CN115737729A - National medicinal preparation for treating osteoporosis and preparation method thereof - Google Patents
National medicinal preparation for treating osteoporosis and preparation method thereof Download PDFInfo
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- CN115737729A CN115737729A CN202211481757.8A CN202211481757A CN115737729A CN 115737729 A CN115737729 A CN 115737729A CN 202211481757 A CN202211481757 A CN 202211481757A CN 115737729 A CN115737729 A CN 115737729A
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- OGBMKVWORPGQRR-UMXFMPSGSA-N teriparatide Chemical compound C([C@H](NC(=O)[C@H](CCSC)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@@H](NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@@H](N)CO)C(C)C)[C@@H](C)CC)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC=1N=CNC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC=1N=CNC=1)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC=1C=CC=CC=1)C(O)=O)C1=CNC=N1 OGBMKVWORPGQRR-UMXFMPSGSA-N 0.000 description 1
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- 231100000167 toxic agent Toxicity 0.000 description 1
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- 235000019166 vitamin D Nutrition 0.000 description 1
- 239000011710 vitamin D Substances 0.000 description 1
- 150000003710 vitamin D derivatives Chemical class 0.000 description 1
- 229940046008 vitamin d Drugs 0.000 description 1
- 229940090761 vitamin d and analogues Drugs 0.000 description 1
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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Abstract
The invention provides a national medicine preparation for treating osteoporosis and a preparation method thereof, belonging to the technical field of national medicines and medicinal preparations. The ethnic medicine preparation for treating osteoporosis comprises the following components in parts by weight: 5-60 parts of fennel; 5-80 parts of pimpinella anisum fruit; 10-100 parts of fig; 10-80 parts of licorice root; 5-60 parts of adiantum; 5-60 parts of moldavica dragonhead; 10-100 parts of rose petals; 10-80 parts of raisin; and 5-300 of the thorn sugar. The national medicinal preparation for treating osteoporosis has a definite curative effect on primary osteoporosis, and pharmacodynamic studies show that the national medicinal preparation can improve the coordination and balance between bone absorption and bone formation and the state of disordered bone biomechanical performance, effectively improve the bone density, and improve symptoms of soreness and weakness of waist and knees, cold intolerance, limb numbness, lusterless complexion, dullness, sticky mouth, white and greasy tongue fur and the like of a patient.
Description
Technical Field
The invention belongs to the technical field of national medicines and medicinal preparations, and particularly relates to a national medicine preparation for treating osteoporosis and a preparation method thereof.
Background
Osteoporosis (OP) is a systemic skeletal disease characterized by decreased bone mass, decreased bone microstructure, increased bone fragility, and susceptibility to fracture, with a higher incidence of morbidity, mortality, and cost of health care. It is estimated that there are approximately 2 billion osteoporosis patients worldwide, and by 2050, the population of the aged over 65 years will increase from 3.23 billion to 15 billion worldwide. Therefore, osteoporosis has become a worldwide problem. Osteoporosis is commonly seen in postmenopausal women, and according to the report of the world health organization, the incidence rate of osteoporosis is raised to the 6 th position which endangers the health diseases of women, about 30 percent of postmenopausal women have osteoporosis, and osteoporosis fracture is one of the main causes of disability and death of middle-aged and old women.
At present, bone formation promoters (calcium, vitamin D, parathyroid hormone, statins and the like), bone resorption inhibitors (estrogen and receptor modulators thereof, diphosphates, calcitonin and the like) and motor therapy are mainly used for treating osteoporosis, and other adjuvant therapies are adopted. Although patients can obtain certain curative effect during treatment, the existing medicines have large side effect and are not suitable for long-term use. No specific drug with advantage on OP is reported.
Disclosure of Invention
In order to solve the problems, the invention provides an ethnic medicine preparation for treating osteoporosis, which comprises the following components in parts by weight:
5-60 parts of fennel; 5-80 parts of pimpinella anisum fruit; 10-100 parts of fig; 10-80 parts of licorice root; 5-60 of adiantum; 5-60 parts of moldavica dragonhead; 10-100 parts of rose petals; 10-80 parts of raisin; and 5-300 of the chewing gum.
In addition, in order to solve the above problems, the present invention further provides a method for preparing the above national herb preparation for treating osteoporosis, comprising:
preparing an extract;
vacuum drying the extract, pulverizing into powder, and sieving to obtain extract powder;
and (3) preparing the national medicine preparation for treating osteoporosis together with auxiliary materials.
Preferably, the preparing of the extract comprises:
the national medicine preparation for treating osteoporosis of claim 1, wherein fennel, anise fruit, fig, licorice root, adiantum capillus-veneris, moldavica dragonhead, rose petals, raisin and acanthose are weighed according to the parts by weight of each component, and are mixed to obtain a target mixture;
extracting the target mixture to obtain an extracting solution; wherein the extraction solvent is water or 40% -80% ethanol;
concentrating the extracting solution at 60-70 deg.C to obtain the extract with relative density of 1.05-1.40.
Preferably, when the extraction solvent is water, the method for extracting the target mixture comprises:
soaking the target mixture with 5-12 times of water for 12 hours;
decocting for 1.5 hr, and filtering to obtain first filtrate;
adding 4-10 times of water into the filter residue, decocting for 1 hour for the second time, and filtering to obtain a second filtrate;
adding 4-8 times of water into the filter residue, decocting for 1 hour for the third time, and filtering to obtain the third filtrate;
and combining the first filtrate, the second filtrate and the third filtrate to obtain the extracting solution.
Preferably, when the extraction solvent is 40% -80% ethanol, the extraction method of the target mixture comprises:
soaking the target mixture in 5-12 times of 40-80% ethanol for 12 hours;
carrying out first reflux extraction for 1.5 hours, and filtering to obtain first filtrate;
adding 40-80% ethanol 4-10 times the amount of the filter residue, performing secondary reflux extraction for 1.5 hours, and filtering to obtain secondary filtrate;
and combining the first filtrate and the second filtrate to obtain the extracting solution.
Preferably, the national medicine preparation for treating osteoporosis is prepared by the extract powder and auxiliary materials together, and comprises the following components:
mixing the extract powder with purified water and 1-20% of adjuvants; wherein the auxiliary material is a flavoring agent; the flavoring agent comprises one or more of sucrose, fructose, stevioside and sorbic acid;
filtering with a plate-and-frame filter to obtain a drug filtrate;
subpackaging and sterilizing the drug filtrate to obtain the national drug preparation for treating osteoporosis in an oral liquid dosage form.
Preferably, the national medicine preparation for treating osteoporosis is prepared by the extract powder and auxiliary materials together, and comprises the following components:
mixing the extract powder with 95% ethanol or water and 10-70 parts of adjuvants to obtain the national medicinal preparation in the form of granule for treating osteoporosis;
the auxiliary material is an adhesive; the adhesive is one or a combination of more of sucrose, lactose, starch, microcrystalline cellulose and dextrin.
Preferably, the national medicine preparation for treating osteoporosis is prepared by the extract powder and auxiliary materials together, and comprises the following steps:
taking the extract powder, adding 1-10 parts of cross-linked polyvinylpyrrolidone, 95% ethanol and 10-50 parts of auxiliary materials, mixing, and tabletting or encapsulating to obtain the national medicine preparation for treating osteoporosis in the form of tablets or capsules;
the auxiliary materials comprise one or more of lactose, starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, pregelatinized starch, silica gel, magnesium stearate and talcum powder.
Preferably, the national medicine preparation for treating osteoporosis is prepared by the extract powder and auxiliary materials together, and comprises the following components:
mixing the extract powder with 5-50 parts of auxiliary materials to obtain a powder formulation of the national medicine preparation for treating osteoporosis;
the auxiliary materials comprise: one or more of starch, microcrystalline cellulose, silica gel, magnesium stearate and talcum powder.
Preferably, the national medicine preparation for treating osteoporosis is prepared by the extract powder and auxiliary materials together, and comprises the following steps:
dissolving the extract powder in purified water, filtering, adding 10-70% of adjuvants, packaging, and sterilizing to obtain syrup for the preparation of national medicinal preparation for treating osteoporosis; the auxiliary material is a flavoring agent; the flavoring agent is one or more of sucrose, fructose, stevioside and sorbic acid;
or mixing the extract powder with 10-30 parts of auxiliary materials to obtain the national medicine preparation for treating osteoporosis in a pill form; the auxiliary materials are one or two of honey and polyethylene glycol;
or mixing the extract powder with 10-80% of honey, and performing subpackage sterilization to prepare the national medicine preparation for treating osteoporosis in the form of honey paste.
The invention provides a national medicine preparation for treating osteoporosis, which comprises the following components in parts by weight: 5-60 parts of fennel; 5-80 parts of pimpinella anisum fruit; 10-100 parts of fig; licorice root 10-80; 5-60 of adiantum; 5-60 parts of moldavica dragonhead; 10-100 parts of rose petals; 10-80 parts of raisin; and 5-300 of the chewing gum. The invention has the characteristics of compatibility of various components and small toxic and side effect based on Uygur medicine, takes the integral view as the guiding idea, passes the preventive treatment idea through the whole process of diseases, and has the advantages of outstanding prevention, health care and rehabilitation treatment characteristics, exact curative effect and little pain. The national medicinal preparation for treating osteoporosis has a definite curative effect on primary osteoporosis, and pharmacodynamic studies show that the national medicinal preparation can improve coordinated balance of bone absorption and bone formation and the state of bone biomechanical property disorder, effectively improve bone density, and also improve symptoms of soreness and weakness of waist and knees, aversion to cold, limb numbness, lusterless complexion, dull complexion, sticky mouth, white and greasy tongue fur and the like of a patient. Can avoid the inconvenience brought to patients caused by the easy deterioration of the traditional Chinese medicine decoction after long-term decoction before taking.
Drawings
FIG. 1 is a three-dimensional reconstruction diagram of Micro CT layer segments of right femoral neck segments of rats in each group;
FIG. 2 shows the comparison of bone density and bone morphometry parameters (A, bone density comparison; B, bone surface area volume comparison; C, percent bone volume D, trabecular number; E, trabecular pattern factor; F, trabecular resolution) for the left femur of each group of rats in this example;
FIG. 3 is a schematic diagram illustrating the detection result of the biomechanical index of the bone in the present embodiment;
FIG. 4 is a schematic diagram showing the results of the detection of HE staining of bone tissue in this example;
FIG. 5 shows the results of the measurement of bone metabolism index (anti-tartrate acid phosphatase content test) by ELISA in this example;
FIG. 6 shows the results of ELISA assay for bone metabolism index (osteocalcin content test) in this example.
The implementation, functional features and advantages of the objects of the present invention will be further explained with reference to the accompanying drawings.
Detailed Description
The technical solutions of the present invention will be described clearly and completely with reference to the following embodiments, and it should be understood that the described embodiments are some, but not all, embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Unless defined otherwise below, all technical and scientific terms used in the detailed description of the present invention are intended to have the same meaning as commonly understood by one of ordinary skill in the art. While the following terms are believed to be well understood by those skilled in the art, the following definitions are set forth to better explain the present invention.
As used herein, the terms "comprising," "including," "having," "containing," or "involving" are inclusive or open-ended and do not exclude additional unrecited elements or method steps. The term "consisting of 8230A" is considered to be a preferred embodiment of the term "comprising". If in the following a certain group is defined to comprise at least a certain number of embodiments, this should also be understood as disclosing a group which preferably only consists of these embodiments.
Where an indefinite or definite article is used when referring to a singular noun e.g. "a" or "an", "the", this includes a plural of that noun.
The term "about" in the present invention denotes an interval of accuracy that can be understood by a person skilled in the art, which still guarantees the technical effect of the feature in question. The term generally means ± 10%, preferably ± 5% of the indicated value.
Furthermore, the terms first, second, third, (a), (b), (c) and the like in the description and in the claims, are used for distinguishing between similar elements and not necessarily for describing a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other sequences than described or illustrated herein.
The following is provided merely to aid in understanding the invention. These definitions should not be construed to have a scope less than understood by those skilled in the art.
The technical solution of the present invention is further described in detail by way of the following specific embodiments, but the present invention is not limited thereto, and any limited number of modifications made by anyone within the scope of the claims of the present invention are still within the scope of the claims of the present invention.
The embodiment provides a national medicine preparation for treating osteoporosis, which comprises the following components in parts by weight:
5-60 parts of fennel; 5-80 parts of anise fruits; 10-100 parts of fig; 10-80 parts of licorice root; 5-60 parts of adiantum; 5-60 parts of moldavica dragonhead; 10-100 parts of rose petals; 10-80 parts of raisin; and 5-300 of the thorn sugar.
In the above, the compound preparation provided in this embodiment is one of the vitamins in national medicine, and the raw material medicines of the preparation include: fennel, anise fruit, licorice root, fig, adiantum, raisin, moldavica dragonhead, rose petals and acanthose.
The names and the drug properties of the raw material medicines are as follows:
(1) Fructus Foeniculi, which is a dried mature fruit of Foeniculum vulgare Mill of Umbelliferae, has effects of dispelling cold, relieving pain, regulating qi-flowing and regulating stomach.
(2) Pimpinella anisum fruit, which is a dried mature fruit of Pimpinella anisum L. of Plectranthus niveus of Umbelliferae, has effects of dissipating cold-qi, promoting natural body concoction, inducing diuresis, dredging channels, moistening intestine and relieving pain.
(3) The licorice root is the dried root and rhizome of Glycyrrhiza uralensis Fisch, glycyrrhiza inflata Bat or Glycyrrhiza glabra L of Leguminosae, and has the effects of invigorating spleen and replenishing qi, clearing away heat and toxic materials, eliminating phlegm and relieving cough, relieving spasm and pain, and harmonizing the effects of the drugs.
(4) The fig is a mature or nearly mature fruit of Tibetan flower and slim fruit of Ficus carica L.of Moraceae, and has effects of generating dampness and generating heat, regulating abnormal spleen fluid, strengthening body constitution, improving digestion, loosening bowel to relieve constipation, diminishing inflammation and relieving cough, relieving swelling and obstruction, promoting urination and dredging channels.
(5) Adiantum capillus-veneris is dry whole plant of Adiantum venustum don. Var. Venetum of Iridaceae, and has effects of maturing abnormal mucus, abnormal spleen fluid, eliminating inflammation, removing toxic substance, relieving cough, eliminating phlegm, inducing diuresis, dredging channels, and fixing hair.
(6) Raisin, which is a dry mature fruit of Vitis vinifera of Vitaceae, has effects of regulating abnormal spleen fluid, nourishing brain, tonifying heart, refreshing heart, relaxing bowels, nourishing liver, relieving swelling, strengthening body constitution, and tonifying yang.
(7) Dracocephalum moldavica L.of Labiatae has effects of benefiting heart, protecting brain, protecting liver, invigorating stomach, enhancing sensory ability, supplementing protective power, replenishing intelligence, and relieving brain occlusion.
(8) Flos Rosae Rugosae, which is dried bud of Rosa rugosa Thunb. Has effects in promoting qi circulation, relieving depression, regulating blood circulation, and relieving pain.
(9) The product is saccharine secretion of stem and branch of Alhagi pseudoalhagi (M.B.) Des of Leguminosae, and has effects of eliminating abnormal bile, and loosening bowel to relieve constipation. Defervesce and relieve cough, resolve phlegm and relieve cough, replenish essence and strengthen yang, and has the functions of fat body and body building.
It should be noted that, in modern medical research, due to the complex pathogenesis of osteoporosis and the unclear specific pathophysiological mechanism at present, no specific medicine with advantages and specificity to osteoporosis is reported. The existing treatment mainly uses the classical anti-osteoporosis drugs comprising calcium agents, active vitamin D and analogues thereof, bisphosphonates, teriparatide, disuzumab, abamectin and the like. Although a certain curative effect can be achieved, the side effect is large, and the long-term use is not suitable.
Therefore, how to provide an effective prevention and treatment scheme for osteoporosis and prevent malignant consequences is an important entry point in traditional Chinese medicine research including medical science.
The Uygur medicine has the characteristics of compatibility of various components and small toxic and side effect, takes the overall view as the guiding thought, runs the preventive treatment thought through the whole process of diseases, and has the advantages of prominent prevention, health care and rehabilitation treatment characteristics, definite curative effect and less pain. The prescription for eliminating dampness and strengthening bones has definite curative effect on preventing and treating primary osteoporosis, and pharmacodynamic studies show that the prescription not only improves the coordination and balance between bone absorption and bone formation, the state of bone biomechanical property disorder, effectively improves the bone density, but also improves the symptoms of soreness and weakness of waist and knees, aversion to cold, limb numbness, lusterless complexion, dullness, sticky mouth, white and greasy tongue fur and the like of patients. Can avoid the inconvenience brought to patients caused by the easy deterioration of the traditional Chinese medicine decoction after long-time decoction before taking.
The national medicine preparation for treating osteoporosis, which is provided by the prescription based on the Uighur medicine for eliminating dampness and strengthening bones, has the effects of regulating abnormal mucus and abnormal spleen fluid, eliminating dampness, dispelling cold, relieving pain, enhancing digestion and driving force, strengthening muscles and bones and the like, and is used for treating the osteoporosis of abnormal mucus type (damp-cold type) and/or abnormal spleen fluid type (dry-cold type) and the primary (postmenopausal) osteoporosis. The prescription has definite curative effect on preventing and treating the primary osteoporosis, and pharmacodynamic researches show that the prescription can improve coordinated balance of bone absorption and bone formation and the state of bone biomechanical property disorder, effectively improve bone density, and also improve symptoms of soreness and weakness of waist and knees, aversion to cold, limb numbness, lusterless complexion, dullness, sticky mouth, white and greasy tongue coating and the like of patients. Can avoid the inconvenience brought to patients caused by the easy deterioration of the traditional Chinese medicine decoction after long-term decoction before taking.
In addition, the embodiment also provides a preparation method of the national medicine preparation for treating osteoporosis, which comprises the following steps:
step S10, preparing an extract;
step S20, drying the extract in vacuum, crushing into powder, and sieving to obtain extract powder;
and step S30, preparing the extract powder and auxiliary materials together to obtain the national medicine preparation for treating osteoporosis.
Further, in step S10, preparing an extract includes:
step S11, weighing fennel, anise fruit, fig, licorice root, adiantum capillus-veneris, moldavica dragonhead, rose petals, raisin and acanthose according to the parts by weight of the components of the ethnic medicine preparation for treating osteoporosis, and mixing to obtain a target mixture;
step S12, extracting the target mixture to obtain an extracting solution; wherein the extraction solvent is water or 40% -80% ethanol;
and S13, concentrating the extracting solution at 60-70 ℃ to obtain the extract with the relative density of 1.05-1.40.
Further, in step S12, two cases are included:
(1) In the first case, when the extraction solvent is water, the method for extracting the target mixture comprises:
step S121, soaking the target mixture with 5-12 times of water for 12 hours; in the present embodiment, water may be preferably in an amount of 10 times;
step S122, carrying out first decoction for 1.5 hours, and filtering to obtain first filtrate;
step S123, adding 4-8 times of water into filter residues, carrying out second decoction for 1 hour, and filtering to obtain a second filtrate; preferably, the amount of water is 8 times that of the total amount of the water;
step S124, adding 4-8 times of water into the filter residue, carrying out third decoction for 1 hour, and filtering to obtain third filtrate; preferably, the amount of water is 8 times that of the total amount of the water;
and step S125, combining the first filtrate, the second filtrate and the third filtrate to obtain the extracting solution.
(2) In the second case: when the extraction solvent is 40% -80% ethanol, the extraction method of the target mixture comprises the following steps:
step S126, soaking the target mixture for 12 hours by using 40-80% ethanol in an amount which is 5-12 times that of the target mixture; preferably, it may be 10 times 60% ethanol;
step S127, carrying out first reflux extraction for 1.5 hours, and filtering to obtain first filtrate;
step S128, adding 4-8 times of 40% -80% ethanol into the filter residue, performing secondary reflux extraction for 1.5 hours, and filtering to obtain secondary filtrate;
and S129, combining the first filtrate and the second filtrate to obtain the extracting solution.
Further, in step S30, the preparation process is divided into different preparation processes for the following dosage forms, and the preparation method is as follows:
(1) For oral liquid dosage forms:
in the step S30, the national medicine preparation for treating osteoporosis is prepared by mixing the extract powder and auxiliary materials, and comprises:
mixing the extract powder with purified water and 1-20% of adjuvants; wherein the auxiliary material is a flavoring agent; the flavoring agent comprises one or more of sucrose, fructose, stevioside and sorbic acid;
filtering with a plate-and-frame filter to obtain a drug filtrate;
subpackaging and sterilizing the drug filtrate to obtain the national drug preparation for treating osteoporosis in an oral liquid dosage form.
(2) For the granule formulation:
in the step S30, the national medicine preparation for treating osteoporosis is prepared by mixing the extract powder and auxiliary materials, and comprises:
mixing the extract powder with 95% ethanol or water and 10-70 parts of adjuvants to obtain the national medicinal preparation in the form of granule for treating osteoporosis;
the auxiliary material is an adhesive; the adhesive is one or a combination of more of sucrose, lactose, starch, microcrystalline cellulose and dextrin.
(3) For tablet or capsule dosage forms:
in the step S30, the national medicine preparation for treating osteoporosis is prepared by mixing the extract powder and auxiliary materials, and comprises:
taking the extract powder, adding 1-10 parts of cross-linked polyvinylpyrrolidone, 95% ethanol and 10-50 parts of auxiliary materials, mixing, and tabletting or encapsulating to obtain the national medicine preparation for treating osteoporosis in the form of tablets or capsules;
the auxiliary materials comprise one or more of lactose, starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, pregelatinized starch, silica gel, magnesium stearate and talcum powder.
(4) For powder formulations:
in the step S30, the national medicine preparation for treating osteoporosis is prepared by mixing the extract powder and auxiliary materials, and comprises:
mixing the extract powder with 5-50 parts of auxiliary materials to obtain a powder formulation of the national medicine preparation for treating osteoporosis;
the auxiliary materials comprise: one or more of starch, microcrystalline cellulose, silica gel, magnesium stearate and pulvis Talci.
(5) For syrup dosage forms:
in the step S30, the national medicine preparation for treating osteoporosis is prepared by mixing the extract powder and auxiliary materials, and comprises:
dissolving the extract powder in purified water, filtering, adding 10-70% of adjuvants, packaging, and sterilizing to obtain syrup for the preparation of national medicinal preparation for treating osteoporosis; the auxiliary material is a flavoring agent; the flavoring agent is one or more of sucrose, fructose, stevioside and sorbic acid;
(6) For pill dosage forms:
in the step S30, the national medicine preparation for treating osteoporosis is prepared by mixing the extract powder and auxiliary materials, and comprises:
mixing the extract powder with 10-30 parts of auxiliary materials to obtain the national medicine preparation for treating osteoporosis in the form of pills; the auxiliary materials are one or two of honey and polyethylene glycol;
(6) For the honey paste formulation:
in the step S30, the national medicine preparation for treating osteoporosis is prepared by mixing the extract powder and auxiliary materials, and comprises:
mixing the extract powder with 10-80% of honey, subpackaging and sterilizing to obtain the national medicinal preparation for treating osteoporosis in the form of honey paste.
The invention is further illustrated by the following specific examples, but it should be understood that these examples are included merely for purposes of illustration in more detail and are not intended to limit the invention in any way.
Example (b):
1. experimental animals and groups:
selecting 70 SPF-grade unmated SD female rats with age of 4 months and weight of 240 +/-10 g, stably breeding for 3 days, and completely randomly dividing into:
(1) A normal control group,
(2) OVX model set (bilateral ovariectomy),
(3) The vitamin group (i.e. the national medicine preparation for treating osteoporosis in the application): a low dose drug group, a medium dose drug group, a high dose drug group;
(4) Positive control group (bujiale);
10 in each group; animal license number: SCXK (New) -2018-0002.
2. And (3) medicine dosage formulation:
the experiment is used for the damp-clearing bone-strengthening formula granules.
Dose scaling was performed according to the drug tolerance of different animal strains.
This experiment was applied to rats, and the equivalent dose was 6.3 times that of humans, which was regarded as a medium dose, 2 times that of the medium dose being a large dose, and 1/2 that of the small dose.
Treatment groups started on day 4 of the molding as 1 mL/gavage for 8 weeks.
3. Animal feeding:
feeding conditions are as follows: the rats of each group were housed. The temperature is 23 +/-2 ℃, and the humidity is 55-65%. The environment is clean, the ventilation is carried out, and the light and shade period is 12 hours.
The rats in each group were fed with standard feed and were fed with free diet.
4. Preparation of OVX model:
(1) Performing bilateral ovariectomy on OVX model group rats by using an animal model modeling method for inducing osteoporosis through menopause, performing intraperitoneal injection anesthesia by using 2% pentobarbital sodium solution according to the dose of (0.5 mL/100 g), taking off a median incision of an abdomen, entering the abdominal cavity layer by layer through fascia, a muscle layer and peritoneum, performing blunt separation, lifting the ovaries of the rats along the direction of one side oviduct, clamping and ligating after separation, cutting off the ovaries, and cutting off partial adipose tissues around the ovaries by a sham operation group.
(2) After operation, the rats are raised in cages. The feed is taken freely and water is taken in a common feeding environment, and the feed is fed for 7 days in a standard way.
(3) The rats are sacrificed 8 weeks after the model building, the femurs are taken to carry out Micro-CT scanning, the bone mass change condition is evaluated, and blood samples are taken to detect the bone metabolism indexes. The hypothalamus, pituitary, kidney and tibia were removed and HE stained for histopathological changes.
5. The experimental results are as follows:
the results show that the vitamin-drug combination in the results is the national drug preparation for treating osteoporosis in the application for experiments.
(1) Compared with a normal control group and a pseudo-operation group, the bone density, the bone morphometry index bone volume, the bone percentage, the bone surface area, the bone surface density and the number of trabeculae of the OVX model group are obviously reduced, and the bone surface area volume ratio, the intersection point area, the trabecular bone pattern factor, the structural model index and the trabecular bone separation degree are increased (P is less than 0.01); the rats in the low, medium and high dose groups of the treatment group all have the increased bone density, compared with the model group, the bone density, the percent of bone volume, the bone surface area, the bone surface density and the number of trabeculae in the prescription high dose group are obviously improved, the bone surface area volume ratio and the structural model index bone trabecular division are obviously reduced (P is less than 0.01), compared with a positive control group, the bone density and the bone morphometry parameters have no statistical significance (P is more than 0.05), and the results show that: the formula for eliminating dampness and strengthening bones can reduce high-level bone resorption and bone formation caused by ovariectomy, and restore the balance state that the bone formation is greater than the bone resorption, thereby causing the increase of bone mass (such as fig. 1 and fig. 2).
(2) The results of bone biomechanical index detection show that the ultimate load, rigidity, elastic modulus, fracture energy and ultimate stress of the model group are all reduced (P is less than 0.01) compared with those of a normal control group and a false operation group. Compared with the model group, the Wei-Yao damp clearing and bone strengthening formula has the advantages that the limit load, the rigidity, the elastic modulus and the limit stress of the medium-dose group and the high-dose group are improved (P is less than 0.01), and the fracture energy high-dose group is improved (P is less than 0.05). Compared with a positive control group, the difference has no statistical significance (P is less than 0.05), and the prescription for eliminating dampness and strengthening bones with the vitamin medicine can improve the bone strength by improving the biomechanical function of bones (as shown in figure 3);
(3) The results of HE staining detection of bone tissues are consistent with the results of Micro CT and bone biomechanical detection (as shown in figure 4), which indicates that the prescription of the vitamin medicine for eliminating dampness and strengthening bone has the prevention and treatment effect on osteoporosis of rats.
(4) The results of ELISA detection on bone metabolism indexes show that the prescription for eliminating dampness and strengthening bones effectively reduces the level (P is less than 0.05) of tartrate-resistant acid phosphatase (TRACP-5 b) and Osteocalcin (OC), improves the level (P is less than 0.05) of Osteoprotegerin (OPG) (as shown in figures 5 and 6), and shows that the prescription for eliminating dampness and strengthening bones can inhibit bone resorption, promote bone formation function and restore the coordination and balance between bone resorption and bone formation.
While the preferred embodiment and corresponding examples of the present invention have been described, it is noted that it will be apparent to those skilled in the art that variations and modifications, including but not limited to, adjustments of proportions, flow paths, amounts and reaction vessels, such as in a continuous flow reactor, may be made without departing from the inventive concept herein, and are within the scope of the invention.
Claims (10)
1. The national medicine preparation for treating osteoporosis is characterized by comprising the following components in parts by weight:
5-60 parts of fennel; 5-80 parts of pimpinella anisum fruit; 10-100 parts of fig; 10-80 parts of licorice root; 5-60 parts of adiantum; 5-60 parts of moldavica dragonhead; 10-100 parts of rose petals; 10-80 parts of raisin; and 5-300 of the thorn sugar.
2. A method for preparing the ethnic pharmaceutical formulation for treating osteoporosis of claim 1, comprising:
preparing an extract;
vacuum drying the extract, pulverizing into powder, and sieving to obtain extract powder;
and (3) preparing the national medicine preparation for treating osteoporosis together with auxiliary materials.
3. The method for preparing the national medicine preparation for treating osteoporosis as claimed in claim 2, wherein the preparing the extract comprises:
the national medicine preparation for treating osteoporosis of claim 1, wherein fennel, anise fruit, fig, licorice root, adiantum capillus-veneris, moldavica dragonhead, rose petals, raisin and acanthose are weighed according to the parts by weight of each component, and are mixed to obtain a target mixture;
extracting the target mixture to obtain an extracting solution; wherein the extraction solvent is water or 40% -80% ethanol;
concentrating the extracting solution at 60-70 deg.C to obtain the extract with relative density of 1.05-1.40.
4. The method for preparing the national pharmaceutical preparation for the treatment of osteoporosis of claim 3, wherein the extraction method of the objective mixture comprises, when the extraction solvent is water:
soaking the target mixture with 5-12 times of water for 12 hours;
decocting for 1.5 hr, and filtering to obtain first filtrate;
adding 4-8 times of water into the filter residue, decocting for 1 hour for the second time, and filtering to obtain a second filtrate;
adding 4-8 times of water into the filter residue, decocting for 1 hour for the third time, and filtering to obtain the third filtrate;
and combining the first filtrate, the second filtrate and the third filtrate to obtain the extracting solution.
5. The method for preparing the national pharmaceutical preparation for the treatment of osteoporosis of claim 3, wherein the extraction method of the objective mixture comprises, when the extraction solvent is 40% -80% ethanol:
soaking the target mixture in 5-12 times of 40-80% ethanol for 12 hours;
carrying out first reflux extraction for 1.5 hours, and filtering to obtain first filtrate;
adding 40-80% ethanol in an amount which is 4-8 times that of the filter residue, performing secondary reflux extraction for 1.5 hours, and filtering to obtain secondary filtrate;
and combining the first filtrate and the second filtrate to obtain the extracting solution.
6. The method for preparing the national medicinal preparation for treating the osteoporosis as claimed in claim 2, wherein the preparing the extract powder and the auxiliary materials together to obtain the national medicinal preparation for treating the osteoporosis comprises:
mixing the extract powder with purified water and 1-20% of adjuvants; wherein the auxiliary material is a flavoring agent; the flavoring agent comprises one or more of sucrose, fructose, stevioside and sorbic acid;
filtering with a plate-and-frame filter to obtain a drug filtrate;
subpackaging and sterilizing the medicine filtrate to obtain the national medicine preparation for treating osteoporosis in an oral liquid dosage form.
7. The method for preparing the ethnic medicine preparation for treating osteoporosis of claim 2, wherein the preparation of the ethnic medicine preparation for treating osteoporosis by the extract powder and the auxiliary materials comprises:
mixing the extract powder with 95% ethanol or water and 10-70 parts of adjuvants to obtain the national medicinal preparation in the form of granule for treating osteoporosis;
the auxiliary material is an adhesive; the adhesive is one or a combination of more of sucrose, lactose, starch, microcrystalline cellulose and dextrin.
8. The method for preparing the ethnic medicine preparation for treating osteoporosis of claim 2, wherein the preparation of the ethnic medicine preparation for treating osteoporosis by the extract powder and the auxiliary materials comprises:
taking the extract powder, adding 1-10 parts of cross-linked polyvinylpyrrolidone, 95% ethanol and 10-50 parts of auxiliary materials, mixing, and tabletting or encapsulating to obtain the national medicine preparation for treating osteoporosis in the form of tablets or capsules;
the adjuvants comprise one or more of lactose, starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, pregelatinized starch, silica gel, magnesium stearate, and pulvis Talci.
9. The method for preparing the ethnic medicine preparation for treating osteoporosis of claim 2, wherein the preparation of the ethnic medicine preparation for treating osteoporosis by the extract powder and the auxiliary materials comprises:
taking the extract powder, adding 5-50 parts of auxiliary materials, and mixing to obtain a powder formulation of the national medicine preparation for treating osteoporosis;
the auxiliary materials comprise: one or more of starch, microcrystalline cellulose, silica gel, magnesium stearate and talcum powder.
10. The method for preparing the national medicinal preparation for treating the osteoporosis as claimed in claim 2, wherein the preparing the extract powder and the auxiliary materials together to obtain the national medicinal preparation for treating the osteoporosis comprises:
dissolving the extract powder in purified water, filtering, adding 10-70% of adjuvants, packaging, and sterilizing to obtain syrup for the preparation of national medicinal preparation for treating osteoporosis; the auxiliary material is a flavoring agent; the flavoring agent is one or more of sucrose, fructose, stevioside and sorbic acid;
or mixing the extract powder with 10-30 parts of auxiliary materials to obtain the national medicine preparation for treating osteoporosis in the form of pills; the auxiliary materials are one or two of honey and polyethylene glycol;
or mixing the extract powder with 10-80% of honey, and performing subpackage sterilization to prepare the national medicine preparation for treating osteoporosis in the form of honey paste.
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Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2003095971A (en) * | 2001-09-27 | 2003-04-03 | National Institute Of Health & Nutrition | Therapeutic agent or composition for osteoporosis |
| WO2004089389A1 (en) * | 2003-04-11 | 2004-10-21 | Nuliv Biomedicine Inc. | Pharmaceutical composition for prevention and treatment of osteoporosis and its preparation |
| CN104306959A (en) * | 2014-10-16 | 2015-01-28 | 河北御芝林生物科技有限公司 | Medicine composition for treating osteoporosis and preparation method thereof |
| KR20170055354A (en) * | 2015-11-11 | 2017-05-19 | 대한민국(농촌진흥청장) | Pharmaceutical composition for preventing or treating osteoporosis comprising panax ginseng extracts, paeonia lactiflora extracts, glycyrrhiza uralensis extracts and chitosan |
| CN107184657A (en) * | 2016-03-15 | 2017-09-22 | 上海中医药大学附属龙华医院 | It is a kind of to treat compound Chinese medicinal preparation of primary osteoporosis and preparation method thereof |
| CN108272917A (en) * | 2018-03-29 | 2018-07-13 | 新疆医科大学 | A kind of Uygur medicine composition and preparation method thereof for treating failure of memory |
| CN109602817A (en) * | 2019-02-27 | 2019-04-12 | 兰州大学 | A kind for the treatment of is reduced the Chinese medicine composition of caused osteoporosis by estrogen |
-
2022
- 2022-11-24 CN CN202211481757.8A patent/CN115737729B/en active Active
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2003095971A (en) * | 2001-09-27 | 2003-04-03 | National Institute Of Health & Nutrition | Therapeutic agent or composition for osteoporosis |
| WO2004089389A1 (en) * | 2003-04-11 | 2004-10-21 | Nuliv Biomedicine Inc. | Pharmaceutical composition for prevention and treatment of osteoporosis and its preparation |
| CN104306959A (en) * | 2014-10-16 | 2015-01-28 | 河北御芝林生物科技有限公司 | Medicine composition for treating osteoporosis and preparation method thereof |
| KR20170055354A (en) * | 2015-11-11 | 2017-05-19 | 대한민국(농촌진흥청장) | Pharmaceutical composition for preventing or treating osteoporosis comprising panax ginseng extracts, paeonia lactiflora extracts, glycyrrhiza uralensis extracts and chitosan |
| CN107184657A (en) * | 2016-03-15 | 2017-09-22 | 上海中医药大学附属龙华医院 | It is a kind of to treat compound Chinese medicinal preparation of primary osteoporosis and preparation method thereof |
| CN108272917A (en) * | 2018-03-29 | 2018-07-13 | 新疆医科大学 | A kind of Uygur medicine composition and preparation method thereof for treating failure of memory |
| CN109602817A (en) * | 2019-02-27 | 2019-04-12 | 兰州大学 | A kind for the treatment of is reduced the Chinese medicine composition of caused osteoporosis by estrogen |
Non-Patent Citations (1)
| Title |
|---|
| 古丽娜孜•肉孜等: "湿寒应激对绝经大鼠骨生物力学及尿骨代谢指标的影响", 《医学研究杂志》, pages 41 - 45 * |
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| CN115737729B (en) | 2023-11-03 |
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