CN112957448A - Composition for increasing bone mineral density, health product and preparation method thereof - Google Patents
Composition for increasing bone mineral density, health product and preparation method thereof Download PDFInfo
- Publication number
- CN112957448A CN112957448A CN202110172153.4A CN202110172153A CN112957448A CN 112957448 A CN112957448 A CN 112957448A CN 202110172153 A CN202110172153 A CN 202110172153A CN 112957448 A CN112957448 A CN 112957448A
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- Prior art keywords
- parts
- composition
- bone
- health
- povidone
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to a composition for increasing bone density, a health-care product and a preparation method thereof, wherein the composition comprises the following components in parts by mass: 12.8-19.2 parts of glucosamine hydrochloride, 10.4-15.6 parts of marine fish bone collagen oligopeptide, 6.4-9.6 parts of sodium chondroitin sulfate and 4.8-7.2 parts of eucommia ulmoides extract. The components of the composition can be matched to effectively increase the bone mineral density and prevent osteoporosis, and the health care product prepared from the composition has no toxic or side effect and has an obvious bone mineral density increasing effect. In the preparation method, microcrystalline cellulose and povidone K30 are added and then wet granulation is carried out, and the mixture is processed into the required dosage form. By adjusting the proportional relation of raw materials and auxiliary materials and optimizing wet granulation, the raw materials can achieve better synergistic improvement effect, namely after the components are combined, the drug effect is remarkably improved compared with that of the single use, and the drug effect is more durable.
Description
Technical Field
The invention relates to the field of health products, in particular to a composition for increasing bone mineral density, a health product and a preparation method thereof.
Background
Bone density, which is called bone mineral density, is an important indicator of bone strength, expressed in grams per cubic centimeter, as an absolute value. When the bone density value is clinically used, the T value is usually used to judge whether the bone density is normal or not because the absolute values of different bone density detectors are different. The T value is a relative value, a normal reference value is between-1 and +1, and is abnormal when the T value is lower than-2.5, and osteoporosis is caused when the T value is abnormal.
Further, osteoporosis is a systemic skeletal disease in which bone mass is reduced and microstructure of bone tissue is damaged, which leads to increase of bone fragility and increase of fracture risk, and is a common disease and frequently encountered disease of middle-aged and elderly people. Its clinical symptoms and signs are mainly pain, followed by short body length, hunchback, fracture and respiratory system disorders. Senile osteoporosis is mainly caused by aging, decrease in bone synthesis function and increase in bone decomposition, and also by decrease in intestinal calcium absorption function and disorder in calcium metabolism in the elderly. Reduced activity in the elderly also results in reduced muscle activity, which in turn reduces muscle stimulation of the bone and reduces osteoblast mass. In addition, the influence of endocrine system and hormone level, among them, in women in early menopause, causes rapid loss of bone mass including estrogen decrease and ovarian function decrease, and in elderly women in late menopause, estrogen secretion decrease occurs, which results in loss of mineral content in bone, so elderly women are more susceptible to osteoporosis.
Chronic pain manifested by osteoporosis and resulting fractures and other complications severely impact the longevity and quality of life of the elderly, and increase the associated medical costs. If the osteoporosis can be prevented and the osteoporosis can be effectively intervened, the senile osteoporosis can be effectively delayed and prevented.
Disclosure of Invention
The first technical problem to be solved by the present invention is to provide a composition for increasing bone density, which can prevent osteoporosis from occurring without side effects, in view of the prior art.
The second technical problem to be solved by the invention is to provide a health care product capable of preventing osteoporosis and increasing bone mineral density without side effect aiming at the prior art.
The third technical problem to be solved by the present invention is to provide a preparation method of the above health care product for the prior art.
The technical scheme adopted by the invention for solving the first technical problem is as follows: the composition for increasing the bone density is characterized by comprising the following components in parts by weight: 12.8-19.2 parts of glucosamine hydrochloride, 10.4-15.6 parts of marine fish bone collagen oligopeptide, 6.4-9.6 parts of sodium chondroitin sulfate and 4.8-7.2 parts of eucommia ulmoides extract.
Glucosamine hydrochloride is D-glucosamine hydrochloride, has a chemical name of 2-amino-2-deoxy-D-glucose hydrochloride, is a derivative prepared from chitin, and has the function of increasing bone density. Modern pharmacological research shows that the supplement of glucosamine can provide necessary support and link for inorganic substances such as bone calcium and the like, prevent the loss of the inorganic substances such as the bone calcium and the like and effectively prevent and treat osteoporosis. Chondroitin sulfate is an acidic mucopolysaccharide existing in cartilage, tendon, sarcolemma and vessel wall of human and animal, and is an important component of connective tissue, and has obvious chondrophilic property, can enter cartilage lipid, protects cartilage, and can promote osteoblast proliferation and new bone formation. Modern pharmacological research shows that the sodium chondroitin sulfate has the function of increasing bone density. The marine fishbone collagen oligopeptide is a powdery product which takes marine fishbone as a raw material and oligopeptide (short peptide) which is produced by an enzymolysis method and has the relative molecular mass of less than 1000u as a main component, and has the advantages of good solubility, no side effect, high safety and the like. Modern pharmacological research shows that the marine fish bone collagen oligopeptide has the function of increasing bone mineral density. Eucommia ulmoides is dry bark of Eucommia ulmoides (Eucommia ulmoides Oliv.) belonging to family Eucommiaceae, and has sweet and warm taste. Enters liver and kidney meridians, and has the effects of nourishing liver and kidney, strengthening tendons and bones, and preventing miscarriage. Can be used for treating deficiency of liver and kidney, soreness of waist and knees, weakness of bones and muscles, dizziness, pregnant hemorrhage, and threatened abortion. Modern pharmacological research shows that eucommia bark has pharmacological effects of preventing bone loss and the like
The technical solution for further solving the second technical problem is as follows: a health product for increasing bone density is characterized by comprising the composition and auxiliary materials acceptable for health products.
Further, the acceptable auxiliary materials for the health care product comprise microcrystalline cellulose and povidone K30, or microcrystalline cellulose, povidone K30 and magnesium stearate.
Further, the mass parts of the microcrystalline cellulose and the povidone K30 in the auxiliary materials acceptable for the health-care products are 13.68-20.52 and 3.2-4.8 respectively;
or 13.68-20.52 parts of microcrystalline cellulose, 3.2-4.8 parts of povidone K30 and 0.72-1.08 parts of magnesium stearate.
Furthermore, the dosage form of the health care product is granules, capsules or tablets.
The technical solution adopted to further solve the third technical problem is as follows: the preparation method of the health care product is characterized by comprising the following steps:
(1) uniformly mixing the components according to the mass parts of the components in the composition, adding a certain amount of auxiliary materials, taking 95% ethanol as a wetting agent, granulating by using a 20-mesh sieve, sieving, granulating, and drying at 60 ℃ to obtain granules;
(2) tabletting or bagging or encapsulating the granules to obtain the required health-care product.
Further, the preparation method comprises the following steps:
(1) preparing eucommia ulmoides extract;
(2) concentrating the above Eucommiae cortex extractive solution to density of 1.02-1.05g/ml to obtain concentrated extractive solution;
(3) spray drying the concentrated extract to obtain eucommia ulmoides extract, wherein the air inlet temperature of spray drying is 180-200 ℃;
(4) uniformly mixing the raw materials and the auxiliary materials in parts by weight: 12.8-19.2 parts of glucosamine hydrochloride, 10.4-15.6 parts of marine fish bone glue oligopeptide, 6.4-9.6 parts of sodium chondroitin sulfate, 4.8-7.2 parts of eucommia ulmoides extract, 13.68-20.52 parts of microcrystalline cellulose and 303.2-4.8 parts of povidone K;
(5) mixing the above raw materials and adjuvants uniformly, granulating with 95% ethanol as wetting agent, sieving with 20 mesh sieve, grading, and oven drying at 60 deg.C to obtain granule;
(6) mixing the granules with 0.72-1.08 parts of magnesium stearate, tabletting and coating to obtain the required health-care product; or covering with capsule to obtain the desired health product; or directly bagging to obtain the required health product.
Compared with the prior art, the invention has the advantages that: the composition of the invention scientifically combines glucosamine hydrochloride, marine fish bone collagen oligopeptide, sodium chondroitin sulfate and eucommia ulmoides extract, wherein the glucosamine hydrochloride can prevent loss of inorganic substances such as bone calcium and the like, the sodium chondroitin sulfate can enter cartilage lipid to protect cartilage and promote osteoblast proliferation and new bone formation, the glucosamine hydrochloride, the marine fish bone collagen oligopeptide and the sodium chondroitin sulfate have the obvious function of increasing bone density, the eucommia ulmoides extract can prevent bone loss, the bone density can be effectively increased and osteoporosis can be prevented through the cooperation of the components, and a health care product prepared from the composition has no toxic or side effect and has an obvious effect of increasing the bone density. In the preparation method, microcrystalline cellulose and povidone K30 are added and then wet granulation is carried out, and the mixture is processed into the required dosage form. By adjusting the proportional relation of raw materials and auxiliary materials and optimizing wet granulation, the raw materials can achieve better synergistic improvement effect, namely after the components are combined, the drug effect is remarkably improved compared with that of the single use, and the drug effect is more durable.
Detailed Description
The present invention will be described in further detail with reference to examples.
Example 1: study on extraction Process of eucommia ulmoides
1-1 determination of optimal cooking conditions
In order to determine the optimal decoction conditions of Eucommiae cortex, the solid extraction rate (%) is used as the index for examination, and L is selected9(34) In the table, three factors of the number of decoction times (A), the decoction time (B) and the water addition amount (C) were subjected to orthogonal tests, and three levels of the factors were screened, as shown in Table 1 below. 100g of eucommia ulmoides is taken, and the eucommia ulmoides is decocted, filtered and concentrated to a certain volume according to the experimental arrangement of the table 1. The results and visual analysis of the measurements of the solids in each test sample are shown in Table 2, and the results of the ANOVA are shown in Table 3.
TABLE 1 test factor level table
TABLE 2L9(34) Experiment arrangement, experiment result and data processing table
TABLE 3 ANOVA TABLE
The analysis of variance results show that: FA is more than F0.05(2, 2), and the level change of the factor A has significant influence on the experimental result; FB < Fc < F0.05(2, 2), and changes in the level of factor B, C had no significant effect on the experimental results. Considering that the factor A solid extraction rate K2 and K3 are not very different, 2 times of extraction are selected, and the factor B, C solid extraction rate K2 and K3 are not very different, from the economic point of view, 8 times of water amount is selected, and the extraction time is 1.5 hours. The best scheme of the extraction process is A2B2C2, namely: the medicinal materials are decocted for 2 times by adding 8 times of water, and each time lasts for 1.5 hours, so that a better decocting effect can be obtained.
1-2 determination of optimum spray drying conditions
The spray drying feed liquid has small density, large volume and prolonged spraying time; the density is high, the atomization drying effect is poor, the wall is easy to stick, and the loss is caused, so that the proper feed liquid density needs to be selected. The relative densities (measured at 60 ℃) of the extract solutions of 1.02, 1.05 and 1.07 are respectively considered, and the powder yield is shown in Table 4 after direct spraying.
TABLE 4 investigation of spray drying of eucommia ulmoides extracts at different densities
Therefore, the liquid medicine with the relative density of 1.02 and 1.05 is not obviously adhered to the wall during spray drying, and the powder yield is high, so the liquid medicine is concentrated to the relative density of 1.02-1.05 for spray drying.
The air inlet temperature is considered to be 200 ℃, 190 ℃, 180 ℃ and 170 ℃, the moisture of the spray powder is measured, and the properties of the spray powder are observed, and the results are shown in table 5. Therefore, the air inlet temperature is selected to be 180-200 ℃ from the energy-saving point of view.
TABLE 5 spray drying conditions at different inlet air temperatures
The optimum spray drying conditions of the eucommia ulmoides extract in the invention are as follows: the relative density is 1.02-1.05, and the air inlet temperature is 180-200 ℃.
In conclusion, the preparation method of the eucommia ulmoides extract comprises the following steps: decocting eucommia ulmoides with water of which the volume is 8 times of that of the eucommia ulmoides for 2 times, wherein each time lasts for 1.5 hours, filtering out liquid medicine, discarding medicine residues, combining the liquid medicine, and concentrating to the density of 1.02-1.05g/ml to obtain an eucommia ulmoides extracting solution; and (3) carrying out spray drying on the extracting solution, wherein the air inlet temperature is 180-200 ℃, and thus obtaining the eucommia ulmoides extract.
Example 2: preparation of the health product of the invention
(1) Preparation of eucommia ulmoides extract (see the preparation method obtained in example 1 above):
decocting Eucommiae cortex with 8 times of water for 2 times, each time for 1.5 hr, filtering to obtain medicinal liquid, discarding residue, mixing medicinal liquids, and concentrating to density of 1.02-1.05g/ml to obtain Eucommiae cortex extractive solution; spray drying the above extractive solution at air inlet temperature of 180 deg.C and 200 deg.C to obtain Eucommiae cortex extract.
(2) Uniformly mixing the raw materials and the auxiliary materials in parts by weight: 12.8-19.2 parts of glucosamine hydrochloride, 10.4-15.6 parts of marine fish bone glue oligopeptide, 6.4-9.6 parts of sodium chondroitin sulfate, 4.8-7.2 parts of eucommia ulmoides extract, 13.68-20.52 parts of microcrystalline cellulose and 303.2-4.8 parts of povidone K.
(3) Mixing the above raw materials and adjuvants uniformly, granulating with 95% ethanol as wetting agent, sieving with 20 mesh sieve, grading, and oven drying at 60 deg.C to obtain granule;
(4) mixing the granules with 0.72-1.08 parts of magnesium stearate, tabletting, and coating to obtain the health product.
Example 3: toxicity test
This example performed first and second-stage toxicity tests on the nutraceutical prepared in example 2 (the dosage form used in this example was a tablet) including rat acute oral toxicity test, Ames test, mouse myelophagocytophilic micronucleus test, mouse teratospermia test, and rat 30-day feeding test. The acute oral toxicity test and the 30-day feeding test adopt SPF SD rats purchased from the experimental animal center of the college of traditional Chinese medicine science of Sichuan province, and are half male and half female. SPF-level Kunming mice are adopted in micronucleus tests, the male mice are half female and half male, SPF-level Kunming male mice are adopted in teratospermia tests, and the micronucleus tests are all purchased from Soudou laboratory animals company Limited.
Acute toxicity test of this example: the group with 15g/kg.bm dose has no animal death within two weeks, has no obvious poisoning symptom or adverse reaction, and has the maximum acute oral tolerance dose of more than 15g/kg.bw for female and male SD rats, which belongs to the nontoxic level.
Micronucleus test for this example: the experiment is provided with three dose groups of 2.5g/kg.bw, 5.0g/kg.bw and 10.0g/kg.bw, the result shows that the difference between the PCE/NCE ratio of each dose group and a negative control group is within 20 percent of the control group, and the statistic shows that the difference is not significant (P is more than 0.05), which indicates that the sample has no adverse reaction on the mouse bone marrow cell proliferation. The results of the Poisson distribution method show that the micronucleus rates of the male and female animals in the positive control group are both obviously higher than those in the negative control group (P is less than 0.01), and the micronucleus rates of all groups of the tested substances have no significant difference (P is more than 0.05) compared with those in the negative control group, which indicates that the test product is a negative result in the micronucleus test of the bone marrow cells of the mice.
Teratospermia test for this example: the test shows that the sperm abnormality rate of the negative control group is obviously higher than that of the negative control group (P is less than 0.01) by setting three dose groups of 2.5g/kg.bw, 5.0g/kg.bw and 10.0g/kg.bw, and the sperm abnormality rate of each dose group of the health product has no obvious difference (P is more than 0.05) compared with the negative control group, which indicates that the health product of the invention has a negative result in the mouse sperm abnormality test.
Ames test of this example: strains TA97, TA98, TA100 and TA102 (all purchased from Shanghai Protect Biotech Co., Ltd.) were selected for the standard plate incorporation test without increasing the liver S9 of mice. The experimental results are as follows: the average number of the reversion colonies per dish of the spontaneous control group is within the normal value range regardless of the test without adding S9, and the average number of the reversion colonies per dish induced by the negative control group is more than twice of that of the spontaneous control group, and the spontaneous control group shows obvious positive reaction. The average reversion colony number of each dosage group and the solvent control group of the health care product does not exceed one time of that of a spontaneous control group, and the health care product shows a negative reaction, namely the effect of no induced test strain reversion.
The rats of this example were fed for 30 days: the experiment is designed with three dose groups of 1.95g/kg.bw, 4.55g/kg.bw and 6.50g/kg.bw, which are equivalent to 30, 70 and 100 times of the recommended intake of people. The experimental results are as follows: the highest dose is 100 times of the recommended intake of human body, the health care product does not cause abnormal changes of important indexes such as the overall health condition, physiological and biochemical functions, organ tissue morphology and the like of the rat, and the initially estimated maximum dose of no harmful effect observed is more than 6.50 g/kg.bw.
Example 4: test for increasing bone Density
Dose design: five groups, namely a sham operation group, a model control group and three dose groups of 325mg/kg.bw, 650mg/kg.bw and 1950mg/kg.bw (the health care product prepared in example 2 is adopted, and the dosage form adopted in the example is a tablet) are set in the test, the five groups correspond to 5, 10 and 30 times of the recommended intake of the human body, and the test period is 13 weeks.
Animals were euthanized at the end of the experiment and bilateral femurs were removed: the right femur was placed in an oven at 105 deg.C, baked to constant weight, and the bone weight was weighed. The calcium content of the right femur is determined by adopting an atomic absorption spectrophotometry, and the bone density of the left femur is determined by adopting a full-automatic high-resolution X-ray machine for small animals.
The experimental results show that: the weights of the sham operation group and the castration operation groups before the experiment are not significantly different, the weights of the model control group are significantly higher than those of the sham operation group in the middle period and the later period of the experiment, the bone density of the left femur and the calcium content of the right femur are significantly lower than those of the sham operation group, and an oophorectomy model is successfully established. The middle-stage and end-stage body weights of the three dose groups of the test object have no significant difference compared with the model control group, the left femur bone density of the three dose groups is significantly higher than that of the model control group, and the other indexes have no significant difference compared with the model control group. It can be seen that the increased health product of the present invention significantly increased bone density in the test animals (same as the test animals used in example 3).
Claims (7)
1. The composition for increasing the bone density is characterized by comprising the following components in parts by weight: 12.8-19.2 parts of glucosamine hydrochloride, 10.4-15.6 parts of marine fish bone collagen oligopeptide, 6.4-9.6 parts of sodium chondroitin sulfate and 4.8-7.2 parts of eucommia ulmoides extract.
2. A nutraceutical for increasing bone density comprising the composition of claim 1 and a nutraceutical acceptable excipient.
3. The nutraceutical of claim 2, wherein said nutraceutical-acceptable excipients comprise microcrystalline cellulose and povidone K30, or microcrystalline cellulose, povidone K30, and magnesium stearate.
4. The health product according to claim 3, wherein the health product acceptable auxiliary materials comprise 13.68-20.52 parts by weight of microcrystalline cellulose and 3.2-4.8 parts by weight of povidone K30;
or 13.68-20.52 parts of microcrystalline cellulose, 3.2-4.8 parts of povidone K30 and 0.72-1.08 parts of magnesium stearate.
5. The health product according to any one of claims 2 to 4, wherein the dosage form of the health product is granules, capsules or tablets.
6. A process for the preparation of a nutraceutical according to any of claims 2 to 5, characterized in that it comprises the following steps:
(1) uniformly mixing the components according to the mass parts of the components in the composition, adding a certain amount of auxiliary materials, taking 95% ethanol as a wetting agent, granulating by using a 20-mesh sieve, sieving, granulating, and drying at 60 ℃ to obtain granules;
(2) tabletting or bagging or encapsulating the granules to obtain the required health-care product.
7. The method of claim 6, comprising the steps of:
(1) preparing eucommia ulmoides extract;
(2) concentrating the above Eucommiae cortex extractive solution to density of 1.02-1.05g/ml to obtain concentrated extractive solution;
(3) spray drying the concentrated extract to obtain eucommia ulmoides extract, wherein the air inlet temperature of spray drying is 180-200 ℃;
(4) uniformly mixing the raw materials and the auxiliary materials in parts by weight: 12.8-19.2 parts of glucosamine hydrochloride, 10.4-15.6 parts of marine fish bone glue oligopeptide, 6.4-9.6 parts of sodium chondroitin sulfate, 4.8-7.2 parts of eucommia ulmoides extract, 13.68-20.52 parts of microcrystalline cellulose and 303.2-4.8 parts of povidone K;
(5) mixing the above raw materials and adjuvants uniformly, granulating with 95% ethanol as wetting agent, sieving with 20 mesh sieve, grading, and oven drying at 60 deg.C to obtain granule;
(6) mixing the granules with 0.72-1.08 parts of magnesium stearate, tabletting and coating to obtain the required health-care product; or covering with capsule to obtain the desired health product; or directly bagging to obtain the required health product.
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