CN109223824A - A kind of process for preparing medicine for treating chronic kidney disease dialysis patient hyperphosphatemia - Google Patents
A kind of process for preparing medicine for treating chronic kidney disease dialysis patient hyperphosphatemia Download PDFInfo
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- CN109223824A CN109223824A CN201811406373.3A CN201811406373A CN109223824A CN 109223824 A CN109223824 A CN 109223824A CN 201811406373 A CN201811406373 A CN 201811406373A CN 109223824 A CN109223824 A CN 109223824A
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- hyperphosphatemia
- kidney disease
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- dialysis patient
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/26—Iron; Compounds thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
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Abstract
The invention discloses a kind of drugs for treating chronic kidney disease dialysis patient hyperphosphatemia, its preparation process are as follows: di-iron trioxide is reacted with hydrochloric acid and generates liquor ferri trichloridi, it is reacted with sodium carbonate liquor, sugarcane sugar and starch is added to stir, sucrose iron oxide hydroxide aqueous solution is made, the solution is taken to be freeze-dried, obtains loose sucrose iron oxide hydroxide powder, then it is mixed again with other compositions, chewable tablets is suppressed using direct powder compression.Since this method is using the method for freeze-drying, loose powdered is made, is equivalent to molecular state, reach the dispersion of height, phosphate binding capacity test result reaches 98% or more, illustrates sufficiently to react with the phosphate in alimentary canal food, substantially increases the curative effect of drug.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, are related to the preparation method of drug, and in particular to a kind of to treat chronic kidney disease saturating
Analyse the process for preparing medicine of patients with hyperphosphatemia.
Background technique
Hyperphosphatemia is the common complication of chronic renal failure, in recent decades, in Patients With Uremia Undergoing Hemodialysis
There is more improvement in terms of the treatment of hyperphosphatemia, but to be still that solve one of dialysis patient needs is important ask for the control of serium inorganic phosphorus
Topic.Haemodialysis is extremely limited the removing of phosphorus, and diet restriction can cause malnutritive and life inconvenient.
Hyperphosphatemia refers to that the level of serum paraoxonase is more than 4.5mg/dl.Serium inorganic phosphorus increases and the progress of kidney trouble, secondary
There are close relationship in hyperparathyroidism, renal osteodystrophy and soft tissue calciffication.Early stage chronic renal failure, glomerular filtration
Variation takes place in the metabolism that rate (GFR) is reduced to 40-80ml/ timesharing phosphorus, and slight serium inorganic phosphorus increases, and stimulates parathyroid hormone
(PTH) secretion increases.PTH, which rises, reduces renal tubule to the reabsorption of phosphorus, promotes excretion of the kidney to phosphorus, serium inorganic phosphorus decline.When
GFR is further decreased to 20-30ml/ timesharing, though there is the raising of blood PTH, effective nephron is reduced, and renal tubule is to the anti-of PTH
Should be able to power also decline, to the excretion of phosphorus obstacle occurs for kidney, and phosphorus starts to accumulate in vivo, and serium inorganic phosphorus is caused persistently to increase.
Hyperphosphatemia and metastatic calcification hyperphosphatemia cause the death rate with the mechanism of disease incidence rising first is that caused by it
Metastatic calcification.Metastatic calcification is increased with calcium, phosphorus product and serium inorganic phosphorus control is bad directly related.When serium inorganic phosphorus increases, calcium phosphorus
It can be deposited in soft tissues such as kidney, angiocarpy, lung, eye, joint, skins.Calcium nephridial tissue accumulation be long-term dialysis complication it
One.Early stage renal failure, just there is the deposition of calcium in nephridial tissue, and the progress of renal failure can be promoted.Renal biospy shows kidney group
The degree of the calcium content and hyperphosphatemia and impaired renal function knitted has direct relationship.Calcium deposition relevant to hyperphosphatemia exists
It is also played an important role in the progress of renal failure.What hemodialysis patient died of cardiovascular complication almost accounts for 50%,
Postmortem discovery, there are heart calcium for most of dialysis patients, equally increase with hyperphosphatemia and calcium-phosphorus product related.Heart calcification can
Cause arrhythmia cordis, coronary sclerosis, heart failure even dead.In addition, 50% hemodialysis patients there are bicuspid valve and
The calcification of its annulus.Currently, the standard clinically recommended is calcium-phosphorus product < 70, to avoid metastatic calcium, but in calcium-phosphorus product 55
When find that the calcification of bicuspid valve and its annulus, and heart failure can be caused.Coronary artery calcium occurs for the patient to dialyse more than 1 year
Change person obviously increases.Therefore, calcium-phosphorus product, which increases, causes the effect of heart calcification that should be worth more paying attention to.Lung in dialysis patient
Calcification is also very common, postmortem incidence 60-80%.The calcification of lung tissue keeps gas exchanges impaired and lung fiber occurs for patient
One of change and the reason of death.Angiosteosis is equally also related with serium inorganic phosphorus and calcium-phosphorus product raising, with the extension of dialysis time,
The risk of angiosteosis also increases.There is 27% generation angiosteosis in 1 year patient of dialysis, 8 years or more persons are up to 83%.Outside
The calcification of all blood vessels keeps fistulization difficult, and the calcification of Renal vascular increases the difficulty of kidney transplant.Recently report, hemodialysis patient is also
Extensive thin vessels calcification may occur, make peripheral tissues' blood supply insufficiency, necrose, infect and threat to life.
U.S. FDA has approved the sucrose of Vifo rFresenius Medical Care Renal Pharma company exploitation
Iron oxide hydroxide chewable tablets, for controlling the serum phosphorus levels for just receiving the Patients with Chronic Renal Disease of dialysis treatment.Hydroxyl aoxidizes sucrose
Iron is the strength phosphate binders based on iron, is multicore FeOOH (III), sucrose and starch mixture, often
Piece contains the elemental iron for being equivalent to 500mg, to chew scheme medication when every meal.Hydroxyl oxidation iron sucrose can absorb the drink in gastrointestinal tract
It is then certainly clear in vivo with defecation to eat source phosphate, the phosphate for thus preventing the phosphate of dietary sources into human blood, and absorbing
It removes.
Sucrose iron oxide hydroxide has also proposed new drug application in the area such as European Union, Switzerland or country.Serum paraoxonase water
Flat raising is commonly referred to as hyperphospheremia, is a kind of severe complication for receiving the Patients with Chronic Renal Disease of dialysis treatment.
Most of dialysis patients all need to treat using phosphate binders.But, although there are many different phosphate binders at present
Target serum phosphorus levels that are alternative, but still having up to 50% dialysis patient that cannot reach and maintain them.Wherein, high medicine
Non-compliance caused by ball burden and bad tolerance is to lead to certain patients not to can control the key factor of hyperphospheremia.Have
Statistics shows that dialysis patient need to daily about 19 phosphate binders.In contrast, the recommendation of sucrose iron oxide hydroxide rises
Medication 1 is chewed when beginning dosage is daily every meal.
Number of patent application: 201480065206.0 publicities are to hydroxyl oxidation iron sucrose using fluidized bed drying, spraying dry
The preparation methods such as dry, wet granulation, dry granulation, but fail to reach most perfect condition, phosphoric acid with the phosphate reaction in food
Salt binding ability test result only has 80%, illustrates to influence therapeutic effect not sufficiently with the phosphate reaction in food.
Summary of the invention
The object of the present invention is to provide a kind of drug for treating chronic kidney disease dialysis patient hyperphosphatemia, the pharmaceutical compositions
Object has high degree of dispersion, sufficiently reacts with the phosphate in alimentary canal food, substantially increases the curative effect of drug.
To achieve the goals above, a kind of chronic kidney disease dialysis patient high phosphorus is treated the technical solution of the present invention is as follows: providing
The process for preparing medicine of mass formed by blood stasis, is prepared by following raw material in parts by weight:
The process for preparing medicine specifically includes the following steps:
1) said ratio is pressed, di-iron trioxide is dissolved in hydrochloric acid, stirring to di-iron trioxide is completely dissolved, and is filtered, is obtained
Obtain filtrate；
2) sodium carbonate is soluble in water, it is slowly added into filtrate made from step 1), it is stirring while adding, after adding, add water
Continue to stir, stand, discard supernatant, repeat 3~8 times, obtains solution；
3) sucrose is added in the solution of step 2), stirring obtains sucrose solution to dissolving；
4) starch is added in sucrose solution, using homogenizer high-speed stirred to being mixed thoroughly, obtains viscous fluid；
5) lower 35 DEG C of viscous fluid zero setting or less are taken to be freezed, freeze-off time is 1~4 hour, guarantees sufficiently to freeze, obtain
Obtain dried frozen aquatic products；
6) the cold well temperature of dryness storehouse is dropped to -40 DEG C first, then dried frozen aquatic products is put into dry vacuum container, it is then right
Dryness storehouse vacuumizes, and freezes 1~2 hour in the dryness storehouse that pressure is 40~60Pa, guarantees that moisture sufficiently freezes, then starts
Lyophilization, time are 48~50 hours, carry out 4~6 hours parsing-desiccations after lyophilization again, obtain moisture content
It for 1~3% loose block of sucrose iron oxide hydroxide, crushes, sieving；
7) sucrose iron oxide hydroxide loose powder and milk-taste essence, magnesium stearate, silica mix, and obtain pharmaceutical composition
Piece is made using powder direct pressure closing in object, the drug for the chronic kidney disease dialysis patient hyperphosphatemia that obtains medical treatment.
Use the angle of repose measurement result of the powder of pharmaceutical composition prepared by the above method for 37.7 °, flow of powder
Property is good, meets the requirement of direct tablet compressing.
In preparation method of the present invention, sieving described in step 6) was 100~500 meshes.
In preparation method of the present invention, mixing described in step 7) is mixed using equivalent gradually-increased.
In preparation method of the present invention, chewable tablets or tablet is made using direct pressure closing in powder in step 8).
In preparation method of the present invention, the tabletting is to control piece hardness in 5~10kg.
Compared with prior art, the present invention has the advantage that
(1) pharmaceutical composition provided by the present invention has and has good stability, high degree of dispersion, to help to improve and disappear
Change the phosphate reaction in road food, substantially increases the curative effect of drug.
(2) sucrose iron oxide hydroxide is the small drug of solubility, and loose powdered is made using freeze-drying in the present invention,
It is equivalent to molecular state, reaches the dispersion of height, phosphate binding capacity test result reaches 98%.
Specific embodiment
Embodiment 1
The drug that the present invention treats chronic kidney disease dialysis patient hyperphosphatemia is prepared using prescription below:
1, prescription
2, preparation method:
(1) di-iron trioxide of recipe quantity is dissolved in the hydrochloric acid of recipe quantity, stirring to di-iron trioxide is completely dissolved, and is filtered
It crosses, takes subsequent filtrate, it is spare.
(2) sodium carbonate of recipe quantity is soluble in water, it is slowly added into solution made from step 1), it is stirring while adding, it is to be added
After complete, water is added to continue to stir, stands, discard supernatant, be repeated 5 times.
(3) sucrose of recipe quantity, stirring to dissolution are continuously added.
(4) starch for continuously adding recipe quantity, using homogenizer high-speed stirred to being mixed thoroughly.
(5) the obtained viscous fluid of step 4) is taken, lower 35 DEG C of zero setting or less are freezed, and freeze-off time is 2 hours, are guaranteed
Can sufficiently it freeze.
(6) the cold well temperature of dryness storehouse is dropped to -40 DEG C first, it is dry that dried frozen aquatic products made from step 5) are then put into vacuum
In dry storehouse, then dryness storehouse is vacuumized, is freezed 1 hour in the dryness storehouse that pressure is 40~60Pa, guarantees that moisture sufficiently freezes
Then knot starts lyophilization, the time is 48 hours, carries out 5 hours parsing-desiccations after lyophilization again, obtains moisture
Content be 2% the loose block of sucrose iron oxide hydroxide, crush, cross 500 meshes to get.
(7) milk-taste essence, the magnesium stearate, two of the resulting sucrose iron oxide hydroxide loose powder of step 6) and recipe quantity are taken
Silica mixes, and obtains pharmaceutical composition.
(8) drug content is measured, slice weight is calculated, with special-shaped punch die or circular die tabletting, control chewing sheet hardness is
8kg。
The embodiment of the present invention 1 prepare chewable tablets, control group (number of patent application: 201480065206.0, patent name:
Pharmaceutical composition comprising phosphate binders particle) it is as shown in table 1 with phosphate binding capacity result comparison result respectively, from
As can be seen that the pharmaceutical composition for preparing of the embodiment of the present invention 1 has has good stability in table 1, high degree of dispersion facilitates
It improves and reaches 98% or more with the phosphate reaction in alimentary canal food, phosphate binding capacity test result.
The chewable tablets of 1 embodiment of the present invention 1 of table preparation, control group is compared with phosphate binding capacity result:
Embodiment 2
The drug that the present invention treats chronic kidney disease dialysis patient hyperphosphatemia is prepared using prescription below:
1, prescription
2, preparation method:
(1) di-iron trioxide of recipe quantity is dissolved in the hydrochloric acid of recipe quantity, stirring to di-iron trioxide is completely dissolved, and is filtered
It crosses, takes subsequent filtrate, it is spare.
(2) sodium carbonate of recipe quantity is soluble in water, it is slowly added into solution made from step 1), it is stirring while adding, it is to be added
After complete, water is added to continue to stir, stands, discard supernatant, be repeated 6 times.
(3) sucrose of recipe quantity, stirring to dissolution are continuously added.
(4) starch for continuously adding recipe quantity, using homogenizer high-speed stirred to being mixed thoroughly.
(5) the obtained viscous fluid of step 4) is taken, lower 35 DEG C of zero setting or less are freezed, and freeze-off time is 3 hours, are guaranteed
Can sufficiently it freeze.
(6) the cold well temperature of dryness storehouse is dropped to -40 DEG C first, it is dry that dried frozen aquatic products made from step 5) are then put into vacuum
In dry storehouse, then dryness storehouse is vacuumized, is freezed 2 hours in the dryness storehouse that pressure is 40~60Pa, guarantees that moisture sufficiently freezes
Then knot starts lyophilization, the time is 49 hours, carries out 4 hours parsing-desiccations after lyophilization again, obtains moisture
The loose block of sucrose iron oxide hydroxide that content is 1% crushes, cross 400 meshes to get.
(7) milk-taste essence, the magnesium stearate, two of the resulting sucrose iron oxide hydroxide loose powder of step 6) and recipe quantity are taken
Silica mixes, and obtains pharmaceutical composition.
(8) drug content is measured, slice weight is calculated, with special-shaped punch die or circular die tabletting, control chewing sheet hardness is
7kg。
The embodiment of the present invention 2 prepare chewable tablets, control group (number of patent application: 201480065206.0, patent name:
Pharmaceutical composition comprising phosphate binders particle) it is as shown in table 2 with phosphate binding capacity result comparison result respectively, from
As can be seen that the pharmaceutical composition for preparing of the embodiment of the present invention 2 has has good stability in table 2, high degree of dispersion facilitates
It improves and reaches 98% or more with the phosphate reaction in alimentary canal food, phosphate binding capacity test result.
The chewable tablets of 2 embodiment of the present invention 2 of table preparation, control group is compared with phosphate binding capacity result:
Above disclosed is only presently preferred embodiments of the present invention, cannot limit the right of the present invention with this certainly
Range, therefore equivalent changes made in accordance with the claims of the present invention still fall within the range that the present invention is covered.
Claims (4)
1. a kind of process for preparing medicine for treating chronic kidney disease dialysis patient hyperphosphatemia, it is characterised in that: by following parts by weight
Several raw materials are prepared:
The process for preparing medicine specifically includes the following steps:
1) said ratio is pressed, di-iron trioxide is dissolved in hydrochloric acid, stirring to di-iron trioxide is completely dissolved, and is filtered, is filtered
Liquid；
2) sodium carbonate is soluble in water, it is slowly added into filtrate made from step 1), it is stirring while adding, after adding, water is added to continue
Stirring is stood, and discards supernatant, is repeated 3~8 times, and solution is obtained；
3) sucrose is added in the solution of step 2), stirring obtains sucrose solution to dissolving；
4) starch is added in sucrose solution, using homogenizer high-speed stirred to being mixed thoroughly, obtains viscous fluid；
5) lower 35 DEG C of viscous fluid zero setting or less are taken to be freezed, freeze-off time is 1~4 hour, guarantees sufficiently to freeze, be frozen
Dry product；
6) the cold well temperature of dryness storehouse is dropped to -40 DEG C first, then dried frozen aquatic products is put into dry vacuum container, then to drying
Storehouse vacuumizes, and freezes 1~2 hour in the dryness storehouse that pressure is 40~60Pa, guarantees that moisture sufficiently freezes, then starts to distil
Dry, the time is 48~50 hours, carries out 4~6 hours parsing-desiccations after lyophilization again, and obtaining moisture content is 1
~3% loose block of sucrose iron oxide hydroxide crushes, sieving；
7) sucrose iron oxide hydroxide loose powder and milk-taste essence, magnesium stearate, silica mix, and obtain pharmaceutical composition,
Piece is made using powder direct pressure closing, the drug for the chronic kidney disease dialysis patient hyperphosphatemia that obtains medical treatment.
2. the process for preparing medicine for the treatment of chronic kidney disease dialysis patient hyperphosphatemia as described in claim 1, it is characterised in that:
100~500 meshes are selected in sieving described in step 6).
3. the process for preparing medicine for the treatment of chronic kidney disease dialysis patient hyperphosphatemia as described in claim 1, it is characterised in that:
Mixing described in step 7) is mixed using equivalent gradually-increased.
4. the process for preparing medicine for the treatment of chronic kidney disease dialysis patient hyperphosphatemia as described in claim 1, it is characterised in that:
Chewable tablets or tablet is made using direct pressure closing in powder in step 8).
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| Application Number | Priority Date | Filing Date | Title |
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| CN201811406373.3A CN109223824A (en) | 2018-11-23 | 2018-11-23 | A kind of process for preparing medicine for treating chronic kidney disease dialysis patient hyperphosphatemia |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201811406373.3A CN109223824A (en) | 2018-11-23 | 2018-11-23 | A kind of process for preparing medicine for treating chronic kidney disease dialysis patient hyperphosphatemia |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115317494A (en) * | 2022-07-22 | 2022-11-11 | 康瑞鑫(天津)药物研究院有限公司 | Sucrose ferric oxide hydroxide with high phosphate bonding force and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105764492A (en) * | 2013-11-27 | 2016-07-13 | 维弗（国际）股份公司 | Pharmaceutical composition, comprising phosphate binder particles |
| WO2017072256A1 (en) * | 2015-10-27 | 2017-05-04 | MEDICE Arzneimittel Pütter GmbH & Co. KG | Nicotinamide for lowering phosphate levels in hyperphosphatemia |
-
2018
- 2018-11-23 CN CN201811406373.3A patent/CN109223824A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105764492A (en) * | 2013-11-27 | 2016-07-13 | 维弗（国际）股份公司 | Pharmaceutical composition, comprising phosphate binder particles |
| WO2017072256A1 (en) * | 2015-10-27 | 2017-05-04 | MEDICE Arzneimittel Pütter GmbH & Co. KG | Nicotinamide for lowering phosphate levels in hyperphosphatemia |
Non-Patent Citations (1)
| Title |
|---|
| 徐成海等: "真空冷冻干燥的现状与展望（一）", 《真空》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115317494A (en) * | 2022-07-22 | 2022-11-11 | 康瑞鑫(天津)药物研究院有限公司 | Sucrose ferric oxide hydroxide with high phosphate bonding force and preparation method thereof |
| CN115317494B (en) * | 2022-07-22 | 2024-02-13 | 康瑞鑫(天津)药物研究院有限公司 | Sucrose ferric hydroxide with high phosphate binding force and preparation method thereof |
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Application publication date: 20190118 |