄美荣 The Chinese herbal medicine for the treatment of fracture, injured bones and muscles
CN111821324A (en) * 2020-07-31 2020-10-27 朱华 Jianzhong fracture setting ointment for preventing and treating children's bone fracture diseases and preparation method thereof

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1095674C (en) * 1999-06-18 2002-12-11 贺云青 Chinese medicinal composition for cerebrovascular disease, rheumatism and rheumatoid disease

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102743550A (en) * 2012-07-12 2012-10-24 朱崇田 Medicine composition for accelerating healing after fracture surgery, preparation method and application
CN104922192A (en) * 2015-06-12 2015-09-23 史风 Traditional Chinese medicine for treating fracture and preparation method thereof
CN108324760A (en) * 2018-05-17 2018-07-27 黄美荣 The Chinese herbal medicine for the treatment of fracture, injured bones and muscles
CN111821324A (en) * 2020-07-31 2020-10-27 朱华 Jianzhong fracture setting ointment for preventing and treating children's bone fracture diseases and preparation method thereof

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