CN105412569A - Composition for increasing bone mineral density and preparation and preparation method thereof - Google Patents
Composition for increasing bone mineral density and preparation and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a composition for increasing the bone mineral density and preparation and a preparation method thereof. The composition is mainly prepared from, by weight of parts, calcium carbonate, D-glucosamine hydrochloride, chondroitin sulfate, collagen protein, a casein phosphopepetides, a davallia mariesii extract and a vitamin K2. On the specific matched condition, the effect of remarkable synergistic interaction for treating osteoporosis is achieved, and the effects of blocking calcium loss and reinforcing calcium absorption are achieved; after traditional Chinese medicines of shaddock peels, chicken shells, purple bergenia herb and schisandra chinensis are added, the effect of increasing the bone density is further enhanced, and meanwhile the effects of treating the joint inflammation, tonifying the spleen and the kidney, strengthening tendons and bones, improving immunity and the like are achieved.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, particularly a kind of increase bone density compositions and preparation and method for making.
Background technology
Osteoporosis (Osteoporosis, OP) be a kind of systemic skeletal disease caused by many reasons, it reduces with bone amount, and bone density declines, osseous tissue microstructure deteriorates to feature, causes bone fragility to increase and a kind of degenerative osteopathy occurred with the increase at age.Osteoporosis is a kind of Senile disease, and women's morbidity, higher than male, is cause dysostosis by many reasons and formed.Bone density is an important symbol of bone mass, reflects osteoporotic degree, the important evidence of prediction osteoporotic fracture.Osteoporosis, as modern civilization diseases, has become one of global important public hygiene problem.According to incompletely statistics, the senile osteoporosis disease sickness rate of China more than 60 years old is about 59.89%, increases bone density, effectively treatment osteoporosis and has become the important topic of people's extensive concern.
According to osteoporotic cause of disease situation, treating and be osteoporoticly broadly divided into bone resorption inhibitor, bone formulation stimulant, bone mineralising promoter and other kinds totally four large classes, take bone resorption inhibitor as primary treatment medicine.Bone resorption inhibitor suppresses the absorption of bone by the production (as estrogen) or minimizing osteoclast activity (as diphosphonate) reducing osteoclast, prevents bone amount from too much losing.Bone resorption inhibitor can be used to treat the serious osteoporosis patient of quick bone loss.After the risk problem exposure of Hormone Replacement Therapy, be dominate at present with bisphosphonates.But the life-time service of these medicines all has obvious side effect, as bisphosphonates side effect comprises the necrosis of oesophageal irritation, hypocalcemia, kidney irritation or very rare mandible, clinical data shows that Diphosphonate treatment also can cause atrial fibrillation.
The product of current increase bone density class is a large class in health food, and this type of health food was very by the welcome of consumer in recent years, and market sale potentiality are larger.Country allows to use the raw material increasing bone density class in health product, its functional component has Chinese herbal medicine class, chondroitin sulfates, aminoglucose saccharide, collagen protein class, vitamins etc., the novelty teabag of a kind of pharmaceutical composition disclosed in Chinese patent application CN103721242A in prevention or treatment osteoporosis, described medicine is prepared from according to certain parts by weight by glucosamine hydrochloride, biological calcium carbonate, Rhizoma Drynariae extract, phosphopeptide caseinate, chondroitin sulfate and Herba Epimedii extract; A kind of health food increasing bone density disclosed in Chinese patent application CN104432029A, D-Glucosamine Hydrochloride, soybean isoflavone, chondroitin sulfate, calcium carbonate, collagen protein, newborn mineral salt, phosphopeptide caseinate, hyaluronate sodium and vitamin D
3combine according to certain parts by weight and be prepared from.But the function of these products, action pathway are single, to suffer from osteoporosis and with the middle-aged and elderly people of the orthopaedic disease such as osteoarthritis, osteodynia there is no preventive effect, and bioavailability is low, poor stability, cannot meet the many-sided needs of people.
Summary of the invention
The invention is characterized in provide a kind of safe and effective, formula rationally, have and increase bone density, protect osteoarthrosis and the composition and method of making the same of multi-efficiency of building up resistance.
For achieving the above object, the concrete technical scheme of the present invention is as follows:
Increase a compositions for bone density, the raw material primarily of following weight portion is prepared from through processing: Radix Rehmanniae 5-16, Radix Ginseng 5-16, Radix Salviae Miltiorrhizae 5-16, Radix Scrophulariae 5-16, Poria 5-16, Radix Polygalae 5-16, Fructus Schisandrae Chinensis 2-10, Radix Angelicae Sinensis 2-10, Radix Asparagi 2-10, Radix Ophiopogonis 2-10, Semen Platycladi 5-16, Semen Ziziphi Spinosae 5-16.
In this described compositions, D-Glucosamine Hydrochloride is from natural chitin extraction, is a kind of marine biological preparation, the synthesis of human body mucopolysaccharide can be promoted, improve the viscosity of knuckle synovia, the metabolism of articular cartilage can be improved, increase synovial fluid synthesis, joint lubrication function is provided; Phosphopeptide caseinate is the polypeptide containing bunch phosphoric acid silk ammonia phenol, and it and Ca2+, Fe2+ ion have affinity, under the condition without the need to increasing vitamin D, can promote the growth of child suffering from rickets's skeleton, and have the effect such as dental caries, anti-bone loss; Chondroitin sulfate has by stimulating chondrocyte synthesis collagen protein, proteoglycan and hyaluronic acid to promote osteoblast proliferation, induction new bone formation; Bone collagen can maintain the automatic generting machanism of human body native cartilage tissue, and Saving cortilage avoids wearing and tearing and damages, and also can prevent the osteoarthritis caused by a variety of causes, this external enwergy is fixed calcareous, avoids calcium loss, causes bone density to reduce; It is calcareous that calcium carbonate can supply needed by human body, supplements the bone amount loss that mid-aged population occurs with aging, can increase calcium content of bone and bone density, have good preventive and therapeutic effect to osteoporosis and rickets; Rhizoma Drynariae extract bitter in the mouth, warm in nature, returning liver, kidney channel, have pain relieving of curing the wound, effect of the kidney invigorating bone strengthening, is one of osteoporotic key agents of the conventional treatment of the traditional Chinese medical science.
Vitamin K
2with above-mentioned six kinds of composition combineds effect, all medicines share, and under said ratio condition, have remarkable Synergistic and treat osteoporotic effect, and have the effect blocking calcium loss, strengthen calcium absorption.
Further, the raw material that described compositions also comprises following weight portion is prepared: Herba Taraxaci 5-13, Polyporus 3-10, Radix Gentianae 3-10, CitrusaurantiumL.Var.amara Engl. 2-9.
The described composite formula of further optimization, in conjunction with theory of Chinese medical science, analyze raw material of Chinese medicine effective ingredient, Chinese and Western combines, make the further synergism of each component after above-mentioned raw materials in addition, multi-faceted, many-sided effect reaching increase bone density, further increases therapeutic effect, and has the effects such as treatment of arthritis disease, strengthening spleen, tonifying kidney, bone and muscle strengthening, raising immunity simultaneously.
Preferably, preparing the raw materials used parts by weight of described compositions is: Radix Rehmanniae 5, Radix Ginseng 5, Radix Salviae Miltiorrhizae 5, Radix Scrophulariae 5, Poria 5, Radix Polygalae 5, Fructus Schisandrae Chinensis 3, Radix Angelicae Sinensis 3, Radix Asparagi 3, Radix Ophiopogonis 3, Semen Platycladi 5, Semen Ziziphi Spinosae 5.
In order to improve ease of use, the oral formulations that the compositions of described increase bone density and pharmaceutically acceptable adjuvant are made by the present invention, described preparation oral liquid, the compositions of described increase bone density and adjuvant ratio of weight and number are 1:0.05-0.1.
Preferably, adjuvant comprises the correctives and antiseptic that ratio of weight and number is 3-4:0.1-0.3.
Further preferably, the mixture of the eudesmol of described correctives to be ratio of weight and number be 1:3:2:2, L-citronellal, citric acid and sodium chloride; The mixture of the butyl p-hydroxybenzoate of described antiseptic to be ratio of weight and number be 5:3:2, disodium edetate and propanoic acid.
Further preferably, described adjuvant also comprises the cosolvent that ratio of weight and number is 0.8-1.2, the mixture of the ethyl lactate of described cosolvent to be ratio of weight and number be 10:4:1,2,2'-ethylenedioxybis(ethanol). and lanoline.
Above-mentioned adjuvant selected by the present invention, with the active component in each component and Chinese medicine extract without effect, three kinds of accessory formulas are reasonable, wherein diluent not only plays the effect of dilution and filling, the characteristic of good mobility can also be taken into account, make constituent content even, drug dose is controlled, plays stable effect to active component simultaneously; Using the mixed adhesive of above-mentioned consumption, the bonding that tablet powder is good can be made, and make tablet have suitable hardness and brittleness, ensureing that tablet quality makes tablet also can ensure good character when carrying out film coating; Use above-mentioned consumption mixing disintegrating agent to match with other adjuvants, ensure the disintegrate effectiveness of tablet, make the active component of compositions can reach maximum absorption with the fastest speed.
In compositions of the present invention, effective ingredient in Chinese medicine extract is many containing optics and biologic activity, fairly be subject to the change of environment and affect and change self structure, thus reduction even loses therapeutic effect, for improving the stability of tablet, film coating is carried out to tablet, comprehensive considering various effects and result of the test, preferably above-mentioned film-coating premixing material, each component is learnt from other's strong points to offset one's weaknesses synergism, play the effect of lucifuge, isolated air and moisture, effectively add medicine stability; Make tablet coating firmly smooth in addition, the stability of film-coating premixing material own is high, increases tablet stability further, is beneficial to and stores and transport.
The invention provides the preparation method of the compositions of described increase bone density further, the method comprises the steps:
1) get Semen Platycladi, Radix Angelicae Sinensis, Radix Gentianae, CitrusaurantiumL.Var.amara Engl., Fructus Schisandrae Chinensis, Radix Scrophulariae, Radix Ginseng and Herba Taraxaci clean dry, adding raw material weight 4-6 mass ratio doubly after pulverizing is the methanol of 1-2:6-8:2-3: ethanol: the mixed solvent of water carries out reflux, extract, three times, extract 3,2,1.5 hours respectively, then merge extractive liquid, concentrating under reduced pressure after filtering, lyophilization, obtains fine powder stand-by;
2) get Radix Rehmanniae, Polyporus, Radix Salviae Miltiorrhizae, Poria, Radix Polygalae, Radix Asparagi, Radix Ophiopogonis and Semen Ziziphi Spinosae clean dry, add raw material gross weight 5-7 soak by water doubly three times, each 2-3 hour, merge decocting liquid, concentrating under reduced pressure after filtering, the fine powder after lyophilization is stand-by;
3) by step 1) fine powder that obtains and step 2) the fine powder mix homogeneously that obtains, obtain described compositions.
Preferred preparation method of the present invention, is through lot of experiments, reasonably plans as a whole and contrast sum up and go out, and extracts comprehensively and remains the effective ingredient of medicine, ensure that reasonability and the high efficiency of medicine.
In addition, the present invention also provides the purposes of described compositions and preparation thereof, for the preparation of the application improved in immunity, improving water flood and antitumor drug.
The compositions of increase bone density of the present invention, in conjunction with theory of Chinese medical science, analyzes raw material of Chinese medicine effective ingredient, and Chinese and Western combines, and is aided with the optimization of clinical application for many years simultaneously, overcomes the problem of taboo combination, has no side effect to health; Each component synergism, under specific conditions of mixture ratios, there is remarkable Synergistic and treat osteoporotic effect, multi-faceted, many-sided effect reaching increase bone density, and have the effect such as blocking-up calcium loss, reinforcement calcium absorption, treatment of arthritis disease, strengthening spleen, tonifying kidney, bone and muscle strengthening, raising immunity.
Detailed description of the invention
Embodiment 1
Increase a compositions for bone density, said composition is prepared from through processing by the raw material of following parts by weight: calcium carbonate 20, D-Glucosamine Hydrochloride 28, chondroitin sulfate 21, bone collagen 15, phosphopeptide caseinate 16, Rhizoma Drynariae extract 17, vitamin K
210.
Embodiment 2
Increase a compositions for bone density, said composition is prepared from through processing by the raw material of following parts by weight: calcium carbonate 20, D-Glucosamine Hydrochloride 25, chondroitin sulfate 20, bone collagen 14, phosphopeptide caseinate 13, Rhizoma Drynariae extract 22, vitamin K
213, Pericarpium Citri grandis 12, Ovum Gallus domesticus crusta 25, Rhizoma Seu Herba Bergeniae 8, Fructus Schisandrae Chinensis 16.
Embodiment 3
Increase a compositions for bone density, said composition is prepared from through processing by the raw material of following parts by weight: calcium carbonate 15, D-Glucosamine Hydrochloride 20, chondroitin sulfate 18, bone collagen 12, phosphopeptide caseinate 10, Rhizoma Drynariae extract 15, vitamin K
28; The preparation method of described Rhizoma Drynariae extract is:
1) Rhizoma Drynariae raw material, the solvent adding parts by weight of raw materials 35 times carries out reflux, extract, three times, extracts 3,2,1.5 hours respectively, the methanol of described solvent to be mass ratio be 1:5:2: ethanol: the mixed solvent of water;
2) merge after extracting liquid filtering, concentrate under reduced pressure at low temperature is extremely without alcohol, and the hot extracted with diethyl ether of crude drug aqueous solution equal-volume obtained four times, after merging organic facies, concentrate under reduced pressure at low temperature, after vacuum drying, obtains Rhizoma Drynariae extract.
Embodiment 4
Increase a compositions for bone density, be prepared from through processing by the raw material of following weight portion: calcium carbonate 28, D-Glucosamine Hydrochloride 32, chondroitin sulfate 22, bone collagen 21, phosphopeptide caseinate 20, Rhizoma Drynariae extract 25, vitamin K
215, Pericarpium Citri grandis 21, Ovum Gallus domesticus crusta 26, Rhizoma Seu Herba Bergeniae 16, Fructus Schisandrae Chinensis 26;
The preparation method of described compositions:
1) Rhizoma Drynariae raw material, the solvent adding parts by weight of raw materials 35 times carries out reflux, extract, three times, extracts 3,2,1.5 hours respectively, the methanol of described solvent to be mass ratio be 2:7:3: ethanol: the mixed solvent of water; Merge after extracting liquid filtering, concentrate under reduced pressure at low temperature to without alcohol, the hot extracted with diethyl ether of crude drug aqueous solution equal-volume obtained four times, after merging organic facies, concentrate under reduced pressure at low temperature, after vacuum drying, obtains Rhizoma Drynariae extract;
2) get Ovum Gallus domesticus crusta clean dry, add after pulverizing raw material weight 2 times 15% aqueous acetic acid soak 12h, then take out dry, again pulverize fine powder is for subsequent use;
3) get Pericarpium Citri grandis, Rhizoma Seu Herba Bergeniae and Fructus Schisandrae Chinensis clean dry, the ethanol water reflux, extract, with 85% three times, first time add 3 times of raw material gross weight ethanol water reflux 4h; Second time adds the ethanol water backflow 3h of 2 times of raw material gross weight; Add the ethanol water backflow 2h of 2 times of raw material gross weight for the third time, merge extractive liquid, concentrating under reduced pressure obtains extractum, obtains powder stand-by after lyophilization;
4) by step 1) Rhizoma Drynariae extract of gained, step 2) fine powder that obtains, step 3) powder that obtains and calcium carbonate, D-Glucosamine Hydrochloride, chondroitin sulfate, bone collagen, phosphopeptide caseinate and vitamin K
2after mix homogeneously, again grind and obtain described compositions.
Embodiment 5
Increase a compositions for bone density, be prepared from through processing by the raw material of following weight portion: calcium carbonate 15, D-Glucosamine Hydrochloride 20, chondroitin sulfate 18, bone collagen 12, phosphopeptide caseinate 10, Rhizoma Drynariae extract 15, vitamin K
28, Pericarpium Citri grandis 12, Ovum Gallus domesticus crusta 20, Rhizoma Seu Herba Bergeniae 5, Fructus Schisandrae Chinensis 16;
The preparation method of described compositions:
1) Rhizoma Drynariae raw material, the solvent adding parts by weight of raw materials 35 times carries out reflux, extract, three times, extracts 3,2,1.5 hours respectively, the methanol of described solvent to be mass ratio be 3:12:5: ethanol: the mixed solvent of water; Merge after extracting liquid filtering, concentrate under reduced pressure at low temperature to without alcohol, the hot extracted with diethyl ether of crude drug aqueous solution equal-volume obtained four times, after merging organic facies, concentrate under reduced pressure at low temperature, after vacuum drying, obtains Rhizoma Drynariae extract;
2) get Ovum Gallus domesticus crusta clean dry, add after pulverizing raw material weight 2 times 15% aqueous acetic acid soak 12h, then take out dry, again pulverize fine powder is for subsequent use;
3) get Pericarpium Citri grandis, Rhizoma Seu Herba Bergeniae and Fructus Schisandrae Chinensis clean dry, the ethanol water reflux, extract, with 98% three times, first time add 5 times of raw material gross weight ethanol water reflux 2h; Second time adds the ethanol water backflow 2h of 3 times of raw material gross weight; Add the ethanol water backflow 1h of 3 times of raw material gross weight for the third time, merge extractive liquid, concentrating under reduced pressure obtains extractum, obtains powder stand-by after lyophilization;
4) by step 1) Rhizoma Drynariae extract of gained, step 2) fine powder that obtains, step 3) powder that obtains and calcium carbonate, D-Glucosamine Hydrochloride, chondroitin sulfate, bone collagen, phosphopeptide caseinate and vitamin K
2after mix homogeneously, again grind and obtain described compositions.
Embodiment 6 tablet
Preparation method:
1) lactose and disodium edetate being joined weight adds in 50% ethanol water of 2 times amount, fully be ground to pastel, compositions prepared by embodiment 1, the locust bean gum of 1/2nd amounts and the mixture of sucrose fatty acid ester are joined in pastel, granulates after mix homogeneously and drying;
2) by residue locust bean gum and the mixture of sucrose fatty acid ester, sodium carboxymethyl cellulose and cholesterol mix homogeneously, after tabletting, label is obtained;
3) film coating pre-mix dose being dissolved in acetone or alcohol, to step 2 after mix homogeneously) label of gained carries out coating, obtains described tablet.
Embodiment 7 tablet
Preparation method:
1) just lactose and disodium edetate join weight and add in 50% ethanol of 2 times amount, fully be ground to pastel, compositions prepared by embodiment 2, the locust bean gum of 1/2nd amounts and the mixture of sucrose fatty acid ester are joined in pastel, granulates after mix homogeneously and drying;
2) by residue locust bean gum and the mixture of sucrose fatty acid ester, sodium carboxymethyl cellulose and cholesterol mix homogeneously, after tabletting, label is obtained;
3) by after acetate fiber dibutylamino carboxylic propyl ether, N-dodecyl amine xyloside, polyoxyethylene ether and silicone oil mix homogeneously, be dissolved in acetone, mix homogeneously adopts nebulization to step 2) label of gained carries out coating, obtains described tablet.
Embodiment 8 tablet
Preparation method: be prepared by the method described in embodiment 7.
Comparative examples 1 tablet
Preparation method: be prepared by the method described in embodiment 7.
Comparative examples 2 tablet
Preparation method: be prepared by the method described in embodiment 7.
Comparative examples 3 tablet
Preparation method: be prepared by the method described in embodiment 7.
Comparative examples 4
Preparation method:
1) just lactose and disodium edetate join weight and add in 50% ethanol of 2 times amount, fully be ground to pastel, compositions prepared by embodiment 2, the locust bean gum of 1/2nd amounts and the mixture of sucrose fatty acid ester are joined in pastel, granulates after mix homogeneously and drying;
2) by residue locust bean gum and the mixture of sucrose fatty acid ester, sodium carboxymethyl cellulose and cholesterol mix homogeneously, after tabletting, described tablet is namely obtained.
Test 1 compositions and increase bone substance density improving function zoopery
1 test material
1.1 test medicine:
Test group 1 is compositions prepared by embodiment 1, test group 2 is the compositions described in embodiment 2, matched group 1 is pharmaceutical composition a kind of disclosed in Chinese patent application CN103721242A, and matched group 2 is the health food increasing bone density a kind of disclosed in Chinese patent application CN104432029A; Human body oral recommended amounts every day is 0.05g/kgbw.
1.2 experimental animals:
Cleaning grade SD rat, body weight is about 100g, and experiment condition is ambient temperature 22 DEG C ~ 24 DEG C, humidity 50%-56%.
2 test methods and result
2.1 test method
After rat adaptability feeds 3d, 5 groups are divided at random by body weight, often organize 10, be respectively blank group, test group 1, test group 2, matched group 1 and matched group 2, test group and matched group are all 30 times of human body recommended amounts to rat dosage, be gavage to quadrat method, the every 100g body weight of blank group gavage every day gives 1.0mL deionized water.Carry out the test of medicine gavage after each group of rat raises 3 weeks continuously with low calcium feedstuff, continue nursing and measure the indices increasing bone substance density improving function afterwards in 60 days, result of the test is in table 1.
The impact of table 1 each treated animal femur weight, calcium content of bone and bone density
Result of the test shows, compositions for increasing bone density of the present invention significantly can increase the femur weight of rat, calcium content of bone and bone density, test group 1 and the compositions curative effect described in test group 2 are all better than contrast 1 group and contrast 2 groups, and test 2 groups for test 1 group, also there is diversity, think according to " health food inspection and assessment technical specification (2003 editions) " criterion, compositions of the present invention has the function increasing bone density.
Test 2 compositionss and strengthen body immunity test
1. test crowd
100 routine experimenters, the age is all between 35-78 year; Whole experimenter checks through clinical, biochemical, cytology etc. and belongs to immunocompromised person.
2. divide into groups
100 routine hypoimmunity experimenters are divided into test 1 group of 33 people at random, test 2 group of 34 people, matched group 33 people; Test 1 group of compositions taken described in the embodiment of the present invention 2; Test 2 groups of compositionss taken described in the embodiment of the present invention 1; Matched group takes a kind of health food increasing bone density disclosed in Chinese patent application CN104432029A; All take 3 months for two groups; Difference venous blood collection before and after whole experimenter is edible, censorship t lymphocyte subset group CD
4 +, CD
8 +.
3. Evaluation of Immunity
Observe t lymphocyte subset group CD
4 +, CD
8 +, CD
4 +/ CD
8 +change.
4. statistical analysis
Test data adopts spss10.0 software to carry out statistical analysis, measurement data with
compare between group and adopt t inspection, in group, different time point compares employing one factor analysis of variance, and P < 0.05 is for there being significant difference.
5. result
The change of three groups of subject immune's power the results are shown in Table 2;
Table 2 liang group to the effectiveness comparison of immunity (
)
For test 2 groups, P
a< 0.05; For matched group, P
a< 0.05, P
b> 0.05.
6. conclusion
After test group patient takes the compositions described in test 1 group, its t lymphocyte subset group CD
4 +, CD
8 +and CD
4 +/ CD
8 +all obviously raise, with take before more variant; And test 2 groups and matched group take before and take rear comparison, CD
4 +, CD
8 +and CD
4 +/ CD
8 +all there is no significant change, illustrate that the compositions described in the embodiment of the present invention 2 is compared relative to embodiment 1, except having increase bone density, improving outside effect of bone mass, also there is the function of obvious enhancing immunity.
Test 3 tablet stability tests
3.1 accelerated test
The tablet of Example 7, embodiment 8, comparative examples 1, comparative examples 2, comparative examples 3 and comparative examples 4, all at temperature 40 DEG C ± 2 DEG C, relative humidity is place 6 months under the condition of 75% ± 5%, sample respectively once 1 month, 2 months, 3 months, 6 the end of month at duration of test, detect the content (%) of the character of tablet, the labelled amount (%) of sulfur acid chrondroitin and Rhizoma Drynariae extract naringin, the results are shown in Table 3.
Wherein, the assay (HPLC method) of Rhizoma Drynariae extract naringin is as follows:
Chromatographic condition: chromatographic column octadecylsilane chemically bonded silica is filler, mobile phase is methanol-acetic acid-water (35:4:65), determined wavelength 283nm, and column temperature 25 DEG C, theoretical cam curve is not less than 3000.
Table 3 is group accelerated test result respectively
As can be seen from above-mentioned result of the test, embodiment 7 is compared with comparative examples 1-3, difference is only diluent components used and content difference, in comparative examples 1, diluent is become microcrystalline Cellulose, diluent in comparative examples 2 has only used a kind of lactose, lactose in comparative examples 3 and the amount ratio of disodium edetate there occurs change, the diluent of comparative examples 1-3 is adopted all to make the stability of tablet significantly reduce, draw thus to only have and select lactose of the present invention and disodium edetate mixture, its ratio is 5:1, and adopt film coating pre-mix dose of the present invention can significantly improve the stability of described tablet, make it under constant high temperature super-humid conditions, place after 6 months, the inner main component of appearance character and tablet and active component have no significant change, and on the other hand, embodiment 7 is compared with comparative examples 4, and film coating can significantly improve the stability of tablet, compared with embodiment 8, embodiment 7 film coating pre-mix dose effect compared with coating pre-mixing agent used in embodiment 8 used is better
3.2 long term test
The tablet of Example 7, embodiment 8, comparative examples 1, comparative examples 2, comparative examples 3 and comparative examples 4, all at temperature 25 DEG C ± 2 DEG C, relative humidity is place 36 months under the condition of 60% ± 10%, respectively at 0 month, 3 months, 6 months, 9 months, 12,18 months and 36 samplings at the end of month, detect the content (%) of the character of tablet, the labelled amount (%) of sulfur acid chrondroitin and Rhizoma Drynariae extract naringin, the results are shown in Table 4.
Table 4 respectively organizes long-term test results
Can be found out by above-mentioned test data, the result of the test of long term test conforms to accelerated test result, known in sum, and above-mentioned accessory formula selected by the present invention is reasonable, and wherein diluent obviously can play stable effect to active component; Using the mixed adhesive of above-mentioned consumption, the bonding that tablet powder is good can be made, and make tablet have suitable hardness and brittleness, ensureing that tablet quality makes it make tablet also can ensure good character when carrying out film coating; Above-mentioned film-coating premixing material, effectively adds medicine stability; Make tablet coating firmly smooth in addition, the stability of film-coating premixing material own is high, increases tablet stability further, is beneficial to and stores and transport.
Test 4 disintegration of tablet time-limit tests
According to the test method that " Chinese Pharmacopoeia version in 2010 two annex XA " record, carry out detecting disintegration to the tablet described in embodiment 6-8, check in variable concentrations hydrochloric acid solution, the all whole disintegrates within 15min of each tablet, tablet of the present invention is described, while ensure that good character performance, disintegration is shorter, fast effective ingredient can be discharged, to reach the absorption maximum of medicine.
Clinical trial
Observe case 573 example, at here outpatients, male 262 example, women 317 example, age 48-71 year, wherein hold concurrently suffer from arthritic patient have 186 example; Make patient take compositions 30-45 days of the present invention, the patient of the transference cure that calcium deficiency osteoporosis causes is up to 98.6%, and wherein arthritis cure rate also can up to 83.87%; After 86.9% user represents and takes compositions of the present invention, mental status is also clearly better, and passive protective physical fitness increases.Compositions of the present invention is confirmed through clinical trial, without any side effects to human body, effectively can increase bone density, treatment osteoarthritis, protect against osteoporosis.
Model case
Zhao, female, 62 years old, long-term lumbago and skelalgia, upper the most difficult downstairs, with arthralgia; Take compositions of the present invention after 30 days, lumbago and skelalgia and arthralgia are clearly better, and continue to take to 45 days, upper downstairs without any discomfort disease.
Claims (10)
1. one kind increases the compositions of bone density, it is characterized in that, described compositions is prepared from through processing primarily of the raw material of following parts by weight: calcium carbonate 15-28, D-Glucosamine Hydrochloride 20-32, chondroitin sulfate 18-22, bone collagen 12-21, phosphopeptide caseinate 10-20, Rhizoma Drynariae extract 15-25, vitamin K
28-15.
2. the compositions increasing bone density as claimed in claim 1, is characterized in that, prepare the raw material that described compositions also comprises following weight portion: Pericarpium Citri grandis 12-21, Ovum Gallus domesticus crusta 20-26, Rhizoma Seu Herba Bergeniae 5-16, Fructus Schisandrae Chinensis 16-26.
3. the compositions increasing bone density as claimed in claim 2, it is characterized in that, the parts by weight preparing described composition material are: calcium carbonate 20, D-Glucosamine Hydrochloride 25, chondroitin sulfate 20, bone collagen 14, phosphopeptide caseinate 13, Rhizoma Drynariae extract 22, vitamin K
213, Pericarpium Citri grandis 12, Ovum Gallus domesticus crusta 25, Rhizoma Seu Herba Bergeniae 8, Fructus Schisandrae Chinensis 16.
4. the compositions increasing bone density as claimed in claim 1, it is characterized in that, the extracting method of described Rhizoma Drynariae extract is:
1) Rhizoma Drynariae raw material, the solvent adding parts by weight of raw materials 35 times carries out reflux, extract, three times, extracts 3,2,1.5 hours respectively, the methanol of described solvent to be mass ratio be 1-2:5-7:2-3: ethanol: the mixed solvent of water;
2) merge after extracting liquid filtering, concentrate under reduced pressure at low temperature is extremely without alcohol, and the hot extracted with diethyl ether of crude drug aqueous solution equal-volume obtained four times, after merging organic facies, concentrate under reduced pressure at low temperature, after vacuum drying, obtains Rhizoma Drynariae extract.
5. the oral formulations that the compositions of the increase bone density as described in as arbitrary in claim 1-3 and pharmaceutically acceptable adjuvant are made, it is characterized in that, described preparation is pill, tablet, capsule, powder or granule; The compositions of described increase bone density and adjuvant ratio of weight and number are 1:2-4.
6. oral formulations as claimed in claim 4, it is characterized in that, described preparation is tablet, and described adjuvant comprises diluent, disintegrating agent, binding agent and the film coating pre-mix dose that ratio of weight and number is 3-4:1-2:0.8-1.2:0.5-0.8.
7. oral formulations as claimed in claim 5, it is characterized in that, described diluent is ratio of weight and number is the lactose of 5:1 and the mixture of disodium edetate; Described disintegrating agent is ratio of weight and number is the locust bean gum of 2:1 and the mixture of sucrose fatty acid ester; Described binding agent is ratio of weight and number is the sodium carboxymethyl cellulose of 5:2 and cholesteric mixture.
8. oral formulations as claimed in claim 5, is characterized in that, the mixture of the acetate fiber dibutylamino carboxylic propyl ether of described film coating pre-mix dose to be ratio of weight and number be 6:4:3:4, N-dodecyl amine xyloside, polyoxyethylene ether and silicone oil.
9. increase a preparation method for the compositions of bone density as claimed in claim 2, it is characterized in that, described preparation method comprises the steps:
1) get Ovum Gallus domesticus crusta clean dry, add after pulverizing raw material weight 2 times 15% aqueous acetic acid soak 12h, then take out dry, again pulverize fine powder is for subsequent use;
2) get Pericarpium Citri grandis, Rhizoma Seu Herba Bergeniae and Fructus Schisandrae Chinensis to clean and dry, by the ethanol water reflux, extract, three times of 85%-98%, first time adds the 3-5 ethanol water backflow 2-4h doubly of raw material gross weight; Second time adds the 2-3 ethanol water backflow 2-3h doubly of raw material gross weight; Add the 2-3 ethanol water backflow 1-2h doubly of raw material gross weight for the third time, merge extractive liquid, concentrating under reduced pressure obtains extractum, obtains powder stand-by after lyophilization;
3) by step 1) fine powder that obtains, step 2) powder that obtains and calcium carbonate, D-Glucosamine Hydrochloride, chondroitin sulfate, Rhizoma Drynariae extract, bone collagen, phosphopeptide caseinate and vitamin K
2after mix homogeneously, again grind and obtain described compositions.
10. the compositions as described in as arbitrary in claim 1-3 for the preparation of increasing bone density, prevent osteoporosis, osteoarthritis and the application that improves in the medicine of immunity.
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Application publication date: 20160323 |