CN109602817B - Traditional Chinese medicine composition for treating osteoporosis caused by estrogen deficiency - Google Patents
Traditional Chinese medicine composition for treating osteoporosis caused by estrogen deficiency Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicine composition for preventing and treating osteoporosis caused by estrogen deficiency, which comprises the following raw material medicines in parts by weight: 6-30 parts of radix hedysari, 3-35 parts of prepared rehmannia root, 3-35 parts of glossy privet fruit, 3-35 parts of medlar and 3-35 parts of radix achyranthis bidentatae. The invention also provides a corresponding preparation method and a traditional Chinese medicine preparation. The traditional Chinese medicine composition and the preparation thereof do not need to be matched with other medicines for use, can effectively prevent and treat various symptoms caused by osteoporosis due to estrogen deficiency, and have obvious curative effect and low medicine cost.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine composition for treating osteoporosis caused by estrogen deficiency, and a preparation method and application thereof.
Background
Osteoporosis (OP), also known as osteoporosis, is a condition of systemic skeletal disease, a condition of bone metabolism characterized by a general tendency to break down the bone microstructure and increase bone fragility, which is a symptom of systemic skeletal component loss due to various causes. Osteoporosis is classified into primary osteoporosis and secondary osteoporosis according to its etiology, and its clinical manifestations are often pain. Postmenopausal osteoporosis and senile osteoporosis are classified as primary osteoporosis, which is very common. Osteoporosis patients generally have no special clinical manifestations, but can generate a series of clinical phenomena such as humpback, respiratory function reduction, fracture and the like under severe conditions, and certain troubles are generated for life of people. And osteoporosis is aggravated in the current aging society, the incidence rate of osteoporosis is increasingly increased, the economic and social burden is gradually and greatly deepened, and people need to be vigilant. The main medicines for treating the disease in western medicine comprise calcium agents, estrogen, calcitonin, fluorine preparations and the like, but the disease has a series of problems of great side effect or insignificant curative effect and the like. Because the traditional Chinese medicine has the characteristics of homology of medicine and food, and has universality and low toxicity, a series of side effects generated by chemical medicines can be effectively avoided when the traditional Chinese medicine is used for treating diseases, and clinical practice experiments also prove that some traditional Chinese medicine compound formulas or single formulas have obvious treatment effect on osteoporosis. Therefore, the development of a traditional Chinese medicine product for treating osteoporosis caused by estrogen deficiency has great market prospect.
Disclosure of Invention
In order to solve the problems in the prior art, the invention provides a traditional Chinese medicine composition which is not required to be used together with other medicines, has good curative effect and can treat osteoporosis caused by estrogen deficiency, and also provides a preparation method and application thereof.
The invention provides a traditional Chinese medicine composition for treating osteoporosis caused by estrogen deficiency, which comprises the following raw material medicines in parts by weight: 6-30 parts of radix hedysari, 3-35 parts of prepared rehmannia root, 3-35 parts of glossy privet fruit, 3-35 parts of medlar and 3-35 parts of radix achyranthis bidentatae.
Preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 12-26 parts of radix hedysari, 9-13 parts of prepared rehmannia root, 9-13 parts of glossy privet fruit, 9-13 parts of medlar and 9-13 parts of radix achyranthis bidentatae;
preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 17 parts of radix hedysari, 10 parts of prepared rehmannia root, 10 parts of glossy privet fruit, 10 parts of medlar and 10 parts of radix achyranthis bidentatae.
The invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the steps of weighing radix hedysari, prepared rehmannia root, glossy privet fruit, medlar and radix achyranthis bidentatae according to the weight ratio, mixing, adding water with the amount of 8-20 times of the total weight, decocting and extracting for 2-4 times, extracting for 1-2 hours each time, combining decoction, filtering, collecting filtrate, and concentrating to obtain extract with the relative density of 1.26-1.35.
The invention also provides a preparation method of the traditional Chinese medicine composition pill, which comprises the following steps:
(1) weighing glossy privet fruit and radix hedysari according to the formula ratio, and crushing to obtain fine powder;
(2) weighing radix rehmanniae Preparata, fructus Lycii and Achyranthis radix in formula amount, mixing, adding 8-20 times of water, decocting for 2-4 times, each time for 1-2 hr, mixing decoctions, filtering, collecting filtrate, and concentrating supernatant under reduced pressure to obtain extract with relative density of 1.26-1.35;
(3) and (3) uniformly mixing the fine powder obtained in the step (1) and the extract obtained in the step (2), pressing into strips, making pills, drying at a temperature of below 80 ℃, and polishing.
The invention also provides application of the traditional Chinese medicine composition in preparing a medicine for treating osteoporosis caused by estrogen deficiency.
The invention also provides a traditional Chinese medicine preparation, the effective components of which are the traditional Chinese medicine composition in claim 1 or 2.
Preferably, the Chinese medicinal preparation further comprises pharmaceutically acceptable auxiliary materials.
Preferably, the auxiliary materials comprise a diluent and an adhesive, wherein the diluent is one or more of starch, dextrin, lactose, maltose, microcrystalline cellulose and mannitol; the adhesive is water or ethanol.
Preferably, the auxiliary materials also comprise a lubricant or a preservative, the lubricant is one or more of talcum powder, micro-powder silica gel and magnesium stearate, and the preservative is one or more of sodium benzoate, potassium sorbate, sodium dehydroacetate, calcium propionate, sodium diacetate, sodium lactate, propyl p-hydroxybenzoate and nisin.
Preferably, the dosage form of the traditional Chinese medicine preparation is granules, capsules, tablets, pills or liquid preparations.
Wherein, radix hedysari is sweet in nature and is slightly warm. Has the effects of invigorating qi, invigorating yang, consolidating superficial resistance, arresting sweating, inducing diuresis, relieving swelling, promoting fluid production, nourishing blood, removing stagnation, relieving arthralgia, removing toxic substance, expelling pus, healing sore, and promoting granulation. Can be used for treating deficiency-type asthenia, anorexia, loose stool, collapse of middle-warmer energy, chronic diarrhea, rectocele, hematochezia, metrorrhagia, exterior deficiency, spontaneous perspiration, edema due to qi deficiency, internal heat, diabetes, blood deficiency, hemiplegia, arthralgia, numbness, carbuncle, cellulitis, and intractable ulcer. The pharmacological activity of the compound mainly comprises immunoregulation, anti-tumor, anti-oxidation, blood sugar reduction, osteoporosis resistance and the like.
Shu Di Huang is sweet in flavor and warm in nature, and enters liver and kidney meridians. Has effects of replenishing blood, moistening, replenishing essence, and replenishing marrow. Can be used for treating blood deficiency and sallow complexion, giddiness and palpitation, liver and kidney yin deficiency, hectic fever and night sweat, spermatorrhea and sexual impotence, infertility, menoxenia, metrorrhagia and metrostaxis, soreness of waist and knees, tinnitus and deafness, blurred vision, early white beard and hair, diabetes, constipation, kidney deficiency and dyspnea. Modern pharmacological research shows that the medicine has the functions of strengthening heart, promoting urination, lowering blood sugar, raising peripheral white blood cell, strengthening immunity, etc.
Lycium chinense, fructus Lycii is sweet in nature and neutral in nature, and enters liver and kidney meridians. Has effects of nourishing liver and kidney, replenishing vital essence, and improving eyesight. Can be used for treating dizziness, vertigo, hypopsia, soreness of waist and knees, spermatorrhea, and diabetes due to liver and kidney deficiency and essence and blood deficiency. Modern pharmacological research shows that the medlar has various pharmacological effects, such as enhancing nonspecific immunity, improving disease resistance, inhibiting tumor growth and cell mutation; closely related to cell apoptosis, can obviously improve the phagocytic function of phagocytes and improve the proliferative capacity of lymphocytes; also has effects in reducing blood lipid, regulating lipid metabolism, lowering blood sugar and blood pressure, improving hemopoiesis function, protecting liver, and resisting oxidation.
The glossy privet fruit is sweet, bitter and cool in nature. Has effects of nourishing liver and kidney, improving eyesight and blackening hair. Can be used for treating liver and kidney yin deficiency, giddiness, tinnitus, soreness of waist and knees, premature gray hair, dim eyesight, internal heat, diabetes, and hectic fever. Modern pharmacological research shows that the health-care tea has the effects of protecting liver, regulating immunity, resisting oxidation, aging and tumors, and also has the effects of reducing blood sugar and blood fat.
Huai niu xi is bitter and sour in taste and neutral in nature. Has effects of promoting blood circulation, dispelling blood stasis, eliminating dampness, promoting urination, and clearing away heat and toxic materials. Can be used for treating gonorrhea, hematuria, female amenorrhea, abdominal mass, rheumatic arthralgia, tinea pedis, edema, dysentery, malaria, diphtheria, carbuncle, and traumatic injury. The modern pharmacological research has a series of good effects of reducing blood pressure, reducing blood sugar, resisting hepatic fibrosis, enhancing cell activity, enhancing humoral immunity, resisting inflammation, resisting aging and the like.
In the formula, the radix hedysari has the functions of tonifying qi, invigorating yang, strengthening the middle-jiao and tonifying qi; radix rehmanniae Preparata has effects of replenishing blood, nourishing yin, replenishing essence, and replenishing marrow; the glossy privet fruit can nourish liver and kidney, improve eyesight and blacken hair; fructus Lycii has effects in warming kidney, tonifying yang, replenishing vital essence, and improving eyesight; achyranthes bidentata has the functions of promoting blood circulation, removing blood stasis, eliminating dampness and promoting urination. Based on the pharmacological knowledge and mutual synergistic action of the five medicinal materials, the traditional Chinese medicine composition with the effects of nourishing liver and kidney, warming kidney and tonifying yang, replenishing vital essence and marrow, tonifying middle-jiao and Qi, and activating blood circulation to dissipate blood stasis is prepared by combining the five medicinal materials.
The raw material medicines are selected by a rat bilateral ovariectomy molding method.
60 3-month-old sexual-maturing SD female rats, each weighing about 200g, were randomly divided into A, B, C, D, E, F6 groups of 10 rats each. The group A is a prescription I (17 parts of radix hedysari, 17 parts of oyster, 17 parts of epimedium herb and 17 parts of angelica sinensis), the group B is a prescription II (17 parts of radix hedysari, 15 parts of radix achyranthis bidentatae, 15 parts of eucommia bark, 15 parts of morinda officinalis and 15 parts of fructus psoraleae), the group C is a prescription III (17 parts of radix hedysari, 10 parts of radix rehmanniae preparata, 10 parts of glossy privet fruit, 10 parts of medlar and 10 parts of radix achyranthis bidentatae), the group D is a model group, the group E is a positive medicine group, and the group F is a. The medicinal materials are weighed and mixed according to the prescription amount in each prescription group, 10 times of water is used for decocting for 3 times, 1.5 hours are carried out on the first two times, 1 hour is carried out on the third time, and the three filtrates are combined and concentrated to obtain the traditional Chinese medicine composition. After the rats were received, they were acclimatized for 1 week. One week later A, B, C, D, E groups prepared osteoporosis models, and rats were anesthetized with ether and their bilateral ovaries were removed. Group F is a normal control group, namely part of adipose tissues beside the ovary are removed after the fallopian tube at the lower end of the plum blossom-shaped ovary is ligated, so that the ovary is kept intact. After the model building operation, the rats are divided into 6 cages, the weight average of each group of rats is kept equal, the rats are fed with normal feed for 3 days, and the rats are formally fed on the fourth day. The group F (sham group) and the group D (model group) were gavaged with physiological saline at a dose of 10ml/kg per day; A. b, C the composition is administered by intragastric administration every day according to the amount of crude drugs; the positive control group adopts chemical estradiol valerate at 0.2mg/kg d-1The dosage of (a) is administered by intragastric administration daily. Gavage was continued for three months and rats were weighed every two weeks to adjust the dose until gavage was complete.
After three months of gavage administration, all rats were anesthetized by intraperitoneal injection of 0.3% barbital valerate sodium, and after anesthesia, the rats were placed flat on a dual-energy X Bone densitometer to measure the Bone Density (BMD) of the rats; the rats were then sacrificed by ether anesthesia, the intact right femurs of the rats were removed, the adjacent muscular fibrous tissue was rubbed off with gauze to expose clean bone structure, and the bone density of the right femurs of the 60 rats was measured with a dual-energy X-bone densitometer.
The results are shown in Table 1.
TABLE 1
Comparison with blank 1) P < 0.05; comparison with model group 2) P < 0.05.
As shown in Table 1, the density of the whole body and the right femur of the model group of the ovariectomized osteoporosis rats is obviously reduced compared with that of the other groups of the osteoporosis rats, and is obviously different from that of the blank group of the osteoporosis rats (P is less than 0.05), which indicates that the modeling is successful. In terms of the whole body bone density, the A group, the C group and the positive drug group have significant difference compared with the model group, and the B group has no statistical significance compared with the model group. Regarding the bone density of the right femur, there is no obvious difference between the bone density of the right femur of rats subjected to intragastric administration of the group A and the group B and the model group, and the bone density of the right femur of the castrated rats of the group C is obviously higher than that of the model group although not as high as that of the positive drug group. In conclusion, the radix hedysari has good curative effects on increasing the bone density of the whole body and the right femur of the rat with ovarian osteoporosis to different degrees by taking radix hedysari as a monarch drug, and particularly has obvious effect by taking the group C (17 parts of radix hedysari, 10 parts of prepared rehmannia root, 10 parts of glossy privet fruit, 10 parts of medlar and 10 parts of radix achyranthis bidentatae).
The results in table 1 further illustrate that the Chinese medicinal composition of the present invention has a better therapeutic effect on osteoporosis caused by estrogen deficiency.
The traditional Chinese medicine composition can effectively treat osteoporosis caused by estrogen deficiency, has no toxic or side effect when in use, and does not need to be compatible with other medicines.
The invention is prepared into modern preparations: granule, capsule, tablet, pill or liquid preparation, and has the advantages of improved utilization rate of Chinese medicinal materials, accurate dosage, rapid dissolution, good taste, convenient carrying and storage, and stable property.
The raw materials and auxiliary materials are common raw materials in the market, the price is low, and the preparation method is simple and easy to implement and is easy for large-scale industrial production.
Detailed Description
The following examples are given to facilitate a better understanding of the invention, but do not limit the invention. The experimental procedures in the following examples are conventional unless otherwise specified. The test materials used in the following examples are commercially available unless otherwise specified. In the present invention, the "parts" are all parts by weight.
The traditional Chinese medicine composition for treating osteoporosis caused by estrogen deficiency comprises the following components in parts by weight: 6-30 parts of radix hedysari, 3-35 parts of prepared rehmannia root, 3-35 parts of glossy privet fruit, 3-35 parts of medlar and 3-35 parts of radix achyranthis bidentatae.
In the preparation of granule, capsule, tablet, pill or liquid preparation, adjuvant such as diluent, antiseptic, binder, PEG6000, correctant and lubricant can be added.
Wherein, the diluent can be one or more of starch, dextrin, lactose, maltose, microcrystalline cellulose and mannitol; the preservative can be one or more of sodium benzoate, potassium sorbate, sodium dehydroacetate, calcium propionate, sodium diacetate, sodium lactate, propyl p-hydroxybenzoate and nisin; the binder may be water or ethanol; the lubricant can be one or more of talcum powder, micro-powder silica gel and magnesium stearate.
The diluent is preferably starch and/or lactose;
the preservative is preferably sodium benzoate;
the adhesive is preferably ethanol;
the lubricant is preferably magnesium stearate.
The preparation method of the traditional Chinese medicine composition for treating osteoporosis caused by estrogen deficiency comprises the following steps:
weighing radix hedysari, radix rehmanniae preparata, glossy privet fruit, medlar and radix achyranthis bidentatae raw materials according to the weight ratio, adding water with the weight being 8-20 times of the total weight of the raw materials into the raw materials, decocting and extracting for 2-4 times, extracting for 1-2 hours each time, combining decoction, filtering and collecting filtrate. Standing the filtrate of the Chinese medicinal composition for 12-24 hr, collecting supernatant, and concentrating under reduced pressure to obtain extract with relative density of 1.26-1.35.
The preparation method of the compound traditional Chinese medicine granule for treating osteoporosis caused by estrogen deficiency comprises the following steps:
(1) drying the concentrated extract at 60-80 deg.C, and pulverizing to obtain extract powder;
(2) mixing the extract powder obtained in the step (1), a diluent and an adhesive according to the proportion, granulating and drying; wherein, the diluent is added into the extract powder before mixing and granulating, the adhesive is added in the granulating process, and the granulating time is 15-60 minutes.
The preparation method of the compound traditional Chinese medicine capsule for treating osteoporosis caused by estrogen deficiency comprises the following steps:
the compound traditional Chinese medicine granules prepared by the method for treating osteoporosis caused by estrogen deficiency are sieved by a 20-50 mesh sieve, and then are filled into capsules according to the conventional process.
The preparation method of the compound traditional Chinese medicine tablet for treating osteoporosis caused by estrogen deficiency comprises the following steps:
(1) drying the concentrated extract at 60-80 deg.C, and pulverizing to obtain extract powder;
(2) mixing the extract powder obtained in step (1) with diluent and adhesive according to the above ratio, granulating for 15-60 minutes, drying, grading with 10-50 mesh sieve, adding lubricant, and tabletting. The diluent is added into the extract powder before mixing and granulating, and the adhesive is added in the granulating process.
The preparation method of the compound traditional Chinese medicine concentrated pill for treating osteoporosis caused by estrogen deficiency comprises the following steps:
(1) weighing fructus Ligustri Lucidi and radix Hedysari, pulverizing, sieving with 100 mesh sieve to obtain fine powder, and sterilizing.
(2) Weighing the total amount of the raw materials of the prepared rehmannia root, the medlar and the radix achyranthis bidentatae, adding water with the weight being 8-20 times of the total weight of the raw materials into the raw materials, decocting and extracting for 2-4 times, extracting for 1-2 hours each time, combining decoction, filtering, collecting filtrate, standing for 12-24 hours, taking supernate, and concentrating under reduced pressure to obtain extract with the relative density of 1.26-1.35.
(3) And (3) uniformly mixing the fine powder obtained in the step (1) and the extract obtained in the step (2), pressing into strips, making pills, drying at the temperature of below 80 ℃, and polishing to obtain the traditional Chinese medicine composition.
The preparation process of the traditional Chinese medicine concentrated pill comprises the following steps: extracting part of the medicinal materials in the prescription, concentrating into extract, pulverizing part of the medicinal materials into fine powder, mixing the extract and the fine powder, and making into pill. If all the extract powders have too high viscosity, the mixture cannot be made into pills, and if all the extract powders are fine powders, the mixture cannot be bonded together to form pills. In the prescription, the cooked rehmannia root and the medlar are too sticky to be pulverized, and the achyranthes root is slightly cutin-shaped and is not easy to be pulverized, so the glossy privet fruit and the radix hedysari are all pulverized into fine powder and mixed with the prepared rehmannia root, the medlar and the achyranthes root extract to prepare pills.
The preparation method of the compound traditional Chinese medicine dripping pill for treating osteoporosis caused by estrogen deficiency comprises the following steps:
(1) drying the concentrated extract at 60-80 deg.C, and pulverizing to obtain extract powder;
(2) heating PEG6000 in oil bath, adding the extract powder obtained in step (1), stirring to melt completely, filtering while hot, adding into a liquid storage bottle, dripping into liquid paraffin (outer layer is ice water bath) condensate, condensing into pill, and removing adhered liquid paraffin.
The preparation method of the traditional Chinese medicine oral liquid preparation for treating osteoporosis caused by estrogen deficiency comprises the following steps:
(1) weighing radix hedysari, prepared rehmannia root, glossy privet fruit, medlar and radix achyranthis bidentatae according to the weight ratio, mixing, adding water with the weight being 8-20 times of the total weight of the mixture, decocting and extracting for 2-4 times, extracting for 1-2 hours each time, merging decoction, filtering and collecting filtrate.
(2) And (2) concentrating the filtrate obtained in the step (1) to 1000ml under reduced pressure, adding a proper amount of preservative and flavoring agent, uniformly stirring, standing for 12 hours, filtering, filling and sterilizing to obtain the traditional Chinese medicine composition.
Example 1
A compound traditional Chinese medicine granule for treating osteoporosis caused by estrogen deficiency is prepared from the following raw materials in parts by weight:
30 parts of radix hedysari, 35 parts of prepared rehmannia root, 35 parts of glossy privet fruit, 35 parts of medlar, 35 parts of radix achyranthis bidentatae, 10 parts of starch and 0.6 part of ethanol.
A method of making the above particles comprising the steps of:
weighing 30 parts of radix hedysari, 35 parts of prepared rehmannia root, 35 parts of glossy privet fruit, 35 parts of Chinese wolfberry and 35 parts of radix achyranthis bidentatae, adding water with 15 times of the total weight into the raw materials, decocting and extracting for 3 times, extracting for 1.5 hours each time, combining decoction, filtering, standing filtrate for 20 hours, taking supernate, concentrating under reduced pressure to obtain extract with the relative density of 1.31, drying at 70 ℃, and crushing to obtain extract powder; and 5 parts of starch is added into the extract powder to be mixed and granulated, 0.5 part of ethanol is added in the granulation process, and the granulation time is 60 minutes.
The granulation process of the present invention employs conventional processes, for example, one-step granulation, extrusion-screening granulation, rotary granulation, high-speed granulation, etc. may be employed.
Example 2
A traditional Chinese medicine composition for treating osteoporosis caused by estrogen deficiency is prepared from the following raw materials in parts by weight: 17 parts of radix hedysari, 10 parts of prepared rehmannia root, 10 parts of glossy privet fruit, 10 parts of medlar and 10 parts of radix achyranthis bidentatae.
The preparation method of the traditional Chinese medicine composition comprises the following steps: weighing 17 parts of radix hedysari, 10 parts of prepared rehmannia root, 10 parts of glossy privet fruit, 10 parts of medlar and 10 parts of radix achyranthis bidentatae, adding water 15 times of the total weight of the raw materials into the raw materials, decocting and extracting for 3 times, extracting for 1.5 hours each time, combining decoction, filtering, standing filtrate for 20 hours, taking supernate, concentrating under reduced pressure to obtain extract with the relative density of 1.30, drying at 70 ℃, and crushing to obtain extract powder.
Example 3
A traditional Chinese medicine composition for treating osteoporosis caused by estrogen deficiency is prepared from the following raw materials in parts by weight: 1 part of radix hedysari, 1 part of prepared rehmannia root, 1 part of glossy privet fruit, 1 part of medlar and 1 part of radix achyranthis bidentatae.
The preparation method of the traditional Chinese medicine composition comprises the following steps: weighing 1 part of radix hedysari, 1 part of prepared rehmannia root, 1 part of glossy privet fruit, 1 part of medlar and 1 part of radix achyranthis bidentatae, adding water with the weight being 12 times of the total weight of the raw materials into the raw materials, decocting and extracting for 2 times, extracting for 1 hour each time, combining decoction, filtering, standing filtrate for 12 hours, taking supernate, concentrating under reduced pressure to obtain extract with the relative density of 1.35, drying at 80 ℃, and crushing to obtain extract powder.
Example 4
A traditional Chinese medicine composition for treating osteoporosis caused by estrogen deficiency is prepared from the following raw materials in parts by weight: 6 parts of radix hedysari, 3 parts of prepared rehmannia root, 3 parts of glossy privet fruit, 3 parts of medlar and 3 parts of radix achyranthis bidentatae.
The preparation method of the traditional Chinese medicine composition comprises the following steps: weighing 6 parts of radix hedysari, 3 parts of prepared rehmannia root, 3 parts of glossy privet fruit, 3 parts of medlar and 3 parts of radix achyranthis bidentatae, adding water with the weight 10 times of the total weight of the raw materials into the raw materials, decocting and extracting for 3 times, extracting for 1 hour each time, combining decoction, filtering, standing filtrate for 14 hours, taking supernate, concentrating under reduced pressure to obtain an extract with the relative density of 1.32, drying at 70 ℃, and crushing to obtain extract powder.
Example 5
A traditional Chinese medicine composition for treating osteoporosis caused by estrogen deficiency is prepared from the following raw materials in parts by weight: 6 parts of radix hedysari, 18 parts of prepared rehmannia root, 18 parts of glossy privet fruit, 18 parts of medlar and 18 parts of radix achyranthis bidentatae.
The preparation method of the traditional Chinese medicine composition comprises the following steps: weighing 6 parts of radix hedysari, 18 parts of prepared rehmannia root, 18 parts of glossy privet fruit, 18 parts of medlar and 18 parts of radix achyranthis bidentatae, adding water 15 times of the total weight of the raw materials into the raw materials, decocting and extracting for 3 times, extracting for 2 hours each time, combining decoction, filtering, standing filtrate for 16 hours, taking supernate, concentrating under reduced pressure to obtain extract with the relative density of 1.30, drying at 60 ℃, and crushing to obtain extract powder.
Example 6
A compound traditional Chinese medicine capsule for treating osteoporosis caused by estrogen deficiency is prepared from the following raw materials in parts by weight:
6 parts of radix hedysari, 13 parts of prepared rehmannia root, 10 parts of glossy privet fruit, 14 parts of medlar, 12 parts of radix achyranthis bidentatae, 4 parts of starch and 0.2 part of ethanol.
The method for preparing the capsule comprises the following steps:
1) weighing 6 parts of radix hedysari, 13 parts of prepared rehmannia root, 10 parts of glossy privet fruit, 14 parts of Chinese wolfberry and 12 parts of radix achyranthis bidentatae, adding water with the weight being 20 times of the total weight of the raw materials into the raw materials, decocting and extracting for 4 times, extracting for 2 hours each time, combining decoction, filtering, standing filtrate for 24 hours, taking supernate, concentrating under reduced pressure to obtain extract with the relative density of 1.26, drying at 60 ℃, and crushing to obtain extract powder.
2) And 4 parts of starch is added into the extract powder for mixing and granulating, 0.2 part of ethanol is added in the granulating process, and the granulating time is 30 minutes.
3) Sieving the granulated medicinal granules with a 50-mesh sieve, and encapsulating according to the conventional process.
Example 7
A compound traditional Chinese medicine tablet for treating osteoporosis caused by estrogen deficiency is prepared from the following raw materials in parts by weight:
24 parts of radix hedysari, 35 parts of prepared rehmannia root, 30 parts of glossy privet fruit, 30 parts of medlar, 30 parts of radix achyranthis bidentatae, 6 parts of starch, 2 parts of lactose, 0.2 part of magnesium stearate and 0.4 part of ethanol.
The preparation method of the compound traditional Chinese medicine tablet comprises the following steps:
1) weighing 24 parts of radix hedysari, 35 parts of prepared rehmannia root, 30 parts of glossy privet fruit, 30 parts of Chinese wolfberry and 30 parts of radix achyranthis bidentatae, adding water with the weight being 12 times of the total weight of the raw materials into the raw materials, decocting and extracting for 3 times, extracting for 1.5 hours each time, combining decoction, filtering, standing filtrate for 16 hours, taking supernate, concentrating under reduced pressure to obtain extract with the relative density of 1.29, drying at 65 ℃, and crushing to obtain extract powder.
2) And (3) adding 6 parts of starch and 2 parts of lactose into the extract powder, mixing and granulating, adding 0.4 part of ethanol during the granulation process, and granulating for 60 minutes.
3) And (3) granulating the granulated medicine granules by using a 50-mesh sieve, adding 0.2 part of magnesium stearate, and tabletting according to a conventional process.
Example 8
A compound traditional Chinese medicine concentrated pill for treating osteoporosis caused by estrogen deficiency is prepared from the following raw materials in parts by weight:
20 parts of radix hedysari, 20 parts of prepared rehmannia root, 20 parts of glossy privet fruit, 15 parts of medlar and 15 parts of radix achyranthis bidentatae.
The preparation method of the concentrated pill comprises the following steps:
1) weighing 20 parts of glossy privet fruit and 20 parts of radix hedysari, crushing, sieving by a 100-mesh sieve to obtain fine powder, and sterilizing.
2) Weighing 20 parts of prepared rehmannia root, 15 parts of medlar and 15 parts of radix achyranthis bidentatae, adding water with the weight being 16 times of the total weight of the raw materials, decocting and extracting for 3 times, extracting for 1.5 hours each time, combining decoction, filtering, collecting filtrate, standing the filtrate for 15 hours, and taking supernatant, and concentrating under reduced pressure to obtain an extract with the relative density of 1.28.
3) Mixing the fine powder obtained in step (1) and the extract obtained in step 2), pressing into strips, making into pills, drying below 80 ℃, and polishing to obtain the final product.
Example 9
A traditional Chinese medicine dripping pill for treating osteoporosis caused by estrogen deficiency is prepared from the following raw materials in parts by weight:
12 parts of radix hedysari, 20 parts of prepared rehmannia root, 30 parts of glossy privet fruit, 25 parts of medlar, 25 parts of radix achyranthis bidentatae and 600020 parts of PEG.
The preparation method of the traditional Chinese medicine dripping pill comprises the following steps:
1) weighing 12 parts of radix hedysari, 20 parts of prepared rehmannia root, 30 parts of glossy privet fruit, 25 parts of Chinese wolfberry and 25 parts of radix achyranthis bidentatae, adding water 15 times of the total weight of the raw materials into the raw materials, decocting and extracting for 3 times, extracting for 2 hours each time, combining decoction, filtering, standing filtrate for 16 hours, taking supernate, concentrating under reduced pressure to obtain an extract with the relative density of 1.30, drying at 60 ℃, and crushing to obtain extract powder.
2) Heating PEG 600020 parts to about 135 ℃ on an oil bath, adding the extract powder obtained in the step (1), continuously stirring to completely melt, filtering while hot, putting into a liquid storage bottle, keeping the temperature at 135 ℃, dripping by using drippers with the inner and outer diameters of 9.0mm and 9.8mm respectively at the dripping speed of 80 drops/min, dripping into liquid paraffin (the outer layer is an ice water bath) condensate to condense into pills, and sucking off the adhered liquid paraffin by using rough edge paper to obtain the liquid paraffin.
Example 10
A compound traditional Chinese medicine oral liquid preparation for treating osteoporosis caused by estrogen deficiency is prepared from the following raw materials in parts by weight:
18 parts of radix hedysari, 15 parts of prepared rehmannia root, 20 parts of glossy privet fruit, 12 parts of medlar, 9 parts of radix achyranthis bidentatae and 0.1 part of sodium benzoate.
The method for preparing the oral liquid preparation comprises the following steps:
1) weighing 18 parts of radix hedysari, 15 parts of prepared rehmannia root, 20 parts of glossy privet fruit, 12 parts of medlar and 9 parts of radix achyranthis bidentatae, adding water with the weight being 10 times of the total weight of the raw materials into the raw materials, decocting and extracting for 4 times, extracting for 2 hours each time, combining decoction, filtering, and standing filtrate for 24 hours.
2) And (2) concentrating the filtrate obtained in the step (1) under reduced pressure to 1000ml (corresponding to 100 parts of water), adding 0.1 part of sodium benzoate and a proper amount of citric acid and sodium cyclamate, uniformly stirring, standing for 12 hours, filtering, filling and sterilizing to obtain the traditional Chinese medicine composition.
Example 11
The traditional Chinese medicine composition disclosed by the invention has a good treatment effect on osteoporosis caused by estrogen deficiency. Wherein, the effect of the traditional Chinese medicine composition prepared in the embodiment 2 is best.
120 female SD rats were randomly divided into 12 groups of 10 rats each, namely a normal control group, a castrated rat osteoporosis model control group and a test group.
Normal control group: the rats were gazed with saline at 10mL/kg body weight.
Model control group: the rats were gazed with saline at 10mL/kg body weight.
Test groups: the examples are converted into the original medicinal material amount and then are infused into the stomach of the rat.
Model control rats were anesthetized with ether and then subjected to bilateral ovariectomy. The normal control group removes partial adipose tissues beside the ovary after the tubal ligation at the lower end of the plum blossom-like ovary of the rat, so that the ovary is kept intact. Except for the normal control group, each group was molded according to the same method as the model group. After the model building operation, the rats are divided into 12 cages, the weight average of each group of rats is kept equal, the rats are fed with normal feed for 3 days, and the rats are formally fed on the fourth day. After 12 weeks of continuous administration, all rats were administered by intraperitoneal injection of 0.3% barbital sodium valerateAnaesthetizing, after anaesthetizing, the rat lies flat and is placed on a dual-energy X Bone densitometer to measure the whole body Bone Density (BMD) of the rat; then, killing the rat by ether anesthesia, taking out the complete right femur of the rat, rubbing off the attached muscle fiber tissue beside the rat by using gauze to expose a clean bone structure, and measuring the bone density of the right femur by using a dual-energy X bone densitometer; blood was collected from the venous plexus of the eyeball at 3000 r.min-1Centrifuging, standing for 10min, separating serum, and measuring ALP, strACP, Ca, P, and IL-1 beta; taking a uterus, and measuring a uterus index; the rat right femur was taken and its maximum load and elastic modulus were determined.
The experimental results of the normal control group, the model group and the test group are shown in tables 2 to 4.
TABLE 2
Comparison with blank 1) P < 0.05; comparison with model group 2) P < 0.05.
As can be seen from Table 2, the density of the whole body and the right femur of the model control group ovariectomized osteoporosis rats is obviously reduced compared with that of the normal control group (P is less than 0.05), and the uterine index of the model control group ovariectomized osteoporosis rats and the model control group ovariectomized osteoporosis rats of the test group is obviously reduced compared with that of the normal control group which only removes partial adipose tissues, and the significant difference (P is less than 0.05) exists, so that the molding success is proved. The whole body bone density and the right femur density of the rat in the test group are obviously increased, and compared with a model control group, the significant difference (P is less than 0.05) exists, which shows that the invention has good curative effect on increasing the whole body bone density and the right femur bone density of the rat with osteoporosis caused by ovariectomy.
TABLE 3
Comparison with blank 1) P < 0.05; comparison with model group 2) P < 0.05.
TABLE 4
Comparison with blank 1) P < 0.05; comparison with model group 2) P < 0.05.
As shown in Table 3, the results of the biomechanical testing of the biology bone show that the elasticity modulus and the maximum load of the right femur of the rat after the model building are greatly reduced, and have significant difference (P is less than 0.05) compared with the model group, and after the drug intervention treatment, all indexes are improved, wherein the performance is most significant by the second embodiment, which shows that the second embodiment can enhance the capability of the femoral bone of the ovariectomized rat to resist the external force impact, and the enhancement amplitude is the highest by the second embodiment.
As can be seen from Table 4, the serum contents of Ca and P in rat are reduced to some extent compared with the test group and the normal control group, which indicates that Ca and P in the skeleton of the OP model group rat are lost, but there is no significant difference, and the model group may be related to the self-regulation of the body. In the case of ALP and strACP, the examples can remarkably enhance the activity of ALP in the serum of castrated rats (P <0.05) and reduce the level of strACP in the serum of ovariectomissed rats (P <0.05), wherein the drug effect is more remarkable compared with other administration groups in example 2. Each example significantly reduced IL-1 β levels in serum of castrated rats (P <0.05) compared to the model group.
The results in tables 3 and 4 further illustrate that the Chinese medicinal composition of the present invention has a better therapeutic effect on osteoporosis caused by estrogen deficiency.
Finally, it should be noted that: although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that changes may be made in the embodiments and/or equivalents thereof without departing from the spirit and scope of the invention. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (11)
1. A traditional Chinese medicine composition for treating osteoporosis caused by estrogen deficiency is characterized in that: the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 6-30 parts of radix hedysari, 3-35 parts of prepared rehmannia root, 3-35 parts of glossy privet fruit, 3-35 parts of medlar and 3-35 parts of radix achyranthis bidentatae.
2. The traditional Chinese medicine composition according to claim 1, characterized in that: the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 12-26 parts of radix hedysari, 9-13 parts of prepared rehmannia root, 9-13 parts of glossy privet fruit, 9-13 parts of medlar and 9-13 parts of radix achyranthis bidentatae.
3. The traditional Chinese medicine composition according to claim 2, characterized in that: the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 17 parts of radix hedysari, 10 parts of prepared rehmannia root, 10 parts of glossy privet fruit, 10 parts of medlar and 10 parts of radix achyranthis bidentatae.
4. A method for preparing the Chinese medicinal composition of any one of claims 1 to 3, which is characterized in that: weighing radix hedysari, prepared rehmannia root, glossy privet fruit, medlar and radix achyranthis bidentatae according to the weight ratio, mixing, adding water with the weight being 8-20 times of the total weight, decocting and extracting for 2-4 times, extracting for 1-2 hours each time, merging decoction, filtering, collecting filtrate, and concentrating to obtain extract with the relative density of 1.26-1.35.
5. A method for preparing a Chinese medicinal composition pill as claimed in any of claims 1-3, which is characterized in that: the method comprises the following steps:
(1) weighing glossy privet fruit and radix hedysari according to the formula ratio, and crushing to obtain fine powder;
(2) weighing radix rehmanniae Preparata, fructus Lycii and Achyranthis radix in formula amount, mixing, adding 8-20 times of water, decocting for 2-4 times, each time for 1-2 hr, mixing decoctions, filtering, collecting filtrate, and concentrating supernatant under reduced pressure to obtain extract with relative density of 1.26-1.35;
(3) and (3) uniformly mixing the fine powder obtained in the step (1) and the extract obtained in the step (2), pressing into strips, making pills, drying at the temperature of below 80 ℃, and polishing.
6. Use of a Chinese medicinal composition according to any one of claims 1 to 3 for the preparation of a medicament for the treatment of osteoporosis due to estrogen deprivation.
7. A traditional Chinese medicine preparation is characterized in that: the effective component of the traditional Chinese medicine composition is the traditional Chinese medicine composition of any one of claims 1 to 3.
8. The traditional Chinese medicine preparation according to claim 7, characterized in that: the traditional Chinese medicine preparation also comprises pharmaceutically acceptable auxiliary materials.
9. The traditional Chinese medicine preparation according to claim 8, characterized in that: the auxiliary materials comprise a diluent and an adhesive, wherein the diluent is one or more of starch, dextrin, lactose, maltose, microcrystalline cellulose and mannitol; the adhesive is water or ethanol.
10. The traditional Chinese medicine preparation according to claim 9, characterized in that: the auxiliary materials also comprise a lubricant or a preservative, the lubricant is one or more of talcum powder, micro-powder silica gel and magnesium stearate, and the preservative is one or more of sodium benzoate, potassium sorbate, sodium dehydroacetate, calcium propionate, sodium diacetate, sodium lactate, propyl p-hydroxybenzoate and nisin.
11. The traditional Chinese medicine preparation according to any one of claims 8 to 10, characterized in that: the dosage form of the traditional Chinese medicine preparation is granules, capsules, tablets, pills or liquid preparations.
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