CN108836945A - A kind of preparation method of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection - Google Patents
A kind of preparation method of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection Download PDFInfo
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Abstract
A kind of preparation method of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection of the present invention, belongs to pharmaceutical field, which mainly includes ingredient, make up a prescription, filter, storing, pre-freeze and drying and other steps, finally obtains the finished product of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection.The filtration step includes that medical fluid A is added to the active carbon of predetermined amount after mixing evenly, carries out decarburization coarse filtration using filter core, recycling filter membrane to carry out refined filtration at least drying steps described in two procedures includes carrying out heating treatment twice to partition respectively.The preparation method of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection provided by the present invention, Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection quality obtained are reliable and stable.
Description
Technical field
The present invention relates to a kind of pharmaceutical methods, specifically a kind of preparation side of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection
Method.
Background technique
Potassium DehydroandrograpolidSuccinate Succinate for Injection is a kind of immune system medication, causes that generates heat to have stronger antipyretic work bacterial endotoxin
With, can promote fever recession, can be used for treating viral pneumonia, the diseases such as viral infection of upper respiratory tract.
It at present mainly include potasium dehydroandrographolisuccinate succinate injection and Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection in Chuanhuning preparation product.Wear amber
Injection for curing is unstable, at room temperature validity period 30.5 days, because potassium dehydroandrographolide succinate is a diterpenes diterpenoids lactones compound, Er Qiefen
There is a conjugated double bond in son, thus chemical activity is high, and hydrolysis and oxidation reaction easily occurs, and also to carry out high temperature in production and go out
Bacterium, and promote decomposition reaction.The pure micro- Huang of potassium dehydroandrographolide succinate aqueous solution show slightly green, but on domestic market potassium dehydroandrographolide succinate liquid drugs injection color
Damp deep, some even becomes yellow or brown color.And the stability of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection is preferable, when preparation
Water content is maintained at 5% or less and in ampoule when nitrogen filled protection, can effectively improve the stability of potassium dehydroandrographolide succinate, validity period is up to two
Year or more.But the Potassium DehydroandrograpolidSuccinate Succinate for Injection of current method preparation may still contain the impurity for causing toxic side effect, these impurity
It mainly include macromolecule plant albumen, the product of potassium dehydroandrographolide succinate hydrolysis oxidation and pigment etc..
A kind of preparation method for the Potassium DehydroandrograpolidSuccinate Succinate for Injection that therefore, it is necessary to quality is reliable and stable, safety is good.
Summary of the invention
The main object of the present invention is to provide a kind of preparation side of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection that safety is good
Method, Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection quality obtained are reliable and stable.
And the technical solution that it is solved the problems, such as,
A kind of preparation method of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection, includes the following steps：
S1, ingredient：Weigh the potassium dehydroandrographolide succinate, sodium bicarbonate and water for injection of predetermined amount；
S2, it makes up a prescription：Potassium dehydroandrographolide succinate and sodium bicarbonate are added in the water for injection of predetermined amount, after stirring makes it completely dissolved,
Remaining water for injection is added to full dose, obtains medical fluid A；
S3, filtering：The active carbon that predetermined amount is added in medical fluid A after mixing evenly, carries out decarburization coarse filtration, then benefit using filter core
Medical liquid B is obtained after carrying out refined filtration with filter membrane, medical liquid B is sampled into inspection；
S4, storage：Qualified medical liquid B is examined to be delivered in the medicine liquid-storage tank of bottling department, it is filling into cillin bottle respectively
For use；
S5, pre-freeze：The cillin bottle for being filled with medical liquid B is gone on the partition of freeze drier, the temperature for reducing partition will
Medical liquid B is frozen into solid intermediate products in advance, when intermediate product temperature is down to -30 DEG C, keeps the temperature 2 hours；
S6, drying：After pre-freeze, 15Pa is evacuated to hereinafter, carrying out heating treatment twice to partition respectively, is infused
Penetrate the finished product with potassium dehydroandrographolide succinate freeze drying powder injection.
Wherein, in the step S1, the ingredient that the Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection of 1000 80mg uses is made
Predetermined amount includes：Potassium dehydroandrographolide succinate is 80g, and sodium bicarbonate 24g, water for injection full dose is 1200ml.
Wherein, in the step S2, the water for injection for the predetermined amount that stirring and dissolving uses is the 40-50% of full dose.
Wherein, in the step S3, the active carbon of predetermined amount is the 0.04-0.08% of medical fluid A total volume, and mixing time is
25-35min。
Wherein, in the step S3, the filter opening for the filter core that coarse filtration uses is 0.45um, and the filter sizes that refined filtration uses are
0.22um。
Wherein, in the step S4, filling liquid volume is 1.2ml in each cillin bottle.
Wherein, in the step S6, heating treatment twice includes：
First time heating treatment：Baffle temperature rises to 2 DEG C, keeps the temperature 2 hours after the ice crystal of intermediate products disappears and obtains powder
Shape product；
Second of heating treatment：Baffle temperature rises to 35 DEG C, constant temperature 3 hours when powder product temperature reaches 20 DEG C.
Further, when first time heating treatment, partition be warming up to 2 DEG C used in the time be 3 hours；Second of heating treatment
When, partition be warming up to 35 DEG C used in the time be 2 hours.
The beneficial effects of the invention are as follows：
Using Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection obtained by the present invention, quality stability is good, in the ring of air drying
It can at least be saved in border 2 years or more, securely and reliably, substantially increase efficacy and saferry when clinical application, it can be effective
Ground enhances curative effect for treating the diseases such as viral pneumonia, viral infection of upper respiratory tract.
Specific embodiment
The following is a clear and complete description of the technical scheme in the embodiments of the invention.It illustrates in the following description
Many details to facilitate a thorough understanding of the present invention, still the present invention can also using other than the one described here its
Its mode is implemented, and those skilled in the art can do similar popularization, therefore this hair without violating the connotation of the present invention
It is bright to be not limited by the specific embodiments disclosed below.
In the examples below that, used raw material is commercial product.
A kind of preparation method of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection of the present invention, mainly includes the following steps that：
S1, ingredient：The potassium dehydroandrographolide succinate, sodium bicarbonate and water for injection of predetermined amount, matching in the formula are weighed according to formula
Material usage amount can be used for making the Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection of 1000 80mg.Wherein the dosage of various composition is：
Potassium dehydroandrographolide succinate is 80g, and sodium bicarbonate 24g, water for injection full dose is 1200ml.
S2, it makes up a prescription：Firstly, injecting the water for injection of full dose 40-50% in Agitation Tank, worn ready in step S1
Amber peace sodium bicarbonate is separately added into Agitation Tank, is sufficiently stirred and is made it completely dissolved, and then adds remaining water for injection extremely
Full dose obtains medical fluid A at this time.
S3, filtering：Including at least coarse filtration and refined filtration two procedures.
S31 coarse filtration：The obtained medical fluid A of step S3 is added to the active carbon of predetermined amount, the addition of used active carbon
The 0.04-0.08% (w/v) of the total volume for the medical fluid A configured is measured, medical fluid A is sufficiently stirred after active carbon is added, is stirred
Time is 25-35min, and filter opening aperture is used to be filtered decarburization for the filter core of 0.45um later, completes coarse filtration.
S32 refined filtration：After the completion of coarse filtration, the filter membrane further progress refined filtration for being 0.22um using aperture obtains medical liquid B.
Medical liquid B is sampled into inspection, can be repeated several times according to the inspection result of sample and carry out above-mentioned coarse filtration and refined filtration operation.
S4, storage：Qualified medical liquid B is examined to be delivered in the medicine liquid-storage tank of bottling department, it is filling into cillin bottle respectively
For use, liquid volume filling in each cillin bottle is 1.2ml.
S5, pre-freeze：On the partition that cillin bottle after step S4 packing transfers to freeze drier, the temperature of partition is reduced
To -35 DEG C, medical liquid B is frozen into solid intermediate products in advance, when intermediate product temperature is down to -30 DEG C, keeps the temperature 2 hours.
S6, drying：After pre-freeze, the treatment region for storing intermediate products is vacuumized, vacuum degree is in 15Pa hereinafter, successively
Heating treatment is carried out to partition in two times, wherein heating treatment twice includes：
S61 first time heating treatment：Baffle temperature was at the uniform velocity risen to 2 DEG C within 3 hours periods, the ice to intermediate products
After crystalline substance disappears, 2 hours persistently are kept the temperature, obtains powder product；
Second of heating treatment of S62：Baffle temperature is at the uniform velocity risen to 35 DEG C using 2 hours, when powder product temperature reaches
At 20 DEG C, kept for constant temperature 3 hours.
After second of heating treatment, the finished product of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection is obtained.
Embodiment 1
A kind of preparation method of the Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection of 80mg, mainly includes the following steps that：
S1, ingredient：According to formula the potassium dehydroandrographolide succinate, sodium bicarbonate and water for injection of predetermined amount are weighed, wherein various composition
Dosage is：Potassium dehydroandrographolide succinate is 80g, and sodium bicarbonate 24g, water for injection full dose is 1200ml.Ingredient usage amount in the formula
It can be used for making 1000 Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injections.
S2, it makes up a prescription：Firstly, injecting the water for injection of full dose 40% in Agitation Tank, amber is worn by ready in step S1
Peace sodium bicarbonate is separately added into Agitation Tank, is sufficiently stirred and is made it completely dissolved, and then adds remaining water for injection to complete
Amount, obtains medical fluid A at this time.
S3, filtering：Including at least coarse filtration and refined filtration two procedures.
S31 coarse filtration：The obtained medical fluid A of step S3 is added to the active carbon of predetermined amount, the addition of used active carbon
0.04% (w/v) of the total volume for the medical fluid A configured is measured, medical fluid A is sufficiently stirred after active carbon is added, mixing time is
30min uses filter opening aperture to be filtered decarburization for the filter core of 0.45um later, completes coarse filtration.
S32 refined filtration：After the completion of coarse filtration, the filter membrane further progress refined filtration for being 0.22um using aperture obtains medical liquid B.
Medical liquid B is sampled into inspection, can be repeated several times according to the inspection result of sample and carry out above-mentioned coarse filtration and refined filtration operation.
S4, storage：Qualified medical liquid B is examined to be delivered in the medicine liquid-storage tank of bottling department, it is filling into cillin bottle respectively
For use, liquid volume filling in each cillin bottle is 1.2ml.
S5, pre-freeze：On the partition that cillin bottle after step S4 packing transfers to freeze drier, the temperature of partition is reduced
To -35 DEG C, medical liquid B is frozen into solid intermediate products in advance, when intermediate product temperature is down to -30 DEG C, keeps the temperature 2 hours.
S6, drying：After pre-freeze, the treatment region for storing intermediate products is vacuumized, vacuum degree is in 15Pa hereinafter, successively
Heating treatment is carried out to partition in two times, wherein heating treatment twice includes：
S61 first time heating treatment：Baffle temperature was at the uniform velocity risen to 2 DEG C within 3 hours periods, the ice to intermediate products
After crystalline substance disappears, 2 hours persistently are kept the temperature, obtains powder product；
Second of heating treatment of S62：Baffle temperature is at the uniform velocity risen to 35 DEG C using 2 hours, when powder product temperature reaches
At 20 DEG C, kept for constant temperature 3 hours.
After second of heating treatment, the finished product of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection is obtained.
The detection of indices is carried out to the finished product for using above-mentioned preparation method to obtain, testing result is shown in Table 1.
Embodiment 2
The present embodiment the difference from embodiment 1 is that：
S2, it makes up a prescription：Firstly, injecting the water for injection of full dose 50% in Agitation Tank, amber is worn by ready in step S1
Peace sodium bicarbonate is separately added into Agitation Tank, is sufficiently stirred and is made it completely dissolved, and then adds remaining water for injection to complete
Amount, obtains medical fluid A at this time.
S31 coarse filtration：The obtained medical fluid A of step S3 is added to the active carbon of predetermined amount, the addition of used active carbon
0.05% (w/v) of the total volume for the medical fluid A configured is measured, medical fluid A is sufficiently stirred after active carbon is added, mixing time is
30min uses filter opening aperture to be filtered decarburization for the filter core of 0.45um later, completes coarse filtration.
Embodiment 3
The present embodiment the difference from embodiment 1 is that：
S2, it makes up a prescription：Firstly, injecting the water for injection of full dose 45% in Agitation Tank, amber is worn by ready in step S1
Peace sodium bicarbonate is separately added into Agitation Tank, is sufficiently stirred and is made it completely dissolved, and then adds remaining water for injection to complete
Amount, obtains medical fluid A at this time.
S31 coarse filtration：The obtained medical fluid A of step S3 is added to the active carbon of predetermined amount, the addition of used active carbon
0.08% (w/v) of the total volume for the medical fluid A configured is measured, medical fluid A is sufficiently stirred after active carbon is added, mixing time is
35min uses filter opening aperture to be filtered decarburization for the filter core of 0.45um later, completes coarse filtration.
Embodiment 4
The present embodiment the difference from embodiment 1 is that：
S2, it makes up a prescription：Firstly, injecting the water for injection of full dose 43% in Agitation Tank, amber is worn by ready in step S1
Peace sodium bicarbonate is separately added into Agitation Tank, is sufficiently stirred and is made it completely dissolved, and then adds remaining water for injection to complete
Amount, obtains medical fluid A at this time.
S31 coarse filtration：The obtained medical fluid A of step S3 is added to the active carbon of predetermined amount, the addition of used active carbon
0.05% (w/v) of the total volume for the medical fluid A configured is measured, medical fluid A is sufficiently stirred after active carbon is added, mixing time is
30min uses filter opening aperture to be filtered decarburization for the filter core of 0.45um later, completes coarse filtration.
Potassium dehydroandrographolide succinate freeze drying powder injection prepared by 1~embodiment of Example 4 carries out performance detection, result such as table one.
Table 1
| Appearance | PH value | Stability | |
| Embodiment 1 | White freeze-drying block | 6.8 | It is stored at room temperature validity period 2 years or more |
| Embodiment 2 | White freeze-drying block | 7.2 | It is stored at room temperature validity period 2 years or more |
| Embodiment 3 | Yellowish freeze-drying block | 7.0 | It is stored at room temperature validity period 2 years or more |
| Embodiment 4 | White freeze-drying block | 7.5 | It is stored at room temperature validity period 2 years or more |
Content described above is only present pre-ferred embodiments, it is clear that described embodiment is only of the invention one
Section Example, instead of all the embodiments.Based on the embodiments of the present invention, those of ordinary skill in the art are not doing
Every other embodiment obtained under the premise of creative work out, shall fall within the protection scope of the present invention.
Claims (8)
1. a kind of preparation method of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection, which is characterized in that include the following steps：
S1, ingredient：Weigh the potassium dehydroandrographolide succinate, sodium bicarbonate and water for injection of predetermined amount；
S2, it makes up a prescription：Potassium dehydroandrographolide succinate and sodium bicarbonate are added in the water for injection of predetermined amount, after stirring makes it completely dissolved, added
Remaining water for injection obtains medical fluid A to full dose；
S3, filtering：The active carbon that predetermined amount is added in medical fluid A after mixing evenly, carries out decarburization coarse filtration using filter core, recycles filter
Film obtains medical liquid B after carrying out refined filtration, and medical liquid B is sampled inspection；
S4, storage：Qualified medical liquid B is examined to be delivered in the medicine liquid-storage tank of bottling department, it is filling stand-by into cillin bottle respectively；
S5, pre-freeze：The cillin bottle for being filled with medical liquid B is gone on the partition of freeze drier, reduces the temperature of partition for medical liquid B
It is frozen into solid intermediate products in advance, when intermediate product temperature is down to -30 DEG C, keeps the temperature 2 hours；
S6, drying：After pre-freeze, 15Pa is evacuated to hereinafter, carrying out heating treatment twice to partition respectively, obtains injection
The finished product of potassium dehydroandrographolide succinate freeze drying powder injection.
2. a kind of preparation method of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection according to claim 1, which is characterized in that described
In step S1, the predetermined amount for making the ingredient that the Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection of 1000 80mg uses includes：Potassium dehydroandrographolide succinate
For 80g, sodium bicarbonate 24g, water for injection full dose is 1200ml.
3. a kind of preparation method of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection according to claim 1, which is characterized in that described
In step S2, the water for injection for the predetermined amount that stirring and dissolving uses is the 40-50% of full dose.
4. a kind of preparation method of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection according to claim 1, which is characterized in that described
In step S3, the active carbon of predetermined amount is the 0.04-0.08%, mixing time 25-35min of medical fluid A total volume.
5. a kind of preparation method of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection according to claim 1, which is characterized in that described
In step S3, the filter opening for the filter core that coarse filtration uses is 0.45um, and the filter sizes that refined filtration uses are 0.22um.
6. a kind of preparation method of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection according to claim 1, which is characterized in that described
In step S4, filling liquid volume is 1.2ml in each cillin bottle.
7. a kind of preparation method of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection according to claim 1, which is characterized in that described
In step S6, heating treatment twice includes：
First time heating treatment：Baffle temperature rises to 2 DEG C, keeps the temperature 2 hours after the ice crystal of intermediate products disappears and obtains powdery production
Product；
Second of heating treatment：Baffle temperature rises to 35 DEG C, constant temperature 3 hours when powder product temperature reaches 20 DEG C.
8. a kind of preparation method of Potassium DehydroandrograpolidSuccinate Succinate for Injection freeze drying powder injection according to claim 7, which is characterized in that first
When secondary heating treatment, partition be warming up to 2 DEG C used in the time be 3 hours；When second of heating treatment, partition is warming up to used in 35 DEG C
Time is 2 hours.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111084760A (en) * | 2020-02-18 | 2020-05-01 | 湖南科伦制药有限公司 | Preparation process of potassium dehydroandrographolide succinate for injection |
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| CN101780051A (en) * | 2008-05-08 | 2010-07-21 | 海南斯达制药有限公司 | Preparation methods of potassium sodium dehydroandroan drographolide succinate and freeze-dried powder injection thereof |
| CN102614136A (en) * | 2012-04-18 | 2012-08-01 | 宁辉 | Potassium sodium dehydroandrographolide succinate composition for injection, and freeze-dried powder injection and preparation method for freeze-dried powder injection |
| CN102657673A (en) * | 2012-05-29 | 2012-09-12 | 海南卫康制药(潜山)有限公司 | Kalii dehydrographolidi succinas freeze-dried powder compound for injection and preparation method thereof |
| CN103040767A (en) * | 2013-01-11 | 2013-04-17 | 成都天台山制药有限公司 | Stable kalii dehydrographolidi succinas freeze-dried powder injection for injection |
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2018
- 2018-09-12 CN CN201811060523.XA patent/CN108836945A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101780051A (en) * | 2008-05-08 | 2010-07-21 | 海南斯达制药有限公司 | Preparation methods of potassium sodium dehydroandroan drographolide succinate and freeze-dried powder injection thereof |
| CN102614136A (en) * | 2012-04-18 | 2012-08-01 | 宁辉 | Potassium sodium dehydroandrographolide succinate composition for injection, and freeze-dried powder injection and preparation method for freeze-dried powder injection |
| CN102657673A (en) * | 2012-05-29 | 2012-09-12 | 海南卫康制药(潜山)有限公司 | Kalii dehydrographolidi succinas freeze-dried powder compound for injection and preparation method thereof |
| CN103040767A (en) * | 2013-01-11 | 2013-04-17 | 成都天台山制药有限公司 | Stable kalii dehydrographolidi succinas freeze-dried powder injection for injection |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111084760A (en) * | 2020-02-18 | 2020-05-01 | 湖南科伦制药有限公司 | Preparation process of potassium dehydroandrographolide succinate for injection |
| CN111084760B (en) * | 2020-02-18 | 2021-09-21 | 湖南科伦制药有限公司 | Preparation process of potassium dehydroandrographolide succinate for injection |
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