CN102579327A - Rifamycin SV sodium injection and preparation method thereof - Google Patents
Rifamycin SV sodium injection and preparation method thereof Download PDFInfo
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- CN102579327A CN102579327A CN2012100300350A CN201210030035A CN102579327A CN 102579327 A CN102579327 A CN 102579327A CN 2012100300350 A CN2012100300350 A CN 2012100300350A CN 201210030035 A CN201210030035 A CN 201210030035A CN 102579327 A CN102579327 A CN 102579327A
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Abstract
Disclosed are a rifamycin SV sodium injection and a preparation method thereof. The rifamycin SV sodium injection is complicated in producing process and extremely high in technicality, related substances are substantially added after hydro-acupuncture high temperature sterilization is performed in prior art, and preservation stability is bad, thereby few manufacturer produces the rifamycin SV sodium injection nowadays, and clinical requirements can not be met. The rifamycin SV sodium injection comprises rifamycin SV sodium and is characterized by further comprising vitamin C sodium which is no more than 50% by mass of the rifamycin SV sodium, stabilizing agents and cosolvents. After preparation, the overall mass of the stabilizing agents which are capable of adjusting potential hydrogen (pH) is no more than 50% of that of the rifamycin SV sodium, the pH value of the solution is adjusted to 6.7-8.0, the concentration is 225g-275g/5000ml, and the volume of the cosolvents is no more than 40% of the overall volume. The rifamycin SV sodium injection serves as a novel antibiotic which is high in bacteriostasis and wide in antibacterial spectrum.
Description
Technical field:
the present invention relates to a kind of injection and preparation method thereof, and particularly a kind of Rifamycine SV sodium injection and preparation method thereof belongs to the medical industry field.
Background technology:
Rifamycine SV sodium has another name called rifamicina, and it is Rifamycine SV sodium that pharmacopeia indicates former name; Be Italian medical research personnel isolated a kind of newer antibiotic from streptomycete fermentation liquid; Its bacteriostasis is strong, and has a broad antifungal spectrum is to gram-positive bacterium such as streptococcus, streptococcus pneumoniae, staphylococcus etc.; Experiment in the body was as long as very low drug level both can play powerful bactericidal action.The seventies in last century, Sichuan antibiotic industrial research is developed production technology, quality standard of the injection crude drug of having accomplished Rifamycine SV sodium (rifamicina) and preparation etc.Domestic several families pharmaceutical factory has obtained the production authentication code of this product later on.But because the Rifamycine SV sodium process for preparing injection liquid is complicated, technical extremely strong, behind the prior art liquid drugs injection high temperature sterilize, the related substance increase is very big, and the stability of placing preservation subsequently is also very poor, therefore manufacturer production is arranged seldom now, can not satisfy clinical needs.
prior art has only added sodium pyrosulfite and vitamin C (sodium ascorbate) in prescription; Use the pH value of sodium hydroxide, sodium carbonate or L arginine regulator solution then; And show that according to our experimental data the principal agent rifamicina is very responsive to pH value; The while rifamicina is under identical PH, and is also different to the reaction of different alkaline conditioners.And the aqueous solution of sodium pyrosulfite is acid, and PH is 4-5, and it is acid that vitamin C also shows; PH is 4-5 (if adding is sodium ascorbate, because be salt, to the not influence of PH of principal agent); And the aqueous solution of crude drug rifamicina is alkalescence, is generally 7--8, if at this moment add the rifamicina powder in the aqueous solution of sodium pyrosulfite; The PH of solution is 4.5-6, and so, rifamicina will be unstable.Also need a large amount of alkaline PH regulators to be transferred to PH between 6.7-8 simultaneously, and at this moment, rifamicina is very sensitive to a large amount of alkaline PH regulators.
Summary of the invention
The technical problem that
the present invention will solve is: solve the deficiency of prior art, provide a kind of high temperature sterilize front and back stable rifamycin injection and method for preparing.
The technical scheme that the present invention takes is:
a kind of Rifamycine SV sodium injection; Its composition comprises: Rifamycine SV sodium is no more than 50% sodium ascorbate of Rifamycine SV sodium quality, stabilizing agent and cosolvent; Its gross mass of stabilizing agent that PH is regulated in the preparation back is no more than 50% of Rifamycine SV sodium quality; The PH of regulator solution is 6.7-8.0, and concentration is 225g--275g/5000ml, and its described cosolvent volume is no more than 40% of cumulative volume.
described Rifamycine SV sodium injection, its described stabilizing agent is sodium pyrosulfite and sodium sulfite, its proportioning is that 1:9 is to 9:1.
described Rifamycine SV sodium injection, its described stabilizing agent is sodium sulfite and sodium sulfite, its proportioning is that 1:9 is to 9:1.
described Rifamycine SV sodium injection, its described cosolvent is a propylene glycol.
above-mentioned Rifamycine SV sodium injection preparation is dissolved in above-mentioned propylene glycol in the degassing water for injection earlier, and cumulative volume is 4000ml, is heated to 50 ℃; Fully dissolving is 15 minutes, and the proportioning that requires according to aforesaid right adds the sodium pyrosulfite and sodium sulfite dissolving of full dose, adding sodium ascorbate; Dissolving is dissolved in above-mentioned solution, stirring and dissolving with the 225g---275g Rifamycine SV sodium again; Supply water for injection again to 5000ml, using sodium sulfite solution or sodium pyrosulfite to dissolve and transferring PH as the liquid stabilizing agent is 6.7-8.0, and the pin that adds 0.01%--1% is then used activated carbon; 50 ℃ were stirred 10 minutes, left standstill to filter afterwards in 20 minutes, and it is 6.7-8.0 that reuse sodium sulfite solution or sodium metabisulfite solution are transferred PH; And cross 0.22 film, inflated with nitrogen is processed 1000 embeddings; Sterilized 30 minutes, and got finished product, omnidistance nitrogen protection.
described Rifamycine SV sodium injection preparation is dissolved in above-mentioned propylene glycol in the water for injection earlier, and cumulative volume is 4000ml, adds the sodium sulfite of full dose; Nitrogen protection is heated to 50 ℃, and fully stirring and dissolving is 30 minutes, adds the sodium pyrosulfite dissolving according to said ratio; Add sodium ascorbate, dissolving is dissolved in above-mentioned solution, stirring and dissolving with the 225g--275g Rifamycine SV sodium again; Supply the water for injection that outgased again to 5000ml, using sodium sulfite solution or sodium metabisulfite solution to transfer PH is 6.7-8.0, and the pin that adds 0.01%--1% is then used activated carbon, and 50 ℃ were stirred 10 minutes; Leave standstill and filtered afterwards in 20 minutes, it is 6.7-8.0 that reuse sodium sulfite solution or sodium metabisulfite solution are transferred PH, and crosses 0.22 film; Inflated with nitrogen is processed 1000, embedding; Sterilized 30 minutes, and got finished product, omnidistance nitrogen protection.
Beneficial effect of the present invention:
prior art has only added sodium pyrosulfite and vitamin C (sodium ascorbate) in prescription; Use the pH value of sodium hydroxide, sodium carbonate or L arginine regulator solution then; And show that according to our experimental data the principal agent rifamicina is very responsive to pH value; The while rifamicina is under identical PH, and is also different to the reaction of different alkaline conditioners.And the aqueous solution of sodium pyrosulfite is acid, and PH is 4-5, and it is acid that vitamin C also shows; PH is 4-5 (if adding is sodium ascorbate, because be salt, to the not influence of PH of principal agent); And the aqueous solution of crude drug rifamicina is alkalescence, is generally 7--8, if at this moment add the rifamicina powder in the aqueous solution of sodium pyrosulfite; The PH of solution is 4.5-6, and so, rifamicina will be unstable.Also need a large amount of alkaline PH regulators to be transferred to PH between 6.7-8 simultaneously, and at this moment, rifamicina is very sensitive to a large amount of alkaline PH regulators.This also is the finished product instability that prior art is produced, underproof reason.
and our solution are to add sodium sulfite, and the aqueous solution of sodium sulfite is alkalescence, and PH is 8-10; With the sodium pyrosulfite proportional mixing, PH is between 6-8, behind adding sodium ascorbate and the rifamicina; PH is between 6.7-8; The principal agent rifamicina does not pass through over-drastic acidity, does not pass through over-drastic alkalescence yet, in solution, does not add alkaline PH regulator yet.Sodium sulfite also is a kind of antioxidant on the contrary, and the principal agent rifamicina is also had protective effect.
are so the creationary PH regulator that does not have use to use always of this programme; Like sodium hydroxide, sodium carbonate, sodium bicarbonate, L arginine etc., use but be used as the PH regulator to the antioxidant sodium sulfite, make the effect of its existing PH adjusting; The effect of antioxygen is arranged again; Form a kind of new combination antioxidant with the sodium pyrosulfite proportional mixing, this combination antioxidant has played beyond thought effect to rifamicina, can be maintained to the PH of solution between 6.7-8; Need not re-use other PH regulators, avoid rifamicina unstable the solution that other PH regulator sensitivity causes.
The character of
, sodium sulfite and sodium pyrosulfite is basic identical.Only need and the sodium sulfite proportional mixing.
, sodium thiosulfate show alkalescence, but meet thermally labile, decompose, and PH changes very greatly, and is inadvisable.
, two kinds of different preparation technologies are arranged under the identical condition of compositions prescription.Difference is that first kind of technology is to remove the dissolved oxygen in the solution with feeding nitrogen or ultransonic method, carries out nitrogen protection simultaneously, reduces the oxidized probability of principal agent; And second kind of technology is to remove the dissolved oxygen in the water with the sodium sulfite method for preparing anaerobic water that is dissolved in the water, and reduces the oxidized probability of principal agent.
two kinds of methods respectively have advantage: first method need feed a large amount of nitrogen or ultrasonic for a long time; Cost is higher; But with can solve the indeterminable problem of prior art after sodium pyrosulfite and sodium sulfite are used in combination, reach good effect; Second method is with the method for preparing anaerobic water, in actual industrial production, uses seldom, and common laboratory is used.But in this specific project of Rifamycine SV sodium injection, this method and sodium pyrosulfite are united the requirement that can satisfy deoxygenation after the use can make PH again in the scope of solution, and the principal agent Rifamycine SV sodium is stable, and impurity is qualified.
one, the sodium hydroxide with 5% are regulated PH, and in 6-8 scope, along with PH raises, related substance increases.Prescription: sodium pyrosulfite 0.8g sodium ascorbate 1.3g rifamicina 10g is made into 200ml such as following table:
conclusion impurity is defective.
two, regulate PH with the 10%L arginine, in 6-8 scopes, the variation of impurity is as above shown.
prescription: sodium pyrosulfite 0.8g sodium ascorbate 1.3g rifamicina 10g is made into 200ml.
conclusion: impurity exceeds standard defective.
three, upward also explanation of table, in 6-8 scope, under identical PH condition, rifamicina is different to the reaction of different alkaline conditioners, and is stronger to the reaction of sodium hydroxide.
four, very little according to our the write out a prescription variation of PH related substance in 6-8 scope of proportioning, and be not linear and go up and down, explain not to be that PH changes the influence of generation, but the influence of other factors in the solution.Like following table:
prescription: sodium pyrosulfite 0.6g sodium sulfite 0.3g sodium ascorbate 1.3g rifamicina 10g is made into 200ml.
| PH | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | ||
| Impurity | 0.6% | 0.4% | 0.7% | 0.3% | 0.45% |
five, rifamycin sodium injection study on the stability, airtight constant temperature 30 degree.
Prescription: sodium pyrosulfite 0.6g sodium sulfite 0.3g sodium ascorbate 1.3g rifamicina 10g PH6.8 is according to the claim prepared
conclusion: under above condition, the rifamycin sodium injection stable content, related substance is qualified.
six, rifamycin sodium injection study on the stability, airtight constant temperature 30 degree.
Prescription: sodium pyrosulfite 0.8g sodium sulfite 0.4g sodium ascorbate 1.3g rifamicina 10g PH7.5 is made into 200ml according to the claim prepared
?
conclusion: under above condition, the rifamycin sodium injection stable content, related substance is qualified.
The specific embodiment:
Embodiment 1:
are dissolved in the 750ml propylene glycol in the degassing water for injection earlier, and cumulative volume is 4000ml, is heated to 50 ℃, fully dissolves 15 minutes; Add sodium pyrosulfite 10g and sodium sulfite 10g dissolving, add sodium ascorbate 32.5g, dissolving is dissolved in above-mentioned solution with 250g Rifamycine SV sodium (in Rifamycine SV sodium) again; Stirring and dissolving is supplied water for injection again to 5000ml, and using a small amount of sodium sulfite solution or sodium metabisulfite solution to transfer PH is 6.7, adds 0.05% pin then and uses activated carbon; 50 ℃ were stirred 10 minutes, left standstill to filter afterwards in 20 minutes, and it is 6.7 that a small amount of sodium sulfite solution of reuse or sodium metabisulfite solution are transferred PH; And cross 0.22 film, inflated with nitrogen is processed 1000; Embedding was sterilized 30 minutes, got finished product.Nitrogen protection
Embodiment 2:
are dissolved in the 1000ml propylene glycol in the water for injection earlier, and cumulative volume is 4000ml, is heated to 50 ℃, fully dissolves 15 minutes; Add sodium pyrosulfite 20g and sodium sulfite 10g dissolving, add sodium ascorbate 50 g, dissolving is dissolved in above-mentioned solution with 250g Rifamycine SV sodium (in Rifamycine SV sodium) again; Stirring and dissolving is supplied water for injection again to 5000ml, and using a small amount of sodium sulfite solution or sodium metabisulfite solution to transfer PH is 7.0, adds 0.08% pin then and uses activated carbon; 50 ℃ were stirred 10 minutes, left standstill to filter afterwards in 20 minutes, and it is 7.0 that a small amount of sodium sulfite solution of reuse or sodium metabisulfite solution are transferred PH; And cross 0.22 film, process 1000, inflated with nitrogen; Embedding was sterilized 30 minutes, got finished product.
Embodiment 3:
are dissolved in the 1500ml propylene glycol in the water for injection earlier, and cumulative volume is 4000ml, is heated to 50 ℃, fully dissolves 15 minutes; Add sodium pyrosulfite 30g and sodium sulfite 18g dissolving, add sodium ascorbate 40 g, dissolving is dissolved in above-mentioned solution with 250g Rifamycine SV sodium (in rifamicina) again; Stirring and dissolving is supplied water for injection again to 5000ml, and using a small amount of sodium sulfite solution or sodium metabisulfite solution to transfer PH is 7.0, adds 0.08% pin then and uses activated carbon; 50 ℃ were stirred 10 minutes, left standstill to filter afterwards in 20 minutes, and it is 7.0 that a small amount of sodium sulfite solution of reuse or sodium metabisulfite solution are transferred PH; And cross 0.22 film, inflated with nitrogen is processed 1000; Embedding was sterilized 30 minutes, got finished product.Omnidistance nitrogen protection.
Embodiment 4:
are dissolved in the 1000ml propylene glycol in the water for injection earlier, and cumulative volume is 4000ml, is heated to 50 ℃, fully dissolves 15 minutes; Add sodium pyrosulfite 13g and sodium sulfite 8g dissolving, add sodium ascorbate 32.5 g, dissolving is dissolved in above-mentioned solution with 250g Rifamycine SV sodium (in rifamicina) again; Stirring and dissolving is supplied water for injection again to 5000ml, and using a small amount of sodium sulfite solution or sodium metabisulfite solution to transfer PH is 7.5, adds 0.09% pin then and uses activated carbon; 50 ℃ were stirred 10 minutes, left standstill to filter afterwards in 20 minutes, and it is 7.5 that a small amount of sodium sulfite solution of reuse or sodium metabisulfite solution are transferred PH; And cross 0.22 film, inflated with nitrogen is processed 1000; Embedding was sterilized 30 minutes, got finished product.
Embodiment 5:
are dissolved in the 1200ml propylene glycol in the water for injection earlier, and cumulative volume is 4000ml, is heated to 50 ℃, fully dissolves 15 minutes; Add sodium pyrosulfite 18g and sodium sulfite 10g dissolving, add sodium ascorbate 38.5 g, dissolving is dissolved in above-mentioned solution with 250g Rifamycine SV sodium (in rifamicina) again; Stirring and dissolving is supplied water for injection again to 5000ml, and using a small amount of sodium sulfite solution or sodium metabisulfite solution to transfer PH is 6.71, adds 0.02% pin then and uses activated carbon; 50 ℃ were stirred 10 minutes, left standstill to filter afterwards in 20 minutes, and it is 6.71 that a small amount of sodium sulfite solution of reuse or sodium metabisulfite solution are transferred PH; And cross 0.22 film, inflated with nitrogen is processed 1000; Embedding was sterilized 30 minutes, got finished product.
Embodiment 6:
are dissolved in the 2400ml propylene glycol in the water for injection earlier, and cumulative volume is 4000ml, is heated to 50 ℃, fully dissolves 15 minutes; Add sodium pyrosulfite 20g and sodium sulfite 15g dissolving, add sodium ascorbate 48.5 g, dissolving is dissolved in above-mentioned solution with 250g Rifamycine SV sodium (in rifamicina) again; Stirring and dissolving is supplied water for injection again to 5000ml, and using a small amount of sodium sulfite solution or sodium metabisulfite solution to transfer PH is 7.3, adds 0.02% pin then and uses activated carbon; 50 ℃ were stirred 10 minutes, left standstill to filter afterwards in 20 minutes, and it is 7.3 that a small amount of sodium sulfite solution of reuse or sodium metabisulfite solution are transferred PH; And cross 0.22 film, inflated with nitrogen is processed 1000; Embedding was sterilized 30 minutes, got finished product.
Embodiment 7:
are dissolved in the 1500ml propylene glycol in the water for injection earlier, and cumulative volume is 4000ml, is heated to 50 ℃, fully dissolves 15 minutes; Add sodium pyrosulfite 22g and sodium sulfite 15g dissolving, add sodium ascorbate 48.5 g, dissolving is dissolved in above-mentioned solution with 250g Rifamycine SV sodium (in rifamicina) again; Stirring and dissolving is supplied water for injection again to 5000ml, and using a small amount of sodium sulfite solution or sodium metabisulfite solution to transfer PH is 7.8; Add 0.02% pin then and use activated carbon, 50 ℃ were stirred 10 minutes, left standstill to filter after 20 minutes; It is 7.8 that a small amount of sodium sulfite solution of reuse or sodium metabisulfite solution are transferred PH, and crosses 0.22 film, inflated with nitrogen; Embedding was sterilized 30 minutes, got finished product.
Embodiment 8:
are dissolved in the 1800ml propylene glycol in the water for injection earlier, and cumulative volume is 4000ml, is heated to 50 ℃, fully dissolves 15 minutes; Add sodium pyrosulfite 24g and sodium sulfite 12g dissolving, add sodium ascorbate 48.5 g, dissolving is dissolved in above-mentioned solution with 250g Rifamycine SV sodium (in rifamicina) again; Stirring and dissolving is supplied water for injection again to 5000ml, and using a small amount of sodium sulfite solution or sodium metabisulfite solution to transfer PH is 7.9, adds 0.56% pin then and uses activated carbon; 50 ℃ were stirred 10 minutes, left standstill to filter afterwards in 20 minutes, and it is 7.9 that a small amount of sodium sulfite solution of reuse or sodium metabisulfite solution are transferred PH; And cross 0.22 film, inflated with nitrogen is processed 1000; Embedding was sterilized 30 minutes, got finished product.
Embodiment 9:
are dissolved in the 850ml propylene glycol in the water for injection earlier, and cumulative volume is 4000ml, is heated to 50 ℃, fully dissolves 15 minutes; Add sodium pyrosulfite 14g and sodium sulfite 7g dissolving, add sodium ascorbate 32.5 g, dissolving is dissolved in above-mentioned solution with 250g Rifamycine SV sodium (in rifamicina) again; Stirring and dissolving is supplied water for injection again to 5000ml, and using a small amount of sodium sulfite solution or sodium metabisulfite solution to transfer PH is 6.8, adds 0.56% pin then and uses activated carbon; 50 ℃ were stirred 10 minutes, left standstill to filter afterwards in 20 minutes, and it is 6.8 that a small amount of sodium sulfite solution of reuse or sodium metabisulfite solution are transferred PH; And cross 0.22 film, inflated with nitrogen is processed 1000; Embedding was sterilized 30 minutes, got finished product.
Embodiment 10:
are dissolved in the 800ml propylene glycol in the water for injection earlier, and cumulative volume is 4000ml, is heated to 50 ℃, fully dissolves 15 minutes; Add sodium sulfite 13g and sodium sulfite 7g dissolving, add sodium ascorbate 32.5 g, dissolving is dissolved in above-mentioned solution with 250g Rifamycine SV sodium (in rifamicina) again; Stirring and dissolving is supplied water for injection again to 5000ml, and using a small amount of sodium sulfite solution or sodium metabisulfite solution to transfer PH is 6.9, adds 0.55% pin then and uses activated carbon; 50 ℃ were stirred 10 minutes, left standstill to filter afterwards in 20 minutes, and it is 6.9 that a small amount of sodium sulfite solution of reuse or sodium metabisulfite solution are transferred PH; And cross 0.22 film, inflated with nitrogen is processed 1000; Embedding was sterilized 30 minutes, got finished product.
Embodiment 11:
are dissolved in propylene glycol 1000ml in the water for injection earlier, and cumulative volume is 4000ml, add sodium sulfite 12g, nitrogen protection; Be heated to 50 ℃, fully stirring and dissolving is 30 minutes, adds sodium pyrosulfite 24g dissolving, adds sodium ascorbate 48.5g; Dissolving is dissolved in above-mentioned solution with 250g Rifamycine SV sodium (in Rifamycine SV sodium) again, and stirring and dissolving is supplied the water for injection that outgased again to 5000ml; Using a small amount of sodium sulfite solution or sodium metabisulfite solution to transfer PH is 6.9, and the pin that adds 0.01%--1% is then used activated carbon, and 50 ℃ were stirred 10 minutes, leaves standstill to filter afterwards in 20 minutes; It is 6.9 that a small amount of sodium sulfite solution of reuse or sodium metabisulfite solution are transferred PH, and crosses 0.22 film, and inflated with nitrogen is processed 1000; Embedding was sterilized 30 minutes, got finished product.(omnidistance nitrogen protection)
Embodiment 12:
are dissolved in propylene glycol 1100ml in the water for injection earlier, and cumulative volume is 4000ml, add sodium sulfite 11g, nitrogen protection; Be heated to 50 ℃, fully stirring and dissolving is 30 minutes, adds sodium pyrosulfite 22g dissolving, adds sodium ascorbate 49g; Dissolving is dissolved in above-mentioned solution with 250g Rifamycine SV sodium (in Rifamycine SV sodium) again, and stirring and dissolving is supplied the water for injection that outgased again to 5000ml; Using a small amount of sodium sulfite solution or sodium metabisulfite solution to transfer PH is 7.5, and the pin that adds 0.01%--1% is then used activated carbon, and 50 ℃ were stirred 10 minutes, leaves standstill to filter afterwards in 20 minutes; It is 7.5 that a small amount of sodium sulfite solution of reuse or sodium metabisulfite solution are transferred PH, and crosses 0.22 film, and inflated with nitrogen is processed 1000; Embedding was sterilized 30 minutes, got finished product, omnidistance nitrogen protection.
Embodiment 13:
are dissolved in propylene glycol 1600ml in the water for injection earlier, and cumulative volume is 4000ml, add sodium sulfite 7.5g, nitrogen protection; Be heated to, fully stirring and dissolving is 30 minutes, adds sodium pyrosulfite 15g dissolving, adds sodium ascorbate 32.5g; Dissolving is dissolved in above-mentioned solution with 250g Rifamycine SV sodium (in Rifamycine SV sodium) again, and stirring and dissolving is supplied the water for injection that outgased again to 5000ml; Using a small amount of sodium sulfite solution or sodium metabisulfite solution to transfer PH is 6.85, and the pin that adds 0.01%--1% is then used activated carbon, and 50 ℃ were stirred 10 minutes, leaves standstill to filter afterwards in 20 minutes; It is 6.85 that a small amount of sodium sulfite solution of reuse or sodium metabisulfite solution are transferred PH, and crosses 0.22 film, and inflated with nitrogen is processed 1000; Embedding was sterilized 30 minutes, got finished product, omnidistance nitrogen protection.
Claims (6)
1. Rifamycine SV sodium injection; Its composition comprises: Rifamycine SV sodium is characterized in that: also comprise 50% the sodium ascorbate that is no more than the Rifamycine SV sodium quality, stabilizing agent and cosolvent; Its gross mass of stabilizing agent that PH is regulated in the preparation back is no more than 50% of Rifamycine SV sodium quality; The PH of regulator solution is 6.7-8.0, and concentration is 225g--275g/5000ml, and its described cosolvent volume is no more than 40% of cumulative volume.
2. Rifamycine SV sodium injection according to claim 1 is characterized in that: described stabilizing agent is sodium pyrosulfite and sodium sulfite, and its proportioning is that 1:9 is to 9:1.
3. Rifamycine SV sodium injection according to claim 1 is characterized in that: described stabilizing agent is sodium sulfite and sodium sulfite, and its proportioning is that 1:9 is to 9:1.
4. according to claim 1 or 2 or 3 described Rifamycine SV sodium injection, it is characterized in that: described cosolvent is a propylene glycol.
5. a claim 1,2,3,4 described Rifamycine SV sodium injection preparations, it is characterized in that: earlier above-mentioned propylene glycol is dissolved in the degassing water for injection, cumulative volume is 4000ml, is heated to 50 ℃; Fully dissolving is 15 minutes, and the proportioning that requires according to aforesaid right adds sodium pyrosulfite and sodium sulfite dissolving, adds sodium ascorbate; Dissolving is dissolved in above-mentioned solution, stirring and dissolving with the 225g---275g Rifamycine SV sodium again; Supply water for injection again to 5000ml, using sodium sulfite solution or sodium pyrosulfite to dissolve and transferring PH as the liquid stabilizing agent is 6.7-8.0, and the pin that adds 0.01%--1% is then used activated carbon; 50 ℃ were stirred 10 minutes, left standstill to filter afterwards in 20 minutes, and it is 6.7-8.0 that reuse sodium sulfite solution or sodium metabisulfite solution are transferred PH; And cross 0.22 film, inflated with nitrogen is processed 1000 embeddings; Sterilized 30 minutes, and got finished product, omnidistance nitrogen protection.
6. a claim 1,2,3,4 described Rifamycine SV sodium injection preparations, it is characterized in that: earlier above-mentioned propylene glycol is dissolved in the water for injection, cumulative volume is 4000ml, adds the sodium sulfite of full dose; Nitrogen protection is heated to 50 ℃, and fully stirring and dissolving is 30 minutes, adds the sodium pyrosulfite dissolving according to said ratio; Add sodium ascorbate, dissolving is dissolved in above-mentioned solution, stirring and dissolving with the 225g--275g Rifamycine SV sodium again; Supply the water for injection that outgased again to 5000ml, using sodium sulfite solution or sodium metabisulfite solution to transfer PH is 6.7-8.0, and the pin that adds 0.01%--1% is then used activated carbon, and 50 ℃ were stirred 10 minutes; Leave standstill and filtered afterwards in 20 minutes, it is 6.7-8.0 that reuse sodium sulfite solution or sodium metabisulfite solution are transferred PH, and crosses 0.22 film; Inflated with nitrogen is processed 1000, embedding; Sterilized 30 minutes, and got finished product, omnidistance nitrogen protection.
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|---|---|---|---|---|
| CN103908674A (en) * | 2014-01-21 | 2014-07-09 | 邓学峰 | Rifamycin sodium combinatorial drug |
| WO2019240677A3 (en) * | 2017-03-09 | 2020-02-27 | Bilici Namik | Composition of vitamin c and vitamin e with rifampicin for the treatment of all infected wounds and all dermatological problems either infected or at risk of being infected |
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