CN100364522C - Sustained releasing preparation of ferrosi succinas and its preparation method - Google Patents
Sustained releasing preparation of ferrosi succinas and its preparation method Download PDFInfo
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- CN100364522C CN100364522C CNB2005100411103A CN200510041110A CN100364522C CN 100364522 C CN100364522 C CN 100364522C CN B2005100411103 A CNB2005100411103 A CN B2005100411103A CN 200510041110 A CN200510041110 A CN 200510041110A CN 100364522 C CN100364522 C CN 100364522C
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Abstract
The present invention relates to a sustained-release preparation of ferrous succinate and a preparation method thereof, wherein the sustained-release preparation can obviously improve the irritant reaction of gastrointestinal tracts. The sustained-release preparation is prepared by one gram of ferrous succinate, 0.4 to 0.8 grams of hydroxypropyl methyl cellulose and / or ethyl cellulose, and an adhesive agent selected from 75% to 85% ethanol or 20% to 35% PVP ethanol liquid. The release degree of the sustained-release preparation conforms to the pharmacopoeia specification. The sustained-release preparation has the advantages of simple technology and good repeatability, and is suitable for industrial production.
Description
Technical field
The invention belongs to medicinal slow releasing preparation and preparation method thereof, but be specially the preparation method of ferrous succinate slow releasing preparation and industrializing implementation thereof.
Background technology
Ferrum is the indispensable element of human body, it is the important composition that constitutes human body hemoglobin, Myoglobin and multiple histaminase, human body is worldwide commonly encountered diseases because of iron deficiency anemia and other iron deficiency illness that iron deficiency causes, especially the highest with the infant sickness rate, developed country is about 24%, developing country is about 30～90%, and China child below 7 years old is up to 25～65%, and iron deficiency anemia becomes one of major issue that influences teenager growth and people constitution.Oral chalybeate is used to prevent or treat the iron deficiency that a variety of causes causes, for example because of supply deficiency in child or the infancy stage need ferrum amount increase food, or ferrum malabsorption person, or the anemia of pregnant woman of pregnant middle and late stage and chronic blood loss patient etc.When the human body iron deficiency, outside the dehematize red eggs are synthetic in vain to be reduced, oxygen carrying capacity reduces, also occur and organize the active relevant symptom that reduces of iron deficiency and iron enzyme: as growth retardation, action unusually, be short of physical strength, mucosal tissue variation and skin, fingernail pathological changes etc.After replenishing chalybeate, above-mentioned symptom all can be corrected gradually.
The ferrous ion form of chalybeate mainly absorbs at duodenum and jejunum near-end, and absorbtivity is relevant with storage capacity in the body.Along with the shortage of storage capacity in the body, the ferrum absorbtivity can proportionally increase.
Organic ferrum and high ferro are difficult for being absorbed by the body, and oral iron supplement medicine is generally inorganic or the organic ferrous salt of micromolecule (single salt or complex), as ferrous sulfate, ferrous fumarate, ferrous lactate, ferrous gluconate, ferrous succinate etc.Because ferrous ion to the gastrointestinal stimulation, often has untoward reaction such as mild nausea, stomach and abdominal pain, laxativeness or constipation behind the oral iron supplement agent clothes.
Ferrous succinate once was stated from version British Pharmacopoeia in 1973.Ferrous succinate is less relatively to the digestive tract stimulation in the above-mentioned iron supplement medicine, the medicine that bioavailability is higher relatively.Domestic ferrous succinate sheet was produced by state approval on May 20th, 1993, and commodity are called " turn of speed phenanthrene ".The clinical use result of ferrous succinate sheet (turn of speed phenanthrene) listing over 11 years confirms that it is a good absorbing, curative effect height, instant effect, the less iron supplement medicine of side effect really.But along with the popularization of product, take the increase of number, the problem of adverse effect still appears gradually, and according to incompletely statistics, the incidence rate of the GI irritation reaction of ferrous succinate sheet still is 15%.
Summary of the invention
The technical problem to be solved in the present invention is a research and development ferrous succinate slow releasing preparation, overcomes the GI irritation reaction of amber acid ferrimagnetic film.The present invention includes the ferrous succinate slow releasing preparation and be suitable for the preparation method of industrializing implementation, not only the dissolution of ferrous succinate slow releasing preparation will meet the pharmacopeia regulation, and technology is unsuitable complicated, and especially repeatability will be got well.
For addressing the above problem, the invention provides following technical scheme.
A kind of ferrous succinate slow releasing preparation is characterized in that the weight ratio of forming comprises:
Ferrous succinate 1 gram, sustained-release matrix material 0.4～0.8 gram, disintegrating agent 0～0.25 gram, binding agent is selected from the PVP ethanol liquid of 75%～85% ethanol or 20%～35%.It is above hypromellose and/or ethyl cellulose of 3000cps that described sustained-release matrix material is selected from viscosity.
Ferrous succinate slow releasing preparation of the present invention weight composition preferably comprises: ferrous succinate 1 gram, viscosity are hypromellose 0.55～0.75 gram of 3000cps～15000cps, disintegrating agent 0.1～0.25 gram; Binding agent is selected from the PVP ethanol liquid of 78%～82% ethanol or 24%～30%; Lubricant 0.03～0.05 gram.
Its more preferred weight is formed and comprised: ferrous succinate 1 gram, viscosity are hypromellose 0.625 gram of 3000～5600cps, disintegrating agent 0.15～0.20 gram, and disintegrating agent is selected from hydroxypropyl cellulose; Binding agent is selected from the PVP ethanol liquid of 80% ethanol or 28%～30%; Lubricant 0.04～0.047 gram, lubricant is selected from magnesium stearate.
Ferrous succinate slow releasing preparation of the present invention, when wherein binding agent was 75%～85% ethanol, binder dosage was 75%～85% ethanol of 1 gram sustained-release matrix material with 1.4～1.6 grams; When binding agent was 20%～35% PVP ethanol liquid, its consumption was 1 gram sustained-release matrix material with 1.2～1.4 milliliters of PVP ethanol liquid.In the preferred version, when binding agent was 75%～85% ethanol, binder dosage was 75%～85% ethanol of 1 gram sustained-release matrix material with 1.5～1..54 gram; When binding agent was 20%～35% PVP ethanol liquid, its consumption was 1 gram sustained-release matrix material with 1.29～1.35 milliliters of PVP ethanol liquid.
Ferrous succinate slow releasing preparation of the present invention wherein can add lactose and/or starch, but the consumption of lactose and/or starch generally must not be greater than the weight of disintegrating agent.
The preparation method of ferrous succinate slow releasing preparation of the present invention is: after taking by weighing ferrous succinate, sustained-release matrix material and disintegrating agent mixing by proportioning, add binding agent, well-established law is granulated, 50 ℃～65 ℃ dryings; Add lubricant, tabletting or encapsulated.
Preparation method is preferably: taking by weighing ferrous succinate, viscosity by proportioning is hypromellose more than the 3000cps and/or ethyl cellulose, disintegrating agent, can add lactose and/or starch, behind the mix homogeneously, and disposable adding binding agent, well-established law is granulated; When binding agent is selected 75%～85% ethanol for use, binder dosage is 75%～85% ethanol of 1 gram sustained-release matrix material with 1.4～1.6 grams, when binding agent was selected 20%～35% PVP ethanol liquid for use, its consumption was 1 gram sustained-release matrix material with 1.2～1.4 milliliters of PVP ethanol liquid; 20%～35% PVP ethanol liquid is with the preparation of 95% ethanol liquid, contains the PVP of 20～35 grams in per 100 milliliter of 95% ethanol liquid.
Ferrous succinate slow releasing preparation of the present invention preferably the side of preparation is: by proportioning take by weighing ferrous succinate, viscosity is hypromellose, disintegrating agent more than the 3000cps, crosses 80 mesh sieves respectively, disposable adding binding agent behind the mix homogeneously, well-established law is granulated; When binding agent is selected 78%～82% ethanol for use, binder dosage is 78%～82% ethanol of 1 gram sustained-release matrix material with 1.5～1..54 gram, when binding agent was selected 24%～30% PVP ethanol liquid for use, its consumption was 1 gram sustained-release matrix material with 1.29～1.35 milliliters of PVP ethanol liquid; 55～60 ℃ of dryings; Add lubricant, tabletting is used the Opadry coating.
This area routine is good and bad with release evaluation prescription.The drug release determination condition is for changeing basket method (Chinese Pharmacopoeia appendix XD), and every burst size 1 hour must not be must not be less than 75% in 40～60%, 6 hours more than 30%, 3 hour of labelled amount.
Ferrous succinate slow releasing preparation of the present invention overcomes the GI irritation reaction of amber acid ferrimagnetic film.Ferrous succinate slow releasing preparation preparation method of the present invention, not only the release of Zhi Bei ferrous succinate slow releasing preparation meets the pharmacopeia regulation, and technology is not complicated, and especially favorable reproducibility is suitable for industrializing implementation.
Though the conventional adjuvant that can be used for preparing slow releasing preparation is more,, the ferrous succinate physicochemical property is more special.For example, ferrous succinate dissolves in dilute hydrochloric acid, and is almost insoluble in water and ethanol.Test data of the present invention shows: in the ferrous succinate slow releasing preparation, (be called for short HPMC) consumption is conventional in full together wants big to hypromellose, and the weight part ratio of principal agent ferrous succinate and hypromellose is 1: 0.4～0.8, preferred 0.55～0.75, more preferably 0.625.The hypromellose consumption is not enough, is the too fast and underproof principal element of release (seeing table) that causes medicine.Hypromellose does not have the pH dependency, with medicine the taboo reaction does not take place, and with after dissolution medium contact, produces firm gel layer in the sheet sub-surface, controlling the release of medicine by gel layer, and protection label depths is not separated by the influence of solvent and a dust avalanche.As time goes on, outer gel layer constantly dissolves, and inside forms glue-line again, dissolves until label to be dissolved in the dissolution medium fully again.The viscosity of used hypromellose is more than the 3000cps among the present invention, preferred 3000-12000cps, more preferably 300-5600cps.
HPMC is to the table that influences of ferrous succinate slow releasing preparation release
| The prescription number | 1 | 2 | 3 | 4 | 5 | 6 | |
| 100 supplementary material consumptions (g) | Ferrous succinate lactose HPMC (E4M or K4M) hyprolose (L) 80% ethanol 30%PVP (95% ethanol liquid) magnesium stearate (adding) | 20.0 4.0 9.0 4.0 an amount of 0 0.8 | 20.0 5.0 7.5 3.5 an amount of 0 0.8 | 20.0 2.5 10.0 2.5 an amount of 0 0.8 | 20.0 2.0 12.5 2.0 0 an amount of 0.8 | 20.0 1.5 12.5 3.0 an amount of 0 0.8 | 20.0 16 an amount of 0 0.8 |
| Quality evaluation | 6 hours burst size % of 3 hours burst size % of 1 hour burst size % | 30.19 59.58 88.76 | 34.64 65.04 90.72 | 29.11 59.28 87.65 | 27.99 57.13 84.93 | 26.78 51.05 81.54 | 26.01 50.05 80.50 |
Data show in the table: No. 5 prescription is suitable prescription, and it is the poorest that its 1 hour, 3 hours, 6 hours release is respectively 26.78%, 51.05%, 81.54%, No. 2 prescription, discharges too fast.This experiment shows that the key factor that influences degree of releasing is the consumption of HPMC.
During the present invention more preferably fills a prescription, contain hyprolose as disintegrating agent.Domestic commercially available hydroxypropyl cellulose (L) belongs to low-substituted hydroxypropyl cellulose at present.The swelling degree of hyprolose in cold water is big, makes tablet have viscosity in pressing process, easy-formation, and hardness is good, and the long preservation dissolution is unaffected, can regulate drug releasing rate.The weight part ratio of principal agent ferrous succinate and hyprolose 1: 0～0.25; Be preferably 1: 0.1～0.25, most preferably be 1: 0.15～0.20.
Present technique field starch, lactose commonly used do not have obvious effect to the slow release of ferrous succinate.Under the constant situation of the weight part ratio of principal agent ferrous succinate and hypromellose, if in slow releasing preparation of the present invention, add a spot of starch, lactose, slow release effect there is not obvious influence, if starch and/or lactose yield will obviously have a negative impact to release greater than the consumption of hyprolose.
For example:
Prescription (per 1,000) 123
Ferrous succinate 200g 200g 200g
HPMC(E4M) 125g 125g 125g
Hyprolose 0 25g 40g
Lactose 50g 25g 0
1 release of writing out a prescription is defective, is respectively 30.3%, 59.7%, 86.4%.2 releases are qualified though write out a prescription, and 1 hour release is respectively 29.1%, 57.4%, 85% too near the edge.It is 3 better to write out a prescription, and is respectively 26.9%, 53.6%, 81.5%.Above-mentioned 3 prescriptions, the consumption of HPMC (E4M) all is 125g, and hydroxypropyl cellulose increases gradually, lactose reduces gradually simultaneously, thereby release is met the requirements more.
For another example:
Prescription (per 1,000) 123
Ferrous succinate 200g 200g 200g
HPMC(E4M) 77g 90g 110g
Hyprolose 25g 25g 5g
Starch 75g 60g 15g
The release of above-mentioned 3 prescriptions is all defective, its 1 hour, 3 hours, 6 hours release.Prescription 1 is 31.5%, 60.6% and 88%.Prescription 2 is 31.6%, 65.7% and 94.6%.Prescription 3 is 28.8%, 61.4% and 87.6%.
The present invention selects certain density ethanol as binding agent, and suitable concentration is 75%～85% ethanol, also can select 20%～35% PVP to make binding agent, and bake out temperature is about 60 ℃, prevents the influence to principal agent of high humidity, high temperature.
Magnesium stearate is the lubricant of conventional granulation or tabletting, and its consumption also is conventional.Opadry is commercially available coating solution, and consumption uses routinely.
Ferrous succinate slow releasing tablet of the present invention, because of can be lastingly, discharge lentamente, obviously having alleviated stimulates gastrointestinal, and untoward reaction is significantly reduced, and simultaneously, slowly makes the treatment concentration length of holding time because of discharging, and human body is more effectively absorbed, thereby curative effect is better.
The specific embodiment
The present invention is raw materials used to be commercial with pharmaceutical adjunct, and meets standards of pharmacopoeia.Polyvinylpyrrolidone (being called for short PVP) (K30, K29, K32).
The drug release determination condition of following embodiment is for changeing basket method (Chinese Pharmacopoeia version appendix in 2000 XD), and every burst size 1 hour must not be must not be less than 75% in 40～60%, 6 hours more than 30%, 3 hour of labelled amount.
Embodiment 1
Take by weighing ferrous succinate 200g, hypromellose (E4M) 160g, magnesium stearate 8.0g.
Preparation: ferrous succinate, hypromellose are crossed 80 mesh sieves respectively, and abundant mix homogeneously, disposable adding 75% ethanol.75% ethanol consumption restrains 75% alcohol meter by 1 gram hypromellose with 1.4.Make soft material, 18 mesh sieves are granulated, 60 ℃ of oven dry; Add magnesium stearate, mix homogeneously during granulate; Tabletting, add the Opadry coating, 1000.Every contains ferrous succinate 200mg.Meet among Chinese Pharmacopoeia version appendix in 2000 XD regulation to the slow releasing preparation release.
Taking dose and method: oral meal, adult treatment amount 0.2～0.4g, once a day.The 0.2g next day of preventive dose (1/2 days), gravid woman 0.2g/ day (1 slice/day), or follow the doctor's advice.
Embodiment 2
Take by weighing ferrous succinate 200g, hydroxypropyl cellulose 20g, hypromellose (K4M) 150g, magnesium stearate 8g.
Prepare: ferrous succinate, hydroxypropyl cellulose (L), hypromellose are crossed 80 mesh sieves respectively, and abundant mix homogeneously, disposable adding 78% ethanol is made soft material in right amount, and 78% ethanol consumption restrains 78% alcohol meter by 1 gram hypromellose with 1.6.18 mesh sieves are granulated, 60 ℃ of oven dry; Add magnesium stearate, mix homogeneously during granulate; Tabletting, add the Opadry coating, 1000.Every contains ferrous succinate 200mg.Meet among 2000 editions appendix XD of Chinese Pharmacopoeia regulation to the slow releasing preparation release.
Taking dose and method: oral meal, adult treatment amount 0.2～0.4g, once a day.The 0.2g next day of preventive dose (1/2 days), gravid woman 0.2g/ day (1 slice/day), or follow the doctor's advice.
Embodiment 3
Take by weighing ferrous succinate 200g, lactose 25g, hydroxypropyl cellulose 30g, hypromellose 125g, magnesium stearate 9.4g.
Preparation: ferrous succinate, lactose, hydroxypropyl cellulose (L), hypromellose are crossed 80 mesh sieves respectively, and abundant mix homogeneously, add 24%PVP (95% ethanol), PVP ethanol liquid consumption is that 1 gram hypromellose is with 1.4 milliliters of PVP ethanol liquid, make soft material, 18 mesh sieves are granulated, 55 ℃ of oven dry; Add magnesium stearate, mix homogeneously during granulate; Tabletting, add the Opadry coating, 1000.Every contains ferrous succinate 200mg.Meet among Chinese Pharmacopoeia version appendix in 2000 XD regulation to the slow releasing preparation release.
Taking dose and method: oral meal, the each 0.2～0.4g of adult treatment amount, once a day.The 0.2g next day of preventive dose (1/2 days), gravid woman 0.2g every day (1 slice/day), or follow the doctor's advice.
Embodiment 4
Take by weighing ferrous succinate 200g, ethyl cellulose 50g, hypromellose (K100) 110g, magnesium stearate 9.4.
Preparation: ferrous succinate, ethyl cellulose, hypromellose are crossed 80 mesh sieves respectively, and abundant mix homogeneously, add 30%PVP (95% ethanol liquid), PVP ethanol liquid consumption is that 1 gram hypromellose is with 1.35 milliliters of PVP ethanol liquid, make soft material, 18 mesh sieves are granulated, 55 ℃ of oven dry; Add magnesium stearate, mix homogeneously during granulate; Tabletting, add the Opadry coating, 1000.Every contains ferrous succinate 200mg.Meet among Chinese Pharmacopoeia version appendix in 2000 XD regulation to the slow releasing preparation release.
Taking dose and method: oral meal, the each 0.2～0.4g of adult treatment amount, once a day.The 0.2g next day of preventive dose (1/2 days), gravid woman 0.2g every day (1 slice/day), or follow the doctor's advice.
Embodiment 5
Take by weighing ferrous succinate 200g, hypromellose (E4M) 125g, hyprolose 40g, magnesium stearate 8 grams.Measure 28%PVP (preparation of 95% ethanol liquid) 150ml.Preparation, instructions of taking get 1000 with embodiment 1.Meet among Chinese Pharmacopoeia version appendix in 2000 XD the regulation of slow releasing preparation release, its 1 hour, 3 hours, 6 hours release is respectively: 27.1%, 54.6%, 83.2%.If also can use with 20%PVP (preparation of 95% alcoholic solution).
Embodiment 6
Take by weighing ferrous succinate 200g, hypromellose (K100) 80g, hyprolose (L) 40g, magnesium stearate 6g.
Preparation: ferrous succinate, hypromellose are crossed 80 mesh sieves respectively, and abundant mix homogeneously, add 35%PVP (95% ethanol liquid), make soft material, PVP ethanol liquid consumption be 1 gram hypromellose with 1.29 milliliters of PVP ethanol liquid, the granulation of 18 mesh sieves, 55 ℃ of oven dry; Add magnesium stearate, mix homogeneously during granulate; Tabletting, add the Opadry coating, 1000.Every contains ferrous succinate 200mg.Meet among Chinese Pharmacopoeia version appendix in 2000 XD regulation to the slow releasing preparation release.
Embodiment 7
Take by weighing ferrous succinate 200g, hypromellose (E10M) 110g, hyprolose (L) 50g, magnesium stearate 10g.
Preparation: ferrous succinate, hypromellose are crossed 80 mesh sieves respectively, and abundant mix homogeneously, adding 24%PVP (95% ethanol liquid) and make soft material, PVP ethanol liquid consumption is 1 gram hypromellose with 1.4 milliliters of PVP ethanol liquid, 18 mesh sieves are granulated, 55 ℃ of oven dry; Add magnesium stearate, mix homogeneously during granulate; Tabletting, add the Opadry coating, 1000.Every contains ferrous succinate 200mg.Meet among Chinese Pharmacopoeia version appendix in 2000 XD regulation to the slow releasing preparation release.
Embodiment 8
Take by weighing ferrous succinate 200g, hypromellose (K4M) 125g, hyprolose 40g, magnesium stearate 8 grams.Binding agent 82% ethanol consumption restrains 82% alcohol meter by 1 gram hypromellose with 1.5.Preparation, instructions of taking get 1000 with embodiment 1.Meet among Chinese Pharmacopoeia version appendix in 2000 XD regulation to the slow releasing preparation release.If make binding agent with 85% ethanol, its consumption restrains 85% alcohol meter by 1 gram hypromellose with 1.54.
Claims (9)
1. ferrous succinate slow releasing preparation is characterized in that the weight ratio of basic composition is:
Ferrous succinate 1 gram, sustained-release matrix material 0.4～0.8 gram, disintegrating agent 0～0.25 gram, binding agent is selected from the PVP ethanol liquid of 75%～85% ethanol or 20%～35%; It is above hypromellose and/or ethyl cellulose of 3000cps that the sustained-release matrix material is selected from viscosity; Disintegrating agent is selected from hydroxypropyl cellulose.
2. the ferrous succinate slow releasing preparation of claim 1 is characterized in that its weight is formed and is:
Ferrous succinate 1 gram, viscosity are hypromellose 0.55～0.75 gram of 3000cps～15000cps, disintegrating agent hydroxypropyl cellulose 0.1～0.25 gram; Binding agent is selected from the PVP ethanol liquid of 78%～82% ethanol or 24%～30%; Lubricant 0.03～0.05 gram.
3. the ferrous succinate slow releasing preparation of claim 2 is characterized in that its weight is formed and is:
Ferrous succinate 1 gram, viscosity are hypromellose 0.625 gram of 3000～5600cps, disintegrating agent hydroxypropyl cellulose 0.15～0.20 gram; Binding agent is selected from the PVP ethanol liquid of 80% ethanol or 28%～30%; Lubricant 0.04～0.047 gram, lubricant is selected from magnesium stearate.
4. the ferrous succinate slow releasing preparation of claim 1, when wherein binding agent was 75%～85% ethanol, binder dosage was 1 gram sustained-release matrix material with 1.4～1.6 75%～85% ethanol that restrain; When binding agent was 20%～35% PVP ethanol liquid, its consumption was 1 gram sustained-release matrix material with 1.2～1.4 milliliters of PVP ethanol liquid.
5. the ferrous succinate slow releasing preparation of claim 4, when wherein binding agent was 75%～85% ethanol, binder dosage was 75%～85% ethanol that 1 gram sustained-release matrix material restrains with 1.5～1..54; When binding agent was 20%～35% PVP ethanol liquid, its consumption was 1 gram sustained-release matrix material with 1.29～1.35 milliliters of PVP ethanol liquid.
6. the ferrous succinate slow releasing preparation of claim 1, when wherein adding lactose and/or starch, the consumption of lactose and/or starch is not more than the weight of disintegrating agent.
7. the preparation method of each ferrous succinate slow releasing preparation of claim 1 to 6 is characterized in that taking by weighing after ferrous succinate, sustained-release matrix material and disintegrating agent mix by proportioning, adds binding agent, and well-established law is granulated, 50 ℃～65 ℃ dryings; Add lubricant, tabletting or encapsulated.
8. the preparation method of claim 7 ferrous succinate slow releasing preparation, it is characterized in that taking by weighing ferrous succinate, viscosity by proportioning is hypromellose more than the 3000cps and/or ethyl cellulose, disintegrating agent, add lactose and/or starch, behind the mix homogeneously, disposable adding binding agent, well-established law is granulated; When binding agent is selected 75%～85% ethanol for use, binder dosage is 75%～85% ethanol of 1 gram sustained-release matrix material with 1.4～1.6 grams, when binding agent was selected 20%～35% PVP ethanol liquid for use, its consumption was 1 gram sustained-release matrix material with 1.2～1.4 milliliters of PVP ethanol liquid; 20%～35% PVP ethanol liquid is with the preparation of 95% ethanol liquid, contains the PVP of 20～35 grams in per 100 milliliter of 95% ethanol liquid.
9. the preparation method of claim 8 ferrous succinate slow releasing preparation, it is characterized in that by proportioning take by weighing ferrous succinate, viscosity is hypromellose, disintegrating agent more than the 3000cps, cross 80 mesh sieves respectively, disposable adding binding agent behind the mix homogeneously, well-established law is granulated; When binding agent is selected 78%～82% ethanol for use, binder dosage is 78%～82% ethanol of 1 gram sustained-release matrix material with 1.5～1..54 gram, when binding agent was selected 24%～30% PVP ethanol liquid for use, its consumption was 1 gram sustained-release matrix material with 1.29～1.35 milliliters of PVP ethanol liquid; 55～60 ℃ of dryings; Add lubricant, tabletting is used the Opadry coating.
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| CN103191078B (en) * | 2012-01-06 | 2018-01-09 | 常州善美药物研究开发中心有限公司 | A kind of double-membrane multiple drug layer controlled-release tablet for salt medicine with high solubility |
| CN111000977A (en) * | 2019-03-22 | 2020-04-14 | 江苏中天药业有限公司 | Novel solid dosage form of iron protein succinate and preparation method thereof |
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