CN103041372A - Method for preparing thymalfasin composition for injection - Google Patents
Method for preparing thymalfasin composition for injection Download PDFInfo
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- CN103041372A CN103041372A CN2012105828368A CN201210582836A CN103041372A CN 103041372 A CN103041372 A CN 103041372A CN 2012105828368 A CN2012105828368 A CN 2012105828368A CN 201210582836 A CN201210582836 A CN 201210582836A CN 103041372 A CN103041372 A CN 103041372A
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Abstract
The invention discloses a method for preparing a thymalfasin composition for injection. The preparation method comprises the following steps: using thymalfasin, ganciclovir, mannitol and water for injection as raw materials; firstly, dissolving the mannitol into part of the water for injection to obtain a mannitol solution; adding and dissolving the thymalfasin and the ganciclovir into part of the water for injection to obtain a mixed solution of the thymalfasin and the ganciclovir; merging and uniformly mixing the mannitol solution with the mixed solution, then regulating the pH value of the mixed solution; adding the residual water for injection, adding medicinal carbon to fade, filtering, filling, and half packing; after half packing, putting the product in a freeze dryer for freezing and drying, and obtaining the product, namely the thymalfasin composition for injection; and finally packing and boxing the obtained product. The method combines the thymalfasin with the ganciclovir to prepare the thymalfasin composition drug used for inhibiting virus activation or curing viral diseases, and the thymalfasin composition drug has good drug stability. The thymalfasin composition can clinically better cure diseases.
Description
Technical field
The present invention relates to pharmaceutical field about pharmaceutical formulation techniques, particularly relate to a kind of preparation method of injection thymalfasin compositions.
Background technology
Thymosin is a kind of proteins and peptides hormone that animal thymus produces, in the history in existing more than 20 year of China's clinical practice.Thymalfasin (has another name called Thymosin alpha 1, English name Thymosin α 1) be the high-end product in the thymosin, it is the main bioactive ingredients of thymosin, be immune regulator important in the human body, this medicine is a kind of small molecule bioactive polypeptide that is gone out by separation and purification in the thymosin fraction 5 (TF5), its content accounts for 0.6% of TF5, its biological activity ratio TF5 is high 10～1000 times, has higher immune-enhancing activity, also has simultaneously the stimulation migration of vascular endothelial cells, promote the effects such as angiogenesis and wound healing, be used for hepatitis B, hepatitis C, in the clinical treatment of malignant tumor and immune deficiency disorder etc. and the research.Thymalfasin has clear and definite structure as a kind of wide spectrum immunomodulator, and clear mechanism need not skin test, its curative effect by numerous doctors and patients cognition.
Ganciclovir [chemical name 9-(1,3-dihydroxy-2-the third oxygen methyl)-and guanine] be the derivant of ucleosides antiviral agents guanosine, 1980 synthetic by JulienVerheyden and the John Martin of Syntex Research, the antivirus action that has stronger more wide spectrum than acyclovir, efficient, low toxicity, antiviral chemical curative that selectivity is strong, be used widely clinically.Ganciclovir is the well-known antiviral drugs of medical domain.It is used for prevention and treatment immunodeficiency patient's cytomegalovirus infection, such as HIV sufferers, accepts the tumor patient of chemotherapy, uses the organ transplantation patient of immunosuppressant.
Summary of the invention
The technical problem to be solved in the present invention provides a kind of preparation method of injection thymalfasin compositions.Technical solution of the present invention combines thymalfasin with ganciclovir, be prepared into the medicine for the thymalfasin compositions that suppresses virus activation or treatment viral disease.
In order to address the above problem, the technical solution used in the present invention is:
The invention provides a kind of preparation method of injection thymalfasin compositions, described preparation method may further comprise the steps:
A, primary raw material form: thymalfasin 1.6g, ganciclovir 50～250g, mannitol 10～40g and water for injection 1000ml;
The preparation of b, medicinal liquid: take by weighing various primary raw materials according to the proportioning ratio between the described primary raw material of step a, at first the mannitol adding that takes by weighing is accounted in the water for injection of water for injection cumulative volume 30%, stir fully dissolving, obtain mannitol solution; Then thymalfasin and the ganciclovir adding that takes by weighing accounted in the water for injection of water for injection cumulative volume 30% in addition, stir fully dissolving, obtain the mixed solution of thymalfasin, ganciclovir; The mannitol solution of preparation and the mixed solution of thymalfasin, ganciclovir are merged, mix, then add pH value and be 7.8 phosphate buffered solution, the pH value to 6.4 of regulator solution～7.3, then add remaining 40% water for injection, and add medicinal charcoal and stir, decolour, filter after stirring, remove medicinal charcoal; Gained filtrate adopts microporous filter membrane to filter, and gained filtrate is carried out fill, half tamponade according to conventional method after filtering;
C, lyophilization: the product after step b half tamponade is placed freeze dryer, and pre-freeze is 2～4 hours under-40 ℃ of conditions, and the condenser refrigeration is evacuated to vacuum and reaches 10～13Pa to-45～-50 ℃ of conditions; Setting program heats up, and baffle temperature is warming up to-25 ℃ with 3 hours time by-45～-50 ℃, and baffle temperature is warming up under-25 ℃ of conditions and kept 4 hours; And then baffle temperature is warming up to-15 ℃ with time of 2 hours by-25 ℃, baffle temperature is warming up to-15 ℃ and kept 2 hours; Setting program heats up, and baffle temperature is warming up to 0 ℃ with 1 hour time by-15 ℃, and baffle temperature is warming up to 0 ℃ and kept 1 hour; Baffle temperature is warming up to 15 ℃ with time of 1 hour by 0 ℃, and baffle temperature is warming up to 15 ℃ and kept 2 hours; Baffle temperature is warming up to 30 ℃ with time of 2 hours by 15 ℃, keeps product temperature under 20～30 ℃ of conditions, to keep 4～5 hours, obtain product injection thymalfasin compositions, at last with its products obtained therefrom tamponade, outlet.
According to the preparation method of above-mentioned injection thymalfasin compositions, primary raw material described in the step a consists of thymalfasin 1.6g, ganciclovir 50g, mannitol 20g and water for injection 1000ml.
According to the preparation method of above-mentioned injection thymalfasin compositions, primary raw material described in the step a consists of thymalfasin 1.6g, ganciclovir 125g, mannitol 20g and water for injection 1000ml.
According to the preparation method of above-mentioned injection thymalfasin compositions, primary raw material described in the step a consists of thymalfasin 1.6g, ganciclovir 250g, mannitol 20g and water for injection 1000ml.
According to the preparation method of above-mentioned injection thymalfasin compositions, pH value described in the step b is that the compound method of 7.8 phosphate buffered solution is: get sodium hydrogen phosphate 35.9g, be dissolved in water, and be diluted to 500ml, obtain first liquid; Get sodium dihydrogen phosphate 2.76g, be dissolved in water, and be diluted to 100ml, obtain second liquid; Get gained first liquid 91.5ml and mix with second liquid 8.5ml, shake up, namely get pH value and be 7.8 phosphate buffered solution.
According to the preparation method of above-mentioned injection thymalfasin compositions, among medicinal charcoal described in the step b and the step a water for injection between the two the ratio of addition be 2g:1000ml.
Positive beneficial effect of the present invention:
1, technical solution of the present invention combines thymalfasin with ganciclovir, is prepared into the medicine for the thymalfasin compositions that suppresses virus activation or treatment viral disease.Can better cure disease clinically.
2, utilize the injection thymalfasin compositions of technical solution of the present invention preparation, have good medicine stability.(the related experiment data that product quality of the present invention detects see table 1 for details).
The product of the present invention test that kept sample through six months, related substance and content almost do not change, and illustrate that it is more stable that product of the present invention is placed under set point of temperature.
Four, the specific embodiment:
Further explain the present invention below in conjunction with embodiment, but do not limit content of the present invention.
Embodiment 1:
The preparation method of injection thymalfasin compositions of the present invention, the detailed step of this preparation method is as follows:
A, primary raw material form: thymalfasin 1.6g, ganciclovir 50g, mannitol 20g and water for injection 1000ml;
The preparation of b, medicinal liquid: take by weighing various primary raw materials according to the proportioning ratio between the described primary raw material of step a, at first the mannitol adding that takes by weighing is accounted in the water for injection of water for injection cumulative volume 30%, stir fully dissolving, obtain mannitol solution; Then thymalfasin and the ganciclovir adding that takes by weighing accounted in the water for injection of water for injection cumulative volume 30% in addition, stir fully dissolving, obtain the mixed solution of thymalfasin, ganciclovir; The mannitol solution of preparation and the mixed solution of thymalfasin, ganciclovir are merged, mix, then add pH value and be 7.8 phosphate buffered solution, the pH value to 6.9 of regulator solution, then add remaining 40% water for injection, and add the 2.0g medicinal charcoal and stir, decolour, filter after stirring, remove medicinal charcoal; Gained filtrate adopts microporous filter membrane to filter, and gained filtrate is carried out fill, half tamponade according to conventional method after filtering;
C, lyophilization: the product after step b half tamponade is placed freeze dryer, and pre-freeze is 2～4 hours under-40 ℃ of conditions, and the condenser refrigeration is evacuated to vacuum and reaches 12Pa to-45 ℃ of conditions; Setting program heats up, and baffle temperature is warming up to-25 ℃ with 3 hours time by-45 ℃, and baffle temperature is warming up under-25 ℃ of conditions and kept 4 hours; And then baffle temperature is warming up to-15 ℃ with time of 2 hours by-25 ℃, baffle temperature is warming up to-15 ℃ and kept 2 hours; Setting program heats up, and baffle temperature is warming up to 0 ℃ with 1 hour time by-15 ℃, and baffle temperature is warming up to 0 ℃ and kept 1 hour; Baffle temperature is warming up to 15 ℃ with time of 1 hour by 0 ℃, and baffle temperature is warming up to 15 ℃ and kept 2 hours; Baffle temperature is warming up to 30 ℃ with time of 2 hours by 15 ℃, keeps product temperature under 20～30 ℃ of conditions, to keep 4～5 hours, obtain product injection thymalfasin compositions, at last with its products obtained therefrom tamponade, outlet.
The pH value that present embodiment adopts is that the compound method of 7.8 phosphate buffered solution is: get sodium hydrogen phosphate 35.9g, be dissolved in water, and be diluted to 500ml, obtain first liquid; Get sodium dihydrogen phosphate 2.76g, be dissolved in water, and be diluted to 100ml, obtain second liquid; Get gained first liquid 91.5ml and mix with second liquid 8.5ml, shake up, namely get pH value and be 7.8 phosphate buffered solution.
Embodiment 2:
The preparation method of injection thymalfasin compositions of the present invention, the detailed step of this preparation method is as follows:
A, primary raw material form: thymalfasin 1.6g, ganciclovir 125g, mannitol 20g and water for injection 1000ml;
The preparation of b, medicinal liquid: take by weighing various primary raw materials according to the proportioning ratio between the described primary raw material of step a, at first the mannitol adding that takes by weighing is accounted in the water for injection of water for injection cumulative volume 30%, stir fully dissolving, obtain mannitol solution; Then thymalfasin and the ganciclovir adding that takes by weighing accounted in the water for injection of water for injection cumulative volume 30% in addition, stir fully dissolving, obtain the mixed solution of thymalfasin, ganciclovir; The mannitol solution of preparation and the mixed solution of thymalfasin, ganciclovir are merged, mix, then add pH value and be 7.8 phosphate buffered solution, the pH value to 6.4 of regulator solution, then add remaining 40% water for injection, and add the 2.0g medicinal charcoal and stir, decolour, filter after stirring, remove medicinal charcoal; Gained filtrate adopts microporous filter membrane to filter, and gained filtrate is carried out fill, half tamponade according to conventional method after filtering;
C, lyophilization: the product after step b half tamponade is placed freeze dryer, and pre-freeze is 2～4 hours under-40 ℃ of conditions, and the condenser refrigeration is evacuated to vacuum and reaches 10Pa to-45 ℃ of conditions; Setting program heats up, and baffle temperature is warming up to-25 ℃ with 3 hours time by-45 ℃, and baffle temperature is warming up under-25 ℃ of conditions and kept 4 hours; And then baffle temperature is warming up to-15 ℃ with time of 2 hours by-25 ℃, baffle temperature is warming up to-15 ℃ and kept 2 hours; Setting program heats up, and baffle temperature is warming up to 0 ℃ with 1 hour time by-15 ℃, and baffle temperature is warming up to 0 ℃ and kept 1 hour; Baffle temperature is warming up to 15 ℃ with time of 1 hour by 0 ℃, and baffle temperature is warming up to 15 ℃ and kept 2 hours; Baffle temperature is warming up to 30 ℃ with time of 2 hours by 15 ℃, keeps product temperature under 20～30 ℃ of conditions, to keep 4～5 hours, obtain product injection thymalfasin compositions, at last with its products obtained therefrom tamponade, outlet.
The pH value that present embodiment adopts is that the compound method of 7.8 phosphate buffered solution is: get sodium hydrogen phosphate 35.9g, be dissolved in water, and be diluted to 500ml, obtain first liquid; Get sodium dihydrogen phosphate 2.76g, be dissolved in water, and be diluted to 100ml, obtain second liquid; Get gained first liquid 91.5ml and mix with second liquid 8.5ml, shake up, namely get pH value and be 7.8 phosphate buffered solution.
Embodiment 3:
The preparation method of injection thymalfasin compositions of the present invention, the detailed step of this preparation method is as follows:
A, primary raw material form: thymalfasin 1.6g, ganciclovir 250g, mannitol 20g and water for injection 1000ml;
The preparation of b, medicinal liquid: take by weighing various primary raw materials according to the proportioning ratio between the described primary raw material of step a, at first the mannitol adding that takes by weighing is accounted in the water for injection of water for injection cumulative volume 30%, stir fully dissolving, obtain mannitol solution; Then thymalfasin and the ganciclovir adding that takes by weighing accounted in the water for injection of water for injection cumulative volume 30% in addition, stir fully dissolving, obtain the mixed solution of thymalfasin, ganciclovir; The mannitol solution of preparation and the mixed solution of thymalfasin, ganciclovir are merged, mix, then add pH value and be 7.8 phosphate buffered solution, the pH value to 6.9 of regulator solution, then add remaining 40% water for injection, and add the 2.0g medicinal charcoal and stir, decolour, filter after stirring, remove medicinal charcoal; Gained filtrate adopts microporous filter membrane to filter, and gained filtrate is carried out fill, half tamponade according to conventional method after filtering;
C, lyophilization: the product after step b half tamponade is placed freeze dryer, and pre-freeze is 2～4 hours under-40 ℃ of conditions, and the condenser refrigeration is evacuated to vacuum and reaches 13Pa to-45 ℃ of conditions; Setting program heats up, and baffle temperature is warming up to-25 ℃ with 3 hours time by-45 ℃, and baffle temperature is warming up under-25 ℃ of conditions and kept 4 hours; And then baffle temperature is warming up to-15 ℃ with time of 2 hours by-25 ℃, baffle temperature is warming up to-15 ℃ and kept 2 hours; Setting program heats up, and baffle temperature is warming up to 0 ℃ with 1 hour time by-15 ℃, and baffle temperature is warming up to 0 ℃ and kept 1 hour; Baffle temperature is warming up to 15 ℃ with time of 1 hour by 0 ℃, and baffle temperature is warming up to 15 ℃ and kept 2 hours; Baffle temperature is warming up to 30 ℃ with time of 2 hours by 15 ℃, keeps product temperature under 20～30 ℃ of conditions, to keep 4～5 hours, obtain product injection thymalfasin compositions, at last with its products obtained therefrom tamponade, outlet.
The pH value that present embodiment adopts is that the compound method of 7.8 phosphate buffered solution is: get sodium hydrogen phosphate 35.9g, be dissolved in water, and be diluted to 500ml, obtain first liquid; Get sodium dihydrogen phosphate 2.76g, be dissolved in water, and be diluted to 100ml, obtain second liquid; Get gained first liquid 91.5ml and mix with second liquid 8.5ml, shake up, namely get pH value and be 7.8 phosphate buffered solution.
Embodiment 4:
The preparation method of injection thymalfasin compositions of the present invention, the detailed step of this preparation method is as follows:
A, primary raw material form: thymalfasin 1.6g, ganciclovir 50g, mannitol 10g and water for injection 1000ml;
The preparation of b, medicinal liquid: take by weighing various primary raw materials according to the proportioning ratio between the described primary raw material of step a, at first the mannitol adding that takes by weighing is accounted in the water for injection of water for injection cumulative volume 30%, stir fully dissolving, obtain mannitol solution; Then thymalfasin and the ganciclovir adding that takes by weighing accounted in the water for injection of water for injection cumulative volume 30% in addition, stir fully dissolving, obtain the mixed solution of thymalfasin, ganciclovir; The mannitol solution of preparation and the mixed solution of thymalfasin, ganciclovir are merged, mix, then add pH value and be 7.8 phosphate buffered solution, the pH value to 6.9 of regulator solution, then add remaining 40% water for injection, and add the 2.0g medicinal charcoal and stir, decolour, filter after stirring, remove medicinal charcoal; Gained filtrate adopts microporous filter membrane to filter, and gained filtrate is carried out fill, half tamponade according to conventional method after filtering;
C, lyophilization: the product after step b half tamponade is placed freeze dryer, and pre-freeze is 2～4 hours under-40 ℃ of conditions, and the condenser refrigeration is evacuated to vacuum and reaches 12Pa to-45 ℃ of conditions; Setting program heats up, and baffle temperature is warming up to-25 ℃ with 3 hours time by-45 ℃, and baffle temperature is warming up under-25 ℃ of conditions and kept 4 hours; And then baffle temperature is warming up to-15 ℃ with time of 2 hours by-25 ℃, baffle temperature is warming up to-15 ℃ and kept 2 hours; Setting program heats up, and baffle temperature is warming up to 0 ℃ with 1 hour time by-15 ℃, and baffle temperature is warming up to 0 ℃ and kept 1 hour; Baffle temperature is warming up to 15 ℃ with time of 1 hour by 0 ℃, and baffle temperature is warming up to 15 ℃ and kept 2 hours; Baffle temperature is warming up to 30 ℃ with time of 2 hours by 15 ℃, keeps product temperature under 20～30 ℃ of conditions, to keep 4～5 hours, obtain product injection thymalfasin compositions, at last with its products obtained therefrom tamponade, outlet.
The pH value that present embodiment adopts is that the compound method of 7.8 phosphate buffered solution is: get sodium hydrogen phosphate 35.9g, be dissolved in water, and be diluted to 500ml, obtain first liquid; Get sodium dihydrogen phosphate 2.76g, be dissolved in water, and be diluted to 100ml, obtain second liquid; Get gained first liquid 91.5ml and mix with second liquid 8.5ml, shake up, namely get pH value and be 7.8 phosphate buffered solution.
Embodiment 5:
The preparation method of injection thymalfasin compositions of the present invention, the detailed step of this preparation method is as follows:
A, primary raw material form: thymalfasin 1.6g, ganciclovir 250g, mannitol 40g and water for injection 1000ml;
The preparation of b, medicinal liquid: take by weighing various primary raw materials according to the proportioning ratio between the described primary raw material of step a, at first the mannitol adding that takes by weighing is accounted in the water for injection of water for injection cumulative volume 30%, stir fully dissolving, obtain mannitol solution; Then thymalfasin and the ganciclovir adding that takes by weighing accounted in the water for injection of water for injection cumulative volume 30% in addition, stir fully dissolving, obtain the mixed solution of thymalfasin, ganciclovir; The mannitol solution of preparation and the mixed solution of thymalfasin, ganciclovir are merged, mix, then add pH value and be 7.8 phosphate buffered solution, the pH value to 6.9 of regulator solution, then add remaining 40% water for injection, and add the 2.0g medicinal charcoal and stir, decolour, filter after stirring, remove medicinal charcoal; Gained filtrate adopts microporous filter membrane to filter, and gained filtrate is carried out fill, half tamponade according to conventional method after filtering;
C, lyophilization: the product after step b half tamponade is placed freeze dryer, and pre-freeze is 2～4 hours under-40 ℃ of conditions, and the condenser refrigeration is evacuated to vacuum and reaches 12Pa to-45 ℃ of conditions; Setting program heats up, and baffle temperature is warming up to-25 ℃ with 3 hours time by-45 ℃, and baffle temperature is warming up under-25 ℃ of conditions and kept 4 hours; And then baffle temperature is warming up to-15 ℃ with time of 2 hours by-25 ℃, baffle temperature is warming up to-15 ℃ and kept 2 hours; Setting program heats up, and baffle temperature is warming up to 0 ℃ with 1 hour time by-15 ℃, and baffle temperature is warming up to 0 ℃ and kept 1 hour; Baffle temperature is warming up to 15 ℃ with time of 1 hour by 0 ℃, and baffle temperature is warming up to 15 ℃ and kept 2 hours; Baffle temperature is warming up to 30 ℃ with time of 2 hours by 15 ℃, keeps product temperature under 20～30 ℃ of conditions, to keep 4～5 hours, obtain product injection thymalfasin compositions, at last with its products obtained therefrom tamponade, outlet.
The pH value that present embodiment adopts is that the compound method of 7.8 phosphate buffered solution is: get sodium hydrogen phosphate 35.9g, be dissolved in water, and be diluted to 500ml, obtain first liquid; Get sodium dihydrogen phosphate 2.76g, be dissolved in water, and be diluted to 100ml, obtain second liquid; Get gained first liquid 91.5ml and mix with second liquid 8.5ml, shake up, namely get pH value and be 7.8 phosphate buffered solution.
Claims (6)
1. the preparation method of an injection thymalfasin compositions is characterized in that, described preparation method may further comprise the steps:
A, primary raw material form: thymalfasin 1.6g, ganciclovir 50～250g, mannitol 10～40g and water for injection 1000ml;
The preparation of b, medicinal liquid: take by weighing various primary raw materials according to the proportioning ratio between the described primary raw material of step a, at first the mannitol adding that takes by weighing is accounted in the water for injection of water for injection cumulative volume 30%, stir fully dissolving, obtain mannitol solution; Then thymalfasin and the ganciclovir adding that takes by weighing accounted in the water for injection of water for injection cumulative volume 30% in addition, stir fully dissolving, obtain the mixed solution of thymalfasin, ganciclovir; The mannitol solution of preparation and the mixed solution of thymalfasin, ganciclovir are merged, mix, then add pH value and be 7.8 phosphate buffered solution, the pH value to 6.4 of regulator solution～7.3, then add remaining 40% water for injection, and add medicinal charcoal and stir, decolour, filter after stirring, remove medicinal charcoal; Gained filtrate adopts microporous filter membrane to filter, and gained filtrate is carried out fill, half tamponade according to conventional method after filtering;
C, lyophilization: the product after step b half tamponade is placed freeze dryer, and pre-freeze is 2～4 hours under-40 ℃ of conditions, and the condenser refrigeration is evacuated to vacuum and reaches 10～13Pa to-45～-50 ℃ of conditions; Setting program heats up, and baffle temperature is warming up to-25 ℃ with 3 hours time by-45～-50 ℃, and baffle temperature is warming up under-25 ℃ of conditions and kept 4 hours; And then baffle temperature is warming up to-15 ℃ with time of 2 hours by-25 ℃, baffle temperature is warming up to-15 ℃ and kept 2 hours; Setting program heats up, and baffle temperature is warming up to 0 ℃ with 1 hour time by-15 ℃, and baffle temperature is warming up to 0 ℃ and kept 1 hour; Baffle temperature is warming up to 15 ℃ with time of 1 hour by 0 ℃, and baffle temperature is warming up to 15 ℃ and kept 2 hours; Baffle temperature is warming up to 30 ℃ with time of 2 hours by 15 ℃, keeps product temperature under 20～30 ℃ of conditions, to keep 4～5 hours, obtain product injection thymalfasin compositions, at last with its products obtained therefrom tamponade, outlet.
2. the preparation method of injection thymalfasin compositions according to claim 1 is characterized in that, primary raw material described in the step a consists of thymalfasin 1.6g, ganciclovir 50g, mannitol 20g and water for injection 1000ml.
3. the preparation method of injection thymalfasin compositions according to claim 1 is characterized in that, primary raw material described in the step a consists of thymalfasin 1.6g, ganciclovir 125g, mannitol 20g and water for injection 1000ml.
4. the preparation method of injection thymalfasin compositions according to claim 1 is characterized in that, primary raw material described in the step a consists of thymalfasin 1.6g, ganciclovir 250g, mannitol 20g and water for injection 1000ml.
5. the preparation method of injection thymalfasin compositions according to claim 1, it is characterized in that pH value described in the step b is that the compound method of 7.8 phosphate buffered solution is: get sodium hydrogen phosphate 35.9g, be dissolved in water, and be diluted to 500ml, obtain first liquid; Get sodium dihydrogen phosphate 2.76g, be dissolved in water, and be diluted to 100ml, obtain second liquid; Get gained first liquid 91.5ml and mix with second liquid 8.5ml, shake up, namely get pH value and be 7.8 phosphate buffered solution.
6. the preparation method of injection thymalfasin compositions according to claim 1 is characterized in that: among medicinal charcoal described in the step b and the step a water for injection between the two the ratio of addition be 2g:1000ml.
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| CN104352458A (en) * | 2014-12-02 | 2015-02-18 | 湖北华世通潜龙药业有限公司 | Acyclovir lyophilized formulation for injection and preparation method acyclovir lyophilized formulation |
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| CN102293756A (en) * | 2011-08-24 | 2011-12-28 | 蚌埠丰原涂山制药有限公司 | Freeze-dried powder injection of menotropins and preparation method thereof |
| CN102579347A (en) * | 2012-03-02 | 2012-07-18 | 海南灵康制药有限公司 | Thymalfasin liposome preparation for injecting |
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Application publication date: 20130417 |