CN104473963B - The preparation method of rare earth chemistry medicine lanthanum carbonate chewable tablets - Google Patents
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Abstract
The preparation method of rare earth chemistry medicine lanthanum carbonate chewable tablets, is related to rare earth chemistry medicine.By the separation product lanthana purification from the ion type rareearth ore of market purchasing, the rare earth lanthanum oxide of the separation product lanthana of the ion type rareearth ore accounts for the 99.99% of total amount of rare earth, the impurity in rare earth lanthanum oxide is removed, Rare Earth Lanthanum and other Rare Earth Separations is realized；The impurity includes the oxide and non-rare earth impurity element of other rare earth elements except lanthana；Principle is adsorbed and be desorbed using ion exchange resin to swap, and is first made organic glass ion exchange column, exchange column filling ion-exchange resin, ion exchange resin is washed till iron-free through 2NHCl, is washed with water to neutrality, it is standby after immersion；Rare Earth Lanthanum is separated with non-rare earth impurity；Removing nitrilotriacetic acid is washed with water, the separation of Rare Earth Lanthanum and other rare earths is realized；Rare earth chemistry medicine lanthanum carbonate chewable tablets is made after obtained pure rare earth lanthanum ion ammonium bicarbonate precipitation is obtained into lanthanum carbonate crystal, sterilizing, drying.
Description
Technical field
The present invention relates to rare earth chemistry medicine, more particularly, to a kind of preparation method of rare earth chemistry medicine lanthanum carbonate chewable tablets.
Background technology
FOX sharp promise FOSRENOL in the U.S. has found that the combination of rare earth metal lanthanum ion and phosphonium ion produces insoluble precipitation, with disappearing
Change road to excrete, do not enter blood circulation system.A large amount of disease subjects do not produce adverse side effect, hence it is evident that be better than and use carbonic acid
Calcium, calcium acetate, the curative effect of aluminium carbonate.
Lanthanum carbonate chewable tablets had especially promoted global 42 countries, the high phosphorus blood of the U.S. 90% since the invention in recent years
Disease patient obtains rehabilitation.This medicine enters China within 2012, has turned into domestic treatment hyperphosphatemia at present and has uniquely promoted mainly medicine.It is tens of
Ten thousand patients are using, and enjoy high-tech achievement.
It is known that China is rare earth resources big country, possess abundant Rare Earth Lanthanum resource.Chinese population is numerous, suffers from chronic renal
The patient of disease almost has 1.2 hundred million nephropathy patients up to 10.2%.Current China uremia patient groups are ill more than 3,000,000 people
Number is annual to be increased with 11%, be there are about 8 one-tenth nephrotics and is died from malpractice, can receive crowd's number of high-tech treatment and have
Limit, is not popularized, and topmost reason is based at 2 points.One is the medicine valency of U.S.'s FOX profit promise lanthanum carbonate chewable tablets is sufficiently expensive,
Medical insurance is not entered into, most patient is difficult to bear the pressure of huge dialysis expense, it more difficult in the expense for receiving high price lanthanum carbonate, quilt
Compel to abandon treatment；The second is scientific propaganda is not popularized still.Not only person having renal failure fears the heart infarction of hyperphosphatemia initiation, heart and brain blood
Pipe necrosis；The same hyperphosphatemia to Patients with geriatric cardiovascular and cerebrovascular diseases, diabetes patient, hypertensive patient endangers, and also triggers heart infarction, to this kind of
The dephosphorization education pole of patient needs to strengthen.
A kind of lanthanum carbonate for being used to treat hyperphosphatemia disclosed in Chinese patent CN102432055A such as Peking University is received
The preparation method of rice grain, comprises the following steps：1) sodium bicarbonate solution is added in lanthanum chloride solution, prepares eight and be hydrated carbonic acid
Lanthanum, 2) then under the conditions of normal pressure, 40~120 DEG C dehydration prepare the stable lanthanum carbonate containing 1~4 water, 3) finally lead to
The method for crossing ball milling, the sample of preparation from micron particles ball milling into nano particle.The invention further relates to thus preparation method and obtained
The eight artificial lanthanite La obtained2(CO3)3·8H2O, the lanthanum carbonate La containing 1~4 water2(CO3)3·xH2O (wherein x is 1~4)
And lanthanum carbonate nano particle, and application of the lanthanum carbonate nano particle in preparing for treating the medicine of hyperphosphatemia.
Johnson Matty Public Limited Co of Britain is a kind of disclosed in Chinese patent CN1184428 to contain selectable lanthanum carbonate water
The pharmaceutical composition of compound, chosen lanthanum carbonate hydrates can be applied through intestines and stomach, treat the serium inorganic phosphorus acid of person having renal failure
The excessive disease of salt.
The content of the invention
It is an object of the invention to provide a kind of preparation method of rare earth chemistry medicine lanthanum carbonate chewable tablets.
The present invention comprises the following steps：
1) it will be purified from the separation product of the ion type rareearth ore of market purchasing-lanthana, the ion type rareearth ore
The rare earth lanthanum oxide of separation product-lanthana accounts for the 99.99% of total amount of rare earth, removes the impurity in rare earth lanthanum oxide, realizes dilute
Native lanthana and other Rare Earth Separations；The impurity includes the oxide and non-rare earth impurity of other rare earth elements except lanthana
Element；
In step 1) in, other described rare earth elements are cerium, praseodymium, neodymium, europium, yttrium etc., the non-rare earth impurity element be calcium,
Aluminium, manganese, copper, lead, zinc etc., the total amount of impurity element are less than 100ppm.
2) principle is adsorbed and be desorbed using ion exchange resin to swap, 60 are filled in organic glass ion exchange column
Mesh styrene strong acid ion exchange resin, the 60 mesh styrene strong acid ion exchange resin is washed till iron-free through 2NHCl, uses
Distillation is washed to neutrality, standby after immersion；
3) Rare Earth Lanthanum is separated with non-rare earth impurity, specific method is as follows：
(1) sample preparation：Rare earth sample is added into hydrochloric acid hydrogen ammonium, hydrochloric acid heating for dissolving is added, is evaporated to and closely does, be diluted with water
Afterwards, it is sent to ion exchange column；
In step 3) in (1) part, the addition of the hydrochloric acid can be 1: 1 with the volume ratio of hydrochloric acid hydrogen ammonium.
(2) non-lanthanum rare earth is washed with nitrilotriacetic acid；
Iron is removed with ammonium thiocyanate and phenanthroline method；
With calcichrome and calcium reagent deliming and magnesium；
Barium is removed with barium sulfate precipitate method；
Aluminium is removed with chrome azurol S method；
With dithizone-carbon tetrachloride extraction copper removal, lead, zinc；
Use potassium permanganate oxidation method demanganization；
4) removing nitrilotriacetic acid is washed with water, the separation of Rare Earth Lanthanum and other rare earths is realized, specific method is as follows：
(1) cerium oxide is removed with perchloric acid oxidation's reducing process；
(2) praseodymium oxide, neodymium, samarium are removed with stannous chloride oxidizing process；
(3) europium oxide is removed with ammonium thiocyanate；
(4) heavy rare earth yttrium etc. is removed with perchloric acid oxidation's method；
(5) with EDTA Separation by Complexation enrichment Rare Earth Lanthanum；
(6) Rare Earth Lanthanum is eluted with acetamide；
5) the ppm values of the front and rear impurity content change of Rare Earth Lanthanum purification are determined；
6) prepared by obtained pure rare earth lanthanum ion and rare earth chemistry medicine lanthanum carbonate nozzle is made after lanthanum carbonate crystal, sterilizing, drying
Chew piece.
In step 6) in, it is described obtained pure rare earth lanthanum ion is prepared into lanthanum carbonate crystal first to use ammonium bicarbonate precipitation
The lanthanum carbonate crystal containing 1~4 crystallization water is prepared, then uses sol-gel process prepared sizes for 40~60nm fine crystallization carbon
Sour lanthanum nano particle；
The ammonium hydrogen carbonate can use AMMONIUM BICARBONATE FOOD GRADE；The use ammonium bicarbonate precipitation is prepared containing 1~4 crystallization
During the lanthanum carbonate crystal of water, pH can be controlled in 5.5~6.0, and temperature can be 55~65 DEG C；
The specific method that sol-gel process prepared sizes are used for 40~60nm fine crystallization lanthanum carbonate nano particle
It is as follows：Citric acid, in mass ratio, lanthanum carbonate: citric acid=1 are added in the obtained lanthanum carbonate crystal containing 1~4 crystallization water
: 2, add polyethylene glycol to homogeneous, mixed solution then formed into colloidal sol, colloidal sol is switched to gel with freezing method, temperature for-
10 DEG C, then gel is ground into gel with Mechanical Method in 110~120 DEG C of drying, that is, it is 40~60nm to obtain granularity, containing 1~4
Crystallization water lanthanum carbonate crystal La2(CO3)3, without alkaline carbonic acid lanthanum La (OH) (CO3) fine crystallization lanthanum carbonate nano particle；
The condition of the sterilizing, drying can be in 20 DEG C of sterilizing vacuum drying chamber drying 48h；The rare earth chemistry medicine lanthanum carbonate
Chewable tablets can be made into 25mg/ pieces, can be packed by every 20 (500mg) or 40 (1000mg) specifications.
Because the purity of existing commercially available rare earth lanthanum oxide only has 99.99%, i.e., still there is 0.01% impurity, equivalent to
100ppm.These 100ppm impurity includes the oxide and non-rare earth impurity element of other rare earth elements, and these impurity are not
Allow to enter in human body, the present invention minimizes the impurity content in existing commercially available rare earth lanthanum oxide, or even close to 0, with true
Protect medicine three zones, that is, have definite curative effect, safety have no side effect, it is cheap.In addition, lanthanum carbonate nozzle produced by the present invention
Chew the lanthanum carbonate in piece and reach nanoscale, its crystal particle diameter is 40~60nm.
Lanthanum carbonate chewable tablets is a kind of rare earth chemistry oral medicine, using rare earth as raw material.This medicine for oral administration is to utilize Rare Earth Lanthanum
Ion is combined with phosphonium ion unnecessary in patient body and generates water insoluble lanthanum orthophosphate precipitation, is excreted with alimentary canal, no
Into the hematological system of people, the unnecessary phosphate ion concentration of alimentary canal is but reduced to appropriateness.Utilize lanthanum ion and phosphatic height
Compatibility, when lanthanum ion is discharged in human stomach in sour environment from carbonic acid, is combined with phosphate in food, is formed not
The lanthanum orthophosphate of dissolubility, thus reduce absorption of the intestines and stomach to phosphorus.
Embodiment
The present invention is further illustrated for following examples.
The embodiment of the present invention comprises the following steps：
1) it will be purified from the separation product of the ion type rareearth ore of market purchasing-lanthana, the ion type rareearth ore
The rare earth lanthanum oxide of separation product-lanthana accounts for the 99.99% of total amount of rare earth, removes the impurity in rare earth lanthanum oxide, realizes dilute
Native lanthanum and other Rare Earth Separations；The impurity includes the oxide and non-rare earth impurity member of other rare earth elements except lanthana
Element；Other described rare earth elements are cerium, praseodymium, neodymium, europium, yttrium etc., and the non-rare earth impurity element is calcium, aluminium, manganese, copper, lead, zinc
Total amount Deng, impurity element is less than 100ppm.
2) principle is adsorbed and be desorbed using ion exchange resin to swap, first make organic glass ion exchange column, have
Machine glass ion-exchange column fills 60 mesh styrene strong acid ion exchange resins, and the 60 mesh styrene strong acid type ion is exchanged
Resin is washed till iron-free through 2NHCl, and neutrality is washed to distillation, standby after immersion (preventing resin bed from drying up)；
3) Rare Earth Lanthanum is separated with non-rare earth impurity, specific method is as follows：
(1) sample preparation：Rare earth sample is added into hydrochloric acid hydrogen ammonium, hydrochloric acid heating for dissolving is added, is evaporated to and closely does, it is dilute with water
Release, be sent to ion exchange column；The addition and rare earth sample of the hydrochloric acid and the volume ratio of hydrochloric acid hydrogen ammonium can be 1: 1.
(2) washed with nitrilotriacetic acid, coutroi velocity, wash non-lanthanum rare earth；
Iron is removed with ammonium thiocyanate and phenanthroline method；
With calcichrome and calcium reagent deliming and magnesium；
Barium is removed with barium sulfate precipitate method；
Aluminium is removed with chrome azurol S method；
With dithizone-carbon tetrachloride extraction copper removal, lead, zinc；
Use potassium permanganate oxidation method demanganization；
Sd.Hg is typically seldom present, Si big portion's dissolutions in hydrochloric acid, is determined with silicon molybdenum blue；
4) removing nitrilotriacetic acid is washed with water, the separation of Rare Earth Lanthanum and other rare earths is realized, specific method is as follows：
(1) cerium oxide is removed with perchloric acid oxidation's reducing process；
(2) praseodymium oxide, neodymium, samarium are removed with stannous chloride oxidizing process；
(3) europium oxide is removed with ammonium thiocyanate；
(4) heavy rare earth yttrium etc. is removed with perchloric acid oxidation's method；
(5) with EDTA Separation by Complexation enrichment Rare Earth Lanthanum；
(6) Rare Earth Lanthanum is eluted with acetamide；
(7) impurity content change ppm values before and after Rare Earth Lanthanum purification are determined；
5) rare earth is made after obtained pure rare earth lanthanum ion ammonium bicarbonate precipitation being obtained into lanthanum carbonate crystal, sterilizing, drying
Chemical drugs lanthanum carbonate chewable tablets.The ammonium hydrogen carbonate can use AMMONIUM BICARBONATE FOOD GRADE；It is described to obtain carbon with ammonium bicarbonate precipitation
During sour lanthanum crystal, pH can be controlled in 5.5~6.0, and temperature can be 55~65 DEG C；The lanthanum carbonate crystal of acquisition is containing 1~4 crystallization
Water, granularity is 40~60nm fine crystallization lanthanum carbonate nano particle；The condition of the sterilizing, drying can be in 20 DEG C of vacuum drying chambers
Dry 48h；The rare earth chemistry medicine lanthanum carbonate chewable tablets can be made into 25mg/ pieces, can be by every 20 (500mg) or 40
(1000mg) specification is packed.
Rare earth chemistry medicine lanthanum carbonate chewable tablets prepared by the present invention is a kind of rare earth chemistry oral medicine, using rare earth as raw material.
This medicine for oral administration is to be combined the water insoluble lanthanum orthophosphate of generation with phosphonium ion unnecessary in patient body using lanthanum ion to sink
Form sediment, excreted with alimentary canal, the hematological system of people is not entered, the unnecessary phosphate ion concentration of alimentary canal is but reduced to appropriateness.
Using lanthanum ion and phosphatic high-affinity, when lanthanum ion is discharged in human stomach in sour environment from carbonic acid, with food
Phosphate is combined in thing, forms insoluble lanthanum orthophosphate, thus reduces absorption of the intestines and stomach to phosphorus.
Table 1
| Detection project | Before purification | After purification |
| Other rare earth elements | 50 | 15 |
| Cerium | 10 | 3 |
| Praseodymium neodymium samarium | 5 | 3 |
| Europium | 10 | 3 |
| Yttrium | 15 | 3 |
| Other rare earths | 10 | 3 |
| Non- lanthanum non-rare earth | 50 | 15 |
| Iron | 10 | 3 |
| Calcium and magnesium | 10 | 3 |
| Barium | 5 | 2 |
| Aluminium | 10 | 3 |
| Copper, lead, zinc | 3 | 0 |
| Manganese | 5 | 2 |
| Cd.Hg | 2 | 0 |
| It is other | 5 | 2 |
| Rare Earth Lanthanum | 99.99 | 99.9995 |
The change ppm values of content are shown in Table 1 before and after non-Rare Earth Lanthanum impurity purification.
Claims (7)
1. the preparation method of rare earth chemistry medicine lanthanum carbonate chewable tablets, it is characterised in that comprise the following steps：
1) it will be purified from the separation product of the ion type rareearth ore of market purchasing-lanthana, the separation of the ion type rareearth ore
The rare earth lanthanum oxide of product-lanthana accounts for the 99.99% of total amount of rare earth, removes the impurity in rare earth lanthanum oxide, realizes rare earth oxygen
Change lanthanum and other Rare Earth Separations；The impurity includes the oxide and non-rare earth impurity member of other rare earth elements except lanthana
Element；
2) principle is adsorbed and be desorbed using ion exchange resin to swap, 60 mesh benzene are filled in organic glass ion exchange column
Ethene strong acid ion exchange resin, the 60 mesh styrene strong acid ion exchange resin is washed till iron-free through 2NHCl, with distillation
Neutrality is washed to, it is standby after immersion；
3) Rare Earth Lanthanum is separated with non-rare earth impurity, specific method is as follows：
(1) sample preparation：Rare earth sample is added into hydrochloric acid hydrogen ammonium, hydrochloric acid heating for dissolving is added, is evaporated to and closely does, after being diluted with water,
It is sent to ion exchange column；
(2) non-lanthanum rare earth is washed with nitrilotriacetic acid；
Iron is removed with ammonium thiocyanate and phenanthroline method；
With calcichrome and calcium reagent deliming and magnesium；
Barium is removed with barium sulfate precipitate method；
Aluminium is removed with chrome azurol S method；
With dithizone-carbon tetrachloride extraction copper removal, lead, zinc；
Use potassium permanganate oxidation method demanganization；
4) removing nitrilotriacetic acid is washed with water, the separation of Rare Earth Lanthanum and other rare earths is realized, specific method is as follows：
(1) cerium oxide is removed with perchloric acid oxidation's reducing process；
(2) praseodymium oxide, neodymium, samarium are removed with stannous chloride oxidizing process；
(3) europium oxide is removed with ammonium thiocyanate；
(4) heavy rare earth yttrium is removed with perchloric acid oxidation's method；
(5) with EDTA Separation by Complexation enrichment Rare Earth Lanthanum；
(6) Rare Earth Lanthanum is eluted with acetamide；
5) the ppm values of the front and rear impurity content change of Rare Earth Lanthanum purification are determined；
6) prepared by obtained pure rare earth lanthanum ion and the chewing of rare earth chemistry medicine lanthanum carbonate is made after lanthanum carbonate crystal, sterilizing, drying
Piece；It is described by obtained pure rare earth lanthanum ion prepare lanthanum carbonate crystal be first using ammonium bicarbonate precipitation prepare containing 1~4 crystallization
The lanthanum carbonate crystal of water, then sol-gel process prepared sizes are used for 40~60nm fine crystallization lanthanum carbonate nano particle；It is described
When preparing the lanthanum carbonate crystal containing 1~4 crystallization water using ammonium bicarbonate precipitation, pH controls 5.5~6.0, temperature is 55~
65℃；It is described to use the sol-gel process prepared sizes to be for the specific method of 40~60nm fine crystallization lanthanum carbonate nano particle：
Add citric acid, in mass ratio, lanthanum carbonate: citric acid=1 in the lanthanum carbonate crystal containing 1~4 crystallization water is obtained: 2, then
Polyethylene glycol is added to homogeneous, mixed solution is then formed into colloidal sol, colloidal sol is switched to gel with freezing method, temperature is -10 DEG C,
Gel is ground into gel with Mechanical Method in 110~120 DEG C of drying again, that is, it is 40~60nm to obtain granularity, containing 1~4 crystallization water
Lanthanum carbonate crystal La2(CO3)3, without alkaline carbonic acid lanthanum La (OH) (CO3) fine crystallization lanthanum carbonate nano particle.
2. the preparation method of rare earth chemistry medicine lanthanum carbonate chewable tablets as claimed in claim 1, it is characterised in that in step 1) in, institute
Other rare earth elements are stated for cerium, praseodymium, neodymium, europium, yttrium.
3. the preparation method of rare earth chemistry medicine lanthanum carbonate chewable tablets as claimed in claim 1, it is characterised in that in step 1) in, institute
Non-rare earth impurity element is stated for calcium, aluminium, manganese, copper, lead, zinc, the total amount of impurity element is less than 100ppm.
4. the preparation method of rare earth chemistry medicine lanthanum carbonate chewable tablets as claimed in claim 1, it is characterised in that in step 3) (1)
In part, the addition of the hydrochloric acid is 1: 1 with the volume ratio of hydrochloric acid hydrogen ammonium.
5. the preparation method of rare earth chemistry medicine lanthanum carbonate chewable tablets as claimed in claim 1, it is characterised in that the ammonium hydrogen carbonate
Using AMMONIUM BICARBONATE FOOD GRADE.
6. the preparation method of rare earth chemistry medicine lanthanum carbonate chewable tablets as claimed in claim 1, it is characterised in that in step 6) in, institute
The condition for stating sterilizing, drying is the vacuum drying chamber drying 48h that sterilized at 20 DEG C.
7. the preparation method of rare earth chemistry medicine lanthanum carbonate chewable tablets as claimed in claim 1, it is characterised in that in step 6) in, institute
State rare earth chemistry medicine lanthanum carbonate chewable tablets 25mg/ pieces are made, packed by every 20 common 500mg or 40 common 1000mg specification.
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| CN106543029B (en) * | 2016-10-26 | 2018-09-11 | 桂林理工大学 | N,N`（2- aminofluorenes）The preparation method of contracting glyoxal schiff bases iron complex |
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| GB9506126D0 (en) * | 1995-03-25 | 1995-05-10 | Johnson Matthey Plc | Pharmaceutical composition and method |
| EA012798B1 (en) * | 2003-08-26 | 2009-12-30 | Шир Холдингз Аг | Pharmaceutical formulation comprising lanthanum compound |
| CN101077338B (en) * | 2006-05-24 | 2012-06-20 | 天津大学 | Nano lanthanum carbonate and orally disintegrating tablet and preparation method |
| CN102432055B (en) * | 2011-09-23 | 2013-10-16 | 北京大学 | Lanthanum carbonate nano-particles for treating hyperphosphatemia, preparation method and use thereof |
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| CN101362605A (en) * | 2008-08-11 | 2009-02-11 | 中国科学院长春应用化学研究所 | A kind of preparation method of rare earth nano oxide |
Non-Patent Citations (2)
| Title |
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| 碳酸氢铵沉淀生产碳酸镧氧化镧;韩江;《稀有金属快报》;20011231(第11期);参见第17页第1.4栏,表4-5 * |
| 碳酸镧咀嚼片;陆志城;《医药经济报》;20050708;全文 * |
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