CN1732980A - Freeze dry formulation of microelement and method for preparing the same - Google Patents
Freeze dry formulation of microelement and method for preparing the same Download PDFInfo
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- CN1732980A CN1732980A CN 200510093306 CN200510093306A CN1732980A CN 1732980 A CN1732980 A CN 1732980A CN 200510093306 CN200510093306 CN 200510093306 CN 200510093306 A CN200510093306 A CN 200510093306A CN 1732980 A CN1732980 A CN 1732980A
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Abstract
The invention relates to a freeze dried preparation of trace elements and its preparing process, wherein the preparation is prepared from compounds containing multiple trace elements and the solution of pharmaceutically acceptable excipient through freezing and drying, the excipient can be mannitol, glycine, lactose, sodium chloride, glucose and/or other pharmaceutically acceptable excipient.
Description
Technical field
The present invention relates to a kind of trace element and add preparation and manufacture method, the especially lyophilized formulations of injection various trace elements and manufacture method thereof.
Background technology
Although human body every day, they were very essential to homergy and the function of keeping human body to the requirement of trace element pettiness extremely.Trace element mainly contains two kinds of existence forms in human body: a kind of is to form metal complex with protein, nucleic acid (RNA) and adenosine triphosphate (ATP) etc.; Another is to combine with the active site of enzyme to form various enzymes, hormone or vitamin, as iron content, copper, zinc, manganese and selenic hundreds of enzyme, the thyroxin that contains iodine, ferruginous cytochrome etc., can make metal-organic double compound produce various unique biological effect, physiological function and biochemical reaction produce tremendous influence to the human life activity.The oxidation of sugar and fat in the vital movement, the generation of water is all finished under the catalysis of the cytochrome of enzyme and iron content or copper.Each trace element all has its special function, shortage or unfavorable to health above limiting the quantity of.Healthy people can absorb from food every day, if but patient at morbid state or for a long time can only be during as energy and nutrition with intravenous hyperalimentation, will cause the shortage of trace element and influence the health and the normal physiological function of human body.
Drug market has only various trace elements injection kind at present, and the present invention is a lyophilized injectable powder, has remedied the single deficiency of dosage form, is easy to transportation again.
Summary of the invention
For solving the problem that prior art exists, the object of the invention is to provide the trace element of a kind of use, convenient transportation and stable performance to add preparation and manufacture method thereof, it has solved existing additive and has had the problems such as inconvenience of using, preserving and transport, and stable performance.
Another object of the present invention is to provide a kind of method for preparing the said medicine preparation, and method is simple for this, and the cycle is short, helps large-scale production.
The inventor is in order to seek stable performance, the convenient suitable vasodilator preparation that uses transportation to store, having done a large amount of deep researchs explores, find by using excipient, the pH value of regulator solution, measures such as employing freeze drying process prepare lyophilized formulations, can solve stability of formulation and problem such as transportation storage etc. effectively, and preparation stabilization, good drug efficacy.
It is a kind of freeze dry formulation of microelement that trace element of the present invention adds preparation, and it is made after lyophilization by the solution that contains zinc chloride, manganese chloride, copper chloride, sodium selenite, potassium iodide, sodium fluoride and pharmaceutically acceptable excipient.Described solution is preferably controlled pH value 1.5～4.0, and preferred 2.0～3.5.
Described solution can also contain: iron chloride, sodium molybdate, Chlorizate chromium.
Described pharmaceutically acceptable excipient is to be generally used for preparing lyophilized formulations, get the filling bracket effect, make exsiccant medicine can keep the material of certain volume, for example: mannitol, glycine, lactose, sodium chloride, glucose or other pharmaceutically acceptable excipient or their mixture, preferred mannitol.
Described solution can be to be the solution of solvent with water, can be to be the solution of solvent with the organic solvent, can be the solution of solvent with water and organic solvent also.Described organic solvent can be pharmaceutically acceptable organic solvent.Preferred water is as solvent.
The consumption of described chemical compound so that in every preparation preferred iron content 18～22 μ mol, zinc 34～110 μ mol, manganese 0.14～5.5 μ mol, copper 2.8～22 μ mol, selenium 0.2～0.48 μ mol, molybdenum 0.16～0.24 μ mol, chromium 0.16～0.24 μ mol, iodine 0.063～1.2 μ mol, fluorine 25.5～55 μ mol and mannitol 0.05g～1g be advisable.
Described solution can comprise pharmaceutically acceptable pH regulator agent, to regulate the pH value of described solution.Described pH regulator agent can be at least a pharmaceutically acceptable material that is used to regulate pH value, can be hydrochloric acid, phosphate buffer, phosphoric acid, acetic acid etc., preferred hydrochloric acid, phosphate buffer.
Can also further comprise acceptable adjuvant on the conventional pharmaceutical such as stabilizing agent, analgesics and buffer agent in the pharmaceutical preparation of the present invention and one or more material in the medicine with other miscellaneous functions is arranged.
The invention provides a kind of preparation method of freeze dry formulation of microelement, comprise: (1) preparation contains the solution of zinc chloride, manganese chloride, copper chloride, sodium selenite, potassium iodide, sodium fluoride and pharmaceutically acceptable excipient, described solution is preferably controlled pH value 1.5～4.0, and preferred 2.0～3.5; And (1) step of (2) lyophilization gained solution.
The described solution of described (1) step can also contain: iron chloride, sodium molybdate, Chlorizate chromium.
In described (1) step, described chemical compound and excipient can be dissolved in water for injection or other solvents separately or together, or the adding of described chemical compound contains in the solution of described excipient, or the adding of described excipient contains in the solution of described chemical compound.Described solution can be to be the solution of solvent with water and/or organic solvent.Described organic solvent can be pharmaceutically acceptable organic solvent.
In described (1) step, can or add before or after adding described chemical compound before the excipient, among or afterwards, add acceptable adjuvant on aforementioned pharmaceutically acceptable pH regulator agent or the conventional pharmaceutical, for example: stabilizing agent, analgesics and/or buffer agent etc.
Before the lyophilization step in described (2) step, the described solution that contains described chemical compound and excipient can be according to the conventional method filtration sterilization.
The lyophilization step in described (2) step can be conventional or known freeze drying process step.Described freeze drying process carries out under aseptic condition, can adjust lyophilization cycle according to conventional or known method according to the demand of clinical preparation and concrete production equipment.
The lyophilization of described (2) step can be carried out in accordance with the following methods:
(1) pre-freeze: respectively the temperature in the freeze drying box is reduced in advance about 0 ℃～-60 ℃, lyophilizing solution is put into carries out pre-freeze on the freeze drying box internal partition treating of installing of branch, and the pre-freeze time can be 2-6 hour;
(2) sublimation drying: vacuum in the freeze drying box is risen to below the 13.33Pa (0.1mmHg post), close fridge, slowly heating, condenser temperature drops to-30 ℃, carries out sublimation drying 12～15 hours; And
(3) dry again: as baking temperature to be controlled at 10 ℃～30 ℃, until treating that the freeze-dried products temperature is near the plate temperature.Condenser temperature drops to below-30 ℃, dry 10～15 hours again.
Various trace elements lyophilized formulations of the present invention can be dissolved in water for injection or other injection to lyophilized formulations before using.Described injection can be conventional injection, as glucose injection or Amino Acid Compound Injection.According to therapeutic process and patient's situation, using the consumption of the Rare Elements Preparations of the present invention dosage of being grown up general every day is one (adult type), and child dose is 1.5 (child forms) to the maximum.
Lyophilized formulations of the present invention is soluble in water, has to be easy to store and transportation, and long-time placement is more stable, uses advantages such as more convenient.And preparation method of the present invention is simple and easy to do, helps large-scale production, and rate of drying is fast in sublimation drying, and is with short production cycle, and production cost is low.Preparation of the present invention has also remedied the single deficiency of present similar pharmaceutical dosage form, satisfy the demand of people to different dosage form, be mainly used in parenteral nutrition and replenish the daily need of adult trace element, or be used for the treatment of or support infant, the children's fundamental need to trace element, have vast market prospect.
The specific embodiment
Below will the invention will be further described by embodiment, these descriptions are not that content of the present invention is done further to limit.One skilled in the art will understand that to be equal to replacement to what technical characterictic of the present invention was done, or corresponding the improvement, still belong within protection scope of the present invention.
Embodiment 1-3
Take by weighing iron chloride (FeCl respectively
36H
2O) 540mg, zinc chloride (ZnCl
2) 1.36g, manganese chloride (MnCl
24H
2O) 99mg, copper chloride (CuCl
2H
2O) 340mg, sodium selenite (Na
2SeO
35H
2O) 10.5mg, sodium molybdate (Na
2MoO
42H
2O) 4.88mg, potassium iodide (KI) 19.9mg, Chlorizate chromium (CrCl
36H
2O) 5.33mg, sodium fluoride (NaF) 210mg and mannitol 20g.Mannitol is added injection water 140ml, be heated to 78 ℃, be stirred to dissolving fully.With iron chloride (FeCl
36H
2O) 540mg is dissolved in 5ml and is added with in advance in the water for injection of 10ul1M hydrochloric acid, with zinc chloride (ZnCl
2) 1.36g, manganese chloride (MnCl
24H
2O) 99mg, copper chloride (CuCl
2H
2O) 340mg, sodium selenite (Na
2SeO
35H
2O) 10.5mg, sodium molybdate (Na
2MoO
42H
2O) 4.88mg, potassium iodide (KI) 19.9mg is dissolved in respectively in the 5ml water for injection, and each solution is joined in the aforementioned mannitol solution, then with Chlorizate chromium (CrCl
36H
2O) 5.33mg, sodium fluoride (NaF) 210mg is dissolved in respectively in the 10ml water for injection, and slowly joins in the mannitol solution.Add the injection water to 200ml, the pH when regulating 25 ℃ respectively with 1M hydrochloric acid is 2.0,3.0,4.0.
With 0.22 μ m microporous filter membrane fine straining degerming.Under aseptic condition gained solution is put in the aseptic cillin bottle, put in the freezer dryer according to the method lyophilization of embodiment 7 after about respectively 22,25,28 hours, sterile sealing promptly gets freeze-dried powder preparation A of the present invention, B, C.
Embodiment 4-6
Take by weighing three parts of zinc chloride (ZnCl respectively
2) 521mg, copper chloride (CuCl
2H
2O) 53.7mg, manganese chloride (MnCl
24H
2O) 3.60mg, sodium fluoride (NaF) 126mg, sodium selenite (Na
2SeO
35H
2O) 6.66mg, potassium iodide (KI) 1.31mg and a mannitol 8g; A glycine 8g, a lactose 8g.Respectively glycine, mannitol, lactose are added injection water 70ml, be heated to 70 ℃, be stirred to dissolving fully.With zinc chloride (ZnCl
2) 521mg, copper chloride (CuCl
2H
2O) 53.7mg, manganese chloride (MnCl
24H
2O) 3.60mg, sodium selenite (Na
2SeO
35H
2O) 6.66mg, potassium iodide (KI) 1.31mg is dissolved in respectively in the 3ml water for injection, and each solution joined respectively in the aforementioned mannitol solution, in the glycine solution, again sodium fluoride (NaF) 126mg is dissolved in the 6ml water for injection in the lactose solution, joins respectively in the mannitol solution, in the glycine solution, add the injection water in the lactose solution to 100ml, the pH when regulating 25 ℃ with 1M hydrochloric acid is 2,3,4.With 0.22 μ m microporous filter membrane fine straining degerming, put gained solution in the aseptic cillin bottle under aseptic condition the qualified back of the inspection of semifinished product, puts lyophilizing in the freezer dryer, and sterile sealing promptly gets trace element freeze-dried powder preparation D of the present invention, E, F.
Embodiment 7
With embodiment 1 to 3 gained solution lyophilization in accordance with the following methods, prepare various trace elements freeze-dried powder preparation of the present invention:
Pre-freeze: respectively the temperature in the freeze drying box is reduced in advance about-20 ℃ ,-25 ℃ ,-35 ℃, lyophilizing solution is put into carries out pre-freeze on the freeze drying box internal partition treating of installing of branch.
Sublimation drying: vacuum in the freeze drying box is risen to below the 13.33Pa (0.1mmHg post), close fridge.Slowly heat by the heating system under the dividing plate, dividing plate suitably is heated to about 10 ℃, to supply with the required heat of distillation of ice, condenser temperature drops to below-30 ℃, carries out sublimation drying 15,11,13 hours.
Dry again: baking temperature is controlled at 20 ℃, 30 ℃, 10 ℃ respectively, and the plate temperature control overlaps with the plate temperature until products temperature below 30 ℃, promptly reaches exsiccant terminal point.Condenser temperature drops to-33 ℃, dry 11,13,15 hours again.
Embodiment 8
The solubility property of the preparation of the present invention that embodiment 1-9 is made is investigated.Preparation A of the present invention, B, C, D, E, F all can dissolve after adding water for injection well, and the clarity of gained solution is all qualified.
Embodiment 9
The preparation A of the present invention that embodiment 1-6 is made, B, C, D, E, F be long preservation under lucifuge, 0～25 ℃ of condition, investigates all qualified of outward appearance, pH value, loss on drying, clarity of solution and color, content, and experimental result shows that performance is very stable.
Claims (9)
1, a kind of freeze dry formulation of microelement is made after lyophilization by the solution that contains zinc chloride, manganese chloride, copper chloride, sodium selenite, potassium iodide, sodium fluoride and pharmaceutically acceptable excipient; The pH value of described solution is 1.5～4.0.
2, freeze dry formulation of microelement according to claim 1 is characterized in that described solution also contains iron chloride, sodium molybdate, reaches Chlorizate chromium.
3, freeze dry formulation of microelement according to claim 1 is characterized in that described pharmaceutically acceptable excipient is one or more the material that is selected from mannitol, glycine, lactose, sodium chloride, glucose or other the pharmaceutically acceptable excipient.
4, freeze dry formulation of microelement according to claim 1, the pH value that it is characterized in that described solution is 2.0～3.5; Pharmaceutically acceptable excipient is a mannitol.
5, freeze dry formulation of microelement according to claim 1, it is characterized in that described solution, also contain acceptable adjuvant on the conventional pharmaceutical that comprises stabilizing agent, analgesics and buffer agent and one or more material in the medicine with other miscellaneous functions is arranged.
6, a kind of freeze dry formulation of microelement is made after lyophilization by the solution that contains iron chloride, zinc chloride, manganese chloride, copper chloride, sodium selenite, sodium molybdate, Chlorizate chromium, potassium iodide, sodium fluoride and pharmaceutically acceptable excipient; The pH value of described solution is 2.0～3.5; Every preparation of described lyophilized formulations iron content 18～22 μ mol/, every preparation of zinc 34～110 μ mol/, every preparation of manganese 0.14～5.5 μ mol/, every preparation of copper 2.8～22 μ mol/, every preparation of selenium 0.2～0.48 μ mol/, every preparation of molybdenum 0.16～0.24 μ mol/, every preparation of chromium 0.16～0.24 μ mol/, every preparation of iodine 0.063～1.2 μ mol/, fluorine every preparation of 25.5～55 μ mol/ and every preparation of mannitol 0.05g～1g/.
7, a kind of freeze dry formulation of microelement is made after lyophilization by the solution that contains zinc chloride, manganese chloride, copper chloride, sodium selenite, potassium iodide, sodium fluoride and pharmaceutically acceptable excipient; The pH value of described solution is 2.0～3.5; Described lyophilized formulations contains every preparation of zinc 34～110 μ mol/, every preparation of manganese 0.14～5.5 μ mol/, every preparation of copper 2.8～22 μ mol/, every preparation of selenium 0.2～0.48 μ mol/, every preparation of iodine 0.063～1.2 μ mol/, fluorine every preparation of 25.5～55 μ mol/ and every preparation of mannitol 0.05g～1g/.
8, a kind of method for preparing freeze dry formulation of microelement comprises:
(1) preparation contains the solution of various trace elements, pharmaceutically acceptable excipient, filtration sterilization;
(2) (1) step of lyophilization gained solution.
9, the method for preparing freeze dry formulation of microelement according to claim 8, it is characterized in that: the lyophilization of described (2) step may further comprise the steps:
(1) pre-freeze: respectively the temperature in the freeze drying box is reduced in advance about 0 ℃～-60 ℃, the lyophilizing solution for the treatment of that branch installs is put into freeze drying box and carried out pre-freeze 2-6 hour;
(2) sublimation drying: vacuum in the freeze drying box is risen to below the 13.33Pa, close fridge, slowly heating, condenser temperature drops to-30 ℃, carries out sublimation drying 12～15 hours; And
(3) dry again: baking temperature is controlled at 10 ℃～30 ℃, and until treating the freeze-dried products temperature near this temperature, condenser temperature drops to below-30 ℃, dry 10～15 hours again.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100933067A CN1330315C (en) | 2005-08-25 | 2005-08-25 | Freeze dry formulation of microelement and method for preparing the same |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100933067A CN1330315C (en) | 2005-08-25 | 2005-08-25 | Freeze dry formulation of microelement and method for preparing the same |
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| Publication Number | Publication Date |
|---|---|
| CN1732980A true CN1732980A (en) | 2006-02-15 |
| CN1330315C CN1330315C (en) | 2007-08-08 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102641288A (en) * | 2012-05-08 | 2012-08-22 | 海南海医药物安全性评价研究有限责任公司 | Nutrition combination for anti experiment beagle transportation stress |
| CN103340895A (en) * | 2013-06-27 | 2013-10-09 | 江西博意特科技有限公司 | Composition containing various microelements, preparation and preparation method thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1517085A (en) * | 2003-01-15 | 2004-08-04 | 华瑞制药有限公司 | Multi-microelement injecta and its preparation method and application |
-
2005
- 2005-08-25 CN CNB2005100933067A patent/CN1330315C/en active Active
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102641288A (en) * | 2012-05-08 | 2012-08-22 | 海南海医药物安全性评价研究有限责任公司 | Nutrition combination for anti experiment beagle transportation stress |
| CN102641288B (en) * | 2012-05-08 | 2013-04-10 | 海南海医药物安全性评价研究有限责任公司 | Nutrition combination for anti experiment beagle transportation stress |
| CN103340895A (en) * | 2013-06-27 | 2013-10-09 | 江西博意特科技有限公司 | Composition containing various microelements, preparation and preparation method thereof |
| CN103340895B (en) * | 2013-06-27 | 2015-02-18 | 江西博意特科技有限公司 | Composition containing various microelements, preparation and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN1330315C (en) | 2007-08-08 |
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