CN103301466A - Hydroprednisone injection composition and preparation method thereof - Google Patents
Hydroprednisone injection composition and preparation method thereof Download PDFInfo
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- CN103301466A CN103301466A CN201310258453XA CN201310258453A CN103301466A CN 103301466 A CN103301466 A CN 103301466A CN 201310258453X A CN201310258453X A CN 201310258453XA CN 201310258453 A CN201310258453 A CN 201310258453A CN 103301466 A CN103301466 A CN 103301466A
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- prednisolone
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- glycine
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Abstract
The invention relates to a hydroprednisone injection composition. The per milliliter of composition comprises 4-6mg of hydroprednisone, 0.05-0.15ml of propylene glycol, 0.4-0.6ml of ethanol, 0.1-0.2mg of glycine, 0.2-0.4mg of vitamin B6 and the balance of injection water. The hydroprednisone injection composition provided by the invention has the advantage of extremely high stability.
Description
Technical field
The present invention relates to medical technical field, be specifically related to a kind of prednisolone injection composition and method of making the same.
Background technology
Andrographolide claims prednisolone again, and its chemistry is by name: 11 β, and 17 α, 21-trihydroxy-pregnant steroid-1,4-diene-3, the 20-diketone (11 β, 17 α, 21-trihydroxypregna-1,4-diene-3,20-dione).Andrographolide is a kind of atomic water-soluble adrenocortical hormone, has good antiinflammatory and anti-allergic effects, is widely used in the treatment of inflammation such as arthritis, asthma, bronchitis.Andrographolide can suppress connective tissue proliferation, reduces the permeability of capillary wall and cell membrane, reduces inflammatory exudation, and can suppress formation and the release of histamine and other toxicant.Andrographolide can also promote protein to decompose and change sugar into, reduces the utilization of glucose, thereby blood glucose and hepatic glycogen are increased, and then glycosuria occurs, increases gastric secretion, appetite stimulator simultaneously.When serious toxic infected, andrographolide and antibiotic were used, and had the effect of good cooling, antitoxin, antiinflammatory, shock and promotion remission.The water-sodium retention of andrographolide and the effect of row's potassium are littler than cortisone, and antiinflammatory and anti-allergic effects are stronger, and side effect is less.Andrographolide is applicable to diseases such as rheumatoid arthritis, rheumatic fever, lupus erythematosus, dermatomyositis, multiple myeloma.
Improve the stability of andrographolide stability of formulation, particularly prednisolone injection, guaranteeing that aspects such as therapeutic effect, guarantee drug safety are significant.
Summary of the invention
In long-term, a large amount of researchs, the inventor is surprised to find, the glycine of certain content, vitamin B6 are united for prednisolone injection, prednisolone injection compositions when the weight content ratio that can improve its stability, particularly glycine, vitamin B6 greatly is 1:2 stable high.Based on this, the invention provides the high prednisolone injection composition and method of making the same of a kind of stability.
Particularly, the present invention relates to a kind of prednisolone injection compositions, every milliliter contains:
Andrographolide 4-6mg,
Propylene glycol 0.05-0.15ml,
Ethanol 0.4-0.6ml,
Glycine 0.1-0.2mg,
Vitamin B
60.2-0.4mg,
The water for injection surplus.
Wherein, as preferably, glycine, vitamin B
6Amount ratio be 1:2.
As optimizing prescriptions of the present invention, described prednisolone injection compositions, every milliliter contains:
Prednisolone 5mg,
Propylene glycol 0.1ml,
Ethanol 0.5ml,
Glycine 0.1mg,
Vitamin B
60.2mg,
The water for injection surplus.
In addition, the invention still further relates to described prednisolone injection preparation of compositions method, comprise the steps:
1) with distilled dissolve with ethanol andrographolide;
2) add propylene glycol, be diluted to the dosing amount with water for injection, stir;
3) add medicinal charcoal and stir, filter through the titanium rod, filter through micropore filter element again;
4) embedding, sterilization, packing.
Wherein, as preferably, it is 15 minutes that step 3) adds the time of stirring behind the active carbon; Sterilization steps is preferably steam sterilization, and sterilising conditions is 121 ℃, 8 minutes; The micropore filter element aperture is 0.45um and 0.22um.
The specific embodiment
The specific embodiment only for further explaining and describing the present invention, should not be interpreted as any limitation of the invention.
The used supplementary material of the present invention is commercial.
The preparation of embodiment 1-6 prednisolone injection
Prescription:
Preparation technology: get distilled ethanol, take by weighing the former powder of andrographolide, in the good volume of ethanol of input amount (if contain in the prescription, down together), be stirred well to complete molten after, add propylene glycol, be diluted to the dosing amount with water for injection, stir, sampling and measuring content, after the alcohol amount of containing is qualified, adds medicinal charcoal and stirred 15 minutes, filter through the titanium rod, again through micropore filter element (0.45um, 0.22um two covers) filter, filtrate checks the qualified back embedding of visible foreign matters, 121 ℃ of sterilizations in 8 minutes of steam, leak detection, lamp inspection, lettering, packing.
Test the stability study of routine prednisolone injection
According to Chinese Pharmacopoeia two (appendix XIX C) crude drug of version in 2010 and pharmaceutical preparation stability test guideline, (temperature is 40 ℃ ± 2 ℃ under hot conditions, relative humidity is that 75%RH ± 5%RH) carries out accelerated stability test (6 months), and detect by the enterprise inner quality standard, detect prednisolone injection that embodiment 1～6 makes before sterilization, back 0 month of sterilization, back 6 months of sterilization and be related substance and andrographolide content under 60% ± 10% the condition at 25 ± 2 ℃ of room temperatures, relative humidity.
The result is as follows:
The result shows that the prednisolone injection that the present invention makes has following characteristics: 1) impurity content before the sterilization is very low; 2) impurity content after the sterilization changes very little; 3) stability of long term storage is very high.
Claims (8)
1. prednisolone injection compositions, every milliliter contains:
Andrographolide 4-6mg,
Propylene glycol 0.05-0.15ml,
Ethanol 0.4-0.6ml,
Glycine 0.1-0.2mg,
Vitamin B
60.2-0.4mg,
The water for injection surplus.
2. prednisolone injection compositions according to claim 1, wherein, glycine, vitamin B
6Amount ratio be 1:2.
3. prednisolone injection compositions according to claim 1, every milliliter contains:
Prednisolone 5mg,
Propylene glycol 0.1ml,
Ethanol 0.5ml,
Glycine 0.1mg,
Vitamin B
60.2mg,
The water for injection surplus.
4. the arbitrary described prednisolone injection preparation of compositions method of claim 1-3 comprises the steps:
1) with distilled dissolve with ethanol andrographolide;
2) add propylene glycol, be diluted to the dosing amount with water for injection, stir;
3) add medicinal charcoal and stir, filter through the titanium rod, filter through micropore filter element again;
4) embedding, sterilization, packing.
5. preparation method according to claim 4, wherein to add the time of stirring behind the active carbon be 15 minutes to step 3).
6. preparation method according to claim 4, wherein the sterilization of step 3) is steam sterilization.
7. preparation method according to claim 6, wherein the steam sterilization condition of step 3) is 121 ℃, 8 minutes.
8. preparation method according to claim 4, wherein the micropore filter element aperture of step 3) is 0.45um and 0.22um.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310258453.XA CN103301466B (en) | 2013-06-26 | 2013-06-26 | Hydroprednisone injection composition and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310258453.XA CN103301466B (en) | 2013-06-26 | 2013-06-26 | Hydroprednisone injection composition and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN103301466A true CN103301466A (en) | 2013-09-18 |
| CN103301466B CN103301466B (en) | 2014-11-19 |
Family
ID=49127471
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310258453.XA Expired - Fee Related CN103301466B (en) | 2013-06-26 | 2013-06-26 | Hydroprednisone injection composition and preparation method thereof |
Country Status (1)
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109125256A (en) * | 2018-10-18 | 2019-01-04 | 江西国药有限责任公司 | A kind of prednisolone injection and preparation method thereof |
| CN111184688A (en) * | 2020-03-10 | 2020-05-22 | 成都天台山制药有限公司 | Dexamethasone acetate injection and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB941371A (en) * | 1959-03-17 | 1963-11-13 | Upjohn Co | Injectable pharmaceutical preparations comprising 6ª -fluoroprednisolone and/or its 21-acetate |
| CN1254560A (en) * | 1999-10-27 | 2000-05-31 | 李忠 | Prednelan composition for treating rheumatism |
-
2013
- 2013-06-26 CN CN201310258453.XA patent/CN103301466B/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB941371A (en) * | 1959-03-17 | 1963-11-13 | Upjohn Co | Injectable pharmaceutical preparations comprising 6ª -fluoroprednisolone and/or its 21-acetate |
| CN1254560A (en) * | 1999-10-27 | 2000-05-31 | 李忠 | Prednelan composition for treating rheumatism |
Non-Patent Citations (1)
| Title |
|---|
| 董荣乔 等: "甲基强的松龙与维生素B6注射液存在配伍禁忌", 《河北中西医结合杂志》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109125256A (en) * | 2018-10-18 | 2019-01-04 | 江西国药有限责任公司 | A kind of prednisolone injection and preparation method thereof |
| CN111184688A (en) * | 2020-03-10 | 2020-05-22 | 成都天台山制药有限公司 | Dexamethasone acetate injection and preparation method thereof |
| CN111184688B (en) * | 2020-03-10 | 2021-09-17 | 成都天台山制药有限公司 | Dexamethasone acetate injection and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN103301466B (en) | 2014-11-19 |
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Granted publication date: 20141119 Termination date: 20180626 |
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