CN100340239C - Andrographolide dispersing tablets - Google Patents
Andrographolide dispersing tablets Download PDFInfo
- Publication number
- CN100340239C CN100340239C CNB2005100048533A CN200510004853A CN100340239C CN 100340239 C CN100340239 C CN 100340239C CN B2005100048533 A CNB2005100048533 A CN B2005100048533A CN 200510004853 A CN200510004853 A CN 200510004853A CN 100340239 C CN100340239 C CN 100340239C
- Authority
- CN
- China
- Prior art keywords
- andrographolide
- granulate
- lactose
- cross
- carboxymethyl cellulose
- 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.)
- Expired - Fee Related
Links
- BOJKULTULYSRAS-OTESTREVSA-N Andrographolide Chemical compound C([C@H]1[C@]2(C)CC[C@@H](O)[C@]([C@H]2CCC1=C)(CO)C)\C=C1/[C@H](O)COC1=O BOJKULTULYSRAS-OTESTREVSA-N 0.000 title claims abstract description 40
- ASLUCFFROXVMFL-UHFFFAOYSA-N andrographolide Natural products CC1(CO)C(O)CCC2(C)C(CC=C3/C(O)OCC3=O)C(=C)CCC12 ASLUCFFROXVMFL-UHFFFAOYSA-N 0.000 title claims abstract description 40
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 44
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims abstract description 27
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims abstract description 24
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 24
- 239000008101 lactose Substances 0.000 claims abstract description 24
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 24
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 24
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 24
- 229920002472 Starch Polymers 0.000 claims abstract description 22
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 22
- 239000008107 starch Substances 0.000 claims abstract description 22
- 235000019698 starch Nutrition 0.000 claims abstract description 22
- 239000002002 slurry Substances 0.000 claims abstract description 21
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims abstract description 18
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims abstract description 18
- 238000002360 preparation method Methods 0.000 claims abstract description 12
- 239000008187 granular material Substances 0.000 claims description 36
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 26
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 26
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 26
- 238000004132 cross linking Methods 0.000 claims description 25
- 239000007919 dispersible tablet Substances 0.000 claims description 22
- 239000004141 Sodium laurylsulphate Substances 0.000 claims description 17
- 239000000203 mixture Substances 0.000 claims description 13
- 238000001035 drying Methods 0.000 claims description 12
- 239000007779 soft material Substances 0.000 claims description 8
- 238000005303 weighing Methods 0.000 claims description 8
- 239000004677 Nylon Substances 0.000 claims description 5
- 229920001778 nylon Polymers 0.000 claims description 5
- 239000000843 powder Substances 0.000 claims description 5
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 2
- 238000005469 granulation Methods 0.000 claims description 2
- 230000003179 granulation Effects 0.000 claims description 2
- 239000003814 drug Substances 0.000 abstract description 9
- 229920003123 carboxymethyl cellulose sodium Polymers 0.000 abstract 1
- 229940063834 carboxymethylcellulose sodium Drugs 0.000 abstract 1
- 239000003826 tablet Substances 0.000 description 20
- 238000012360 testing method Methods 0.000 description 14
- 238000003556 assay Methods 0.000 description 9
- 238000004090 dissolution Methods 0.000 description 8
- 239000000047 product Substances 0.000 description 8
- 238000005070 sampling Methods 0.000 description 7
- 238000012545 processing Methods 0.000 description 6
- 239000003242 anti bacterial agent Substances 0.000 description 4
- 229940088710 antibiotic agent Drugs 0.000 description 4
- 238000005286 illumination Methods 0.000 description 4
- 238000012856 packing Methods 0.000 description 4
- 239000000126 substance Substances 0.000 description 4
- 230000000844 anti-bacterial effect Effects 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 239000011521 glass Substances 0.000 description 3
- 238000007689 inspection Methods 0.000 description 3
- 239000002932 luster Substances 0.000 description 3
- 238000005453 pelletization Methods 0.000 description 3
- 238000012216 screening Methods 0.000 description 3
- 239000011265 semifinished product Substances 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- 241000746375 Andrographis Species 0.000 description 2
- 230000003115 biocidal effect Effects 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 238000005259 measurement Methods 0.000 description 2
- 239000012047 saturated solution Substances 0.000 description 2
- 201000009032 substance abuse Diseases 0.000 description 2
- 208000004429 Bacillary Dysentery Diseases 0.000 description 1
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 208000035473 Communicable disease Diseases 0.000 description 1
- 206010012735 Diarrhoea Diseases 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 206010017915 Gastroenteritis shigella Diseases 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 241001597008 Nomeidae Species 0.000 description 1
- 206010035664 Pneumonia Diseases 0.000 description 1
- 206010057190 Respiratory tract infections Diseases 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 206010046306 Upper respiratory tract infection Diseases 0.000 description 1
- 208000036142 Viral infection Diseases 0.000 description 1
- 230000003509 anti-fertility effect Effects 0.000 description 1
- 239000002260 anti-inflammatory agent Substances 0.000 description 1
- 230000001741 anti-phlogistic effect Effects 0.000 description 1
- 230000000259 anti-tumor effect Effects 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 229940084030 carboxymethylcellulose calcium Drugs 0.000 description 1
- 230000002279 cholagogic effect Effects 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 239000006184 cosolvent Substances 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- HYPPXZBJBPSRLK-UHFFFAOYSA-N diphenoxylate Chemical compound C1CC(C(=O)OCC)(C=2C=CC=CC=2)CCN1CCC(C#N)(C=1C=CC=CC=1)C1=CC=CC=C1 HYPPXZBJBPSRLK-UHFFFAOYSA-N 0.000 description 1
- 229960004192 diphenoxylate Drugs 0.000 description 1
- 238000010494 dissociation reaction Methods 0.000 description 1
- 230000005593 dissociations Effects 0.000 description 1
- 229930004069 diterpene Natural products 0.000 description 1
- 150000004141 diterpene derivatives Chemical class 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000000284 extract Substances 0.000 description 1
- 229930184727 ginkgolide Natural products 0.000 description 1
- 230000002440 hepatic effect Effects 0.000 description 1
- 239000001341 hydroxy propyl starch Substances 0.000 description 1
- 235000013828 hydroxypropyl starch Nutrition 0.000 description 1
- 230000003308 immunostimulating effect Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 210000000265 leukocyte Anatomy 0.000 description 1
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 description 1
- 231100000053 low toxicity Toxicity 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 231100000957 no side effect Toxicity 0.000 description 1
- 230000009965 odorless effect Effects 0.000 description 1
- 230000000242 pagocytic effect Effects 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 231100000614 poison Toxicity 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 201000005113 shigellosis Diseases 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 206010044008 tonsillitis Diseases 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 239000003440 toxic substance Substances 0.000 description 1
- 239000010924 used plastic bottle Substances 0.000 description 1
- 230000009385 viral infection Effects 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
The present invention relates to a medicine preparation, particularly to an andrographolide dispersing tablet. Per 1000 andrographolide dispersing tablets are prepared from 10 to 100g of andrographolide, 50 to 200g of lactose, 50 to 200 g of microcrystalline cellulose, 20 to 80 g of carboxymethyl cellulose sodium, 1 to 4 g of sodium laurylsulfate, a proper amouth of starch slurry accounting for 5% and 0.5 to 2 g of magnesium stearate.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparation, design andrographolide dispersed tablet preparation and preparation method thereof especially.
Background technology
Andrographolide system extracts the diterpene ginkgolide that obtains in acanthaceous plant Herba Andrographis, be Chinese medicine Herba Andrographis mainly contain one of effective constituent, it is colourless, odorless, bitter in the mouth have effects such as heat-clearing and toxic substances removing, removing heat from blood detumescence.Be used for the treatment of bacillary dysentery, tonsillitis, upper respiratory tract infection, pneumonia etc.Modern pharmacological research shows, andrographolide and derivant thereof have antiphlogistic antibacterial, antibacterial, strengthen the functions such as phagocytic activity, viral infection resisting, antitumor, anti-cardiovascular disease, immunostimulation, hepatic cholagogic and antifertility of human leukocytes to antibacterial.
Along with the medical science technical merit improves constantly, clinical common various infectious disease have all obtained better treatment and control.But also necessary acutely aware, the phenomenon that China abuses antibiotics at present is very serious, because with new, a large amount of antibiotics extensive uses is clinical, thereby caused bacterial dissociation and Resistant strain to increase, add up according to interrelated data, the drug level of China's antibiotics and dosage are all above developed country's level, be far from suitable with the national conditions of China, go down like this, certainly will cause the resource medicine waste and increase the weight of society, individual burden, for this reason, be badly in need of clinically at present a kind of have efficient, low toxicity, the tcm product of the anti-inflammation of safety, to satisfy market and needs of medical treatment, this also is that national industrial policies are given priority to product.Existing in the market chemical drugs of the same type has antibiotic (as than woods class, xacin-series etc.) and diarrhea (as diphenoxylate) all because of the harm of abuse of antibiotics and its toxic and side effects of bringing careful usefulness of behaving.The andrographolide sheet is as tcm product, and its determined curative effect has no side effect, and is accepted by extensive patients, and the good reputation of " Chinese medicine antibiotic " is arranged.But not soluble in water because of andrographolide, cause conventional tablet medicine dissolution rate and poor solubility, reduce its utilization ratio, and taken inconvenience.
The present invention is modified as dispersible tablet with it, has found optimum formula, has improved medicine dissolution rate and dissolubility.Disperse, suspendible, release and availability are higher fast in the suction body.
Summary of the invention
The invention provides a kind of is the dispersible tablet of active component with the andrographolide.
Dispersible tablet of the present invention contains the andrographolide of effective dose and is fit to any pharmaceutically useful carrier of preparation dispersible tablet.Every of dispersible tablet of the present invention contains andrographolide 10-100mg.Dispersible tablet of the present invention, described pharmaceutically suitable carrier is selected from, lactose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, sodium lauryl sulphate, starch, magnesium stearate.
Per 1000 composed as follows of dispersible tablet of the present invention:
Andrographolide 10-100g
Lactose 50-200g
Microcrystalline Cellulose 50-200g
Cross-linking sodium carboxymethyl cellulose 20-80g
Sodium lauryl sulphate 1-4g
5% starch slurry is an amount of
Magnesium stearate 0.5-2g
Dispersible tablet of the present invention, preferred per 1000 is composed as follows:
Andrographolide 50g
Lactose 100g
Microcrystalline Cellulose 100g
Cross-linking sodium carboxymethyl cellulose 40g
Sodium lauryl sulphate 2g
5% starch slurry is an amount of
Magnesium stearate 1g
The present invention also comprises the preparation method of dispersible tablet of the present invention, it is characterized in that, prepares 1000 dispersible tablets of the present invention, may further comprise the steps:
A. it is standby andrographolide to be pulverized 200 mesh sieves, and it is standby that lactose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, sodium lauryl sulphate are crossed 100 mesh sieves respectively;
B. press recipe quantity weighing andrographolide, lactose, microcrystalline Cellulose, 35g cross-linking sodium carboxymethyl cellulose, sodium lauryl sulphate, mix homogeneously;
C. granulate;
D. dry;
E. granulate;
F. add remaining 5g cross-linking sodium carboxymethyl cellulose, magnesium stearate, mix homogeneously;
G. tabletting.
Wherein,
In the step c granulation step, with 5% starch slurry system soft material, granulate with 24 order nylon wires, the granule that makes should lack fine powder;
In the steps d drying steps: 55-65 ℃ drying baker inner drying 2-3 hour;
In the step e granulate step: sieve and select 30 mesh sieve granulate for use;
It below is the prescription screening of dispersible tablet of the present invention
Dispersible tablet requires the disintegrate of tablet very fast, thus in the prescription screening process, regulate by adding disintegrating agent, cosolvent, so that tablet reaches disintegrate faster.Selected prescription is as follows:
Prescription 1 prescription 2
Andrographolide 50g andrographolide 50g
Lactose 100g lactose 100g
Microcrystalline Cellulose 100g microcrystalline Cellulose 100g
Sodium carboxymethyl cellulose 20g hydroxypropyl starch 20g
An amount of 5% starch slurry of 5% starch slurry is an amount of
Magnesium stearate 1g magnesium stearate 2g
Make 1000 and make 1000
Prescription 3 prescriptions 4
Andrographolide 50g andrographolide 50g
Lactose 100g lactose 100g
Microcrystalline Cellulose 100g microcrystalline Cellulose 100g
Low-substituted hydroxypropyl cellulose 20g crospolyvinylpyrrolidone 20g
An amount of 5% starch slurry of 5% starch slurry is an amount of
Magnesium stearate 1g magnesium stearate 1g
Make 1000 and make 1000
Prescription 5 prescriptions 6
Andrographolide 50g andrographolide 50g
Lactose 100g lactose 100g
Microcrystalline Cellulose 100g microcrystalline Cellulose 100g
Carboxymethylcellulose calcium 20g cross-linking sodium carboxymethyl cellulose 20g
An amount of 5% starch slurry of 5% starch slurry is an amount of
Magnesium stearate 1g magnesium stearate 1g
Make 1000 and make 1000
Table 1 stripping curve measurement result (%)
| The prescription number | 1 | 2 | 3 | 4 | 5 | 6 |
| 5 minutes | 16.4 | 15.0 | 18.2 | 17.6 | 15.3 | 25.6 |
| 10 minutes | 33.5 | 31.2 | 35.7 | 35.8 | 36.4 | 48.9 |
| 30 minutes | 72.4 | 73.0 | 73.2 | 75.8 | 76.3 | 86.4 |
| 50 minutes | 85.3 | 84.6 | 88.3 | 85.4 | 87.1 | 96.7 |
| 75 minutes | 95.4 | 98.9 | 98.4 | 97.3 | 98.6 | 100.6 |
| Hardness | 5.8Kg | 5.5Kg | 6.1Kg | 5.9Kg | 5.6Kg | 6.3Kg |
| Dispersing uniformity | 4 minutes 19 seconds | 4 minutes 21 seconds | 4 minutes 16 seconds | 4 minutes 27 seconds | 4 minutes 15 seconds | 3 minutes 22 seconds |
According to above result of the test: prescription 1-prescription 6 reached maximum dissolution in 75 minutes though measure stripping curve under the approaching situation of hardness, the stripping curve of prescription 6 obviously is better than other several prescriptions; But dispersing uniformity all defective (by the requirement of dispersible tablet dispersing uniformity among two appendix I of Chinese Pharmacopoeia version in 2000 A: get 2 of dispersible tablets and put jolting in the 100ml water, in 20 ℃ ± 1 water, all disintegrates and in 3 minutes by No. 2 sieves.); Simultaneously the consumption of disintegrating agent is improved and change inside and outside addition into so we will add surfactant on the basis of above prescription 6, improve the dissolution and the dispersing uniformity of dispersible tablet with this.
Prescription 7 prescriptions 8
Andrographolide 50g andrographolide 50g
Lactose 100g lactose 100g
Microcrystalline Cellulose 100g microcrystalline Cellulose 100g
Cross-linking sodium carboxymethyl cellulose 25g cross-linking sodium carboxymethyl cellulose 35g
Sodium lauryl sulphate 1g sodium lauryl sulphate 2g
An amount of 5% starch slurry of 5% starch slurry is an amount of
Cross-linking sodium carboxymethyl cellulose 5g cross-linking sodium carboxymethyl cellulose 5g
Magnesium stearate 1g magnesium stearate 2g
Make 1000 and make 1000
Table 2 prescription 7, prescription 8 stripping curve measurement results (%)
| The prescription number | 5 minutes | 10 minutes | 30 minutes | 50 minutes | 75 minutes | Dispersing uniformity | Hardness |
| 7 | 39.2 | 71.8 | 95.0 | 98.9 | 101.2 | 1 minute 30 seconds | 5.25 |
| 8 | 52.8 | 82.4 | 94.6 | 100.2 | 102.1 | 1 minute 05 second | 5.51 |
Show by above experimental result: prescription 7 and 8 the stripping curve of writing out a prescription all have clear improvement than before and dispersing uniformity good; Prescription 8 is more superior than prescription 7 in these two prescriptions, so we select to write out a prescription 8 as making ultimum praescriptus.
3. influence factor's test
(1) influence factor of 4500LX ± 500LX illumination condition test:
Get 031008 batch of andrographolide dispersed tablet and place glass dish, placed 10 days under the illumination of 4500LX ± 500LX, detect in sampling in 0,5,10 day, testing result sees Table 3:
Table 3 4500LX ± 500LX illumination condition influence factor result of the test
| Blanking time (my god) | Appearance luster | Differentiate | Limit test of microbe | Dissolution (%) | Dispersing uniformity | Related substance (%) | Content (%) |
| 0 | Complete white tablets | Up to specification | Up to specification | 95.3 | Up to specification | 0.48 | 101.0 |
| 5 | Complete white tablets | Up to specification | Up to specification | 93.1 | Up to specification | 0.53 | 100.1 |
| 10 | Complete white tablets | Up to specification | Up to specification | 93.4 | Up to specification | 0.53 | 99.6 |
2) temperatures involved factorial experiments:
Get 031008 batch of andrographolide dispersed tablet and place glass dish, placed 10 days in 60 ℃ ± 2 ℃ calorstat, detect in sampling in 0,5,10 day, testing result sees Table 4:
60 ℃ of temperatures involved factorial experimentss of table 4 result
| Blanking time (my god) | Appearance luster | Differentiate | Limit test of microbe | Dissolution (%) | Dispersing uniformity | Related substance (%) | Content (%) |
| 0 | Complete white tablets | Up to specification | Up to specification | 95.3 | Up to specification | 0.48 | 101.0 |
| 5 | Complete white tablets | Up to specification | Up to specification | 94.9 | Up to specification | 0.50 | 99.9 |
| 10 | Complete white tablets | Up to specification | Up to specification | 93.8 | Up to specification | 0.57 | 99.4 |
(3) high humidity influence factor result of the test:
The andrographolide dispersed tablet of getting 031008 batch places glass dish, at 25 ℃ of relative humidity 92.5% ± 5% (KNO
3Saturated solution) placed 10 days in the calorstat, detect in sampling in 0,5,10 day, testing result sees Table 5
Table 5 92.5% high humidity influence factor result of the test
| Blanking time (my god) | Appearance luster | Differentiate | Limit test of microbe | Hydroscopicity (%) | Dissolution (%) | Dispersing uniformity | Related substance (%) | Content (%) |
| 0 | Complete white tablets | Up to specification | Up to specification | 95.3 | Up to specification | 0.48 | 101.0 | |
| 5 | Complete from color chips | Up to specification | Up to specification | 4.89 | 90.8 | Up to specification | 0.58 | 99.9 |
| 10 | Complete white tablets | Up to specification | Up to specification | 6.65 | 85.3 | Up to specification | 0.61 | 100.3 |
Above result of the test shows: this product is at 4500LX ± 500LX illumination condition, under 60 ℃ ± 2 hot conditionss, under 25 ℃, RH92.5% ± 5% super-humid conditions, place 10 days comparatively stable.
The present invention has found optimum formula by screening, has improved medicine dissolution rate and dissolubility.Disperse, suspendible, release and availability are higher fast in the suction body.
The specific embodiment:
Further specify the present invention by the following examples.
Embodiment 1
Prescription:
Per 1000 composed as follows of dispersible tablet of the present invention:
Andrographolide 50g
Lactose 100g
Microcrystalline Cellulose 100g
Cross-linking sodium carboxymethyl cellulose 40g
Sodium lauryl sulphate 2g
5% starch slurry is an amount of
Magnesium stearate 1g
Preparation:
The preparation of 1 supplementary material and processing:
It is standby that andrographolide was pulverized 200 mesh sieves, and it is standby that lactose, microcrystalline Cellulose, 35g cross-linking sodium carboxymethyl cellulose, sodium lauryl sulphate are crossed 100 mesh sieves respectively.
2 weighings with mix:
2.1 take by weighing above-mentioned supplementary material respectively through the double calculating inventory of checking according to recipe quantity.
2.2 with above-mentioned supplementary material mix homogeneously.
3 granulate:
3.1 the system soft material is granulated with 24 order nylon wires with 5% starch slurry system soft material, the granule that makes should lack fine powder.
3.2 it is dry: 55-65 ℃ drying baker inner drying 2-3 hour.
3.3 the processing of dried granule before tabletting:
Granulate: in pelletization, excessive granule is arranged, the granulate that need sieve makes it become the single-size that is fit to tabletting; Sieve and select 30 mesh sieve granulate for use.
3.4 add 5g cross-linking sodium carboxymethyl cellulose, magnesium stearate, mix homogeneously is placed in the hermetic container, after the assay was approved tabletting.
4 measure granule content, and it is heavy to calculate sheet:
5 tablettings: heavy according to the actual sheet of result of calculation gained, regulate the tablet machine tabletting, put into hermetic container sampling check dispersing uniformity after finishing.
6 inspections of semifinished product: pack after the assay was approved by the quality standard requirement.
7 pack according to the requirement of product, and packing back warehouse-in can dispatch from the factory after the assay was approved according to quality standard.
Embodiment 2
Prescription:
Per 1000 composed as follows of dispersible tablet of the present invention:
Andrographolide 10g
Lactose 50g
Microcrystalline Cellulose 50g
Cross-linking sodium carboxymethyl cellulose 20g
Sodium lauryl sulphate 1g
5% starch slurry is an amount of
Magnesium stearate 0.5g
Preparation:
The preparation of 1 supplementary material and processing:
It is standby that andrographolide was pulverized 200 mesh sieves, and it is standby that lactose, microcrystalline Cellulose, 17.5g cross-linking sodium carboxymethyl cellulose, sodium lauryl sulphate are crossed 100 mesh sieves respectively.
2 weighings with mix:
2.1 take by weighing above-mentioned supplementary material respectively through the double calculating inventory of checking according to recipe quantity.
2.2 with above-mentioned supplementary material mix homogeneously.
3 granulate:
3.1 the system soft material is granulated with 24 order nylon wires with 5% starch slurry system soft material, the granule that makes should lack fine powder.
3.2 it is dry: 55-65 ℃ drying baker inner drying 2-3 hour.
3.3 in the processing of granule before tabletting:
Granulate: in pelletization, excessive granule is arranged, the granulate that need sieve makes it become the single-size that is fit to tabletting; Sieve and select 30 mesh sieve granulate for use.
3.4 add 2.5g cross-linking sodium carboxymethyl cellulose, magnesium stearate, mix homogeneously is placed in the hermetic container, after the assay was approved tabletting.
4 measure granule content, and it is heavy to calculate sheet:
5 tablettings: heavy according to the actual sheet of result of calculation gained, regulate the tablet machine tabletting, put into hermetic container sampling check dispersing uniformity after finishing.
6 inspections of semifinished product: pack after the assay was approved by the quality standard requirement.
7 pack according to the requirement of product, and packing back warehouse-in can dispatch from the factory after the assay was approved according to quality standard.
Embodiment 3
Prescription:
Per 1000 composed as follows of dispersible tablet of the present invention:
Andrographolide 100g
Lactose 200g
Microcrystalline Cellulose 200g
Cross-linking sodium carboxymethyl cellulose 80g
Sodium lauryl sulphate 4g
5% starch slurry is an amount of
Magnesium stearate 2g
Preparation:
The preparation of 1 supplementary material and processing:
It is standby that andrographolide was pulverized 200 mesh sieves, and it is standby that lactose, microcrystalline Cellulose, 87.5g cross-linking sodium carboxymethyl cellulose, sodium lauryl sulphate are crossed 100 mesh sieves respectively.
2 weighings with mix:
2.1 take by weighing above-mentioned supplementary material respectively through the double calculating inventory of checking according to recipe quantity.
2.2 with above-mentioned supplementary material mix homogeneously.
3 granulate:
3.1 the system soft material is granulated with 24 order nylon wires with 5% starch slurry system soft material, the granule that makes should lack fine powder.
3.2 it is dry: 55-65 ℃ drying baker inner drying 2-3 hour.
3.3 the processing of dried granule before tabletting:
Granulate: in pelletization, excessive granule is arranged, the granulate that need sieve makes it become the single-size that is fit to tabletting; Sieve and select 30 mesh sieve granulate for use.
3.4 add 12.5g cross-linking sodium carboxymethyl cellulose, magnesium stearate, mix homogeneously is placed in the hermetic container, after the assay was approved tabletting.
4 measure granule content, and it is heavy to calculate sheet:
5 tablettings: heavy according to the actual sheet of result of calculation gained, regulate the tablet machine tabletting, put into hermetic container sampling check dispersing uniformity after finishing.
6 inspections of semifinished product: pack after the assay was approved by the quality standard requirement.
7 pack according to the requirement of product, and packing back warehouse-in can dispatch from the factory after the assay was approved according to quality standard.
Embodiment 4
The testing data of stability study
One, constant temperature accelerated stability test:
Get andrographolide dispersed tablet, lot number 031008,031010,031012 is used plastic bottle packing, and constant temperature is placed under 40 ℃ ± 2 ℃ relative humiditys 75% (NaCL saturated solution) condition, respectively at 0,1,2,3, the sampling in June detects.The result shows: this product is under the condition of 40 ℃ ± 2 ℃ of relative humiditys 75%, and in 6 months of having investigated, each investigates every index of project does not have significant change, has stability preferably.
Claims (4)
1, a kind of is the dispersible tablet of active component with the andrographolide, it is characterized in that, per 1000 is composed as follows:
Andrographolide 10-100g
Lactose 50-200g
Microcrystalline Cellulose 50-200g
Cross-linking sodium carboxymethyl cellulose 20-80g
Sodium lauryl sulphate 1-4g
5% starch slurry is an amount of
Magnesium stearate 0.5-2g.
2, the dispersible tablet of claim 1 is characterized in that, per 1000 is composed as follows:
Andrographolide 50g
Lactose 100g
Microcrystalline Cellulose 100g
Cross-linking sodium carboxymethyl cellulose 40g
Sodium lauryl sulphate 2g
5% starch slurry is an amount of
Magnesium stearate 1g.
3, the preparation method of the dispersible tablet of claim 2 is characterized in that, prepares 1000 dispersible tablets, may further comprise the steps:
A. it is standby andrographolide to be pulverized 200 mesh sieves, and it is standby that lactose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, sodium lauryl sulphate are crossed 100 mesh sieves respectively;
B. press recipe quantity weighing andrographolide, lactose, microcrystalline Cellulose, 35g cross-linking sodium carboxymethyl cellulose, sodium lauryl sulphate, mix homogeneously;
C. granulate;
D. dry;
E. granulate;
F. add remaining 5g cross-linking sodium carboxymethyl cellulose, magnesium stearate, mix homogeneously;
G. tabletting;
Wherein, in the step c granulation step, with 5% starch slurry system soft material, granulate with 24 order nylon wires, the granule that makes should lack fine powder;
In the steps d drying steps: 55-65 ℃ drying baker inner drying 2-3 hour;
In the step e granulate step: sieve and select 30 mesh sieve granulate for use.
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| CN1561997A (en) * | 2004-04-20 | 2005-01-12 | 成都厚发科技开发有限公司 | Medicinal composition having anti-inflammation and anti-infection function |
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| CN1561997A (en) * | 2004-04-20 | 2005-01-12 | 成都厚发科技开发有限公司 | Medicinal composition having anti-inflammation and anti-infection function |
Non-Patent Citations (2)
| Title |
|---|
| 用固体分散法提高穿心莲内酯片溶出速率的研究 仁天池等，中成药研究，第1985卷第3期 1985 * |
| 黄心分散片抗菌作用的研究 包旭等，中药药理与临床，第17卷第5期 2001 * |
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