CN101011362A - Dispersible tablet of pidotimod and its preparing process and use - Google Patents
Dispersible tablet of pidotimod and its preparing process and use Download PDFInfo
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- CN101011362A CN101011362A CN 200710013444 CN200710013444A CN101011362A CN 101011362 A CN101011362 A CN 101011362A CN 200710013444 CN200710013444 CN 200710013444 CN 200710013444 A CN200710013444 A CN 200710013444A CN 101011362 A CN101011362 A CN 101011362A
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Abstract
The invention relates to a method for preparing pidomud disperser and relative application. The invention comprises the active components as pidomud, adhesive, disintegration agent, stuff, and lubricant and sweat agent. The invention also provides relative preparation and application. The inventive disperser has better disperse state, short disintegration time and quick release, or the like, while it can be orally taken, eaten or mixed in water.
Description
Technical field
The invention belongs to pharmaceutical field, relate to dispersible tablet of pidotimod and its production and application.
Background technology
Pidotimod (pidotimod) is a kind of brand-new synthetic immunomodulator, and its similar is in dipeptides.Pharmacodynamic study shows that pidotimod is an immunopotentiating agent, can promote nonspecific immune reaction, also can promote specific immune response.Animal experiment and clinical trial show; although pidotimod does not have directly antibiotic and antiviral activity; but can bring into play the effect of significant treatment antibacterial and viral infection by promoting body's immunological function; animal for bacterial infections such as escherichia coli, proteus vulgaris, special Bacillus proteuss has strong protective effect, but and the life span of significant prolongation infection Mengo virus, herpesvirus and influenza A virus animal.Clinically, pidotimod is used for the treatment of repeatedly respiratory tract infection, the otorhinolaryngology repeated infection of outbreak, the patient of genitourinary system repeated infection, can be used for prevention infection acute stage disease, shorten the course of disease, the order of severity that palliates a disease, reduce attack times repeatedly, the adjuvant drug of antibacterial drug therapy when also can be used for actute infection.
Pidotimod is a kind of high-purity dipeptides of synthetic, it is unique a kind of oral bioactive immunopotentiating agent that has, the later stage eighties 20th century is successfully synthesized by Italian Poli industria chimica S.P.A chemical company, and got permission listing in 1993 and be used for clinical, domestic existing by Taiyangshi's production tablet, Suzhou ChangZheng-Xinkai Pharmaceutical Co.,Ltd's raw materials for production and oral solution, Zhejiang Province XianJu Pharmacy stock Co., Ltd produces granule.
The quality standard of pidotimod raw material and tablet all records in become a full member 35 of standards of new drug.
CN1526390 discloses granule of a kind of pidotimod and preparation method thereof, includes pidotimod and 30 POVIDONE K 30 BP/USP 30; Sodium carbonate; Sucrose; Adjuvants such as cocoanut flavour are made granule again through the system soft material.Be diluent wherein with sodium carbonate, sucrose; 30 POVIDONE K 30 BP/USP 30 is a binding agent; Sucrose, sodium carbonate, cocoanut flavour are correctives.Be mainly used in all kinds of patients' of treatment immunodeficiency immunologic function promoter.
CN1680427 discloses and has been easy to water-soluble pidotimod double salt and preparation method thereof.CN1868464 discloses a kind of Piduomode soft capsule preparation and preparation method thereof, be with one in active component pidotimod and diluent, cosolvent, solubilizing agent, suspending agent, the surfactant and/or a plurality of, the mixed content that gets, adopt the soft capsule preparation method to prepare soft capsule, soft capsule is through solidifying by cooling in wind, drying, wash ball, do eventually, promptly with appropriate solvent.
But the clinical practice dosage form of pidotimod has only conventional tablet, oral administration solution and granule, and for increasing the selection of clinical practice, we have developed dispersible tablet of pidotimod.
Summary of the invention
The purpose of this invention is to provide a kind of taking convenience, dispersible tablet of pidotimod that bioavailability is high and preparation method thereof.
The formulation and technology design considerations:
The pidotimod raw material is a white crystalline powder, odorless, sour in the mouth.This product is dissolved in dimethyl formamide, and is molten in the water part omitted, slightly soluble, almost insoluble in chloroform in methanol or ethanol.According to the prescription of relevant dispersible tablet among two appendix IA of Chinese Pharmacopoeia version in 2005, among the dispersible tablet Ying Zaishui (100ml, 20 ℃ ± 1 ℃), should all dissolve in 3 minutes, and by No. 2 sieves.
Therefore, emphasis is considered from following several respects in prescription screening and technological design:
(1) the high-quality disintegrating agent and the suspending agent of Ying Yonging;
(2) adopt the stronger binding agent of hydrophilic;
(3) select sweeting agent to improve the tablet taste.
The invention provides a kind of dispersible tablet of pidotimod, comprise active component pidotimod and medically acceptable pharmaceutic adjuvant.
Described adjuvant comprises binding agent, disintegrating agent, filler, lubricant and sweeting agent.
Described dispersible tablet of pidotimod, it is as follows to fill a prescription:
Pidotimod 380-420 part
Disintegrating agent 80-400 part
Binding agent 10-30 part
Filler 10-30 part
Lubricant 2-3 part
Sweeting agent 2-3 part
Be weight portion.
Preferably, disintegrating agent is selected from one or more in low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, the microcrystalline Cellulose.
Preferably, filler is selected from one or more in lactose, amylum pregelatinisatum, dextrin, Icing Sugar, the microcrystalline Cellulose.
Preferably, binding agent is selected from one or more in polyvidone, hypromellose, polyvinylpyrrolidone, methylcellulose, the sodium carboxymethyl cellulose.
Preferably, lubricant is selected from one or more in magnesium stearate, micropowder silica gel, the Pulvis Talci.
Preferably, sweeting agent is selected from one or more in aspartame, stevioside, the protein sugar.
Preferably, for satisfying the requirement of dispersible tablet dispersing uniformity, particulate granularity should be controlled at below 30 orders during granulation.
This provides prescription to be best prescription (by 1000 consumptions):
Pidotimod 400
Microcrystalline Cellulose 230
Low-substituted hydroxypropyl cellulose 60g
5% polyvinylpyrrolidone (50% alcoholic solution) 15g
Lactose 20g
Magnesium stearate 1.0%
Aspartame 1.0%
Make 1000
The present invention also provides the preparation method of described dispersible tablet of pidotimod, and step is as follows:
1) presses recipe quantity, accurately take by weighing all raw materials and adjuvant, cross 30～120 mesh sieves; Wherein disintegrating agent and filler are divided into Nei Jia and Extra Section, and the ratio of Nei Jia and Extra Section is 1～4: 1, weight ratio; In add and respectively weighing of Extra Section, and carry out labelling;
2) put mix homogeneously in the mixer altogether with adding adjuvant in pidotimod raw material and all; Add binding agent, continue to mix, make suitable soft material, 30 mesh sieves are granulated;
3) with granule after 50 ℃～55 ℃ oven dry, 30 mesh sieve granulate;
4) add all by prescription and add adjuvant, fully mixing; Measure granule content, it is heavy to calculate sheet; The stamping of ￠ 10mm scrobicula, aluminum-plastic packaged after promptly.
Preferably, disintegrating agent and filler are microcrystalline Cellulose and low-substituted hydroxypropyl cellulose; Binding agent is a polyvinylpyrrolidone;
Preferred, binding agent is 50% a alcoholic solution of polyvinylpyrrolidone; Concentration is 2%～10%, and preferred concentration is 5%.
Advantage of the present invention is: have that good dispersing state, disintegration time are short, the medicine stripping is rapid; Absorption is fast, bioavailability is high; Taking convenience can be swallowed, chew to contain and suck or with taking after the aqueous dispersion, especially is fit to old man, paralytic and the patient of the difficulty of swallowing such as takes at advantage.
Description of drawings
Fig. 1 is a dispersible tablet of pidotimod preparation technology flow chart.
The specific embodiment
Following examples are to further specify of the present invention, but the present invention is not limited thereto.
Embodiment 1: the preparation method of dispersible tablet of pidotimod
(1) by best prescription amount provided by the invention, accurately take by weighing all raw materials and adjuvant, raw material pulverizing is crossed 100 mesh sieves; Cross 30 mesh sieves during the wet grain of system, and with 30 mesh sieve granulate.
(2) adopt microcrystalline Cellulose and low-substituted hydroxypropyl cellulose disintegrating agent and filler, and add in adopting and add bonded method with the disintegration rate that improves tablet and the dissolution of pidotimod, microcrystalline Cellulose and low-substituted hydroxypropyl cellulose are divided into Nei Jia and Extra Section, in add and the ratio that adds adds in being: add=2: 1 weight ratio.
(3) use 50% alcoholic solution of polyvinylpyrrolidone to do binding agent, working concentration is generally 2%～10%.
(4) lactose that adds formula ratio improves tablet appearance as filler.
(5), and, therefore, after filtering out best prescription, carry out the selection of sweeting agent again by orthogonal test to a few nothing influences of the performance of preparation because the consumption of sweeting agent in prescription is very little.
(6) the tentative magnesium stearate of lubricant.
(7) put mix homogeneously in the mixer altogether with adding adjuvant in pidotimod raw material and all, 50% the alcoholic solution that adds 5% polyvinylpyrrolidone is an amount of, continues to mix, and makes suitable soft material, and 30 mesh sieves are granulated; With granule after 50 ℃～55 ℃ oven dry, 30 mesh sieve granulate;
(8) add all by prescription and add adjuvant, fully mixing; Measure granule content, it is heavy to calculate sheet; The stamping of ￠ 10mm scrobicula, aluminum-plastic packaged after promptly.
Embodiment 2: the preparation of dispersible tablet of pidotimod
1) by best prescription amount provided by the invention, accurately take by weighing all raw materials and adjuvant, raw material is crossed 120 mesh sieves, adjuvant is crossed 100 mesh sieves; Wherein microcrystalline Cellulose and low-substituted hydroxypropyl cellulose are divided into Nei Jia and Extra Section, add in microcrystalline Cellulose and the low-substituted hydroxypropyl cellulose and Extra Section weighing respectively, and carry out labelling; The ratio that adds in microcrystalline Cellulose and the low-substituted hydroxypropyl cellulose with Extra Section is 3: 1, weight ratio;
2) put mix homogeneously in the mixer altogether with adding adjuvant in pidotimod raw material and all; 50% the alcoholic solution that adds 5% polyvinylpyrrolidone is an amount of, continues to mix, and makes suitable soft material, and 30 mesh sieves are granulated;
3) with granule after 50 ℃～55 ℃ oven dry, 30 mesh sieve granulate;
4) add all by prescription and add adjuvant, fully mixing; Measure granule content, it is heavy to calculate sheet; The stamping of ￠ 10mm scrobicula, aluminum-plastic packaged after promptly.
The method of granulating in the tablet manufacturing process is divided into wet granulation and dry granulation, sees so that wet granulation is more in the actual production.The present invention screens this product prescription by orthogonal experiment.
Embodiment 3: orthogonal experiment
(what adjuvant referred to is exactly microcrystalline Cellulose, low-substituted hydroxypropyl cellulose to get pidotimod 40g and pharmaceutic adjuvant, polyvinylpyrrolidone), with microcrystalline Cellulose, low-substituted hydroxypropyl cellulose consumption, polyvinylpyrrolidone concentration and in add, add adjuvant ratio (in add, add adjuvant ratio be 2: 1) be factor, design three levels and screen, the results are shown in Table 1.
Table 1. formulation optimization four factors three water-glasses
| Level | Factor | |||
| A(MCC) | B(L-HPC) | C (PVPk30 concentration) | D (lactose) | |
| 1 2 3 | 15g 20g 23g | 4g 5g 6g | 2％ 5％ 10％ | 1g 2g 3g |
Wherein, the consumption of microcrystalline Cellulose, low-substituted hydroxypropyl cellulose is a gross weight, in add, add adjuvant ratio be 2: 1.
Get pidotimod and adjuvant, cross 100 mesh sieves,, accurately take by weighing all supplementary materials by orthogonal design table, wherein microcrystalline Cellulose and low-substituted hydroxypropyl cellulose in add and respectively weighing of Extra Section (ratio of Nei Jia and Extra Section is 2.: 1), and carry out labelling; Add the adjuvant mix homogeneously with in pidotimod raw material and all, add binding agent, continue to mix, make suitable soft material, 30 mesh sieves are granulated; With granule after 50-55 ℃ of oven dry, 30 mesh sieve granulate; Add all by prescription and add adjuvant, fully mixing; Tabletting promptly.Preparation method is with embodiment 1.
Table 2 orthogonal experiments
| Experiment numbers | 1 | 2 | 3 | 4 | Experimental result (dispersing uniformity) | |
| A | B | C | D | Disintegration (second) | Cross sieve No. 2 | |
| Experiment 1 | 1 | 1 | 1 | 1 | 124 | All sieve |
| Experiment 2 | 1 | 2 | 2 | 2 | 108 | All sieve |
| Experiment 3 | 1 | 3 | 3 | 3 | 91 | All do not sieve |
| Experiment 4 | 2 | 1 | 2 | 3 | 110 | All sieve |
| Experiment 5 | 2 | 2 | 3 | 1 | 85 | All do not sieve |
| Experiment 6 | 2 | 3 | 1 | 2 | 64 | All sieve |
| Experiment 7 | 3 | 1 | 3 | 2 | 58 | All sieve |
| Experiment 8 | 3 | 2 | 1 | 3 | 33 | All sieve |
| Experiment 9 | 3 | 3 | 2 | 1 | 16 | All sieve |
| Average 1 | 107.67 | 97.33 | 73.66 | 75.00 | ||
| Average 2 | 86.33 | 75.33 | 78.00 | 76.66 | ||
| Average 3 | 35.67 | 57.00 | 78.00 | 78.00 | ||
| Extreme difference | 72.00 | 40.33 | 4.34 | 3.00 | ||
The analysis showed that each adjuvant is A＞B＞C＞D to the influence degree of the disintegrating property of this product, prescription A
3B
3C
2D
1Disintegration the shortest; Consider that lactose is heavy to the influence and the sheet of this product outward appearance, determines this product prescription A
3B
3C
2D
2Be 40 parts of pidotimods, 23 parts of MCC, 6 parts of L-HPC, PVPk30 concentration 5%, 2 parts of lactose, weight portion.
Embodiment 4: the sweeting agent consumption is investigated
Because pidotimod raw material sour in the mouth, according to the formulation characteristic of dispersible tablet, for increasing the compliance of clinical patients medication, the aspartame that adds different amounts is investigated as sweeting agent.
By above-mentioned prescription A
3B
3C
2D
2, promptly pidotimod is 40 parts, 23 parts of MCC, 6 parts of L-HPC, PVPk30 concentration 5%, 2 parts of lactose, weight portion.Get supplementary material, make tablet according to the method adding of embodiment 1 respectively, give a mark, determine optimum amount, the results are shown in Table 3 by 5 volunteers' mouthfeel experiment.
The selection of sweeting agent in the table 3 dispersible tablet of pidotimod prescription
| Experimenter's numbering | Sweeting agent consumption (g) | |||
| 0.5％ | 1.0％ | 1.5％ | 2.0％ | |
| 1 | 4 | 9 | 8 | 7 |
| 2 | 5 | 8 | 7 | 6 |
| 3 | 5 | 8 | 7 | 6 |
| 4 | 4 | 9 | 8 | 8 |
| 5 | 5 | 7 | 8 | 7 |
| Average mark | 4.6 | 8.2 | 7.6 | 6.8 |
As seen from the experiment, add 1% aspartame and can obtain mouthfeel preferably as sweeting agent.
Embodiment 5: the consumption of magnesium stearate is investigated
For guaranteeing the particulate flowability of this product, reach the bright and clean of tablet, add an amount of magnesium stearate.General consumption is 0.25%～2.0%.
Get pidotimod 40g, press A
3B
3C
2D
2The prescription ratio is got adjuvant, granulates according to the technology of embodiment 1, and drying adds adjuvant and sweeting agent aspartame 1.5%, and mixing is divided into 3 parts, adds magnesium stearate 0.5%, 1.0%, 1.5% respectively, mixing, tabletting, each prescription of overall merit.The results are shown in Table 4.
Table 4 tablet key property evaluation result
| Prescription | Magnesium stearate consumption (%) | Mobility of particle (angle of repose) | Compressibility | Dispersing uniformity |
| 1 | 0.5％ | 37° | Sticking once in a while | Up to specification |
| 2 | 1.0％ | 35° | Better | Up to specification |
| 3 | 1.5％ | 34° | Better | Up to specification |
The result shows that this product good fluidity satisfies technological requirement; The magnesium stearate consumption is big more, and the tablet compressibility is good, and outward appearance is bright and clean, considers the disintegrate and the stripping of tablet, and the consumption of determining magnesium stearate is 1.0%.
Embodiment 6: pharmacological action
Pidotimod is an immunopotentiating agent, can promote nonspecific immune reaction to promote specific immune response again.Pidotimod can promote the activate the phagocytic capacity of macrophage and neutrophilic granulocyte, improves its chemotaxis; Activate natural killer cell; The former lymphopoiesis that causes of mitosis promoting, the helper T lymphocyte (CD that reduces when making immunologic hypofunction
4 +) and suppressor T lymphocyte (CD
8 +) ratio raise to recover normal; By stimulating interleukin-2 and gamma interferon to promote cell immune response.
Although all showing pidotimod, animal experiment and clinical trial do not have directly antibiotic and antiviral activity, by bringing into play the curative effect that significant treatment antibacterial (Diplococcus pneumoniae, escherichia coli, bacillus pyocyaneus, Bacillus proteus etc.) and virus (influenza virus, herpes simplex virus, murine encephalomyocarditis virus and Mengo virus etc.) infect to the promotion of the immunologic function of human body.
Embodiment 7: toxicological study
Repeat administration toxicity: continuous 52 weeks of rat gavage this product 200,400,800mg/kg/ day, middle and high dosage group jenny body weight obviously increases, 800mg/kg/ day (is pressed the body surface area conversion, being equivalent to 4.9 times of clinical recommendation maximal dose) treated animal urine pH value and urine protein increase, the visible high dose group buck of histological examination lymphonodi cervicales exodermis cell increases, minority jenny stomach, duodenum expand the part mucosal hyperplasia, may be relevant with administration.Gavage this product 1200mg/kg/ day (press body surface area and convert, be equivalent to 7.3 times of clinical recommendation maximal dose) continuous 4 weeks of rat, can cause that minority animal diarrhoea, calmness, reactivity reduce, activity reduces and thyroid slightly increases, but inorganization change.Continuous 52 weeks of Beagle dog gavage this product, dosage reaches (presses the body surface area conversion 600mg/kg/ day, be equivalent to 12.2 times of clinical recommendation maximal dose) time, accidental minority animal diarrhoea, kidney weight increase, renal tubules is slightly expanded and the interstitial fibers hypertrophy, and serum urea nitrogen and creatinine slightly increase.
Genetoxic: this product Salmonella reversion test, L5178Y cytogene mutant test, Chinese hamster ovary celI chromosomal aberration test, mammal Hela S3 cell DNA damage test and mouse microkernel test result are all negative.
Embodiment 6: genotoxicity:
General genotoxicity: female, male SD rat oral gives this product dosage and reaches 600mg/kg/ day (press body surface area converts, be equivalent to 3.6 times of clinical recommendation maximal dose), reproductivity is not had influence, F1 and F2 are not had influence for fertility, somatic movement, behavior and the neurodevelopment of filial mice yet.
Sensitive period to teratogenic agent toxicity: the sensitive period to teratogenic agent female sd inbred rats gavages dosage and reaches 600mg/kg/ during day, does not see teratogenecity; Quiet notes 250,500 and 1000mg/kg/ are during day, and the food ration of female Mus reduces, weight increase slows down.Middle and high dosage treated animal implantation rate descends, but fetal development is not had obvious influence, and non-toxic reaction dosage is 250mg/kg/ day (press body surface area and convert, be equivalent to 12.2 times of clinical recommendation day injection volume).New zealand rabbit gavages at sensitive period to teratogenic agent that dosage reaches 300mg/kg/ day, quiet injecting amount reaches 500mg/kg/ day, there is no teratogenecity.
Perinatal toxicity: the SD rat gavaged continuously to the 21st day puerperal on the 16th day from gestation that dosage reaches 600mg/kg/ day, quiet injecting amount reaches 500mg/kg/ day, and the general situation of female Mus, fertility condition, F1 are not all had influence for the survival of ZISHU, growth promoter etc.
Embodiment 8: pharmacokinetics
Behind 18 healthy male volunteers single oral dose this product 800mg, blood Chinese medicine peak time is 1.9 ± 0.6h, reaching peak concentration is 5.843 ± 1.96g μ g/ml, the elimination half-life is 1.65 ± 0.33h, area under curve is 24.68 ± 6.88 μ g/mlh, and each medicine is for the parameter and the difference of comparing from the pidotimod oral liquid of Italian import that there are no significant.
Embodiment 9: indication
This product is an immunopotentiating agent, is applicable to:
1. respiratory repeated infection (pharyngitis, tracheitis, bronchitis, tonsillitis) up and down;
2. department of otorhinolaryngology repeated infection (rhinitis, sinusitis, otitis media);
3. urinary system infection;
4. gynecological infection;
5. the low clinical patients of cellular immune function after the chemotherapy.
Be used to reduce the number of times of acute attack, shorten the course of disease, alleviate the degree of outbreak, antibiotic adjuvant drug when this product also can be used as actute infection.
Embodiment 10: usage and dosage
The adult:
Acute stage medication: oral.Each 0.8g of two weeks of beginning, a twice-daily.Be kept to each 0.8g subsequently, once-a-day, or follow the doctor's advice.
Prevention phase medication: oral.Each 0.8g, once-a-day, continuous use 60 days or follow the doctor's advice.
The child:
Acute stage medication: oral.Began for two weeks, each 0.4g, a twice-daily.Be kept to each 0.4g subsequently, once-a-day, continuous use 60 days or follow the doctor's advice.
Prevention phase medication: oral.Each 0.4g, once-a-day, continuous use 60 days or follow the doctor's advice.
Claims (9)
1. a dispersible tablet of pidotimod comprises active component pidotimod and medically acceptable pharmaceutic adjuvant.
2. a dispersible tablet of pidotimod as claimed in claim 1 is characterized in that, described adjuvant comprises binding agent, disintegrating agent, filler, lubricant and sweeting agent.
3. a dispersible tablet of pidotimod as claimed in claim 1 or 2 is characterized in that, described dispersible tablet of pidotimod prescription is as follows:
Pidotimod 380-420 part
Disintegrating agent 30-100 part
Binding agent 10-30 part
Filler 10-30 part
Lubricant 2-3 part
Sweeting agent 2-3 part
Be weight portion.
4. dispersible tablet of pidotimod as claimed in claim 3, it is characterized in that disintegrating agent is selected from one or more in low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, carboxymethyl starch sodium, PVPP, cCMC-Na, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, the microcrystalline Cellulose;
Filler is selected from one or more in lactose, amylum pregelatinisatum, dextrin, Icing Sugar, the microcrystalline Cellulose;
Binding agent is selected from one or more in polyvidone (PVP), HPMC, polyvinylpyrrolidone, methylcellulose, the sodium carboxymethyl cellulose;
Lubricant is selected from one or more in magnesium stearate, micropowder silica gel, the Pulvis Talci;
Sweeting agent is selected from one or more in aspartame, stevioside, the protein sugar.
5. a dispersible tablet of pidotimod as claimed in claim 3 is characterized in that, particulate granularity should be controlled at below 30 orders during granulation.
6. the preparation method of a dispersible tablet of pidotimod as claimed in claim 3, step is as follows:
1) presses recipe quantity, accurately take by weighing all raw materials and adjuvant, cross 30～120 mesh sieves; Wherein disintegrating agent and filler are divided into Nei Jia and Extra Section, and the ratio of Nei Jia and Extra Section is 1～4: 1, weight ratio; In add and respectively weighing of Extra Section, and carry out labelling;
2) put mix homogeneously in the mixer altogether with adding adjuvant in pidotimod raw material and all; Add binding agent, continue to mix, make soft material, 30 mesh sieves are granulated;
3) with granule after 50 ℃～55 ℃ oven dry, 30 mesh sieve granulate;
4) add all by prescription and add adjuvant, fully mixing; Measure granule content, it is heavy to calculate sheet; The stamping of ￠ 10mm scrobicula, aluminum-plastic packaged after promptly.
7. the preparation method of dispersible tablet of pidotimod as claimed in claim 6 is characterized in that, disintegrating agent and filler are microcrystalline Cellulose and low-substituted hydroxypropyl cellulose; Binding agent is a polyvinylpyrrolidone.
8. the preparation method of dispersible tablet of pidotimod as claimed in claim 7 is characterized in that, described binding agent is 50% a alcoholic solution of polyvinylpyrrolidone; Concentration is 2%～10%.
9. the preparation method of dispersible tablet of pidotimod as claimed in claim 8 is characterized in that, binder concn is 5%.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104784134A (en) * | 2015-04-12 | 2015-07-22 | 石家庄四药有限公司 | Lacosamidesolid preparation and preparation method thereof |
| CN105073137A (en) * | 2013-04-05 | 2015-11-18 | 波利化学公司 | Use of pidotimod to treat irritable bowel syndrome |
| CN105769784A (en) * | 2014-12-24 | 2016-07-20 | 广州朗圣药业有限公司 | Oral tablet of acotiamide hydrochloride trihydrate and preparation method thereof |
| CN105943505A (en) * | 2016-05-26 | 2016-09-21 | 杭州百诚医药科技股份有限公司 | Pidotimod pharmaceutical composition and preparation method thereof |
| CN108300755A (en) * | 2018-01-26 | 2018-07-20 | 北京朗依制药有限公司 | The microbial limit tests of dispersible tablet of pidotimod |
-
2007
- 2007-02-01 CN CN 200710013444 patent/CN101011362A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105073137A (en) * | 2013-04-05 | 2015-11-18 | 波利化学公司 | Use of pidotimod to treat irritable bowel syndrome |
| CN105769784A (en) * | 2014-12-24 | 2016-07-20 | 广州朗圣药业有限公司 | Oral tablet of acotiamide hydrochloride trihydrate and preparation method thereof |
| CN105769784B (en) * | 2014-12-24 | 2019-01-01 | 广州朗圣药业有限公司 | A kind of oral tablet of acotiamide hydrochloride trihydrate and preparation method thereof |
| CN104784134A (en) * | 2015-04-12 | 2015-07-22 | 石家庄四药有限公司 | Lacosamidesolid preparation and preparation method thereof |
| CN104784134B (en) * | 2015-04-12 | 2018-05-29 | 石家庄四药有限公司 | A kind of scheme for lacosamide solid pharmaceutical preparation and preparation method thereof |
| CN105943505A (en) * | 2016-05-26 | 2016-09-21 | 杭州百诚医药科技股份有限公司 | Pidotimod pharmaceutical composition and preparation method thereof |
| CN108300755A (en) * | 2018-01-26 | 2018-07-20 | 北京朗依制药有限公司 | The microbial limit tests of dispersible tablet of pidotimod |
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