CN106389372A - Enteric iron citrate tablets and preparation method thereof - Google Patents
Enteric iron citrate tablets and preparation method thereof Download PDFInfo
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- CN106389372A CN106389372A CN201510447751.2A CN201510447751A CN106389372A CN 106389372 A CN106389372 A CN 106389372A CN 201510447751 A CN201510447751 A CN 201510447751A CN 106389372 A CN106389372 A CN 106389372A
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- enteric
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- coating
- ironic citrate
- xanthans
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Abstract
The present invention relates to the field of enteric tablets for treatment of hyperphosphatemia in patients with chronic kidney diseases, more particularly to an enteric iron citrate tablets and a preparation method thereof. The enteric iron citrate tablets comprise an iron citrate tablet core and a coating coated on the outer portion of the iron citrate tablet core, wherein the coating comprises the following raw materials by weight: 5-10 parts of xanthan gum, 50-100 parts of sorbitol, and 15-35 parts of talc powder. According to the present invention, the enteric iron citrate tablets have characteristics of no irritation to stomach, good taste, no dissolution in stomach, slow release in intestinal tract, minimization of side effects such as nausea, vomiting, and the like, bitter taste covering, patient compliance improving, and the like, and can meet the CKD treatment purposes.
Description
Technical field
The present invention relates to the enteric coatel tablets field for the treatment of Patients with Chronic Kidney Disease hyperphospheremia, particularly to a kind of enteric solubility ironic citrate
Piece and preparation method thereof.
Background technology
Phosphorus is only second to the mineral matter element that calcium is that human body includes flow control more than two, and wherein 85% has bone, 14% exist muscle,
The soft tissues such as internal organ intracellular, 1% there is blood and tissue fluid in remaining, and the person of recording only about 0.15% that can certainly take a blood sample,
Phosphorus, except crystallizing structure skeletogenous main mine material composition with calcium salt, is also the constituent of the inhereditary materials such as cell membrane and nucleic acid,
And also have the transmission of intracellular message relevant with the energy production of cell and storage.Also can be problematic but phosphorus is many, in human body
Mainly by the phosphorus in gastrointestinal tract diet, the exchange of phosphorus, and the phosphorus that RE is unnecessary are reached in skeleton metabolism for the regulation and control of phosphorus
Reach.With the decline of renal function, the ability that kidney excludes phosphorus decreases, and leads to the phosphorus concentration in tissue and blood to rise, high
Serium inorganic phosphorus by suppression vitamin D the activation of kidney and deposit with calcium together with the tissue and lead to blood calcium reduction, human body in order to
Maintain the concentration of blood calcium and increase the exclusion in kidney for the phosphorus, increase the secretion of parathryoid hormone, if things go on like this cause time property sent out
Accessory thyroid glands is hyperfunction, and then leads to the change of skeleton mineral deposit and structure, and that is, so-called renal osteodystrophy becomes, and hyperphospheremia also may be used
Blood vessel and soft tissue calciffication can be led to, and research in the past finds Patients with Chronic Kidney Disease (chronic kidney disease, CKD)
General mortality rate, cardiovascular morbidity and the death rate be also stepped up with serium inorganic phosphorus concentration, therefore hyperphosphatemia becomes impact chronic renal
Popular name for and accept end stage renal patient's quality of the life of dialysis and deposit
One of important complication of motility rate.
Treatment hyperphosphatemia will be from the aspect of these.First, should keep on a diet the absorption of middle phosphorus, but excessively strict again can shadow
Ring the absorption of other nutriment.Secondly, phosphate binder should be used.The aluminium phosphate binder that past is commonly used may lead to poisoning by aluminum,
Less use.Citric acid iron plate can treat the hyperphospheremia of chronic kidney disease dialysis patient.As phosphate binder, citric acid
The phosphorus that iron plate passes through to be coupled in enteron aisle meals forms ferric phosphate precipitation, and the phosphorus to suppress new in enteron aisle absorbs.
At present, citric acid iron plate, taste and its bitterness, the ironic citrate lozenge developed by Bao Ling Fujin, Taiwan company is in Japan
Examined by listing with the U.S., its auxiliary material is IR, cellulose, polyvinyl alcohol. acrylic acid. methyl-prop
E pioic acid methyl ester copolymer, hydroxypropyl cellulose, PVPP, calcium stearate, Hydroxypropyl methylcellulose, titanium dioxide, talcum,
Polyethylene glycol.Using IR film coating it is impossible to enough cover the bitter taste of citric acid iron plate.Patient's
Poor compliance.
Although the hardship of ironic citrate can be covered by the ironic citrate chewable tablets that Yi Xinming Pharmaceutical Technology Co., Ltd of Anhui Province develops
Taste, but will react under one's belt because after its chewing, and chalybeate can stimulate stomach.After some patients take chalybeate, permissible
Nausea and vomiting, stomach upset, diarrhoea etc. is had to react.
Content of the invention
The present invention is directed to the deficiencies in the prior art, proposes one kind and can either cover ironic citrate bitter taste, will not be disintegrated under one's belt again
Enteric solubility citric acid iron plate and preparation method thereof.
The technical scheme is that：
A kind of enteric solubility citric acid iron plate, including ironic citrate label and the coating being wrapped in outside described ironic citrate label, its
It is characterised by, described coating is made up of the raw material of following parts by weight：5-10 part xanthans, 50-100 part sorbierite, 15-35
Part talcum powder.
Preferably, described enteric solubility ironic citrate coating tablets include the raw material of following parts by weight：8 parts of xanthans, 80 parts of mountains
Pears alcohol, 25 parts of talcum powder.
Sweetener sorbitol metabolism in coating constituents does not cause blood glucose rise, can meet the need of diabetes dialysis hyperphosphatemic patients
Ask.Slow controlled-release material xanthans is a kind of boiomacromolecule polysaccharide, and stable chemical nature is nontoxic, has good biology simultaneously
Compatibility and bioadhesive, can extend this medicine in GI transhipment and soak time, reach the purpose for the treatment of hyperphosphatemia.
Because xanthans has extremely strong hydrophily, stir insufficient if be directly added in water, outer layer water swelling becomes micelle,
Thus stoping moisture from entering nexine, and then affect mixture homogeneity, and add ten times or ten times of xanthans mountain to be dried with upper volume
Pears alcohol, mixes well, and is then slowly poured in the water in stirring, you can so that xanthans is completely dissolved, gives full play to effectiveness, may be used again
Improve the mouthfeel of tablet, play the purpose of doulbe-sides' victory.
Further object is that disclosing a kind of method preparing enteric solubility citric acid iron plate：
(1) after taking xanthans to cross the sieve of 200 mesh, mixed well with the sorbierite being dried, add xanthans in sorbierite while stirring,
Then be slowly poured in the distilled water in stirring, soak two hours, continue stirring, speed of agitator be 100rpm-200rpm it
Between, to being completely dissolved；
(2) cross 80 mesh sieves after talcum powder being ground, add in the mixed solution that step 1 obtains, need to stir to mix,
After mixing, standing, as enteric coating solution；
(3) ironic citrate piece label is placed in coating pan, sprays into above-mentioned enteric coating solution, pot temperature controls at 35 DEG C about,
Spray in 4 hours, obtained final product ironic citrate enteric liquid.
The invention has the beneficial effects as follows：
Citric acid iron plate disclosed by the invention has to stomach nonirritant, in good taste, does not dissolve in stomach, is sustained in enteron aisle
The feature of dissolving, the advantages of can meeting CKD patient's therapeutic purposes, and the side effects such as Nausea and vomiting are reduced to minimum, covers
Lid bitter taste, improves patient's compliance.
Brief description
Accompanying drawing 1 is the specific embodiment of the invention 1 and existing ironic citrate tablet release profiles in intestinal juice.
Specific embodiment
The specific embodiment of the present invention is as follows：
Embodiment 1
Ironic citrate enteric coating composition
| Ironic citrate hydrate (label) | 150 parts |
| Xanthans | 5 parts |
| Sorbierite | 50 parts |
| Talcum powder | 15 parts |
| Distilled water | In right amount |
Enteric coating preparation technology
(1) after taking xanthans to cross the sieve of 200 mesh, mixed well with the sorbierite being dried, add xanthans in sorbierite while stirring,
Then be slowly poured in the distilled water in stirring, soak two hours, continue stirring, speed of agitator be 100rpm-200rpm it
Between, to being completely dissolved；
(2) cross 80 mesh sieves after talcum powder being ground, add in the mixed solution that step 1 obtains, need to stir to mix,
After mixing, standing, as enteric coating solution；
(3) ironic citrate piece label is placed in coating pan, sprays into above-mentioned enteric coating solution, pot temperature controls at 35 DEG C about,
Spray in 4 hours, obtained final product ironic citrate enteric liquid.
Embodiment 2
Ironic citrate enteric coating tablets prescription
| Ironic citrate hydrate (label) | 150 parts |
| Xanthans | 8 parts |
| Sorbierite | 80 parts |
| Talcum powder | 25 parts |
| Distilled water | In right amount |
Preparation technology is with example 1
Embodiment 3
Ironic citrate enteric coating tablets prescription
| Ironic citrate hydrate (label) | 150 parts |
| Xanthans | 10 parts |
| Sorbierite | 100 parts |
| Talcum powder | 35 parts |
| Distilled water | In right amount |
Preparation technology is with example 1
In order to verify insoluble drug release, the stability test situation of present invention coating further, the present invention has done following experimental verification.
The enteric solubility coated tablet that the embodiment of the present invention 1 is prepared is compared with existing citric acid iron plate release in gastric juice,
As shown in the table：
| Prescription (crosses gastric juice 2h) | Enteric solubility coating tablet | Existing tablet |
| Insoluble drug release | 0% | 12% |
Existing citric acid iron plate component：Ironic citrate, auxiliary material be IR, cellulose,Polyvinyl alcohol Acrylic arid methacrylic acid methyl terpolymer, hydroxypropyl cellulose, PVPP, calcium stearate,Hydroxypropyl methylcellulose、Titanium dioxide, talcum, polyethylene glycol.Wherein, the main component of coating is polyvinyl alcohol acrylic arid methacrylic acid methyl esters
Copolymer, Hydroxypropyl methylcellulose, titanium dioxide, talcum and polyethylene glycol.
Stability test：
The pharmaceutical film coating that xanthans of the present invention is formed carries out the test of stability, to be coated front label burst size as radix
100%, enteric solubility film coating (being designated as prescription 1) of the present invention and existing ironic citrate tablet (note prescription 2) are with same operation
Parameter is compared with tablet to batch label, coating weight gain 5%, accelerated test 6 months,
Every January, being detected once, data is as shown in the table to label
As shown above, the pharmaceutical film coating made with xanthans of the present invention has good stability, through the guarantor of six months
Deposit the phase, in the chip of coating the inside active ingredient is oxidized or the lacking of the moisture absorption, be reduced to 92.5% from 100%, can be fine
Protection chip.
Fig. 1 is the pharmaceutical film coating and release profiles in intestinal juice for the existing ironic citrate tablet that the xanthans of the present invention is formed, figure
In, the release profiles of the pharmaceutical film coating that curve 1 is formed for xanthans of the present invention；Curve 2 is existing ironic citrate tablet
Release profiles.Xanthans forms release with ironic citrate tablet in intestinal juice (PH is 6.8) for the pharmaceutical film coating and is tested,
Both reached when fast 30 minutes and discharge completely, and the soak time in human body and trap are close.
Claims (3)
1. a kind of enteric solubility citric acid iron plate, including ironic citrate label with the coating being wrapped in outside described ironic citrate label it is characterised in that described coating is made up of the raw material of following parts by weight：5-10 part xanthans, 50-100 part sorbierite, 15-35 part talcum powder.
2. enteric solubility citric acid iron plate according to claim 1 is it is characterised in that described enteric solubility ironic citrate coating tablets include the raw material of following parts by weight：8 parts of xanthans, 80 parts of sorbierites, 25 parts of talcum powder.
3. a kind of method of the enteric solubility citric acid iron plate prepared described in claim 1 or 2：
（1）After taking xanthans to cross the sieve of 200 mesh, mixed well with the sorbierite being dried, add xanthans in sorbierite while stirring, be then slowly poured in the distilled water in stirring, soak two hours, continue stirring, speed of agitator is between 100rpm-200rpm, to being completely dissolved；
（2）Cross 80 mesh sieves after talcum powder is ground, add in the mixed solution that step 1 obtains, need to stir to mix, after mixing, standing, as enteric coating solution；
（3）Ironic citrate piece label is placed in coating pan, sprays into above-mentioned enteric coating solution, pot temperature controls at 35 DEG C about, has sprayed in 4 hours, obtains final product ironic citrate enteric liquid.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510447751.2A CN106389372B (en) | 2015-07-27 | 2015-07-27 | Enteric-coated iron citrate tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510447751.2A CN106389372B (en) | 2015-07-27 | 2015-07-27 | Enteric-coated iron citrate tablet and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN106389372A true CN106389372A (en) | 2017-02-15 |
| CN106389372B CN106389372B (en) | 2019-12-24 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510447751.2A Active CN106389372B (en) | 2015-07-27 | 2015-07-27 | Enteric-coated iron citrate tablet and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2019105401A1 (en) * | 2017-11-29 | 2019-06-06 | Shin Era Technology Co. Ltd. | Enteric coated pharmaceutical composition and use thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1276009A (en) * | 1997-10-17 | 2000-12-06 | 一洋药品株式会社 | Electric coated microgranules for stabilizing lactic acid bacteria |
| US20120121703A1 (en) * | 2010-07-20 | 2012-05-17 | Japan Tobacco Inc. | Tablet containing ferric citrate |
| CN104688706A (en) * | 2015-04-01 | 2015-06-10 | 成都欣捷高新技术开发有限公司 | Ferric citrate composition high in drug loading capacity and capable of being dissolved out quickly and preparation method thereof |
-
2015
- 2015-07-27 CN CN201510447751.2A patent/CN106389372B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1276009A (en) * | 1997-10-17 | 2000-12-06 | 一洋药品株式会社 | Electric coated microgranules for stabilizing lactic acid bacteria |
| US20120121703A1 (en) * | 2010-07-20 | 2012-05-17 | Japan Tobacco Inc. | Tablet containing ferric citrate |
| CN104688706A (en) * | 2015-04-01 | 2015-06-10 | 成都欣捷高新技术开发有限公司 | Ferric citrate composition high in drug loading capacity and capable of being dissolved out quickly and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 罗丽娟等: "枸橼酸铁肠溶微囊的制备及评价", 《中国医药工业杂志》 * |
| 蒋建新等: "《功能性多糖胶开发与应用》", 31 January 2013, 中国轻工业出版社 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2019105401A1 (en) * | 2017-11-29 | 2019-06-06 | Shin Era Technology Co. Ltd. | Enteric coated pharmaceutical composition and use thereof |
| CN111727037A (en) * | 2017-11-29 | 2020-09-29 | 世展科技股份有限公司 | Enteric-coated pharmaceutical composition and use thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN106389372B (en) | 2019-12-24 |
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