CN106309488A - Multi-trace-element injection for children - Google Patents
Multi-trace-element injection for children Download PDFInfo
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- CN106309488A CN106309488A CN201610862434.1A CN201610862434A CN106309488A CN 106309488 A CN106309488 A CN 106309488A CN 201610862434 A CN201610862434 A CN 201610862434A CN 106309488 A CN106309488 A CN 106309488A
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- injection
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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
- A61K33/34—Copper; Compounds thereof
-
- 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
-
- 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
- A61K33/30—Zinc; Compounds thereof
-
- 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
- A61K33/32—Manganese; Compounds thereof
-
- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K9/08—Solutions
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses multi-trace-element injection for children. The injection is prepared from the following components: ZnSO4 7H2O, CuSO4 5H2O, MnSO4 H2O, CrCl3 6H2O and water for injection; the pH value of the injection is 1.7-2.7. Each milliliter of unit preparation is prepared from the following components: 6.4-6.8mg of the ZnSO4 7H2O, 0.37-0.41mg of the CuSO4 5H2O, 75-79mu g of the MnSO4 H2O, 4.34-4.38mu g of the CrCl3 6H2O and the balance of the water for injection. The multi-trace-element injection for children adopts a newborn formula; when in use, the injection provided by the invention is added into a total parenteral nutrition (TPN) nutrient solution in a sterile environment under a laminar flow cover. The trace elements in the newborn formula usually have a physical compatibility with the common electrolyte and vitamins in an amino acid/glucose solution used for the TPN.
Description
Technical field
The present invention relates to a kind of children's's multi-microelement injecta, belong to field of pharmaceutical preparations.
Background technology
Children's's multi-microelement injecta is parenteral nutrition additive.Suffer from for TPN (parenteral total intravenous nutrition)
Person.The infant that can not accept Oral feeding for a long time, also known as intravenous nutrition, is provided by parenteral total intravenous nutrition by vein
Various nutrients, thus reach normal growth promoter, save and extend a kind of effective treatment means of infant life.As far back as
Nineteen forty-four existing intravenous nutrition confirms for the report of department of pediatrics, nineteen sixty-eight Dudrick, with containing aminoacid, glucose, inorganic
Salt, the nutrient infusion of vitamin, prolonged application can maintain the growth of animal and people.It was demonstrated that nutrition is to sending out in clinic
Organ in educating, especially on immature brain, lung impact greatly, even if the ofest short duration malnutrition also can be to the god in later stage
The infringement of irreversibility is caused through system.Therefore TPN becomes rescue critical diseased children, and the most each internal organs do not grow perfect height
One of important measures of danger youngster.
During longer-term TPN, it should be noted that with or without the shortage of trace element and supplemented children's's special microelement system in time
Agent.Contrast demand and the existing procucts kind of domestic various trace elements, it is seen that, domestic various trace elements kind is dilute
Few, alternative poor, and malnutrition individual variation is fairly obvious.Therefore, according to domestic and international correlational study and guide
Recommend, introduce suitable various trace elements kind, make various trace elements kind diversification, increase clinicist and patient
Selectivity, has good clinical value and market value.
Summary of the invention
It is an object of the invention to provide a kind of children's's multi-microelement injecta, it is adaptable to neonate, add this injection
Liquid to TPN nutritional solution can help to maintain zinc in blood plasma, copper, manganese and the normal level of chromium, prevents from being lost storage in human body this
Secondary element slightly, and these trace element preventing human body from storing be depleted produce subsequent symptom.
Children's's multi-microelement injecta provided by the present invention, its composition is as follows:
Zinc sulfate (ZnSO4·7H2O), copper sulfate (CuSO4·5H2O), manganese sulfate (MnSO4·H2O), Chlorizate chromium
(CrCl3·6H2And water for injection O)；
The pH value of described injection is 1.7～2.7.
The composition of every mL unit formulation is as follows:
The water for injection of surplus.
Often the composition of mL unit formulation is concretely:
The water for injection of surplus.
In the most every mL injection, the content of 4 kinds of trace element is: zinc 1.5mg, copper 0.1mg, manganese 25 μ g, chromium 0.85 μ g.
Invention further provides the preparation method of described injection, comprise the steps:
1) by the described zinc sulfate of recipe quantity, described copper sulfate, described manganese sulfate and the described injection of described Chlorizate chromium
Water dissolution obtains medicinal liquid；
2) regulate the pH value of described medicinal liquid to 2.3～2.7, add described water for injection to full dose；
3) to step 2) medicinal liquid that obtains adds activated carbon it is stirred absorption；After described stirring and adsorbing terminates, filter
Remove described activated carbon；
4) through step 3) medicinal liquid that processes is successively through fine straining, potting and sterilizing, thus obtaining the product.
In above-mentioned preparation method, step 1) in, the consumption of described water for injection is the 10%～90% of its total amount, specifically
Can be 80%.
In above-mentioned preparation method, step 2) in, use sulphuric acid or sodium hydroxide solution regulation pH value.
In above-mentioned preparation method, step 3) in, the addition of described activated carbon is step 2) quality of liquid medicine
0.05%～0.5%, concretely 0.2%；
The time of described stirring and adsorbing is 10min～30min, concretely 20min.
In above-mentioned preparation method, step 4) in, the filter using aperture to be 0.22 μm carries out fine straining；
Before described potting step, described method also includes checking step as follows: in outward appearance, visible foreign matters, content, antibacterial
Toxin, pH etc..
Children's's multi-microelement injecta of the present invention is neonate formula, and during use, under laminar flow hood, aseptic interpolation is invented
Injection is to TPN nutritional solution.Trace element in neonate formula is common with in the aminoacid/glucose solution of TPN
Electrolyte and vitamin are generally of physical compatibility.
Children's's multi-microelement injecta of the present invention has the advantage that
1, injection prescription of the present invention composition is simple, without additional special adjuvant, only for the sulfur of pH regulator in addition to raw material
Acid and/or sodium hydroxide.
2, the preparation technology of injection prescription of the present invention is simple to operation, uses water for injection to dissolve four kinds of raw materials in technique
Rear regulation proper pH value, add charcoal, filtration, constant volume, sterilizing.
3, the production of injection of the present invention is without special preparation equipment, can complete to produce in conventional liquid drugs injection workshop.
4, injection end product quality good stability of the present invention, amplifies and produces multiple batches of sample all in acceleration, long-time stability
Steady quality in setting-out.
Accompanying drawing explanation
Fig. 1 is the flow chart of injection preparation of the present invention.
Detailed description of the invention
Experimental technique used in following embodiment if no special instructions, is conventional method.
Material used in following embodiment, reagent etc., if no special instructions, the most commercially obtain.
Embodiment 1,
Prescription
Prepare according to the step shown in Fig. 1:
1) material dissolution: weigh the zinc sulfate of recipe quantity, copper sulfate, manganese sulfate and Chlorizate chromium, adds to preparing total amount
The water for injection of 80% dissolves.
2) pH regulator: after raw material is completely dissolved, sampling detects medicinal liquid pH value, regulates pH value with sulphuric acid or sodium hydroxide.
3) constant volume: mend and inject water to prepare total amount.
4) activated carbon adsorption: add activated carbon stirring and adsorbing 20min of solution total amount (quality) 0.2%, filters carbon removal.
5) fine straining: filter with the polyethersulfone membranes of 0.22 μm.
6) intermediate inspection: taking liquid is appropriate, respectively detection solution appearance character, pH value, content, bacterial endotoxin.
7) fill sealing by fusing: medicinal liquid is sub-packed in 2ml in borosilicate glass ampoule, every theoretical loading amount 2ml, sealing by fusing；
8) high temperature sterilize: after subpackage, sample is through 121 DEG C of sterilizing 15min.
In the present embodiment preparation process, the control standard of committed step is as shown in table 1.
The control of committed step in table 1 preparation method of the present invention
The study on the stability of intermediate medicinal liquid in injection preparation process of the present invention:
The different pH value liquid medicine filling of preparation is in ampoule bottle according to the method described above, and is placed on high temperature 60 DEG C and illumination
Place 10 days under the conditions of 5000lux, carry out Key Quality contrast with 0 day sample and investigate, select the pH span of control being suitable for.Prescription
Design and prescription form respectively as shown in table 2 and table 3.
The different pH value liquid medicine stability of table 2 investigates Formulation
The different pH value liquid medicine stability of table 3 investigates prescription composition
The different pH sample stability of table 4 investigates result (0 day)
The different pH sample stability of table 5 investigates result (illumination in 10 days)
The different pH sample stability of table 6 investigates result (10 days high temperature)
By the investigation result of table 4-table 6, contrast 0 day and 10 days high temperature and the appearance character of illumination, pH value, visible foreign matters,
Particulate matter, osmotic pressure, content results are basically identical, have no significant change.Consider from the controllability of formulation and technology, in preparation
During medicinal liquid, regulate pH to 2.3～2.7.
The study on the stability of injection of the present invention:
In conjunction with the investigation result of above-mentioned pH value, this injection medicinal liquid is carried out study on the stability, investigates at ambient temperature
12 hours inner liquid medicine content, selects to be suitable for the storage time to ensure the intermediate medicinal liquid quality stability at memory period.Prescription
Design and prescription form respectively as shown in table 7 and table 8.
Table 7 liquid medicine stability investigates Formulation
Table 8 liquid medicine stability investigates prescription composition
Table 9 liquid medicine stability investigates preparation technology
Table 10 liquid medicine stability investigates result
By the investigation result of table 10, it is known that, medicinal liquid at 12 hours outer character of room temperature, pH value and content with 0 little phase
Ratio, basically identical, have no significant change, show that medicinal liquid is placed stable in room temperature 12 hours.
Claims (8)
1. children's's multi-microelement injecta, it is characterised in that: the composition of described injection is as follows:
Zinc sulfate (ZnSO4·7H2O), copper sulfate (CuSO4·5H2O), manganese sulfate (MnSO4·H2O), Chlorizate chromium (CrCl3·
6H2And water for injection O)；
The pH value of described injection is 1.7～2.7.
Injection the most according to claim 1, it is characterised in that: the composition of every mL unit formulation is as follows:
Injection the most according to claim 2, it is characterised in that: the composition of every mL unit formulation is as follows:
4., according to the preparation method of injection according to any one of claim 1-3, comprise the steps:
1) the described zinc sulfate of recipe quantity, described copper sulfate, described manganese sulfate and described Chlorizate chromium is water-soluble by described injection
Solve medicinal liquid；
2) regulate the pH value of described medicinal liquid to 2.3～2.7, add described water for injection to full dose；
3) to step 2) medicinal liquid that obtains adds activated carbon it is stirred absorption；After described stirring and adsorbing terminates, filter and remove
Described activated carbon；
4) through step 3) medicinal liquid that processes is successively through fine straining, potting and sterilizing, thus obtaining the product.
Preparation method the most according to claim 4, it is characterised in that: step 1) in, the consumption of described water for injection is it
The 10%～90% of total amount.
6. according to the preparation method described in claim 4 or 5, it is characterised in that: step 2) in, use sulphuric acid or sodium hydroxide molten
Liquid regulation pH value.
7. according to the preparation method according to any one of claim 4-6, it is characterised in that: step 3) in, described activated carbon
Addition is step 2) quality of liquid medicine 0.05%～0.5%；
The time of described stirring and adsorbing is 10min～30min.
8. according to the preparation method according to any one of claim 4-7, it is characterised in that: step 4) in, employing aperture is
The filter of 0.22 μm carries out fine straining.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610862434.1A CN106309488A (en) | 2016-09-28 | 2016-09-28 | Multi-trace-element injection for children |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610862434.1A CN106309488A (en) | 2016-09-28 | 2016-09-28 | Multi-trace-element injection for children |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106309488A true CN106309488A (en) | 2017-01-11 |
Family
ID=57820992
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610862434.1A Pending CN106309488A (en) | 2016-09-28 | 2016-09-28 | Multi-trace-element injection for children |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1830455A (en) * | 2005-03-08 | 2006-09-13 | 巴里莫尔制药（通化）有限公司 | Preparation method of multi-kind micro-element injection |
| US20080050453A1 (en) * | 2004-04-29 | 2008-02-28 | Laurie Robert N | Trace elements |
| CN102526103A (en) * | 2010-12-07 | 2012-07-04 | 西藏海思科药业集团股份有限公司 | Multi-trace element injection and preparation method thereof |
| CN104971074A (en) * | 2014-04-10 | 2015-10-14 | 北京京卫信康医药科技发展有限公司 | Multiple trace element composition and preparation method thereof |
| CN106309487A (en) * | 2016-09-28 | 2017-01-11 | 北京百奥药业有限责任公司 | Pediatric injection liquid containing various trace elements |
-
2016
- 2016-09-28 CN CN201610862434.1A patent/CN106309488A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20080050453A1 (en) * | 2004-04-29 | 2008-02-28 | Laurie Robert N | Trace elements |
| CN1830455A (en) * | 2005-03-08 | 2006-09-13 | 巴里莫尔制药（通化）有限公司 | Preparation method of multi-kind micro-element injection |
| CN102526103A (en) * | 2010-12-07 | 2012-07-04 | 西藏海思科药业集团股份有限公司 | Multi-trace element injection and preparation method thereof |
| CN104971074A (en) * | 2014-04-10 | 2015-10-14 | 北京京卫信康医药科技发展有限公司 | Multiple trace element composition and preparation method thereof |
| CN106309487A (en) * | 2016-09-28 | 2017-01-11 | 北京百奥药业有限责任公司 | Pediatric injection liquid containing various trace elements |
Non-Patent Citations (4)
| Title |
|---|
| RXLIST PEDTRACE®-4: "Pedtrace®-4", 《HTTPS://WWW.RXLIST.COM/PEDTRACE-DRUG.HTM#DESCRIPTION》 * |
| 孙琛主编: "《临床用药大全》", 31 May 1995, 中国大百科全书出版社上海分社 * |
| 楼凤昌主编: "《国家执业药师手册》", 31 January 2004, 清华大学出版社 * |
| 金花: "微生物发酵法研制富铬酵母", 《中国优秀博硕学位论文全文数据库（硕士）工程科技I辑》 * |
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| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| CB03 | Change of inventor or designer information |
Inventor after: Lin Junfu Inventor after: Zheng Baisong Inventor after: Bian Huaxin Inventor after: Luo Huan Inventor after: Gu Haidong Inventor before: Lin Junfu Inventor before: Zheng Baisong Inventor before: Bian Huaxin |
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| COR | Change of bibliographic data | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20170111 |
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| RJ01 | Rejection of invention patent application after publication |