CN101015682A - Medicine composition with compact bone substance density improving function, preparing process and quality controlling means thereof - Google Patents
Medicine composition with compact bone substance density improving function, preparing process and quality controlling means thereof Download PDFInfo
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Abstract
This invention relates to a Chinese medicinal composition with effect in increasing bone density and its preparation and quality control method. The composition is prepared from rhizoma drynariae, skunk bugbane, D-glucoseamine hydrochloride, chondroitin sulfate, calcium citrate, casein phosphopeptide, soybean isoflavone, pearl powder, and calcium carbonate by pulverizing D-glucoseamine hydrochloride, chondroitin sulfate, calcium citrate, casein phosphopeptide, soybean isoflavone, pearl powder, and calcium carbonate to fine powder; extracting rhizoma drynariae and skunk bugbane with ethanol under reflux; concentrating; drying to obtain dry extract powder; mixing with the fine powder; and making into clinically acceptable preparation. The quality control indicator of the composition is calcium, total flavone of D-glucoseamine, and chondroitin sulfate as per 100g preparation contains calcium greater than or equal to 13.0 g, total flavone of D-glucoseamine greater than or equal to 20.5 g, and chondroitin sulfate greater than or equal to 10.3g.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation method thereof and method of quality control with bone density improving function.
Background technology
Osteoporosis is meant that unit volume internal skeleton amount in the skeleton reduces, the osseous tissue microstructure is unusual, bone fragility increases, a kind of disease of fracture takes place easily, show as ache all over, easy fracture that cramp in the leg, hunchback, change are short, serious and be difficult for healing.Osteoporosis is reduced to feature with the bone amount, and the leading indicator of reflection bone amount is a bone mineral density, claims bone density (BMD) usually.The measurement of bone density is to estimate bone loss, diagnoses one of osteoporotic important means.Have experimental result to show: each position bone density of osteoporosis crowd is starkly lower than the normal control group.
The status of osteoporosis (OP) in whole world commonly encountered diseases, frequently-occurring disease rises to the 7th gradually, and number of patients surpasses 200,000,000.The whole world is used for the expense of osteoporosis and related complication treatment thereof above 25,000,000,000 dollars.China's per 14 philtrums at present just has 1 people to suffer from degrees of osteoporotic disease.Wherein people's sickness rate in 50-60 year is 21%, and people's sickness rate in 60-70 year is 58%, and people's sickness rate in 70-80 year is almost 100%, and especially the postmenopausal women sickness rate is higher.State-owned 6000-7000 ten thousand patients in the estimation, annual medical expense conservative estimation is 1,500,000 yuan.Development along with society, the trend of world population aging is more and more obvious, because the incidence rate of aged tendency of population and OP is obvious positive correlation, can estimate that the sickness rate of OP will increase year by year from now on, so OP has become one of global public health problem at present.
By retrieval, the health food with bone density improving of the granted code of China has: in grind logical board ginseng ketone sheet, precious difficult to understand
Power state capsule, the ample refined board that is full of are full of ample refined capsule, silver board silver in age U.S. capsule in age, the fine and soft capsule of silver board shell in age, the happy successively capsule of a brand, glad appearance companion's board cypress caring soft capsule, the vigorous and graceful board soybean isoflavone sheet of dimension, the good board isoflavone capsule of dimension, day lion board nutritious rich-calcium electuary, day occasion and extensively moisten happy Biocal, the polynary safe capsule of Yolanda Soler board, time crystal board collagen protein powder, the body and mind of living of board
Virtue relieving capsule, match and the strong precious grace capsule of board, match beauty board yak marrow tonic powder, Nuo Kanglai board calcium magnesium slice, be the travel board dimension bone-recovering particles of Jie Er board Jie Erjinmei capsule, dream, young attitude board strength capsule etc., beautiful her board Ai Suofei capsule, the green Xiangyuan board yak for making bone stronger granule (low-sugar type) etc. tieed up.Statistics show that the health food of bone density improving is few in number in the market.Simultaneously, people are progressively deepening the understanding of calcium deficiency harm, more and more to demand with " bone density improving " product, mainly contain calcium preparation, diphosphonic acid salt, estrogen, androgen, vitamin D3 class, calcitonin and Hormone Replacement Therapy and treat and prevent and treat osteoporotic medicine at present.
To sum up, along with global aging, increasing people will face along with the age increases and the serious health problem of calcium loss, and its result causes bone density to reduce, and causes osteoporosis.Therefore, generally run off and the osteoporosis that causes at aged tendency of population calcium, with the syllabus of putting prevention first, select raw material for use with clear and definite bone density improving effect, human body is had no side effect, the health care that bone density improving is arranged, and cheap, exploitation is that the health food of major function also has new product development market prospect preferably with the bone density improving.
Summary of the invention
The purpose of this invention is to provide a kind of pharmaceutical composition with bone density improving function.
Another object of the present invention provides the preparation method and the quality control index of this drug combination preparation.
Medicine of the present invention is made up of the raw material of following parts by weight:
Rhizoma Drynariae 10～50 weight portions, Rhizoma Cimicifugae 10～50 weight portions, D-glucosamine hydrochlorate 1～20 weight portion, chondroitin sulfate 1～10 weight portion, calcium citrate 1～10 weight portion, phosphopeptide caseinate 0.1～5 weight portion, soybean isoflavone 0.5～5 weight portion, Margarita powder 0.1～5 weight portion, calcium carbonate 1～30 weight portion.
The raw material of the best prescription parts by weight of the prescription of medicine of the present invention is:
Rhizoma Drynariae 340 weight portions, Rhizoma Cimicifugae 340 weight portions, D-glucosamine hydrochlorate 130 weight portions, chondroitin sulfate 70 weight portions, calcium citrate 60 weight portions, phosphopeptide caseinate 18 weight portions, soybean isoflavone 36 weight portions, Margarita powder 20 weight portions, calcium carbonate 156 weight portions.
The present invention has the pharmaceutical composition of bone density improving function, more than also can add Rhizoma Homalomenae 1～10 weight portion in the side of basis, Herba Saussureae Involueratae 1～10 weight portion, Cortex Acanthopancis 1～10 weight portion, Radix Achyranthis Bidentatae 1～10 weight portion, Radix Morindae Officinalis 1～10 weight portion, Rhizoma Curculiginis 1～10 weight portion, the Cortex Eucommiae 1～10 weight portion, Radix Polygoni Multiflori Preparata 1～10 weight portion, Carapax Et Plastrum Testudinis 1～10 weight portion, Cortex Periplocae 1～10 weight portion, Herba Taxilli 1～10 weight portion, Cornu Cervi 1～10 weight portion, Cornu Cervi Pantotrichum 1～5 weight portion, Herba Pyrolae 1～10 weight portion, Herba Epimedii 1～10 weight portion, Radix Dipsaci 1～10 weight portion, at least a in Herba Visci 1～10 weight portion.
The present invention has the pharmaceutical composition of bone density improving function and is made by following method:
Select crude drug:
Rhizoma Drynariae 10～50 weight portions, Rhizoma Cimicifugae 10～50 weight portions, D-glucosamine hydrochlorate 1～20 weight portion, chondroitin sulfate 1～10 weight portion, calcium citrate 1～10 weight portion, phosphopeptide caseinate 0.1～5 weight portion, soybean isoflavone 0.5～5 weight portion, Margarita powder 0.1～5 weight portion, calcium carbonate 1～30 weight portion.
Earlier Rhizoma Drynariae, Rhizoma Cimicifugae carried out remove impurity respectively, clean, dry, use 30～70% alcohol reflux 1～4 time then, each alcohol adding amount is 5～20 times of amounts of medical material, each 0.5～2 hour, filters, merge extractive liquid,, extracting solution is concentrated after drying, get dry extract and be broken into powder or the direct dry extract powder that gets, standby; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; Above-mentioned dry extract powder is mixed with the medical material fine powder, behind the mix homogeneously, add conventional adjuvant and make clinical acceptable preparation.
By [" pharmacy of Chinese materia medica " (using) for Chinese medicine class specialty, the Shanghai science and technology is published in December, 1997 front page; " pharmaceutical preparation research and development and production new technique technology use complete works of ", contemporary China audio ﹠ video press] conventional method, adjuvant commonly used make clinical acceptable preparation.
The preferred method for making of pharmaceutical composition that the present invention has the bone density improving function is:
Select crude drug:
Rhizoma Drynariae 10～50 weight portions, Rhizoma Cimicifugae 10～50 weight portions, D-glucosamine hydrochlorate 1～20 weight portion, chondroitin sulfate 1～10 weight portion, calcium citrate 1～10 weight portion, phosphopeptide caseinate 0.1～5 weight portion, soybean isoflavone 0.5～5 weight portion, Margarita powder 0.1～5 weight portion, calcium carbonate 1～30 weight portion.
Earlier Rhizoma Drynariae, Rhizoma Cimicifugae carried out remove impurity respectively, clean, dry, use 30～70% alcohol reflux 1～4 time then, each alcohol adding amount is 5～20 times of amounts of medical material, each 0.5～2 hour, filters, merge extractive liquid,, extracting solution is concentrated after drying, get dry extract and be broken into powder or the direct dry extract powder that gets, standby; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; Above-mentioned dry extract powder is mixed with the medical material fine powder, make granule or powder or tablet or capsule behind the mix homogeneously according to a conventional method.
The preferred method for making of pharmaceutical composition that the present invention has the bone density improving function is:
Select crude drug:
Rhizoma Drynariae 10～50 weight portions, Rhizoma Cimicifugae 10～50 weight portions, D-glucosamine hydrochlorate 1～20 weight portion, chondroitin sulfate 1～10 weight portion, calcium citrate 1～10 weight portion, phosphopeptide caseinate 0.1～5 weight portion, soybean isoflavone 0.5～5 weight portion, Margarita powder 0.1～5 weight portion, calcium carbonate 1～30 weight portion.
Earlier Rhizoma Drynariae, Rhizoma Cimicifugae are carried out remove impurity, cleaning, drying respectively, use 30～70% alcohol reflux 1～4 time then, each alcohol adding amount is 5～20 times of amounts of medical material, each 0.5～2 hour, filters, merge extractive liquid, concentrates the back spray drying with extracting solution, gets the dry extract powder; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; Above-mentioned dry extract powder is mixed with the medical material fine powder, and mix homogeneously is granulated.Again microcrystalline Cellulose 0.1～20 weight portion and magnesium stearate 0.01～5 weight portion are added in the above-mentioned granule that makes, mix homogeneously, tabletting adds stomach dissolved film coating pre-mix dose 0.1～25 weight portion at last and carries out film coating, can obtain tablet.
The best method for making of pharmaceutical composition that the present invention has the bone density improving function is:
Select crude drug:
Rhizoma Drynariae 340 weight portions, Rhizoma Cimicifugae 340 weight portions, D-glucosamine hydrochlorate 130 weight portions, chondroitin sulfate 70 weight portions, calcium citrate 60 weight portions, phosphopeptide caseinate 18 weight portions, soybean isoflavone 36 weight portions, Margarita powder 20 weight portions, calcium carbonate 156 weight portions.
Elder generation carries out remove impurity, cleaning, drying respectively with Rhizoma Drynariae, Rhizoma Cimicifugae, uses 50% alcohol reflux 2 times then, and each alcohol adding amount is 10 times of amounts of medical material, and each 1.5 hours, filter, merge extractive liquid, concentrates the back spray drying with extracting solution, gets the dry extract powder; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; Above-mentioned dry extract powder is mixed with the medical material fine powder, and mix homogeneously is granulated.Again microcrystalline Cellulose 14 weight portions and magnesium stearate 3 weight portions are added in the above-mentioned granule that makes, mix homogeneously, tabletting adds stomach dissolved film coating pre-mix dose 21 weight portions at last and carries out film coating, can obtain tablet.
The present invention has following technique effect:
1, this product adopts the Chinese and western medicine principle of combining, the prescription thinking of this product: according to the theory of the traditional Chinese medical science " the kidney generating marrow and dominating bone ", angle is started with from suffering from a deficiency of the kidney, the Chinese medicine Rhizoma Drynariae of selecting for use has the effect of invigorating the kidney and strengthening the bones, bone and muscle strengthening, be aided with Rhizoma Cimicifugae simultaneously with anti-osteoporosis activity, both synergism improve the sclerotin bone density improving, use the compatibility relationship prescription of each stock yard of Chinese medicine, thereby reach the effect of bone density improving; And can protect articular cartilage with D-glucosamine hydrochlorate and chondroitin sulfate; Select for use calcium citrate, Margarita powder and calcium carbonate as the calcium source, bone strength is kept in prevention and the generation of alleviation bone loss to prevent to fracture; Replenishing phosphopeptide caseinate simultaneously promotes human body that calcium is had preferably absorption; Soybean isoflavone in the prescription has the enhancing hormonal action, can promote proliferation and differentiation of osteoblasts.In a word, this prescription is considered and is replenished the calcium, protects articular cartilage and promote to carry out on the three aspect factor basis such as osteocyte propagation prescription.Make this prescription can on different links, bring into play the comprehensive function of bone density improving.This prescription carries out prescription from modern nutriology and modern pharmacology angle again both from traditional Chinese medical science angle, to reach the effect of the bone density improving of working along both lines.
2, production and processing of the present invention is simple, meets modern's allegro life; Realized suitability for industrialized production simultaneously.
The test example:
Be the safety that shows medicine of the present invention and the effect of bone density improving, carried out the dependency experiment of this medicine, specific as follows:
The bone density improving animal experiment
1. material and method
1.1 experimental animal and environment: 50 of the cleaning level male SD rats of body weight 71.02 ± 4.23 grams, available from the animal department of the Chinese Academy of Sciences of University Of Nanhua, laboratory animal production licence number SCXK (Hunan) 2004-0009.23～24 ℃ of experimental session experimental situation temperature, humidity 54-58%.The laboratory animal occupancy permit number is SYXK (Hunan) 2003-0002 number.
1.2 dosage is selected and is tried thing to give mode:
Low calcium feed formula (gram %): casein 10.0, analysis for soybean powder 15.0, wheat flour 54.0, Oleum Arachidis hypogaeae semen 4.0, cellulose 2.0, AIN
-76Mixed vitamin 1.0, choline chloride 0.2, DL-methionine 0.2, starch 11.0 adds CaCO
3Make feed calcium content reach 150mg/100g, as low calcium feedstuff (the low calcium feedstuff calcium content of actual measurement is 152.99mg/100g).
Sample (test medicine): Rhizoma Drynariae 340 weight portions, Rhizoma Cimicifugae 340 weight portions, D-glucosamine hydrochlorate 130 weight portions, chondroitin sulfate 70 weight portions, calcium citrate 60 weight portions, phosphopeptide caseinate 18 weight portions, soybean isoflavone 36 weight portions, Margarita powder 20 weight portions, calcium carbonate 156 weight portions.Elder generation carries out remove impurity, cleaning, drying respectively with Rhizoma Drynariae, Rhizoma Cimicifugae, uses 50% alcohol reflux 2 times then, and each alcohol adding amount is 10 times of amounts of medical material, and each 1.5 hours, filter, merge extractive liquid, concentrates the back spray drying with extracting solution, gets the dry extract powder; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; Above-mentioned dry extract powder is mixed with the medical material fine powder, and mix homogeneously is granulated.Again microcrystalline Cellulose 14 weight portions and magnesium stearate 3 weight portions are added in the above-mentioned granule that makes, mix homogeneously, tabletting adds stomach dissolved film coating pre-mix dose 21 weight portions at last and carries out film coating, can obtain tablet (specification: the 0.6g/ sheet).Pack with medicinal polyethylene bottle, can get finished product.
Instructions of taking: every day 3 times, each 3, the adult is by 60kg, and amounting to dosage is 0.09g/kg.bw.
According to the oral recommended amounts of human body, if the basic, normal, high dosage of sample is respectively 0.45g/kg.bw, 0.90g/kg.bw, 2.70g/kg.bw (be equivalent to respectively human body recommended dose 5,10,30 times), calcium carbonate control group gives the calcium carbonate (calcium content that is equivalent to the sample high dose) of 0.878g/kg.bw dosage.During the sample preparation, basic, normal, high dosage sample thief 4.5g, 9.0g, 27.0g respectively adds deionized water to 100ml, calcium carbonate control group is got 8.78g calcium carbonate man deionized water to 100ml, low calcium matched group gives isopyknic deionized water, give animal subject respectively and irritate stomach, irritate stomach every day once, irritate the long-pending 1.0ml/100g.bw of being of body of stomach.
From on-test, all single cage of each treated animal is raised, and feed hangs down calcium feedstuff material, and the filling stomach gives the test solution that is subjected to separately, drinks deionized water, the record food-intake.Totally 12 weeks.
1.3 key instrument:
1.3.1 atomic absorption spectrophotometer (GBC Avanta M9-126 type).
1.3.2 SD-1000C bone mineral measuring instrument (Beijing Geology Research Inst., Ministry of Nuclear Industry's centre).
1.4 experimental technique
1.4.1 animal growth index: weigh in weekly and height.
1.4.2 metabolism experiment: give this product after 4 weeks, rat put carry out metabolism in three days experiment in the rustless steel metabolic cage, collect 72 hours excrement, urine and feedstuff samples, behind nitric acid and perchloric acid mixed acid digestion, measure calcium content with atomic absorption spectrophotometer, each GBW 07604 Folium Populi Pseudo-simonii of ratifying with State Bureau of Technical Supervision measured all is as the Quality Control material.
1.4.3 femoral bmd is measured: when experiment finishes, disconnected neck is put to death rat, peels off right femur, and is roasting to constant weight in 105 ℃ of baking boxs, after being cooled to room temperature, measure bone width (BW), bone mineral content (BMC) and the bone density (BMD) of femur midpoint and distal end.
1.4.4 calcium content of bone is measured: after the gross weight of weighing femur, put into triangular flask through salt acid treatment dry cleansing, add nitric acid-perchloric acid (4: 1) mixed acid 8ml, after the digestion, use the deionized water standardize solution, measure with atomic absorption spectrophotometer, measure GBW 07604 Folium Populi Pseudo-simonii with State Bureau of Technical Supervision's approval at every turn as the Quality Control material.
1.5 experimental data statistics: adopt SPSS software to carry out variance analysis, result system represents with mean+SD
1.6 the result judges that the calcium content of bone tried the thing group or bone density are significantly higher than low calcium matched group and compare and do not have significant difference, the absorbance of calcium is not less than calcium carbonate control group, and this is tried the effect that thing has bone density improving decidable.
2 results
2.1 sample the results are shown in Table 1 to the influence of rat body weight.The initial body weight of respectively organizing rat before the experiment does not have significant difference (P＞0.05); The body weight of back each the dosage experiments group of experiment is compared in low calcium matched group with the weight increase value does not have significant difference (P＞0.05), and end-body weight of high dose experimental group rat and calcium carbonate control group thereof are compared does not have marked difference (P＞0.05).
Table 1 sample is to the influence of rat body weight
2.2 sample the results are shown in Table 2 to the influence of rat height.The initial height of respectively organizing rat before the experiment does not have significant difference (P＞0.05); After the experiment, the lifelong length of calcium carbonate control group, high dose experimental group and height have a net increase of the value added low calcium matched group (P＜0.05 or P＜0.01) that is significantly higher than; The lifelong length of high dose experimental group rat and have a net increase of value added comparing and do not have marked difference (P＞0.05) with calcium carbonate control group.
Table 2 sample is to the influence of rat height
2.3 sample the results are shown in Table 3 to the influence of rat femur length and bone density.The femur length of high dose experimental group rat, femur center bone density, femur distal end bone density are compared with corresponding calcium carbonate control group, do not have significant difference (P＞0.05); Senior amount rats in test groups femur length is significantly greater than low calcium matched group (P＜0.01), and high dose experimental group rat femur center bone density and femur distal end bone density are significantly greater than low calcium matched group (P＜0.01).
Table 3 sample is to the influence of rat femur length and bone density
2.4 sample the results are shown in Table 4 to the influence of rat femur weight and calcium content.The femur weight of high dose group rat is significantly greater than low calcium matched group (P＜0.05), and the femur weight of high dose experimental group rat is compared with corresponding calcium carbonate control group does not have significant difference (P＞0.05); Femur calcium content of high dose group rat and TC are significantly greater than low calcium matched group (P＜0.05 or P＜0.01), and femur calcium content of high dose experimental group rat and TC are compared with corresponding calcium carbonate control group does not have significant difference (P＞0.05).
Table 4 sample is to the influence of rat femur weight, calcium content of bone and TC
2.5 the influence that sample is taken in calcium, excrement calcium and urinated calcium rat the results are shown in Table 5.Basic, normal, high dosage experiments group rat is taken in calcium and is significantly higher than low calcium matched group (P＜0.01); Big Oletum Ratti norvegici calcium of basic, normal, high dosage group and urine calcium calcium are significantly higher than low calcium matched group (P＜0.01); The absorption calcium of high dose experimental group rat, excrement calcium and urine calcium output, compared with corresponding calcium carbonate control group and do not had significant difference (P＞0.05).
Table 5 sample is taken in the influence of calcium, excrement calcium and urine calcium to rat
2.6 sample retains the influence of rate to apparent absorbance of rat and calcium, the results are shown in Table 6.Apparent absorbance of middle and high dosage experiments group and calcium carbonate control group rat and the calcium rate that retains significantly is lower than calcium matched group (P＜0.01); The apparent absorbance of high dose experimental group calcium and the rate that retains of calcium are compared with corresponding calcium carbonate control group does not have significant difference (P＞0.05).
Table 6 sample is to the metabolic influence of calcium in rats
Apparent absorbance (%)=(taking in calcium-excrement calcium)/absorption calcium * 100; Calcium retains rate (%)=(taking in calcium-excrement calcium-urine calcium)/absorption calcium * 100
3. brief summary
Show for the result of rat oral gavage after 12 weeks with the sample of 0.45g/kg.bw, 0.90g/kg.bw, 2.70g/kg.bw dosage: bone density, femur weight, femur calcium content and TC, absorption calcium, excrement calcium, urine calcium content that height of experimental group rat and height have a net increase of value added, femur length, femur center and distal end are significantly higher than low calcium matched group, apparent absorbance of calcium and calcium retain rate and significantly are lower than the calcium matched group, and difference has significance (P＜0.01 or P＜0.05).Above every index of high dose experimental group rat does not relatively have significant difference (P＞0.05) with corresponding calcium carbonate control group.The prompting sample has the effect that increases rat bone density.
The functional component method of inspection:
A1 calcium: measure according to GB/T 5009.92-2003 " mensuration of calcium in the food " method
The mensuration of A2 D-glucosamine
A2.1 phosphate buffer: the phosphoric acid (analytical pure) of 1.0ml is added in the 2L water, stirs; Regulate Ph value to 3.0 with NaOH then.
A2.2 mobile phase: phosphate buffer solution and acetonitrile (3: 2) mixed, ultrasonic Treatment 15 minutes, with the funnel (sandbox) of 0.5 μ m filter or more the pinhole funnel filter, also can be as required mobile phase be adjusted (high performance liquid chromatography detection system be correlated with item (621))
The preparation of A2.3 standard specimen: will meet the accurately weighing of D-glucosamine hydrochlorate (RS) of USP, and be mixed with the solution (about 1.0mg/ml) of concentration known, the source of D-glucosamine hydrochlorate is that purity is in 100% available from Chinese biological goods calibrating institute.
A2.4 treats the preparation of test sample: weighing 100mg D-glucosamine hydrochlorate to be measured is transferred in the volumetric flask of 100ml exactly, adds the 30ml water dissolution, the vibration dissolving, and thin up is to scale.
The A2.5 chromatographic system is (referring to high performance liquid chromatography detection system (621): the detection of highly effective liquid phase chromatographic system is transferred to 195nm, the chromatographic column of supporting 4.6mm * 25cm; Flow rate of mobile phase is controlled at 0.6ml/min.Detect standard specimen earlier, note the reaction peak of testing process, influence factor's end peak is no more than 2% to the interference of the peak value of D-glucosamine hydrochlorate, and the parallel detection time error of identical standard specimen is no more than 2%.
A2.6 detection method: with the blended standard specimen of equal-volume (10 μ l) with treat that test sample injects chromatographic system, the peak value of record testing process.Calculate C by peak area and formula
6H
13NO
3The percentage composition of HCL in the D-glucosamine hydrochlorate:
C/W＝Vs/Vv×100％
C: the D-glucosamine hydrochlorate standard specimen that meets the USP standard;
W: the quality for the treatment of test sample D-glucosamine hydrochlorate
Vv: be the peak value for the treatment of test sample
Vs: the peak value that is standard specimen
Annotate: this method adopts American Pharmacopeia 29 editions to measure
The mensuration of A3 chondroitin sulfate
Method by Ministry of Health of the People's Republic of China's " drug standard " two ones the 6th (biochemical drug first fascicle) is carried out.
The A4 examination criteria:
| Functional component | Index |
| D-glucosamine, g/100g 〉= | 20.5 |
| Chondroitin sulfate, g/100g 〉= | 10.3 |
| Calcium (in Ca), g/100g 〉= | 13.0 |
The specific embodiment:
Further specify technology of the present invention below by specific embodiment:
Embodiment 1:
1. be raw material with Rhizoma Drynariae 100g, Rhizoma Cimicifugae 100g, D-glucosamine hydrochlorate 10g, chondroitin sulfate 10g, calcium citrate 10g, phosphopeptide caseinate 1g, soybean isoflavone 5g, Margarita powder 1g, calcium carbonate 10g.
2. Rhizoma Drynariae, Rhizoma Cimicifugae carry out remove impurity, cleaning, drying respectively in earlier will be 1., use 70% alcohol reflux 1 time then, and alcohol adding amount is 5 times of amounts of medical material, extracts 2 hours, collects extracting solution, concentrates the back drying under reduced pressure, gets dry extract, is ground into fine powder, and is standby; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; With above-mentioned dry extract powder and medical material fine powder mix homogeneously, get mixed powder.
3. 2. middle mixed powder is made capsule, get final product.
Embodiment 2:
1. be raw material with Rhizoma Drynariae 50g, Rhizoma Cimicifugae 50g, D-glucosamine hydrochlorate 20g, chondroitin sulfate 10g, calcium citrate 10g, phosphopeptide caseinate 5g, soybean isoflavone 5g, Margarita powder 5g, calcium carbonate 30g.
2. Rhizoma Drynariae, Rhizoma Cimicifugae carry out remove impurity, cleaning, drying respectively in earlier will be 1., use 50% alcohol reflux 2 times then, and alcohol adding amount is 10 times of amounts of medical material, extracts 1.5 hours, collects extracting solution, concentrates the back drying under reduced pressure, gets dry extract, is ground into fine powder, and is standby; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; With above-mentioned dry extract powder and medical material fine powder mix homogeneously, get mixed powder.
3. the direct general ball after drying of mixed powder water in inciting somebody to action is 2. made the 0.2g pill.
Embodiment 3:
1. be raw material with Rhizoma Drynariae 25g, Rhizoma Cimicifugae 25g, D-glucosamine hydrochlorate 10g, chondroitin sulfate 5g, calcium citrate 5g, phosphopeptide caseinate 2.5g, soybean isoflavone 2.5g, Margarita powder 2.5g, calcium carbonate 15g.
2. Rhizoma Drynariae, Rhizoma Cimicifugae carry out remove impurity, cleaning, drying respectively in earlier will be 1., use 60% alcohol reflux 3 times then, and each alcohol adding amount is 15 times of amounts of medical material, each 0.5 hour, collect extracting solution, concentrate the back spray drying, the dry extract powder, standby; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; With above-mentioned dry extract powder and medical material fine powder mix homogeneously, get mixed powder.
3. 2. middle mixed powder is made capsule, get final product.
Embodiment 4:
1. be raw material with Rhizoma Drynariae 100g, Rhizoma Cimicifugae 100g, D-glucosamine hydrochlorate 50g, chondroitin sulfate 25g, calcium citrate 25g, phosphopeptide caseinate 5g, soybean isoflavone 15g, Margarita powder 5g, calcium carbonate 30g.
2. Rhizoma Drynariae, Rhizoma Cimicifugae carry out remove impurity, cleaning, drying respectively in earlier will be 1., use 30% alcohol reflux 4 times then, and each alcohol adding amount is 20 times of amounts of medical material, each 1 hour, collect extracting solution, concentrate the back spray drying, the dry extract powder, standby; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; With above-mentioned dry extract powder and medical material fine powder mix homogeneously, get mixed powder.
3. 2. middle mixed powder is made granule, 60 ℃ of dryings add 50g polyvinylpolypyrrolidone, 10g magnesium stearate tabletting, get final product.
Embodiment 5:
1. be raw material with Rhizoma Drynariae 170g, Rhizoma Cimicifugae 170g, D-glucosamine hydrochlorate 65g, chondroitin sulfate 35g, calcium citrate 30g, phosphopeptide caseinate 9g, soybean isoflavone 18g, Margarita powder 10g, calcium carbonate 78g, Rhizoma Homalomenae 5g, Herba Saussureae Involueratae 5g, Cortex Acanthopancis 5g.
2. the 1. middle Rhizoma Drynariae of first general, Rhizoma Cimicifugae, Rhizoma Homalomenae, Herba Saussureae Involueratae, Cortex Acanthopancis carry out remove impurity, cleaning, drying respectively, use 50% alcohol reflux 2 times then, alcohol adding amount is 10 times of amounts of medical material, extracts 1.5 hours, collects extracting solution, concentrate the back spray drying, get the dry extract powder, standby; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; With above-mentioned dry extract powder and medical material fine powder mix homogeneously, get mixed powder.
3. 2. middle mixed powder is made granule, 60 ℃ of dryings, adding 30g carboxymethyl starch is received, 10g magnesium stearate tabletting, gets final product.
Embodiment 6:
1. be raw material with Rhizoma Drynariae 350g, Rhizoma Cimicifugae 350g, D-glucosamine hydrochlorate 120g, chondroitin sulfate 60g, calcium citrate 50g, phosphopeptide caseinate 30g, soybean isoflavone 30g, Margarita powder 25g, calcium carbonate 150g, Radix Achyranthis Bidentatae 8g, Radix Morindae Officinalis 8g, Rhizoma Curculiginis 8g.
2. the 1. middle Rhizoma Drynariae of first general, Rhizoma Cimicifugae, Radix Achyranthis Bidentatae, Radix Morindae Officinalis, Rhizoma Curculiginis carry out remove impurity, cleaning, drying respectively, use 50% alcohol reflux 2 times then, alcohol adding amount is 10 times of amounts of medical material, extracts 1.5 hours, collects extracting solution, concentrate the back spray drying, get the dry extract powder, standby; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; With above-mentioned dry extract powder and medical material fine powder mix homogeneously, get mixed powder.
3. 2. middle mixed powder adding 45g hypromellose is pressed into bulk or big lamellar, and then it is broken into granule, add 10g Pulvis Talci or 5g micropowder silica gel, tabletting gets final product.
Embodiment 7:
1. be raw material with Rhizoma Drynariae 300g, Rhizoma Cimicifugae 300g, D-glucosamine hydrochlorate 100g, chondroitin sulfate 50g, calcium citrate 50g, phosphopeptide caseinate 20g, soybean isoflavone 20g, Margarita powder 20g, calcium carbonate 120g, Cortex Eucommiae 8g, Radix Polygoni Multiflori Preparata 8 g, Carapax Et Plastrum Testudinis 8g.
2. the 1. middle Rhizoma Drynariae of first general, Rhizoma Cimicifugae, the Cortex Eucommiae, Radix Polygoni Multiflori Preparata, Carapax Et Plastrum Testudinis carry out remove impurity, cleaning, drying respectively, use 50% alcohol reflux 2 times then, alcohol adding amount is 10 times of amounts of medical material, extracts 1.5 hours, collects extracting solution, concentrate the back spray drying, get the dry extract powder, standby; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; With above-mentioned dry extract powder and medical material fine powder mix homogeneously, get mixed powder.
8. 2. middle mixed powder is made soft capsule, get final product.
Embodiment 8:
1. be raw material with Rhizoma Drynariae 340g, Rhizoma Cimicifugae 340g, D-glucosamine hydrochlorate 130g, chondroitin sulfate 70g, calcium citrate 60g, phosphopeptide caseinate 18g, soybean isoflavone 36g, Margarita powder 20g, calcium carbonate 156g, Cortex Periplocae 10g, Herba Taxilli 10g, Cornu Cervi 10g.
2. the 1. middle Rhizoma Drynariae of first general, Rhizoma Cimicifugae, Cortex Periplocae, Herba Taxilli, Cornu Cervi carry out remove impurity, cleaning, drying respectively, use 30% alcohol reflux 4 times then, each alcohol adding amount is 20 times of amounts of medical material, each 1 hour, collects extracting solution, concentrate the back spray drying, get the dry extract powder, standby; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; With above-mentioned dry extract powder and medical material fine powder mix homogeneously, make powder.
Embodiment 9:
1. be raw material with Rhizoma Drynariae 400g, Rhizoma Cimicifugae 400g, D-glucosamine hydrochlorate 180g, chondroitin sulfate 80g, calcium citrate 70g, phosphopeptide caseinate 40g, soybean isoflavone 45g, Margarita powder 16g, calcium carbonate 220g, Cornu Cervi Pantotrichum 5g, Herba Pyrolae 10g, Herba Epimedii 10g.
2. the 1. middle Rhizoma Drynariae of first general, Rhizoma Cimicifugae, Cornu Cervi Pantotrichum, Herba Pyrolae, Herba Epimedii carry out remove impurity, cleaning, drying respectively, use 50% alcohol reflux 2 times then, alcohol adding amount is 10 times of amounts of medical material, extracts 1.5 hours, collects extracting solution, concentrate the back spray drying, get the dry extract powder, standby; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; With above-mentioned dry extract powder and medical material fine powder mix homogeneously, get mixed powder.
3. 2. middle mixed powder is added 70% an amount of ethanol, make granule, drying, granulate is made granule.
Embodiment 10:
1. be raw material with Rhizoma Drynariae 120g, Rhizoma Cimicifugae 110g, D-glucosamine hydrochlorate 60g, chondroitin sulfate 50g, calcium citrate 20g, phosphopeptide caseinate 10g, soybean isoflavone 15g, Margarita powder 12g, calcium carbonate 50g, Radix Dipsaci 5g, Herba Visci 5g.
2. the 1. middle Rhizoma Drynariae of first general, Rhizoma Cimicifugae, Radix Dipsaci, Herba Visci carry out remove impurity, cleaning, drying respectively, use 50% alcohol reflux 2 times then, alcohol adding amount is 10 times of amounts of medical material, extracts 1.5 hours, collects extracting solution, concentrate the back spray drying, get the dry extract powder, standby; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; With above-mentioned dry extract powder and medical material fine powder mix homogeneously, get mixed powder.
3. 2. middle mixed powder can be made lozenge according to conventional method.
Embodiment 11:
1. be raw material with Rhizoma Drynariae 250g, Rhizoma Cimicifugae 200g, D-glucosamine hydrochlorate 110g, chondroitin sulfate 100g, calcium citrate 60g, phosphopeptide caseinate 20g, soybean isoflavone 30g, Margarita powder 20g, calcium carbonate 150g.
2. Rhizoma Drynariae, Rhizoma Cimicifugae carry out remove impurity, cleaning, drying respectively in earlier will be 1., use 50% alcohol reflux 2 times then, and alcohol adding amount is 10 times of amounts of medical material, extracts 1.5 hours, collects extracting solution, concentrates the back spray drying, gets the dry extract powder, and is standby; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; With above-mentioned dry extract powder and medical material fine powder mix homogeneously, get mixed powder.
3. 2. middle mixed powder is added 70% an amount of ethanol, make granule, drying, granulate is made granule.
Embodiment 12:
1. be raw material with Rhizoma Drynariae 45g, Rhizoma Cimicifugae 40g, D-glucosamine hydrochlorate 18g, chondroitin sulfate 10g, calcium citrate 8g, phosphopeptide caseinate 4g, soybean isoflavone 4g, Margarita powder 4g, calcium carbonate 25g.
2. Rhizoma Drynariae, Rhizoma Cimicifugae carry out remove impurity, cleaning, drying respectively in earlier will be 1., use 50% alcohol reflux 2 times then, and alcohol adding amount is 10 times of amounts of medical material, extracts 1.5 hours, collects extracting solution, concentrates the back spray drying, gets the dry extract powder, and is standby; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; With above-mentioned dry extract powder and medical material fine powder mix homogeneously, get mixed powder.
8. 2. middle mixed powder is added 70% an amount of ethanol, make granule, drying, granulate, standby.
4. 3. add carboxymethyl starch sodium 15g and magnesium stearate 1.5g in the dried particles of middle gained, mix homogeneously, tabletting gets final product.
Embodiment 13:
1. be raw material with Rhizoma Drynariae 35g, Rhizoma Cimicifugae 30g, D-glucosamine hydrochlorate 12g, chondroitin sulfate 6g, calcium citrate 5g, phosphopeptide caseinate 2.5g, soybean isoflavone 3g, Margarita powder 3g, calcium carbonate 18g.
2. Rhizoma Drynariae, Rhizoma Cimicifugae carry out remove impurity, cleaning, drying respectively in earlier will be 1., use 50% alcohol reflux 2 times then, and alcohol adding amount is 10 times of amounts of medical material, extracts 1.5 hours, collects extracting solution, concentrates the back spray drying, gets the dry extract powder, and is standby; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; With above-mentioned dry extract powder and medical material fine powder mix homogeneously, get mixed powder.
3. 2. middle mixed powder is added 70% an amount of ethanol, make granule, drying, granulate, standby.
4. 8. add carboxymethyl starch sodium 15g and magnesium stearate 1.5g in the dried particles of middle gained, mix homogeneously is made capsule and is got final product.
Embodiment 14:
1. be raw material with Rhizoma Drynariae 340g, Rhizoma Cimicifugae 340g, D-glucosamine hydrochlorate 130g, chondroitin sulfate 70g, calcium citrate 60g, phosphopeptide caseinate 18g, soybean isoflavone 36g, Margarita powder 20g, calcium carbonate 156g.
2. Rhizoma Drynariae, Rhizoma Cimicifugae carry out remove impurity, cleaning, drying respectively in earlier will be 1., use 50% alcohol reflux 2 times then, and alcohol adding amount is 10 times of amounts of medical material, extracts 1.5 hours, collects extracting solution, concentrates the back spray drying, gets the dry extract powder, and is standby; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; With above-mentioned dry extract powder and medical material fine powder mix homogeneously, get mixed powder.
3. 2. middle mixed powder is added 70% an amount of ethanol, make granule, drying, granulate, standby.
4. 8. add microcrystalline Cellulose 14g and magnesium stearate 3g in the dried particles of middle gained, mix homogeneously, tabletting, standby.
5. in 4., add stomach dissolved film coating pre-mix dose 21g and carry out film coating, can obtain thin membrane coated tablet.
Claims (9)
1, the present invention relates to a kind of pharmaceutical composition, be characterised in that said composition made by following raw material medicaments: Rhizoma Drynariae 10～50 weight portions, Rhizoma Cimicifugae 10～50 weight portions, D-glucosamine hydrochlorate 1～20 weight portion, chondroitin sulfate 1～10 weight portion, calcium citrate 1～10 weight portion, phosphopeptide caseinate 0.1～5 weight portion, soybean isoflavone 0.5～5 weight portion, Margarita powder 0.1～5 weight portion, calcium carbonate 1～30 weight portion with bone density improving function.
2, a kind of pharmaceutical composition with bone density improving function as claimed in claim 1 is characterised in that said composition made by following raw material medicaments: Rhizoma Drynariae 340 weight portions, Rhizoma Cimicifugae 340 weight portions, D-glucosamine hydrochlorate 130 weight portions, chondroitin sulfate 70 weight portions, calcium citrate 60 weight portions, phosphopeptide caseinate 18 weight portions, soybean isoflavone 36 weight portions, Margarita powder 20 weight portions, calcium carbonate 156 weight portions.
3, as claim 1,2 described pharmaceutical compositions with bone density improving function is characterized in that: also can add Rhizoma Homalomenae 1～10 weight portion, Herba Saussureae Involueratae 1～10 weight portion, Cortex Acanthopancis 1～10 weight portion, Radix Achyranthis Bidentatae 1～10 weight portion, Radix Morindae Officinalis 1～10 weight portion, Rhizoma Curculiginis 1～10 weight portion, the Cortex Eucommiae 1～10 weight portion, Radix Polygoni Multiflori Preparata 1～10 weight portion, Carapax Et Plastrum Testudinis 1～10 weight portion, Cortex Periplocae 1～10 weight portion, Herba Taxilli 1～10 weight portion, Cornu Cervi 1～10 weight portion, Cornu Cervi Pantotrichum 1～5 weight portion, Herba Pyrolae 1～10 weight portion, Herba Epimedii 1～10 weight portion, Radix Dipsaci 1～10 weight portion, at least a in Herba Visci 1～10 weight portion.
4, a kind of preparation of drug combination method with bone density improving function is characterized in that this pharmaceutical composition made by following method:
Select crude drug:
Rhizoma Drynariae 10～50 weight portions, Rhizoma Cimicifugae 10～50 weight portions, D-glucosamine hydrochlorate 1～20 weight portion, chondroitin sulfate 1～10 weight portion, calcium citrate 1～10 weight portion, phosphopeptide caseinate 0.1～5 weight portion, soybean isoflavone 0.5～5 weight portion, Margarita powder 0.1～5 weight portion, calcium carbonate 1～30 weight portion.
Earlier Rhizoma Drynariae, Rhizoma Cimicifugae carried out remove impurity respectively, clean, dry, use 30～70% alcohol reflux 1～4 time then, each alcohol adding amount is 5～20 times of amounts of medical material, each 0.5～3 hour, filters, merge extractive liquid,, extracting solution is concentrated after drying, get dry extract and be broken into powder or the direct dry extract powder that gets, standby; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; Above-mentioned dry extract powder is mixed with the medical material fine powder, behind the mix homogeneously, add conventional adjuvant and make clinical acceptable preparation.
5, preparation of drug combination method as claimed in claim 4 is characterized in that this pharmaceutical composition made by following method:
Select crude drug:
Rhizoma Drynariae 10～50 weight portions, Rhizoma Cimicifugae 10～50 weight portions, D-glucosamine hydrochlorate 1～20 weight portion, chondroitin sulfate 1～10 weight portion, calcium citrate 1～10 weight portion, phosphopeptide caseinate 0.1～5 weight portion, soybean isoflavone 0.5～5 weight portion, Margarita powder 0.1～5 weight portion, calcium carbonate 1～30 weight portion.
Earlier Rhizoma Drynariae, Rhizoma Cimicifugae carried out remove impurity respectively, clean, dry, use 30～70% alcohol reflux 1～4 time then, each alcohol adding amount is 5～20 times of amounts of medical material, each 0.5～3 hour, filters, merge extractive liquid,, extracting solution is concentrated after drying, get dry extract and be broken into powder or the direct dry extract powder that gets, standby; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; Above-mentioned dry extract powder is mixed with the medical material fine powder, make granule or powder or tablet or capsule behind the mix homogeneously according to a conventional method.
6, preparation of drug combination method as claimed in claim 5 is characterized in that this pharmaceutical composition made by following method:
Select crude drug:
Rhizoma Drynariae 10～50 weight portions, Rhizoma Cimicifugae 10～50 weight portions, D-glucosamine hydrochlorate 1～20 weight portion, chondroitin sulfate 1～10 weight portion, calcium citrate 1～10 weight portion, phosphopeptide caseinate 0.1～5 weight portion, soybean isoflavone 0.5～5 weight portion, Margarita powder 0.1～5 weight portion, calcium carbonate 1～30 weight portion.
Earlier Rhizoma Drynariae, Rhizoma Cimicifugae are carried out remove impurity, cleaning, drying respectively, use 30～70% alcohol reflux 1～4 time then, each alcohol adding amount is 5～20 times of amounts of medical material, each 0.5～3 hour, filters, merge extractive liquid, concentrates the back spray drying with extracting solution, gets the dry extract powder; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; Above-mentioned dry extract powder is mixed with the medical material fine powder, and mix homogeneously is granulated.Again microcrystalline Cellulose 0.1～20 weight portion and magnesium stearate 0.01～5 weight portion are added in the above-mentioned granule that makes, mix homogeneously, tabletting adds stomach dissolved film coating pre-mix dose 0.1～25 weight portion at last and carries out film coating, can obtain tablet.
7, preparation of drug combination method as claimed in claim 6 is characterized in that this pharmaceutical composition made by following method:
Select crude drug:
Rhizoma Drynariae 340 weight portions, Rhizoma Cimicifugae 340 weight portions, D-glucosamine hydrochlorate 130 weight portions, chondroitin sulfate 70 weight portions, calcium citrate 60 weight portions, phosphopeptide caseinate 18 weight portions, soybean isoflavone 36 weight portions, Margarita powder 20 weight portions, calcium carbonate 156 weight portions.
Elder generation carries out remove impurity, cleaning, drying respectively with Rhizoma Drynariae, Rhizoma Cimicifugae, uses 50% alcohol reflux 2 times then, and each alcohol adding amount is 10 times of amounts of medical material, and each 1.5 hours, filter, merge extractive liquid, concentrates the back spray drying with extracting solution, gets the dry extract powder; Again D-glucosamine hydrochlorate, chondroitin sulfate, calcium citrate, phosphopeptide caseinate, soybean isoflavone, Margarita powder, Paris white are broken into fine powder; Above-mentioned dry extract powder is mixed with the medical material fine powder, and mix homogeneously is granulated.Again microcrystalline Cellulose 14 weight portions and magnesium stearate 3 weight portions are added in the above-mentioned granule that makes, mix homogeneously, tabletting adds stomach dissolved film coating pre-mix dose 21 weight portions at last and carries out film coating, can obtain tablet.
8, drug combination preparation as claimed in claim 7, it is characterized in that its quality control index is calcium, D-glucosamine total flavones, chondroitin sulfate, stipulate every 100g unit formulation calcic (in Ca) for more than or equal to 13.0g, contain the D-glucosamine total flavones more than or equal to 20.5g, sulfur acid chrondroitin more than or equal to 10.3g.
9, use in medicine as claim 1,2,3 described pharmaceutical compositions with bone density improving function.
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| CN2007100173852A CN101015682B (en) | 2007-02-01 | 2007-02-01 | Medicine composition with compact bone substance density improving function, preparing process and quality controlling means thereof |
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| CN2007100173852A CN101015682B (en) | 2007-02-01 | 2007-02-01 | Medicine composition with compact bone substance density improving function, preparing process and quality controlling means thereof |
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