CN115737729B - Ethnic medicine preparation for treating osteoporosis and preparation method thereof - Google Patents
Ethnic medicine preparation for treating osteoporosis and preparation method thereof Download PDFInfo
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- CN115737729B CN115737729B CN202211481757.8A CN202211481757A CN115737729B CN 115737729 B CN115737729 B CN 115737729B CN 202211481757 A CN202211481757 A CN 202211481757A CN 115737729 B CN115737729 B CN 115737729B
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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
Landscapes
- Medicines Containing Plant Substances (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The application provides an ethnic medicine preparation for treating osteoporosis and a preparation method thereof, belonging to the technical field of ethnic medicine and pharmaceutical 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 figs; 10-80 parts of licorice root; 5-60 parts of fern; 5-60 parts of moldavica dragonhead; 10-100 parts of rose petals; 10-80% of raisins; 5-300 parts of spinose. The ethnic medicine preparation for treating osteoporosis provided by the application has definite curative effect on preventing and treating primary osteoporosis, and pharmacodynamics researches show that the ethnic medicine preparation can improve the bone resorption and bone formation coordination balance and bone biomechanical property disorder state, effectively improve bone density, and improve the symptoms of soreness and weakness of waist and knees, aversion to cold, numbness of limbs, lusterless complexion, white and greasy tongue fur and the like of patients.
Description
Technical Field
The application belongs to the technical field of national medicines and pharmaceutical preparations, and in particular relates to a national medicine preparation for treating osteoporosis and a preparation method thereof.
Background
Osteoporosis (OP) is a systemic skeletal disease characterized by reduced bone mass, degraded bone microstructure, increased bone fragility, and susceptibility to fracture, and is a major concern in terms of morbidity, mortality, and health care costs. It is currently estimated that about 2 million osteoporosis patients worldwide, by 2050, the aged population over 65 years worldwide will increase from 3.23 to 15 billion. Thus, osteoporosis has become a worldwide problem. Osteoporosis is common in postmenopausal women, and the world health organization reports that the incidence of osteoporosis has risen to 6 th site, which is a hazard to female health, and about 30% of postmenopausal women have osteoporosis, and osteoporosis fracture is one of the main causes of disability and death in middle-aged and elderly women.
Currently, bone formation promoters (calcium, vitamin D, parathyroid hormone, statins, etc.), bone resorption inhibitors (estrogen and its receptor modulators, bisphosphates, calcitonin, etc.), and exercise therapies, as well as other adjuvant therapies, are mostly used in the treatment of osteoporosis. Although patients can obtain a certain curative effect during treatment, the existing medicines have large side effects and are not suitable for long-term use. No report on the medicine with the advantage and specificity to OP is available.
Disclosure of Invention
In order to solve the problems, the application 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 figs; 10-80 parts of licorice root; 5-60 parts of fern; 5-60 parts of moldavica dragonhead; 10-100 parts of rose petals; 10-80% of raisins; 5-300 parts of spinose.
In addition, in order to solve the above problems, the present application also provides a method for preparing an ethnic medicine preparation for treating osteoporosis, comprising:
preparing an extract;
vacuum drying the extract, pulverizing into powder, and sieving to obtain extract powder;
the extract powder and auxiliary materials are prepared together to obtain the ethnic medicine preparation for treating osteoporosis.
Preferably, the preparing extract comprises:
weighing the components of the ethnic medicine preparation for treating osteoporosis in parts by weight, namely fennel, pimpinella anisum, fig, licorice root, fern, moldavica dragonhead, rose petals, raisin and thorn, and mixing 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 extractive solution at 60-70deg.C to obtain extract with relative density of 1.05-1.40.
Preferably, when the extraction solvent is water, the extraction method of the target mixture includes:
soaking the target mixture with 5-12 times of water for 12 hours;
performing primary decoction for 1.5 hours, and filtering to obtain primary filtrate;
adding 4-10 times of water into the filter residue, decocting for 1 hr for the second time, and filtering to obtain the second filtrate;
adding 4-8 times of water into the filter residue, performing third decoction for 1 hr, and filtering to obtain 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 the following steps:
soaking the target mixture in 5-12 times of 40% -80% ethanol for 12 hours;
extracting under reflux for 1.5 hr, filtering to obtain first filtrate;
adding 40% -80% ethanol into the filter residue in an amount which is 4-10 times of the filter residue, carrying out secondary reflux extraction for 1.5 hours, and filtering to obtain a secondary filtrate;
and combining the first filtrate and the second filtrate to obtain the extracting solution.
Preferably, the preparation method of the ethnic medicine preparation for treating osteoporosis by jointly preparing the extract powder and auxiliary materials comprises the following steps:
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 by using a plate-frame filter to obtain medicinal filtrate;
and subpackaging and sterilizing the medicine filtrate to obtain the ethnic medicine preparation in the form of oral liquid for treating osteoporosis.
Preferably, the preparation method of the ethnic medicine preparation for treating osteoporosis by jointly preparing the extract powder and auxiliary materials comprises the following steps:
mixing the extract powder with 95% ethanol or water and 10-70 parts of adjuvants to obtain granule preparation 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 preparation method of the ethnic medicine preparation for treating osteoporosis by jointly preparing the extract powder and auxiliary materials comprises the following steps:
mixing the extract powder with 1-10 parts of cross-linked polyvinylpyrrolidone, 95% ethanol and 10-50 parts of auxiliary materials, tabletting or encapsulating to obtain the ethnic medicine preparation for treating osteoporosis in the form of tablet or capsule;
the auxiliary materials comprise lactose, starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, pregelatinized starch, differential silica gel, magnesium stearate and talcum powder.
Preferably, the preparation method of the ethnic medicine preparation for treating osteoporosis by jointly preparing the extract powder and auxiliary materials comprises the following steps:
mixing the extract powder with 5-50 parts of auxiliary materials to obtain a powder preparation of the ethnic medicine for treating osteoporosis;
the auxiliary materials comprise: starch, microcrystalline cellulose, differential silica gel, magnesium stearate and talcum powder.
Preferably, the preparation method of the ethnic medicine preparation for treating osteoporosis by jointly preparing the extract powder and auxiliary materials comprises the following steps:
dissolving the extract powder in purified water, filtering, adding 10-70% of auxiliary materials, and preparing the syrup preparation for treating osteoporosis by split charging and sterilization; the auxiliary materials are flavoring agents; the flavoring agent is one or a combination of 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 in the form of pill for treating osteoporosis; the auxiliary material is one or two of honey and polyethylene glycol;
or mixing the extract powder with 10-80% of honey, packaging, and sterilizing to obtain honeyed unguent.
The application 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 figs; 10-80 parts of licorice root; 5-60 parts of fern; 5-60 parts of moldavica dragonhead; 10-100 parts of rose petals; 10-80% of raisins; 5-300 parts of spinose. The application is based on the characteristics of compatibility of various components and small toxic and side effects of Uygur medicine, takes the whole view as a guiding idea, and has outstanding characteristics of prevention, health care and rehabilitation treatment, definite curative effect and less pain by penetrating the idea of treating the disease through the whole process of the disease. The ethnic medicine preparation for treating osteoporosis provided by the application has definite curative effect on preventing and treating primary osteoporosis, and pharmacodynamics researches show that the ethnic medicine preparation can improve the coordination and balance of bone absorption and bone formation, and the bone biomechanical property disorder state, effectively improve bone density and improve the symptoms of cold aversion, lusterless complexion, dullness, sticky mouth, white and greasy tongue fur and the like of patients. Can avoid temporary decoction before taking the traditional Chinese medicine decoction, and the traditional Chinese medicine decoction is easy to mildew, spoil and bring inconvenience to patients after long-term placement.
Drawings
FIG. 1 is a graph of a three-dimensional reconstruction of the Micro CT layer segments of the right femoral neck segment of each group of rats in this example;
FIG. 2 is a graph showing the comparison of bone morphology parameters (A, bone density; B, bone surface area volume; C, bone volume percentage D; bone trabecular number; E, bone trabecular model factor; F, bone trabecular separation) of the left femur bone density and bone morphology parameters of each group of rats in this example;
FIG. 3 is a diagram showing the results of the bone biomechanical index detection in the present embodiment;
FIG. 4 is a graph showing the results of HE staining of bone tissue according to the present embodiment;
FIG. 5 is a result of ELISA for detecting bone metabolism index (test result of tartrate-resistant acid phosphatase content) in the present example;
FIG. 6 shows the results of ELISA for detecting bone metabolism index (osteocalcin content test result) in this example.
The achievement of the objects, functional features and advantages of the present application will be further described with reference to the accompanying drawings, in conjunction with the embodiments.
Detailed Description
The technical solutions of the present application will be clearly and completely described in connection with the embodiments, and it is apparent that the described embodiments are some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.
Unless defined otherwise hereinafter, all technical and scientific terms used in the detailed description of the application are intended to be identical to what is 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 application.
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 …" is considered to be a preferred embodiment of the term "comprising". If a certain group is defined below to contain at least a certain number of embodiments, this should also be understood to disclose a group that preferably consists of only these embodiments.
The indefinite or definite article "a" or "an" when used in reference to a singular noun includes a plural of that noun.
The term "about" in the present application means a range of accuracy that one skilled in the art can understand while still guaranteeing the technical effect of the features in question. The term generally means a deviation of + -10%, preferably + -5%, from 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 application described herein are capable of operation in other sequences than described or illustrated herein.
The following is provided merely to aid in the understanding of the present application. 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 application is further described in detail below with reference to specific embodiments, but the present application is not limited thereto, and any modifications made by anyone within the scope of the claims of the present application are still within the scope of the claims of the present application.
The embodiment 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 figs; 10-80 parts of licorice root; 5-60 parts of fern; 5-60 parts of moldavica dragonhead; 10-100 parts of rose petals; 10-80% of raisins; 5-300 parts of spinose.
The compound preparation provided in this embodiment is one of the vitamin drugs in the national medicine, and the raw materials of the preparation include: fennel, pimpinella, licorice root, fig, fern, raisin, moldavica dragonhead, rose petals and thorn candy.
The names and the drug properties of the raw materials are as follows:
(1) Fennel is a dry mature fruit of Foeniculum vulgare Foeniculum vulgare Mill belonging to the family Umbelliferae, and has effects of dispelling cold, relieving pain, regulating qi-flowing and regulating stomach.
(2) The pimpinella anisum fruit is a dry mature fruit of pimpinella anisum L. Of Umbelliferae, and has effects of dispelling cold, promoting natural follow-up of organism, promoting urination, dredging channels, moisturizing intestine and relieving pain.
(3) The licorice root, the dried root and rhizome of Glycyrrhiza Glycyrrhiza uralensis Fisch. Glycyrrhiza glabra Glycyrrhiza inflata Bat. Or Glycyrrhiza glabra Glycyrrhiza glabra L. Has effects of invigorating spleen, replenishing qi, clearing away heat and toxic materials, eliminating phlegm, relieving cough, relieving pain, and harmonizing the above medicines.
(4) The fructus fici is mature or near mature fructus fici Ficus carial of Moraceae, and has effects of generating damp heat, regulating abnormal spleen fluid quality, strengthening body constitution, improving digestion, loosening bowel to relieve constipation, relieving inflammation and cough, relieving swelling, dredging resistance, promoting urination, and dredging channels.
(5) The product is dried whole herb of Adiantum venosum Don. Var. Venosum of Adiantum of family , and has effects of relieving inflammation, removing toxic substances, relieving cough, eliminating phlegm, promoting urination, dredging channels, and fixing hair.
(6) Raisins are dry mature fruits of grape, which are plants of the family Vitaceae, and have the effects of regulating abnormal spleen fluid quality, tonifying brain and heart, refreshing heart and improving mind, relaxing bowels, nourishing liver and detumescence, and strengthening yang.
(7) The product is dry aerial part of herba Dracocephali Dracocephalum moldavica L of Labiatae, and has effects in tonifying heart, protecting brain, protecting liver, invigorating stomach, enhancing sensory power, supplementing protective power, improving intelligence, and activating brain occlusion.
(8) The flos Rosae Rugosae is dry bud of Rosa rugosa Thunb. Has effects in promoting qi circulation, resolving stagnation, regulating blood, and relieving pain.
(9) The product is a sugar secretion of Des. Stem and branch of Alhagi sparsifolia Alhagi pseudoalhagi (M.B.) belonging to Leguminosae, and has effects in removing abnormal bile, loosening bowel, and relieving constipation. Has effects of relieving fever and cough, eliminating phlegm and relieving cough, replenishing essence and strengthening yang, and strengthening body constitution.
In modern medical research, the pathogenesis of osteoporosis is complex, and the specific pathophysiological mechanism is currently unknown, so that no specific medicine with advantages on osteoporosis is reported. The existing treatment mainly uses classical anti-osteoporosis drugs including calcium agents, active vitamin D and analogues thereof, bisphosphonates, teriparatide, deshu monoclonal antibody, abamectin and the like. Although a certain curative effect can be obtained, the traditional Chinese medicine composition has large side effects and is not suitable for long-term use.
Therefore, how to provide an effective prevention and treatment scheme for osteoporosis and prevent malignant consequences is an important point of entry in the research of traditional Chinese medicine, including vitamin.
The Uighur medicine has the characteristics of compatibility of various components and small toxic and side effects, takes the whole view as a guiding idea, and has outstanding characteristics of prevention, health care and rehabilitation treatment, definite curative effect and less pain by penetrating the idea of treating the disease through the whole process of the disease. The traditional Chinese medicine composition has definite curative effect of eliminating dampness and strengthening bones, and has the advantages of improving the symptoms of soreness and weakness of waist and knees, aversion to cold, numbness of limbs, lusterless complexion, darkness, sticky mouth, white and greasy tongue fur and the like of patients besides improving the bone absorption and bone formation coordination balance and bone biomechanical property disorder state through pharmacodynamics study. Can avoid temporary decoction before taking the traditional Chinese medicine decoction, and the traditional Chinese medicine decoction is easy to mildew, spoil and bring inconvenience to patients after long-term placement.
The ethnic medicine preparation for treating osteoporosis provided by the application based on the vitamin dampness eliminating and bone strengthening prescription has the effects of regulating abnormal mucinous quality and abnormal spleen fluid quality, eliminating dampness, dispelling cold, relieving pain, enhancing digestion, strengthening muscles and bones and the like, and is used for treating abnormal mucinous (wet cold type) and/or abnormal spleen fluid type (dry cold type) osteoporosis and primary (postmenopausal) osteoporosis. The prescription has definite curative effect for preventing and treating primary osteoporosis, and pharmacodynamic researches show that the prescription can improve the coordination and balance of bone absorption and bone formation and the disorder state of bone biomechanical property, effectively improve bone density and also improve the symptoms of soreness and weakness of waist and knees, aversion to cold, numbness of limbs, lusterless complexion, sticky mouth, white and greasy tongue fur and the like of patients. Can avoid temporary decoction before taking the traditional Chinese medicine decoction, and the traditional Chinese medicine decoction is easy to mildew, spoil and bring inconvenience to patients after long-term placement.
In addition, the embodiment also provides a preparation method of the ethnic medicine preparation for treating osteoporosis, which comprises the following steps:
step S10, preparing extractum;
step S20, vacuum drying the extract, crushing the extract into powder, and sieving the powder to obtain extract powder;
and step S30, preparing the extract powder and auxiliary materials together to obtain the ethnic medicine preparation for treating osteoporosis.
Further, in the step S10, the preparation of the extract includes:
step S11, weighing fennel, pimpinella anisum, figs, licorice roots, iron wire fern, moldavica dragonhead, rose petals, raisins and thorn sugar according to the weight parts 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 step S13, concentrating the extracting solution at 60-70 ℃ to obtain the extractum 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 extraction method of the target mixture includes:
step S121, soaking the target mixture with 5-12 times of water for 12 hours; in this embodiment, 10 times the amount of water may be preferable;
step S122, performing primary decoction for 1.5 hours, and filtering to obtain primary filtrate;
step S123, adding 4-8 times of water into filter residues, performing second decoction for 1 hour, and filtering to obtain second filtrate; preferably, it may be 8 times the amount of water;
step S124, adding 4-8 times of water into filter residues, performing third decoction for 1 hour, and filtering to obtain third filtrate; preferably, it may be 8 times the amount of water;
and step S125, combining the first filtrate, the second filtrate and the third filtrate to obtain the extracting solution.
(2) 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 5-12 times of 40% -80% ethanol; preferably, it may be 10 times 60% ethanol;
step S127, performing first reflux extraction for 1.5 hours, and filtering to obtain first filtrate;
step S128, adding 4-8 times of 40% -80% ethanol into filter residues, performing secondary reflux extraction for 1.5 hours, and filtering to obtain secondary filtrate;
and step S129, combining the first filtrate and the second filtrate to obtain the extracting solution.
Further, in the step S30, the preparation method is divided into different preparation processes for the following dosage forms, and the preparation method is as follows:
(1) For oral liquid dosage forms:
step S30, preparing the extract powder and auxiliary materials together to obtain the ethnic medicine preparation for treating osteoporosis, wherein the ethnic medicine preparation 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 by using a plate-frame filter to obtain medicinal filtrate;
and subpackaging and sterilizing the medicine filtrate to obtain the ethnic medicine preparation in the form of oral liquid for treating osteoporosis.
(2) For the granule formulation:
step S30, preparing the extract powder and auxiliary materials together to obtain the ethnic medicine preparation for treating osteoporosis, wherein the ethnic medicine preparation comprises the following components:
mixing the extract powder with 95% ethanol or water and 10-70 parts of adjuvants to obtain granule preparation 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:
step S30, preparing the extract powder and auxiliary materials together to obtain the ethnic medicine preparation for treating osteoporosis, wherein the ethnic medicine preparation comprises the following components:
mixing the extract powder with 1-10 parts of cross-linked polyvinylpyrrolidone, 95% ethanol and 10-50 parts of auxiliary materials, tabletting or encapsulating to obtain the ethnic medicine preparation for treating osteoporosis in the form of tablet or capsule;
the auxiliary materials comprise lactose, starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, pregelatinized starch, differential silica gel, magnesium stearate and talcum powder.
(4) For powder dosage forms:
step S30, preparing the extract powder and auxiliary materials together to obtain the ethnic medicine preparation for treating osteoporosis, wherein the ethnic medicine preparation comprises the following components:
mixing the extract powder with 5-50 parts of auxiliary materials to obtain a powder preparation of the ethnic medicine for treating osteoporosis;
the auxiliary materials comprise: starch, microcrystalline cellulose, differential silica gel, magnesium stearate and talcum powder.
(5) For syrup dosage forms:
step S30, preparing the extract powder and auxiliary materials together to obtain the ethnic medicine preparation for treating osteoporosis, wherein the ethnic medicine preparation comprises the following components:
dissolving the extract powder in purified water, filtering, adding 10-70% of auxiliary materials, and preparing the syrup preparation for treating osteoporosis by split charging and sterilization; the auxiliary materials are flavoring agents; the flavoring agent is one or a combination of more of sucrose, fructose, stevioside and sorbic acid;
(6) For pill dosage forms:
step S30, preparing the extract powder and auxiliary materials together to obtain the ethnic medicine preparation for treating osteoporosis, wherein the ethnic medicine preparation comprises the following components:
mixing the extract powder with 10-30 parts of auxiliary materials to obtain the ethnic medicine preparation in the form of pill for treating osteoporosis; the auxiliary material is one or two of honey and polyethylene glycol;
(6) For honey paste type:
step S30, preparing the extract powder and auxiliary materials together to obtain the ethnic medicine preparation for treating osteoporosis, wherein the ethnic medicine preparation comprises the following components:
mixing the extract powder with 10-80% of honey, packaging and sterilizing to obtain honey paste type ethnic medicine preparation for treating osteoporosis.
The application is further illustrated by the following specific examples, but it should be understood that these examples are for the purpose of illustration only and are not to be construed as limiting the application in any way.
Examples:
1. experimental animals and groupings:
SPF-grade non-mated SD female rats were selected and were 70, 4 months old, 240+ -10 g in weight, and after 3 days of adaptive feeding, completely randomized:
(1) A normal control group,
(2) OVX model group (double-sided ovariectomy),
(3) Vitamin group (i.e. ethnic formulation for treating osteoporosis in the present application): low dose, medium dose, high dose;
(4) Positive control group (bujiale);
10 in each group; animal license number: SCXK (new) -2018-0002.
2. Drug dosage formulation:
the experiment is used for the dampness eliminating and bone strengthening prescription granule.
Dose scaling was performed according to the tolerance of different animal strains to drugs.
The experiment was applied to rats, the equivalent dose was 6.3 times that of humans, and was regarded as a medium dose, 2 times that of the medium dose was a large dose, and 1/2 was a small dose.
The treatment group began administration at 1 mL/lavage for 8 weeks at day 4 of molding.
3. Animal feeding:
feeding conditions: rats of each group were housed separately. The temperature is 23+/-2 ℃ and the humidity is 55-65%. The environment is clean, ventilated and has a bright-dark period of 12 hours.
The large mice in each group are fed with quasi-feed, and all the groups are free to drink water.
4. OVX model preparation:
(1) The method comprises the steps of performing operation by using a model modeling method of the menopause induced osteoporosis animal model, performing bilateral oophorectomy on rats in an OVX model group, performing intraperitoneal injection anesthesia by using 2% pentobarbital sodium solution according to the dosage of 0.5mL/100g, taking off a median incision of the abdomen, enabling the incision to enter the abdominal cavity layer by layer through fascia, myometrium and peritoneum, performing blunt separation, lifting the ovaries of the rats along the oviduct direction on one side, clamping and ligating the ovaries after separation, shearing off the ovaries, and resecting partial adipose tissues around the ovaries by a false operation group.
(2) The rats of each group are fed in separate cages after operation. All the plants are fed and watered freely in the common feeding environment, and are fed for 7 days in standard.
(3) Rats were sacrificed 8 weeks after molding, femur was taken for Micro-CT scan, bone mass change was evaluated, and blood samples were taken to detect bone metabolism index. The tibia was HE stained for histopathological changes.
5. Experimental results:
(1) Compared with the normal control group and the false operation group, the bone density, bone morphology and metering index bone volume, bone percentage, bone surface area, bone surface density and bone trabecular number of the OVX model group are obviously reduced, and the bone surface area volume ratio, the intersection point area, the bone trabecular model factor, the structural model index and the bone trabecular separation degree are increased (P is less than 0.01); the bone density of the rats in the treatment group with low, medium and high doses is increased, compared with the model group, the bone density, the bone volume percentage, the bone surface area, the bone surface density and the bone trabecular number of the prescription with high doses are obviously improved, the bone surface area volume ratio, the structural model index bone is obviously reduced by Liang Fendu (P < 0.01), and compared with the positive control group, the bone density and the bone morphology parameters have no statistical significance (P > 0.05), and the result shows that: the dampness eliminating and bone strengthening formulation can reduce high level bone resorption and bone formation caused by ovariectomy, and restore the balance state of bone formation greater than bone resorption, thereby increasing bone mass (as shown in figures 1 and 2).
(2) The bone biomechanical index detection result shows that compared with the normal control group and the false operation group, the ultimate load, rigidity, elastic modulus, breaking energy and ultimate stress of the model group are all reduced (P is less than 0.01). Compared with the model group, the limit load, rigidity, elastic modulus and limit stress of the medium-dose and high-dose groups of the vitamin dampness eliminating and bone strengthening prescription are improved (P is less than 0.01), and the fracture energy of the high-dose groups is improved (P is less than 0.05). Compared with the positive control group, the difference has no statistical significance (P is less than 0.05), which indicates that the vitamin medicine dampness eliminating and bone strengthening formula enhances the bone strength by improving the biomechanical function of the bone (as shown in figure 3);
(3) The results of the HE staining detection of bone tissue are consistent with the results of the Micro CT and bone biomechanics detection (as shown in figure 4), which shows that the vitamin medicine formula for eliminating dampness and strengthening bones has the effect of preventing and treating the osteoporosis of rats.
(4) The ELISA detection results show that the anti-tartaric acid phosphatase (TRACP-5 b) and Osteocalcin (OC) levels (P < 0.05) are effectively reduced by the Wired drug dampness-dispelling and bone-strengthening prescription (as shown in figures 5 and 6), which shows that the Wired drug dampness-dispelling and bone-strengthening prescription has the functions of inhibiting bone absorption, promoting bone formation and restoring the coordination balance between bone absorption and bone formation.
While the foregoing is directed to the preferred embodiments and examples of the present application, it will be apparent to those skilled in the art that various modifications and improvements can be made without departing from the inventive concepts, including but not limited to, adjustments in the ratio, flow, amount and reaction vessel, such as the use of a continuous flow reactor, which are within the scope of the present application.
Claims (10)
1. The national medicine preparation for treating osteoporosis is characterized by being prepared from the following components in parts by weight:
5-60 parts of fennel, 5-80 parts of fennel fruit, 10-100 parts of fig, 10-80 parts of licorice root, 5-60 parts of fern, 5-60 parts of moldavica dragonhead, 10-100 parts of rose petals, 10-80 parts of raisin and 5-300 parts of spinose.
2. A method of preparing an ethnic formulation for treating osteoporosis according to claim 1, comprising:
preparing an extract;
vacuum drying the extract, pulverizing into powder, and sieving to obtain extract powder;
the extract powder and auxiliary materials are prepared together to obtain the ethnic medicine preparation for treating osteoporosis.
3. The method of preparing an ethnic formulation for treating osteoporosis of claim 2, wherein said preparing an extract comprises:
weighing fennel, pimpinella anisum, fig, licorice root, iron wire fern, moldavica dragonhead, rose petals, raisin and spinose according to the weight parts of the components of the national medicinal preparation for treating osteoporosis, and mixing 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 extractive solution at 60-70deg.C to obtain extract with relative density of 1.05-1.40.
4. A method for preparing an ethnic medicine preparation for treating osteoporosis according to claim 3, wherein when said extraction solvent is water, said extraction method of said extract comprises:
soaking the target mixture with 5-12 times of water for 12 hours;
performing primary decoction for 1.5 hours, and filtering to obtain primary filtrate;
adding 4-8 times of water into the filter residue, performing second decoction for 1 hour, and filtering to obtain second filtrate;
adding 4-8 times of water into the filter residue, performing third decoction for 1 hour, and filtering to obtain third filtrate;
and combining the first filtrate, the second filtrate and the third filtrate to obtain the extracting solution.
5. A method for preparing an ethnic medicine preparation for treating osteoporosis according to claim 3, wherein when the extraction solvent is 40% -80% ethanol, the extraction method of the extract comprises:
soaking the target mixture in 5-12 times of 40% -80% ethanol for 12 hours;
extracting under reflux for 1.5 hr, filtering to obtain first filtrate;
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 combining the first filtrate and the second filtrate to obtain the extracting solution.
6. The method for preparing the ethnic medicine preparation for treating osteoporosis according to claim 2, wherein the preparing the ethnic medicine preparation for treating osteoporosis by jointly preparing the extract powder and auxiliary materials comprises the following steps:
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 by using a plate-frame filter to obtain medicinal filtrate;
and subpackaging and sterilizing the medicine filtrate to obtain the ethnic medicine preparation in the form of oral liquid for treating osteoporosis.
7. The method for preparing the ethnic medicine preparation for treating osteoporosis according to claim 2, wherein the preparing the ethnic medicine preparation for treating osteoporosis by jointly preparing the extract powder and auxiliary materials comprises the following steps:
mixing the extract powder with 95% ethanol or water and 10-70 parts of adjuvants to obtain granule preparation 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 according to claim 2, wherein the preparing the ethnic medicine preparation for treating osteoporosis by jointly preparing the extract powder and auxiliary materials comprises the following steps:
mixing the extract powder with 1-10 parts of cross-linked polyvinylpyrrolidone, 95% ethanol and 10-50 parts of auxiliary materials, tabletting or encapsulating to obtain the ethnic medicine preparation for treating osteoporosis in the form of tablet or capsule;
the auxiliary materials comprise lactose, starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, pregelatinized starch, micro powder silica gel, magnesium stearate and talcum powder.
9. The method for preparing the ethnic medicine preparation for treating osteoporosis according to claim 2, wherein the preparing the ethnic medicine preparation for treating osteoporosis by jointly preparing the extract powder and auxiliary materials comprises the following steps:
mixing the extract powder with 5-50 parts of auxiliary materials to obtain a powder preparation of the ethnic medicine for treating osteoporosis;
the auxiliary materials comprise: one or more of starch, microcrystalline cellulose, aerosil, magnesium stearate and talcum powder.
10. The method for preparing the ethnic medicine preparation for treating osteoporosis according to claim 2, wherein the preparing the ethnic medicine preparation for treating osteoporosis by jointly preparing the extract powder and auxiliary materials comprises the following steps:
dissolving the extract powder in purified water, filtering, adding 10-70% of auxiliary materials, and preparing the syrup preparation for treating osteoporosis by split charging and sterilization; the auxiliary materials are flavoring agents; the flavoring agent is one or a combination of 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 in the form of pill for treating osteoporosis; the auxiliary material is one or two of honey and polyethylene glycol;
or mixing the extract powder with 10-80% of honey, packaging, and sterilizing to obtain honeyed unguent.
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