CN1583133A - Effervescent tablets for bone diseases and their preparation - Google Patents
Effervescent tablets for bone diseases and their preparation Download PDFInfo
- Publication number
- CN1583133A CN1583133A CN 200410046192 CN200410046192A CN1583133A CN 1583133 A CN1583133 A CN 1583133A CN 200410046192 CN200410046192 CN 200410046192 CN 200410046192 A CN200410046192 A CN 200410046192A CN 1583133 A CN1583133 A CN 1583133A
- Authority
- CN
- China
- Prior art keywords
- extract
- effervescent tablet
- extracted
- radix
- hour
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Abstract
A Chinese medicine in the form of effervescent tablet for treating osteopathy is prepared from 6 Chinese-medicinal materials including epimedium, dipsacus root, red sage root, rehmannia root, etc through extracting, mixing with auxiliary and tabletting.
Description
Technical field
The invention belongs to technical field of Chinese medicines, be specifically related to a kind of effervescent tablet for the treatment of orthopaedic disease and preparation method thereof, this effervescent tablet is referred to as Xianlinggubao effervescent tablet again.
Technical background
XIANLING GUBAO PIAN and XIANLING GUBAO JIAONANG are the Chinese patent medicines that has gone on the market at present, have the function of kidney-tonifying health-care, reunion of bone, the strong bone of tonifying YANG, gain feelings will.Patent CN97107552 mentions that it is mainly used in prevention and treats osteoporosis, fracture, osteoarthritis, bone aseptic necrosis and climacteric syndrome.Osteoporosis and menopause syndrome etc. after primary osteoporosis, senile osteoporosis, bone aseptic necrosis, the paraplegia all there is the good clinical therapeutic effect.Contain Herba Epimedii, Radix Dipsaci, Radix Salviae Miltiorrhizae, the Rhizoma Anemarrhenae, Fructus Psoraleae, Radix Rehmanniae Six-element medical material in the prescription.Documents and materials [Yang Yun, etc.Natural Medicine Chemistry component extraction separation handbook.China Traditional Chinese Medicine Publishing House.] report that the main effective ingredient of Herba Epimedii is the icariin of flavonoid; The effective ingredient of Radix Dipsaci is saponin and alkaloid; The effective ingredient of Radix Salviae Miltiorrhizae is fat-soluble tanshinone etc. and water miscible danshensu, protocatechualdehyde etc.; The effective ingredient of the Rhizoma Anemarrhenae is a steroidal saponin; The effective ingredient of Radix Rehmanniae is a glycoside; The effective ingredient of Fructus Psoraleae is psoralen and isopsoralen.
Application number be CN97107552 patent disclosure composition and the tablet and the capsular preparation technology of its prescription.The extraction process that it all adopts Six-element medical material decocting to boil.Bibliographical information [Liu Chongfang, etc.The different extraction processes of Radix Salviae Miltiorrhizae relatively.Chinese patent medicine, 1999 (21) 8:385] extraction process of Radix Salviae Miltiorrhizae, when decocting boiled, aqueous soluble active constituents such as danshensu wherein, protocatechualdehyde extracted fully and fat-soluble extracts active ingredients such as Tanshinone I I A are extremely incomplete; When using ethanol extraction, fat-soluble extracts active ingredients such as tanshinone wherein water soluble ingredients such as danshensu, protocatechualdehyde is fully extracted then incomplete.This studies explanation, all can lose effective ingredient contained in the red rooted salvia to the technology that red rooted salvia only carries out that water is carried or only carries out alcohol extraction, thereby be unscientific extraction process.Tablet and capsular extraction process have only been carried out water to red rooted salvia and have been carried among the patent CN97107552, have therefore lost fat-soluble effective ingredient contained in the red rooted salvia.
What now gone on the market has XIANLING GUBAO JIAONANG and two kinds of dosage forms of XIANLING GUBAO PIAN.The fine powder that XIANLING GUBAO JIAONANG adopts Radix Dipsaci, Radix Salviae Miltiorrhizae, Fructus Psoraleae three flavor medical materials and all the other Herba Epimedii, the Rhizoma Anemarrhenae, Radix Rehmanniae three extractum that the filtrate of medical material water after carrying is condensed into of distinguishing the flavor of mixes, granulate again, dry, encapsulated preparation technology [National Drug Administration. national standard for traditional Chinese medicines compilation (orthopedics department fascicle), 2002,368].This technology drug administration amount is big, has increased patient's burden; Bioavailability is low, influences the therapeutic effect of medicine.The extractum that filtrate after XIANLING GUBAO PIAN adopts the red rooted salvia fine powder and all the other Herba Epimedii, Radix Dipsaci, the Rhizoma Anemarrhenae, Fructus Psoraleae, Radix Rehmanniae five tastes medical material water are carried is condensed into mixes, and granulates drying, the preparation technology [National Drug Administration of tabletting again.Country's standard for traditional Chinese medicines compilation (orthopedics department fascicle), 2002,372].Though this technology has kept the fat-soluble and aqueous soluble active constituent in the red rooted salvia, red rooted salvia is used as medicine with powder, has not only increased dose, the more important thing is the crude drug availability, has directly influenced the therapeutic effect of XIANLING GUBAO PIAN.
Effervescent tablet is that what to develop in recent years is a kind of novel form that disintegrating agent is made with the effervescent material, can dissolve in the short period of time, have that onset is rapid, bioavailability is high, convenient carrying, the patient who is specially adapted to child, old man and can not swallows solid preparation, so effervescent tablet has the dosage form novelty, the characteristics that market prospect is wide.
Summary of the invention
According to the characteristics of raw medicinal material, the present invention adopts the fat-soluble effective ingredient of red rooted salvia in the 70%-95% ethanol extraction prescription, and medicinal residues and Herba Epimedii, Radix Dipsaci, the Rhizoma Anemarrhenae, Fructus Psoraleae, Radix Rehmanniae medical material are through the water boiling and extraction aqueous soluble active constituent; With the pharmaceutic adjuvant combination, be prepared into effervescent tablet again.The content of product active ingredient of the present invention significantly increases, and drug effect also is greatly improved, and this is not to be because the effect that the dosage form of effervescent tablet itself is brought.
The present invention is achieved through the following technical solutions:
One, process recipes
(1) raw medicinal material of Xianlinggubao effervescent tablet composition weight portion is:
Herba Epimedii 12-16 Radix Dipsaci 1-3 Radix Salviae Miltiorrhizae 1-2 Rhizoma Anemarrhenae 1-2 Fructus Psoraleae 1-2
Radix Rehmanniae 1-2
(2) raw medicinal material of effervescent tablet composition weight portion is:
Herba Epimedii 14 Radix Dipsacis 2 Radix Salviae Miltiorrhizaes 1 Rhizoma Anemarrhenae 1 Fructus Psoraleae 1 Radix Rehmanniae 1
(3) get red rooted salvia, pulverize, make solvent with 70%-95% ethanol and extract twice with multi-functional extractor; Be equivalent to medical material weight 6-8 70%-95% ethanol doubly each the adding; Extracted 1-3 hour for the first time, extracted 1-2 hour for the second time; Merge ethanol extract, filter, filtrate is concentrated into the extractum that relative density is 1.15-1.30 (50 ℃); Again the medicinal residues behind the red rooted salvia ethanol extraction are mixed with Herba Epimedii, Radix Dipsaci, the Rhizoma Anemarrhenae, Fructus Psoraleae, Radix Rehmanniae medical material, use multi-functional extractor water extraction three times; Be equivalent to medical material weight 6-14 water doubly each the adding; Extracted 2-4 hour for the first time, extracted 1-3 hour for the second time, extracted for the third time 0.5-1.5 hour; Merge the water extract, filter.Filtrate is concentrated into the extractum that relative density is 1.15-1.30 (50 ℃); Alcohol-extracted extract is mixed with the water extracted immersing paste, and spray drying, pulverizing obtain extract;
(4) effervescent tablet prescription composition (percentage by weight) is: extract 20-80 part, sour agent 25-60 part, alkaline agent 60-140 part, sweeting agent 1-10 part, correctives 1-5 part;
(5) extract is mixed with pharmaceutic adjuvant, wherein alkaline agent wraps up with Polyethylene Glycol, with conventional pharmaceutical technology technology granulation, drying, granulate, tabletting, check, pack, obtains effervescent tablet.
Two, assay analysis
1. content Determination of Icariin in the high effective liquid chromatography for measuring XIANLING GUBAO ZHIJI
1.1 instrument and reagent high performance liquid chromatograph comprise LC-10ATvp type solvent delivery pump, SPD-10ATvp type UV, visible light detector (day island proper Tianjin company); N2000 chromatographic work station (Zhejiang University's intelligent information Graduate School of Engineering); KQ3200 type ultrasonic washing instrument (Kunshan Ultrasonic Instruments Co., Ltd.), TGL-16G high speed tabletop centrifuge (Anting Scientific Instrument Factory, Shanghai).Chromatographically pure methanol (Beijing chemical reagent company limited); Water is tri-distilled water (self-control); Other reagent is analytical pure.XIANLING GUBAO PIAN and XIANLING GUBAO JIAONANG (Tongjitang Pharmacy Co., Ltd., Guizhou); Xianlinggubao effervescent tablet (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides); Icariin reference substance (Nat'l Pharmaceutical ﹠ Biological Products Control Institute).
1.2 chromatographic condition and system suitability test chromatographic column: the C of Di Ma company
18Post (5 μ m, 150mm * 4.6mm, I.D); Mobile phase: methanol-1.5% glacial acetic acid (60: 40); Flow velocity: 1.0ml/min; Detect wavelength: 270nm.Number of theoretical plate should be not less than 2000 by icariin peak compute.
Take by weighing icariin reference substance 1.10mg 1.3 reference substance solution prepares precision, insert in the 1ml measuring bottle, add methanol, ultrasonicly make dissolving, add methanol again to scale, promptly.
1.4 accurate respectively above-mentioned reference substance solution 5 μ l, 10 μ l, 15 μ l, the 20 μ l of drawing of standard curve preparation, sample introduction is measured under the said determination condition, icariin is the good linear relation in 0.550 μ g～2.22 μ g scopes as a result, and regression equation is Y=5.81 * 10
6X-9.43 * 10
4, r=0.9996.
1.5 10 of this product are got in the preparation of need testing solution, the accurate title, decided porphyrize, get 0.5g, the accurate title, decide, and puts in the tool plug conical flask, the accurate methanol 10ml that adds claims to decide weight, supersound process 1 hour, put coldly, claim again to decide weight, supply the weight that subtracts mistake with methanol, shake up, filter, get subsequent filtrate centrifugal (12000rpm) 10min, supernatant is as need testing solution.
1.6 accurate each the 10 μ l of need testing solution that draw of algoscopy inject chromatograph of liquid, measure peak area, calculate content with standard curve.The results are shown in Table 1.
2. the content of psoralen and isopsoralen in the high effective liquid chromatography for measuring XIANLING GUBAO ZHIJI
2.1 instrument and reagent high performance liquid chromatograph comprise LC-10ATvp type solvent delivery pump, SPD-10ATvp type UV, visible light detector (day island proper Tianjin company); N2000 chromatographic work station (Zhejiang University's intelligent information Graduate School of Engineering); KQ3200 type ultrasonic washing instrument (Kunshan Ultrasonic Instruments Co., Ltd.), TGL-16G high speed tabletop centrifuge (Anting Scientific Instrument Factory, Shanghai).Trifluoroacetic acid aqueous solution (Merck KGaA company); Water is tri-distilled water (self-control); Other reagent is analytical pure.XIANLING GUBAO PIAN and XIANLING GUBAO JIAONANG (Tongjitang Pharmacy Co., Ltd., Guizhou); Xianlinggubao effervescent tablet (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides); Psoralen reference substance and isopsoralen reference substance (Nat'l Pharmaceutical ﹠ Biological Products Control Institute).
2.2 chromatographic condition and system suitability test chromatographic column: the C of Di Ma company
18Post (5 μ m, 150mm * 4.6mm, I.D); Mobile phase: acetonitrile-water (30: 70); Flow velocity: 1.0ml/min; Detect wavelength 245nm; Number of theoretical plate should be not less than 3000 by psoralen peak compute.
2.3 psoralen and isopsoralen reference substance mixed solution are prepared respectively, and precision takes by weighing psoralen reference substance 1.50mg and isopsoralen 1.00mg inserts in the 2mL measuring bottle, add methanol, ultrasonicly make dissolving, add methanol again to scale, accurate this solution of 0.25mL of drawing is gone in the 5mL measuring bottle, add methanol to scale, dilute 20 times, promptly get the mixing reference substance solution that contains psoralen 0.0375mg/mL and isopsoralen 0.025mg/mL.
2.4 above reference substance solution 5 μ l, 10 μ l, 15 μ l and 20 μ l are got in the standard curve preparation respectively, sample introduction is measured under the said determination condition.The result shows, psoralen sample size and peak area in 0.075 μ g～0.75 μ g scope are the good linear relation, and linear equation is Y=2.23 * 10
7X+2.16 * 10
5, r=0.9999; Isopsoralen sample size and peak area in the scope of 0.05 μ g～0.5 μ g are good linear relationship, and linear equation is Y=2.26 * 10
7X+2.27 * 10
5, r=0.9999.
2.5 10 of this product are got in the preparation of need testing solution, the accurate title, decided porphyrize, get 0.5g, the accurate title, decide, and puts in the tool plug conical flask, the accurate methanol 10ml that adds claims to decide weight, supersound process 1 hour, put coldly, claim again to decide weight, supply the weight that subtracts mistake with methanol, shake up, get supernatant liquid filtering, get subsequent filtrate, promptly.
2.6 accurate each the 10 μ l of need testing solution that draw of algoscopy inject chromatograph of liquid, measure peak area, calculate content with standard curve.The results are shown in Table 1.
3. the content of tanshinone in the high effective liquid chromatography for measuring XIANLING GUBAO ZHIJI
3.1 instrument and reagent high performance liquid chromatograph comprise LC-10ATvp type solvent delivery pump, SPD-10ATvp type UV, visible light detector (day island proper Tianjin company); N2000 chromatographic work station (Zhejiang University's intelligent information Graduate School of Engineering); KQ3200 type ultrasonic washing instrument (Kunshan Ultrasonic Instruments Co., Ltd.), TGL-16G high speed tabletop centrifuge (Anting Scientific Instrument Factory, Shanghai).Chromatographically pure methanol (Beijing chemical reagent company limited); Water is tri-distilled water (self-control); Other reagent is analytical pure.XIANLING GUBAO PIAN and XIANLING GUBAO JIAONANG (Tongjitang Pharmacy Co., Ltd., Guizhou); Xianlinggubao effervescent tablet (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides); Tanshinone I I A reference substance (Nat'l Pharmaceutical ﹠ Biological Products Control Institute).
3.2 chromatographic condition and system suitability test chromatographic column: the C of Di Ma company
18Post (5 μ m, 150mm * 4.6mm, I.D); Mobile phase: methanol-water (15: 5); Flow velocity: 1.0ml/min; Detect wavelength: 270nm.Number of theoretical plate should be not less than 2000 by tanshinone peak compute.
3.3 the preparation precision of reference substance solution takes by weighing tanshinone reference substance 10.26mg, puts in the 10mL measuring bottle, adds methanol to scale, shakes up, and promptly gets reference substance storing solution (every 1ml contains tanshinone 1026 μ g).
3.4 the accurate absorption of standard curve preparation Tanshinone I I A reference substance solution 1,5,9,13,17,20mL put in the 20ml volumetric flask, add methanol to scale, getting concentration is the tanshinone reference substance solution of 51.30,256.5,461.7,666.9,872.1,1026 μ g/ml; Drawing each 20 μ l of above-mentioned 6 kinds of solution respectively, inject hplc determination, is vertical coordinate with peak area A, and concentration C is an abscissa, and drawing standard curve, regression equation are A=10227.8C+864.6, correlation coefficient r=0.9996.The result shows that tanshinone is good in the concentration range internal linear relation of 0.1026～20.52mg.
3.5 10 of this product are got in the preparation of need testing solution, the accurate title, decided porphyrize, get 0.5g, the accurate title, decide, and puts in the tool plug conical flask, the accurate methanol 10ml that adds claims to decide weight, supersound process 1 hour, put coldly, claim again to decide weight, supply the weight that subtracts mistake with methanol, shake up, filter, get subsequent filtrate centrifugal (12000rpm) 10min, supernatant is as need testing solution.
3.6 accurate each the 10 μ l of need testing solution that draw of algoscopy inject chromatograph of liquid, measure peak area, calculate content with standard curve.The results are shown in Table 1.
Active constituent content relatively in three kinds of XIANLING GUBAO ZHIJI of table 1
Icariin psoralen isopsoralen tanshinone
Group
(mg/ grain) (mg/ grain) (mg/ grain) (mg/ grain)
XIANLING GUBAO PIAN 2.55 0.382 0.396 0.224
XIANLING GUBAO JIAONANG 2.46 0.457 0.483 0.238
Xianlinggubao effervescent tablet 3.24 0.486 0.512 0.264
Conclusion: above assay description of test, the content of effective ingredient icariin in the Xianlinggubao effervescent tablet of the present invention, psoralen, isopsoralen, Tanshinone I I A all increases than XIANLING GUBAO PIAN and XIANLING GUBAO JIAONANG, and Xianlinggubao effervescent tablet bioavailability of the present invention is higher, proves absolutely that preparation technology of the present invention has practical significance.
Three, disintegration
By " inspection method of effervescent tablet has been carried out inspection disintegration to Xianlinggubao effervescent tablet of the present invention in inspection technique disintegration (appendix VII A) of Chinese pharmacopoeia (version was an one in 2000), forms clear solution in 3 minutes as a result.
Four, stability
Xianlinggubao effervescent tablet of the present invention has been carried out the study on the stability that room temperature keeps sample, and the result is stable in 1.5 years.
Five, pharmacology embodiment
1. XIANLING GUBAO ZHIJI is to the influence of the whole bone amount of spay osteoporosis model rat vertebral body
Laboratory animal: the female healthy rat of 10 monthly age Wistar, body weight 350 ± 20g.Quality certification 19-052 is provided by Peking University's Experimental Animal Center.
Experiment medicine: XIANLING GUBAO PIAN and XIANLING GUBAO JIAONANG (Tongjitang Pharmacy Co., Ltd., Guizhou's production); Xianlinggubao effervescent tablet (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides);
Experimental technique: with 50 rats, be divided into 5 groups at random, 10 every group.1 group is removed group for the ovary sham cut, or claims normal group; 2 groups is the oophorectomize model group; 3 groups is the XIANLING GUBAO PIAN group: 4 groups is the XIANLING GUBAO JIAONANG group; 5 groups is the Xianlinggubao effervescent tablet group.The normal group not spay of only performing an operation, other 4 groups of row ovariectomys.Postoperative is normal raises and fullly begins medication after 3 months, and wherein XIANLING GUBAO PIAN group, Xianlinggubao effervescent tablet group dosage are equivalent to clinical equivalent dosage: every every day 100mg.Normal group and not medication of model group.Successive administration was expired in 3 months, put to death animal, and the 3rd lumbar vertebra of complete taking-up rat picks the soft tissue and the cartilage that adhere to only, remove spinous process and articular process, the two ends stress surface is polished and and axis normal, the vacuum dehumidifying, weigh, buoyancy method is measured the vertebral body volume, calculates whole bone amount.It is long-pending as the average cross-section of vertebral body to get the high ratio of vertebral body volume and vertebral body.At last vertebral body is placed on the electronic universal material testing machine, getting loading velocity is per minute 6mm, carries out the measurement and the analysis of vertebral body compressive stress.The results are shown in Table 2.
Table 2 XIANLING GUBAO ZHIJI is to spay osteoporosis rat model the 3rd lumbar vertebra
Whole bone amount and bone structure mechanics parameter influence X ± S
The disrumpent feelings bearing capacity of whole bone amount maximum load capacity
Group n
(mm·mm
-3) (N) (N)
Normal group 10 1.402 ± 0.032
*466.72 ± 85.65
*433.69 ± 107.64
*
Model group 10 1.273 ± 0.018 362.83 ± 104.53 310.27 ± 97.66
XIANLING GUBAO PIAN group 10 1.387 ± 0.042
*397.96 ± 104.13 381.26 ± 103.27
*
XIANLING GUBAO JIAONANG group 10 1.392 ± 0.036
*405.88 ± 102.76 393.64 ± 104.88
*
Xianlinggubao effervescent tablet group 10 1.414 ± 0.0767
*★ 427.64 ± 108.26
*★ 427.86 ± 113.88
*★
Compare with model group:
*P＜0.01;
Compare with XIANLING GUBAO PIAN group, XIANLING GUBAO JIAONANG group: ★ P＜0.05
XIANLING GUBAO PIAN group, XIANLING GUBAO JIAONANG group, Xianlinggubao effervescent tablet group and model group compare, and whole bone amount obviously increases (P＜0.01).XIANLING GUBAO PIAN group, XIANLING GUBAO JIAONANG group, Xianlinggubao effervescent tablet group and normal group are compared, and whole bone amount does not have significant difference (P＞0.05).Xianlinggubao effervescent tablet group and XIANLING GUBAO PIAN group, XIANLING GUBAO JIAONANG group compare, and whole bone amount increases (P＜0.05).This explanation rat whole bone loss after spay is accelerated, use Xianlinggubao effervescent tablet or XIANLING GUBAO PIAN, XIANLING GUBAO JIAONANG that the whole bone amount of vertebral body is increased, these medicines can suppress losing of whole bone amount that spay causes in other words, and the Xianlinggubao effervescent tablet action effect is better than XIANLING GUBAO PIAN and XIANLING GUBAO JIAONANG group.
2. XIANLING GUBAO ZHIJI is to the influence of spay osteoporosis model rat vertebral body compressive property
Laboratory animal: the female healthy rat of 10 monthly age Wistar, body weight 350 ± 20g.Quality certification 19-052 is provided by Peking University's Experimental Animal Center.
Experiment medicine: XIANLING GUBAO PIAN and XIANLING GUBAO JIAONANG group (Tongjitang Pharmacy Co., Ltd., Guizhou's production); Xianlinggubao effervescent tablet (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides);
Experimental technique: the same.Experimental result sees Table 3.
Table 3 XIANLING GUBAO ZHIJI is to spay osteoporosis rat model
The 3rd lumbar vertebra mechanics of materials parameter influence X ± S
Elastic modelling quantity ultimate strength rupture strength
Group n
(N·mm-2) (N·mm-2) (N·mm-2)
Normal 10 687.66 ± 108.26
*32.46 ± 7.25
*30.53 ± 7.74
*
Model group 10 554.35 ± 68.44 24.77 ± 6.54 20.86 ± 5.68
XIANLING GUBAO PIAN group 10 673.71 ± 147.51
*27.94 ± 7.89
*26.17 ± 7.69
*
XIANLING GUBAO JIAONANG group 10 676.24 ± 138.83
*28.13 ± 6.44
*27.26 ± 6.47
*
Xianlinggubao effervescent tablet 10 697.12 ± 103.86
*31.07 ± 5.77
*★ 29.83 ± 5.84
*★
Compare with model group:
*P＜0.01;
Compare with XIANLING GUBAO PIAN group, XIANLING GUBAO JIAONANG group: ★ P＜0.05
Model group and normal rats bone photo ratio, mechanics of materials parameter, elastic modelling quantity, ultimate strength, rupture strength etc. all obviously reduce (P＜0.01), and after this explanation rat cut ovum, the mechanics of materials parameter and the structural mechanics parameter of bone all changed.Xianlinggubao effervescent tablet group, XIANLING GUBAO PIAN group, XIANLING GUBAO JIAONANG group are compared with model group, and said structure mechanics and mechanics of materials index all have improve (P＜0.01) in various degree, compare indifference with normal group.The Xianlinggubao effervescent tablet group is compared with XIANLING GUBAO PIAN group, XIANLING GUBAO JIAONANG group, to said structure mechanics and mechanics of materials index also change (P＜0.05).This explanation, rat is constantly lost the mechanical properties decrease of bone along with whole bone amount after spay; After Xianlinggubao effervescent tablet, XIANLING GUBAO PIAN, XIANLING GUBAO JIAONANG treatment, the mechanical property of bone is improved or recovers, and the Xianlinggubao effervescent tablet action effect is better than XIANLING GUBAO PIAN and XIANLING GUBAO JIAONANG.
Above pharmacological evaluation proves that the Xianlinggubao effervescent tablet for preparing with new technology has better therapeutic effect than XIANLING GUBAO PIAN and XIANLING GUBAO JIAONANG.
Six, preparation embodiment
Embodiment 1
(1) raw medicinal material of 1000 of Xianlinggubao effervescent tablets consists of:
Herba Epimedii 1167g Radix Dipsaci 167g Radix Salviae Miltiorrhizae 83g
Rhizoma Anemarrhenae 83g Fructus Psoraleae 83g Radix Rehmanniae 83g
(2) get red rooted salvia, pulverize, make solvent with 95% ethanol and extract twice with multi-functional extractor; Each 95% ethanol that is equivalent to 6 times of medical material weight that adds; Extracted 1 hour for the first time, extracted 1 hour for the second time; Merge ethanol extract, filter, filtrate is concentrated into the extractum that relative density is 1.20 (50 ℃); Again the medicinal residues behind the red rooted salvia ethanol extraction are mixed with Herba Epimedii, Radix Dipsaci, the Rhizoma Anemarrhenae, Fructus Psoraleae, Radix Rehmanniae medical material, extract three times with multi-functional extractor with water as solvent; Each water that is equivalent to 6 times of medical material weight that adds; Extracted 2 hours for the first time, extracted 1 hour for the second time, extracted for the third time 0.5 hour; Merge the water extract, filter.Filtrate is concentrated into the extractum that relative density is 1.15 (50 ℃); Alcohol-extracted extract is mixed with the water extracted immersing paste, and spray drying, pulverizing obtain extract 200g;
(3) set of dispense ratio:
XIANLING GUBAO extract powder 200g
Citric acid 433g
Sodium carbonate 660g
Sodium bicarbonate 560g
PEG6000 67g
Stevioside 43g
Orange essence 37g
Make 1000
(4) extract is mixed with pharmaceutic adjuvant (wrapping up alkaline agent with Polyethylene Glycol), granulation, drying, granulate, tabletting, check, packing obtain 1000 of Xianlinggubao effervescent tablets.
Gained Xianlinggubao effervescent tablet any surface finish, exquisiteness.A slice effervescent tablet input is filled in the 250ml beaker of 20 ℃ of drinking waters of 200ml, at the bottom of being sunken to very soon glass, and seethe up and down immediately, emit a large amount of bubbles, tablet is dissolving rapidly thereupon, forms clear solution in 2.5 minutes.
Embodiment 2
(1) raw medicinal material of 1000 of Xianlinggubao effervescent tablets consists of:
Herba Epimedii 1050g Radix Dipsaci 217g Radix Salviae Miltiorrhizae 100g
Rhizoma Anemarrhenae 100g Fructus Psoraleae 100g Radix Rehmanniae 100g
(2) get red rooted salvia, pulverize, make solvent with 90% ethanol and extract twice with multi-functional extractor; Each 90% ethanol that is equivalent to 8 times of medical material weight that adds; Extracted 2 hours for the first time, extracted 1 hour for the second time; Merge ethanol extract, filter, filtrate is concentrated into the extractum that relative density is 1.15 (50 ℃); Again the medicinal residues behind the red rooted salvia ethanol extraction are mixed with Herba Epimedii, Radix Dipsaci, the Rhizoma Anemarrhenae, Fructus Psoraleae, Radix Rehmanniae medical material, extract three times with multi-functional extractor with water as solvent; Each water that is equivalent to 8 times of medical material weight that adds; Extracted 3 hours for the first time, extracted 1 hour for the second time, extracted for the third time 1 hour; Merge the water extract, filter.Filtrate is concentrated into the extractum that relative density is 1.20 (50 ℃); Alcohol-extracted extract is mixed with the water extracted immersing paste, and spray drying, pulverizing obtain extract 367g;
(3) set of dispense ratio:
XIANLING GUBAO extract powder 367g
Tartaric acid 500g
Sodium carbonate 973g
PEG6000 73g
Aspartame 54g
Flavoring orange essence 33g
Make 1000
(4) extract is mixed with pharmaceutic adjuvant (wrapping up alkaline agent with Polyethylene Glycol), granulation, drying, granulate, tabletting, check, packing obtain 1000 of Xianlinggubao effervescent tablets.
Gained Xianlinggubao effervescent tablet any surface finish, exquisiteness.A slice effervescent tablet input is filled in the 250ml beaker of 20 ℃ of drinking waters of 200ml, at the bottom of being sunken to very soon glass, and seethe up and down immediately, emit a large amount of bubbles, tablet is dissolving rapidly thereupon, forms clear solution in 3 minutes.
Embodiment 3
(1) raw medicinal material of 1000 of Xianlinggubao effervescent tablets consists of:
Herba Epimedii 1245g Radix Dipsaci 186g Radix Salviae Miltiorrhizae 83g
Rhizoma Anemarrhenae 83g Fructus Psoraleae 83g Radix Rehmanniae 83g
(2) get red rooted salvia, pulverize, make solvent with 80% ethanol and extract twice with multi-functional extractor; Each 80% ethanol that is equivalent to 10 times of medical material weight that adds; Extracted 3 hours for the first time, extracted 1 hour for the second time; Merge ethanol extract, filter, filtrate is concentrated into the extractum that relative density is 1.30 (50 ℃); Again the medicinal residues behind the red rooted salvia ethanol extraction are mixed with Herba Epimedii, Radix Dipsaci, the Rhizoma Anemarrhenae, Fructus Psoraleae, Radix Rehmanniae medical material, extract three times with multi-functional extractor with water as solvent; Each water that is equivalent to 12 times of medical material weight that adds; Extracted 3 hours for the first time, extracted 3 hours for the second time, extracted for the third time 1 hour; Merge the water extract, filter.Filtrate is concentrated into the extractum that relative density is 1.27 (50 ℃); Alcohol-extracted extract is mixed with the water extracted immersing paste, and spray drying, pulverizing obtain extract 582g;
(3) set of dispense ratio:
XIANLING GUBAO extract powder 582g
Malic acid 293g
Sodium bicarbonate 960g
PEG6000 71g
Protein sugar 58g
Fructus Citri Limoniae essence 36g
Make 1000
(4) extract is mixed with pharmaceutic adjuvant (wrapping up alkaline agent with Polyethylene Glycol), granulation, drying, granulate, tabletting, check, packing obtain 1000 of Xianlinggubao effervescent tablets.
Gained Xianlinggubao effervescent tablet any surface finish, exquisiteness.A slice effervescent tablet input is filled in the 250ml beaker of 20 ℃ of drinking waters of 200ml, at the bottom of being sunken to very soon glass, and seethe up and down immediately, emit a large amount of bubbles, tablet is dissolving rapidly thereupon, forms clear solution in 3 minutes.
Embodiment 4
(1) raw medicinal material of 1000 of Xianlinggubao effervescent tablets consists of:
Herba Epimedii 1320g Radix Dipsaci 150g Radix Salviae Miltiorrhizae 70g
Rhizoma Anemarrhenae 70g Fructus Psoraleae 80g Radix Rehmanniae 70g
(2) get red rooted salvia, pulverize, make solvent with 70% ethanol and extract twice with multi-functional extractor; Each 70% ethanol that is equivalent to 12 times of medical material weight that adds; Extracted 3 hours for the first time, extracted 2 hours for the second time; Merge ethanol extract, filter, filtrate is concentrated into the extractum that relative density is 1.25 (50 ℃); Again the medicinal residues behind the red rooted salvia ethanol extraction are mixed with Herba Epimedii, Radix Dipsaci, the Rhizoma Anemarrhenae, Fructus Psoraleae, Radix Rehmanniae medical material, extract three times with multi-functional extractor with water as solvent; Each water that is equivalent to 14 times of medical material weight that adds; Extracted 4 hours for the first time, extracted 3 hours for the second time, extracted for the third time 1 hour; Merge the water extract, filter.Filtrate is concentrated into the extractum that relative density is 1.30 (50 ℃); Alcohol-extracted extract is mixed with the water extracted immersing paste, and spray drying, pulverizing obtain extract 800g;
(3) set of dispense ratio:
XIANLING GUBAO extract powder 800g
Malic acid 90g
Tartaric acid 250g
Sodium bicarbonate 700g
PEG6000 72g
Protein sugar 30g
Cyclamate 28g
Herba Menthae essence 30g
Make 1000
(4) extract is mixed with pharmaceutic adjuvant (wrapping up alkaline agent with Polyethylene Glycol), granulation, drying, granulate, tabletting, check, packing obtain 1000 of Xianlinggubao effervescent tablets.
Gained Xianlinggubao effervescent tablet any surface finish, exquisiteness.A slice effervescent tablet input is filled in the 250ml beaker of 20 ℃ of drinking waters of 200ml, at the bottom of being sunken to very soon glass, and seethe up and down immediately, emit a large amount of bubbles, tablet is dissolving rapidly thereupon, forms clear solution in 3 minutes.
Claims (6)
1. effervescent tablet for the treatment of orthopaedic disease, it is characterized in that it is made up of the extract and the pharmaceutic adjuvant of Herba Epimedii, Radix Dipsaci, Radix Salviae Miltiorrhizae, the Rhizoma Anemarrhenae, Fructus Psoraleae, Radix Rehmanniae Six-element medical material, each weight portion of forming is: extract 20-80 part, acid agent 25-60 part, alkaline agent 60-140 part, sweeting agent 1-10 part, correctives 1-5 part; The effective ingredient content Determination of Icariin is not less than 2.0mg/ sheet, psoralen content and is not less than that 0.4mg/ sheet, isopsoralen content are not less than the 0.4mg/ sheet, tanshinone content is not less than the 0.2mg/ sheet in the preparation.
2. a kind of effervescent tablet for the treatment of orthopaedic disease according to claim 1, its preparation method may further comprise the steps:
(1) raw medicinal material of effervescent tablet composition weight portion is:
Herba Epimedii 12-16 Radix Dipsaci 1-3 Radix Salviae Miltiorrhizae 1-2 Rhizoma Anemarrhenae 1-2 Fructus Psoraleae 1-2 Radix Rehmanniae 1-2;
(2) get red rooted salvia, pulverize, make solvent with 70%-95% ethanol and extract twice with multi-functional extractor; Be equivalent to medical material weight 6-8 70%-95% ethanol doubly each the adding; Extracted 1-3 hour for the first time, extracted 1-2 hour for the second time; Merge ethanol extract, filter, filtrate is concentrated into the extractum that relative density is 1.15-1.30 in the time of 50 ℃; Again the medicinal residues behind the red rooted salvia ethanol extraction are mixed with Herba Epimedii, Radix Dipsaci, the Rhizoma Anemarrhenae, Fructus Psoraleae, Radix Rehmanniae medical material, extract three times with multi-functional extractor with water as solvent; Be equivalent to medical material weight 6-14 water doubly each the adding; Extracted 2-4 hour for the first time, extracted 1-3 hour for the second time, extracted for the third time 0.5-1.5 hour; Merge the water extract, filter, relative density was the extractum of 1.15-1.30 when filtrate was concentrated into 50 ℃; Alcohol-extracted extract is mixed with the water extracted immersing paste, and spray drying, pulverizing obtain extract;
(3) extract is mixed with pharmaceutic adjuvant, wherein alkaline agent wraps up with Polyethylene Glycol, mixes, and granulation, drying, granulate, tabletting, check, packing obtain effervescent tablet.
3. effervescent tablet according to claim 1, wherein sweeting agent is to be selected from cyclamate, stevioside, aspartame, the protein sugar one or more; Correctives wherein is selected from orange essence, flavoring orange essence, Herba Menthae essence or Fructus Citri Limoniae essence.
4. effervescent tablet according to claim 2, the weight portion of its crude drug is: Herba Epimedii 14, Radix Dipsaci 2, Radix Salviae Miltiorrhizae 1, the Rhizoma Anemarrhenae 1, Fructus Psoraleae 1, Radix Rehmanniae 1.
5. the sour agent of effervescent tablet according to claim 2 is to be selected from tartaric acid, malic acid, the citric acid one or more.
6. effervescent tablet according to claim 2, wherein alkaline agent is sodium carbonate and or the sodium bicarbonate with the Polyethylene Glycol parcel.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410046192 CN1583133A (en) | 2004-06-03 | 2004-06-03 | Effervescent tablets for bone diseases and their preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410046192 CN1583133A (en) | 2004-06-03 | 2004-06-03 | Effervescent tablets for bone diseases and their preparation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1583133A true CN1583133A (en) | 2005-02-23 |
Family
ID=34601955
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410046192 Pending CN1583133A (en) | 2004-06-03 | 2004-06-03 | Effervescent tablets for bone diseases and their preparation |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1583133A (en) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100341489C (en) * | 2005-07-06 | 2007-10-10 | 北京正大绿洲医药科技有限公司 | Xianling gubao dripping pills having functions of reinforcing kidney strengthening bone, and its prepn method |
| CN103083521A (en) * | 2013-02-20 | 2013-05-08 | 贵州同济堂制药有限公司 | Extraction method, separated extract and preparation of Xianlinggubao |
| CN104224911A (en) * | 2013-06-17 | 2014-12-24 | 天士力制药集团股份有限公司 | New radix salviae milliorrhizae extract and preparation thereof |
| CN105998860A (en) * | 2016-07-26 | 2016-10-12 | 钦州市中医医院 | Traditional Chinese medicinal composition for treating osteoarthropathy |
| CN108815313A (en) * | 2018-08-01 | 2018-11-16 | 申意伟 | The Chinese prescription for treating osteonecrosis |
-
2004
- 2004-06-03 CN CN 200410046192 patent/CN1583133A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100341489C (en) * | 2005-07-06 | 2007-10-10 | 北京正大绿洲医药科技有限公司 | Xianling gubao dripping pills having functions of reinforcing kidney strengthening bone, and its prepn method |
| CN103083521A (en) * | 2013-02-20 | 2013-05-08 | 贵州同济堂制药有限公司 | Extraction method, separated extract and preparation of Xianlinggubao |
| CN103083521B (en) * | 2013-02-20 | 2015-04-15 | 贵州同济堂制药有限公司 | Extraction method, separated extract and preparation of Xianlinggubao |
| CN104224911A (en) * | 2013-06-17 | 2014-12-24 | 天士力制药集团股份有限公司 | New radix salviae milliorrhizae extract and preparation thereof |
| CN104224911B (en) * | 2013-06-17 | 2018-08-03 | 天士力医药集团股份有限公司 | A kind of new Salvia root P.E and its preparation |
| CN105998860A (en) * | 2016-07-26 | 2016-10-12 | 钦州市中医医院 | Traditional Chinese medicinal composition for treating osteoarthropathy |
| CN108815313A (en) * | 2018-08-01 | 2018-11-16 | 申意伟 | The Chinese prescription for treating osteonecrosis |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1899361A (en) | Zhenqi medicinal composition and its preparation | |
| CN1457808A (en) | Iron scale dendrobium compound preposition and preparation and use | |
| CN1245972C (en) | Naringin and its salt used for preparing cough suppressing phlegm tramsforming medicine | |
| CN1762401A (en) | Compound formulation of notoginseng for treating cardiovascular and cerebrovascular diseases, preparation method and application thereof | |
| CN101057925A (en) | Preparation technology for 'jieguqili' capsule and its quality control method | |
| CN101062113A (en) | Milkwort extract, its preparation method and application | |
| CN1876018A (en) | A herbal extract, its preparation method and use | |
| CN103191198A (en) | Rhizoma corydalis extract as well as preparation method and use thereof | |
| CN1583134A (en) | Effervescent tablets of taraxacum mongolicum and their preparation | |
| CN1583133A (en) | Effervescent tablets for bone diseases and their preparation | |
| CN1931255A (en) | Medicine for treating thrombocytopenia and anemia and its prepn process and quality control method | |
| CN1923263A (en) | Traditional Chinese medicine composition, its preparing method and quality controlling means | |
| CN101028348A (en) | Chinese medicinal capsule, its production and quality controlling method | |
| CN1876097A (en) | Improved Chinese medicinal capsule for treating climacteric syndrome | |
| CN1857588A (en) | Quality control method for Xianlinggubao preparation | |
| CN100341489C (en) | Xianling gubao dripping pills having functions of reinforcing kidney strengthening bone, and its prepn method | |
| CN1850230A (en) | Chinese medicine composition for treating osteoporosis and preparing method | |
| CN1283289C (en) | Chinese medicinal formulation for treating dizziness and its quality control method | |
| CN1857385A (en) | Medicine composition for treating cervical spondylosis and its preparing method | |
| CN1292741C (en) | Ginseng and schisandra fruit dripping pill and its preparing method | |
| CN1857592A (en) | Quality control method for trauma treating Diedahongyao preparation | |
| CN1316959C (en) | Acanthopanax bark-ginseng-Chinese angelica root-astragalus root dripping pill and its preparing method | |
| CN1415318A (en) | Chinese herb medical preparation for treating diabetes and its preparation method | |
| CN1297254C (en) | Drop pills containing bear gall and tendril-leaved fritillary bulb and preparation method thereof | |
| CN1296083C (en) | Effervesce tablet of black-bone chicken and white phoenix, and preparation method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| AD01 | Patent right deemed abandoned | ||
| C20 | Patent right or utility model deemed to be abandoned or is abandoned |