CN104127388A - Special ultrafine carbazochrome sodium sulfonate powder freeze-dried preparation and preparation method thereof - Google Patents
Special ultrafine carbazochrome sodium sulfonate powder freeze-dried preparation and preparation method thereof Download PDFInfo
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- CN104127388A CN104127388A CN201410060353.0A CN201410060353A CN104127388A CN 104127388 A CN104127388 A CN 104127388A CN 201410060353 A CN201410060353 A CN 201410060353A CN 104127388 A CN104127388 A CN 104127388A
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Abstract
The invention discloses a special ultrafine carbazochrome sodium sulfonate powder freeze-dried preparation and a preparation method thereof. The method comprises the following steps: step 1, dissolving carbazochrome sodium sulfonate in water, adding sodium bisulfite and carrying out a reaction so as to prepare a mixed liquor; step 2, adding a decolorant into the mixed liquor for decoloring and carrying out filtering so as to obtain a filtrate; step 3, adjusting the pH value of the filtrate by using sodium hydroxide, carrying out cooling, allowing a crystal to be precipitated and then successively carrying out filtering, washing and vacuum drying so as to obtain carbazochrome sodium sulfonate; and step 4, carrying out air jet pulverization on dried carbazochrome sodium sulfonate, dissolving special ultrafine powder of carbazochrome sodium sulfonate in injection water, carrying out low-temperature pre-freezing, then carrying out low-temperature pressure-reduced vacuum drying and finally, carrying out high temperature drying so as to prepare the special ultrafine carbazochrome sodium sulfonate powder freeze-dried preparation. The special ultrafine carbazochrome sodium sulfonate powder freeze-dried preparation prepared in the invention has the advantages of high stability, high purity, a few impurities, a small size, a great specific surface area, good dissolvability, small toxic and side effects, uneasy incurrence of irritability, etc.
Description
Technical field
The present invention relates to extraordinary superfine powder lyophilized formulations of a kind of carbazochrome sodium sulfonate and preparation method thereof, belong to medical technical field.
Background technology
Carbazochrome sodium sulfonate, its chemical name is: 1-methyl-6-oxo-2,3,5,6-tetrahydro indole-5-semicarbazone-2-sulfonate sodium trihydrate, English Carbazochrome Sodium Sulfonate by name, molecular formula: C10H11N4O5SNa3H2O, molecular weight: 376.32, structural formula is as follows:
Carbazochrome sodium sulfonate can be developed by day Honda limit pharmacy strain formula the earliest, is now recorded as Pharmacopeia of Japan the 12 edition (1992) by Japanese health ministry.Carbazochrome sodium sulfonate is blood vessel hemorrhage of new generation, is the blood vessel hardening agent that a kind of utmost point has clinical value.It is the derivant of carbazochrome, the sodium group that induces one on point clamp mechanism, and the dissolubility that has overcome carbazochrome is little, must be by the shortcoming of salicylic acid hydrotropy, thus produce obvious haemostatic effect.Carbazochrome sodium sulfonate can increase the resistance of blood capillary to damage, reduces the permeability of blood capillary, promotes the retraction of blood capillary fracture end and stops blooding.
Carbazochrome sodium sulfonate is hemorrhage for urinary system, upper digestive tract, respiratory tract and obstetrical and gynecological disease clinically, also can be used for wound and operative hemorrhage.The less stable of carbazochrome sodium sulfonate, is easily subject to the impact of temperature, oxygen, light, and the change of degraded or other physicochemical properties occurs, and impact is used curative effect even to increase the security risk of use.
In December, 1999, " extraordinary superfine powder technology of preparing " obtains first-class National Scientific and Technological Progress Award, prize-winning unit: Institutes Of Technology Of Nanjing (Li Fengsheng), certificate number: 30-1-003-01.On January 2nd, 2014, Institutes Of Technology Of Nanjing exclusively assigns in Chang Dian pharmaceuticals about " application of extraordinary superfine powder technology of preparing in pharmaceutical preparation ", and corresponding product is carried out to formulation development and industrialization.
The shortcomings such as existing carbazochrome sodium sulfonate existence and stability is poor, purity is low, impurity is many, granule is large, specific surface area is little, poorly soluble, toxic and side effects large, easy allergy.
Summary of the invention
The object of the present invention is to provide extraordinary superfine powder lyophilized formulations of a kind of carbazochrome sodium sulfonate and preparation method thereof, make carbazochrome sodium sulfonate there is the advantages such as stability is high, purity is high, impurity is few, granule is little, specific surface area is large, dissolubility is good, toxic and side effects is little, difficult allergy.
For solving the problems of the technologies described above, the extraordinary superfine powder lyophilized formulations of carbazochrome sodium sulfonate of the present invention is taking carbazochrome and sodium sulfite as raw material, and after reaction, mixed liquor carries out decolorization filtering, and filtrate carries out decrease temperature crystalline, dry after filtration, air flow super, lyophilizing make.
For solving the problems of the technologies described above, the preparation method of the extraordinary superfine powder lyophilized formulations of carbazochrome sodium sulfonate of the present invention, the method comprises the steps:
Step 1, carbazochrome is soluble in water, add sodium sulfite to react, make mixed liquor;
Step 2 adds bleaching agent bleaching in mixed liquor, filters, and obtains filtrate;
Step 3, with the pH value of sodium hydroxide adjusting filtrate, lowers the temperature, and crystallization body, filters, washing, and vacuum drying, obtains carbazochrome sodium sulfonate;
Step 4, dry carbazochrome sodium sulfonate is become to superfine powder with comminution by gas stream, then the extraordinary superfine powder of carbazochrome sodium sulfonate is dissolved in to water for injection, carry out low temperature pre-freeze, carry out again low-temperature reduced-pressure vacuum drying, finally carry out high temperature drying and make the extraordinary superfine powder lyophilized formulations of carbazochrome sodium sulfonate.
As improvement of the present invention, while reaction in this step 1, also add vitamin C, reaction temperature is 70～80 DEG C, the response time is 30～50 minutes.
As improvement of the present invention, in this step 2, depigmenting agent is active carbon, and active carbon weight is mixed liquor 0.15～0.25%.
As improvement of the present invention, in this step 3, naoh concentration is 5～20%, and the pH value of filtrate is 5～8, and crystallize out temperature is 0～5 DEG C, and the crystallize out time is 8～16 hours.
As improvement of the present invention, in this step 3, crystalline solid washing is first washed by purified water, then uses washing with acetone; Vacuum drying vacuum is-0.08～0.095Mpa, and baking temperature is 60～80 DEG C, and be 6～10 hours drying time.
As improvement of the present invention, in this step 1, the weight ratio of carbazochrome, sodium sulfite, vitamin C and water is 1:(0.35～1.2): (0.04～0.5): (3.5～10).
As improvement of the present invention, in this step 4, the air velocity of comminution by gas stream is 350～450m/s, and the particle diameter of superfine powder is 0.5～3 μ m.
As improvement of the present invention, in this step 4, comminution by gas stream adopts multi-stage crushing.
As improvement of the present invention, in this step 4, carbazochrome sodium sulfonate is 20～40g when lyophilizing, and water for injection adds to 2000ml, makes 1000 bottles after lyophilizing; Pre-freeze temperature is-45 DEG C, and the pre-freeze time is 2～4 hours; The dry temperature of reduced vacuum is-45～-10 DEG C, and be 8～10 hours drying time; High temperature drying temperature is 28～35 DEG C, and be 8～10 hours drying time.
Compared with prior art, the extraordinary superfine powder lyophilized formulations of carbazochrome sodium sulfonate of the present invention has the advantages that stability is high, purity is high, impurity is few, granule is little, specific surface area is large, dissolubility is good, can reduce the use of adjuvant, reduce impurity, reduce toxic and side effects and anaphylaxis, increased safety.Specific surface area is large, and also corresponding increase of surface, makes it have good dispersibility and absorption property.In the time of dosing, can dissolve fully, dissolve rapidly, can improve the utilization rate of effective ingredient, reduce drug consumption, strengthen pharmaceutical effectiveness.Along with diminishing of granularity, the surface atom number of particle is multiplied, and makes it have stronger surface activity and catalytic, more easily absorbs, and easily reaches disease sites, can stop faster the hemorrhage of affected part.Can improve dosing speed, be reduced in dosing process and produce relative substance, improve drug quality.
Detailed description of the invention
Below in conjunction with specific embodiment, embodiment of the present invention are described in detail.Should be appreciated that enforcement of the present invention is not limited to the following examples, any pro forma accommodation that the present invention is made and/or change all will fall into protection scope of the present invention.
Embodiment 1
1000 grams of carbazochromes are dissolved in 3500 grams of water, and add 350 grams of sodium sulfitees and 40 grams of vitamin Cs to react, when reaction, stir, reaction temperature is 70 DEG C, and the response time is 50 minutes, makes mixed liquor.In mixed liquor, add 7.5 grams of active carbons to decolour, maintain 70 DEG C of temperature and stir decolouring 60 minutes, after decolouring, filter, obtain filtrate.Sodium hydroxide solution with 5% regulates the pH value to 5 of filtrate, filtrate is lowered the temperature, be down to 0 DEG C and standing 8 hours, separate out mass crystallization body, isolated by filtration crystalline solid, successively water and washing with acetone crystalline solid, then crystalline solid is carried out to vacuum drying, vacuum drying vacuum is-0.08Mpa, baking temperature is 80 DEG C, be 6 hours drying time, obtains carbazochrome sodium sulfonate, and purity is 99.4%.
Dry carbazochrome sodium sulfonate is ground into superfine powder with multi-grade air current ultra-fine pulverizer, and pulverizing air velocity is 350m/s, and the particle diameter of superfine powder is 1～3 μ m.
The extraordinary superfine powder 20g of carbazochrome sodium sulfonate is dissolved in to water for injection, adds to 2000ml, after lyophilizing, make 1000 bottles.Mixed liquor carries out low temperature pre-freeze 2 hours at-45 DEG C, then carries out reduced vacuum dry 10 hours at-45 DEG C, finally carries out high temperature drying at 35 DEG C and within 8 hours, makes the extraordinary superfine powder lyophilized formulations of carbazochrome sodium sulfonate.
Embodiment 2
1000 grams of carbazochromes are dissolved in 7000 grams of water, and add 800 grams of sodium sulfitees and 200 grams of vitamin Cs to react, when reaction, stir, reaction temperature is 75 DEG C, and the response time is 40 minutes, makes mixed liquor.In mixed liquor, add 18 grams of active carbons to decolour, maintain 75 DEG C of temperature and stir decolouring 50 minutes, after decolouring, filter, obtain filtrate.Sodium hydroxide solution with 10% regulates the pH value to 7 of filtrate, filtrate is lowered the temperature, be down to 2 DEG C and standing 12 hours, separate out mass crystallization body, isolated by filtration crystalline solid, successively water and washing with acetone crystalline solid, then crystalline solid is carried out to vacuum drying, vacuum drying vacuum is-0.09Mpa, baking temperature is 70 DEG C, be 8 hours drying time, obtains carbazochrome sodium sulfonate, and purity is 99.5%.
Dry carbazochrome sodium sulfonate is ground into superfine powder with multi-grade air current ultra-fine pulverizer, and pulverizing air velocity is 400m/s, and the particle diameter of superfine powder is 0.8～1.5 μ m.
The extraordinary superfine powder 30g of carbazochrome sodium sulfonate is dissolved in to water for injection, adds to 2000ml, after lyophilizing, make 1000 bottles.Mixed liquor carries out low temperature pre-freeze 3 hours at-45 DEG C, then carries out reduced vacuum dry 9 hours at-25 DEG C, finally carries out high temperature drying at 30 DEG C and within 9 hours, makes the extraordinary superfine powder lyophilized formulations of carbazochrome sodium sulfonate.
Embodiment 3
1000 grams of carbazochromes are dissolved in 10 kg water, and add 1200 grams of sodium sulfitees and 500 grams of vitamin Cs to react, when reaction, stir, reaction temperature is 80 DEG C, and the response time is 30 minutes, makes mixed liquor.In mixed liquor, add 32 grams of active carbons to decolour, maintain 80 DEG C of temperature and stir decolouring 40 minutes, after decolouring, filter, obtain filtrate.Sodium hydroxide solution with 20% regulates the pH value to 8 of filtrate, filtrate is lowered the temperature, be down to 5 DEG C and standing 16 hours, separate out mass crystallization body, isolated by filtration crystalline solid, successively water and washing with acetone crystalline solid, then crystalline solid is carried out to vacuum drying, vacuum drying vacuum is-0.095Mpa, baking temperature is 60 DEG C, be 10 hours drying time, obtains carbazochrome sodium sulfonate, and purity is 99.6%.
Dry carbazochrome sodium sulfonate is ground into superfine powder with multi-grade air current ultra-fine pulverizer, and pulverizing air velocity is 450m/s, and the particle diameter of superfine powder is 0.5～1.2 μ m.
The extraordinary superfine powder 40g of carbazochrome sodium sulfonate is dissolved in to water for injection, adds to 2000ml, after lyophilizing, make 1000 bottles.Mixed liquor carries out low temperature pre-freeze 4 hours at-45 DEG C, then carries out reduced vacuum dry 8 hours at-10 DEG C, finally carries out high temperature drying at 28 DEG C and within 10 hours, makes the extraordinary superfine powder lyophilized formulations of carbazochrome sodium sulfonate.
When the particle diameter of the superfine powder of carbazochrome sodium sulfonate is 0.5～3 μ m, can make carbazochrome sodium sulfonate there is good dissolubility.In the time that particle diameter is less than 0.5 μ m, dissolubility no longer increases along with diminishing of particle diameter.Therefore, the particle diameter of the superfine powder of carbazochrome sodium sulfonate employing 0.5～3 μ m is very cost-effective.
Adopt high pressure draught to spray grinding mode and prepare superfine powder, production process is simple and easy to control, can make product fineness reach 0.3～5 μ m, and Granularity Distribution is narrower, and particle surface is smooth, grain shape rule.Adopting air flow multi-stage to pulverize can reasonable energy utilization, less energy consumption, and can control as required sub-micron-powder diameter.
Compared with prior art, the extraordinary superfine powder lyophilized formulations of carbazochrome sodium sulfonate of the present invention has the advantages that stability is high, purity is high, impurity is few, granule is little, specific surface area is large, dissolubility is good, can reduce the use of adjuvant, reduce impurity, reduce toxic and side effects and anaphylaxis, increased safety.Specific surface area is large, and also corresponding increase of surface, makes it have good dispersibility and absorption property.In the time of dosing, can dissolve fully, dissolve rapidly, can improve the utilization rate of effective ingredient, reduce drug consumption, strengthen pharmaceutical effectiveness.Along with diminishing of granularity, the surface atom number of particle is multiplied, and makes it have stronger surface activity and catalytic, more easily absorbs, and easily reaches disease sites, can stop faster the hemorrhage of affected part.Can improve dosing speed, be reduced in dosing process and produce relative substance, improve drug quality.
Claims (10)
1. the extraordinary superfine powder lyophilized formulations of carbazochrome sodium sulfonate, it is characterized in that: the extraordinary superfine powder lyophilized formulations of described carbazochrome sodium sulfonate is taking carbazochrome and sodium sulfite as raw material, after reaction, mixed liquor carries out decolorization filtering, filtrate carries out decrease temperature crystalline, dry after filtration, air flow super, lyophilizing make.
2. a preparation method for the extraordinary superfine powder lyophilized formulations of carbazochrome sodium sulfonate, is characterized in that: the method comprises the steps:
Step 1, carbazochrome is soluble in water, add sodium sulfite to react, make mixed liquor;
Step 2 adds bleaching agent bleaching in mixed liquor, filters, and obtains filtrate;
Step 3, with the pH value of sodium hydroxide adjusting filtrate, lowers the temperature, and crystallization body, filters, washing, and vacuum drying, obtains carbazochrome sodium sulfonate;
Step 4, dry carbazochrome sodium sulfonate is become to superfine powder with comminution by gas stream, then the extraordinary superfine powder of carbazochrome sodium sulfonate is dissolved in to water for injection, carry out low temperature pre-freeze, carry out again low-temperature reduced-pressure vacuum drying, finally carry out high temperature drying and make the extraordinary superfine powder lyophilized formulations of carbazochrome sodium sulfonate.
3. the preparation method of the extraordinary superfine powder lyophilized formulations of carbazochrome sodium sulfonate according to claim 2, is characterized in that: while reaction in described step 1, also adding vitamin C, reaction temperature is 70～80 DEG C, and the response time is 30～50 minutes.
4. the preparation method of the extraordinary superfine powder lyophilized formulations of carbazochrome sodium sulfonate according to claim 2, is characterized in that: in described step 2, depigmenting agent is active carbon, and active carbon weight is mixed liquor 0.15～0.25%.
5. the preparation method of the extraordinary superfine powder lyophilized formulations of carbazochrome sodium sulfonate according to claim 2, it is characterized in that: in described step 3, naoh concentration is 5～20%, the pH value of filtrate is 5～8, and crystallize out temperature is 0～5 DEG C, and the crystallize out time is 8～16 hours.
6. the preparation method of the extraordinary superfine powder lyophilized formulations of carbazochrome sodium sulfonate according to claim 2, is characterized in that: in described step 3, crystalline solid washing is first washed by purified water, then uses washing with acetone; Vacuum drying vacuum is-0.08～0.095Mpa, and baking temperature is 60～80 DEG C, and be 6～10 hours drying time.
7. the preparation method of the extraordinary superfine powder lyophilized formulations of carbazochrome sodium sulfonate according to claim 3, is characterized in that: in described step 1, the weight ratio of carbazochrome, sodium sulfite, vitamin C and water is 1:(0.35～1.2): (0.04～0.5): (3.5～10).
8. the preparation method of the extraordinary superfine powder lyophilized formulations of carbazochrome sodium sulfonate according to claim 2, is characterized in that: in described step 4, the air velocity of comminution by gas stream is 350～450m/s, and the particle diameter of superfine powder is 0.5～3 μ m.
9. the preparation method of the extraordinary superfine powder lyophilized formulations of carbazochrome sodium sulfonate according to claim 8, is characterized in that: in described step 4, comminution by gas stream adopts multi-stage crushing.
10. the preparation method of the extraordinary superfine powder lyophilized formulations of carbazochrome sodium sulfonate according to claim 2, is characterized in that: in described step 4, carbazochrome sodium sulfonate is 20～40g when lyophilizing, and water for injection adds to 2000ml, makes 1000 bottles after lyophilizing; Pre-freeze temperature is-45 DEG C, and the pre-freeze time is 2～4 hours; The dry temperature of reduced vacuum is-45～-10 DEG C, and be 8～10 hours drying time; High temperature drying temperature is 28～35 DEG C, and be 8～10 hours drying time.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104800172A (en) * | 2015-05-26 | 2015-07-29 | 成都天台山制药有限公司 | Carbazochrome sodium sulfonate powder injection for injection and preparation method thereof |
| CN105434371A (en) * | 2015-12-29 | 2016-03-30 | 江苏吴中医药集团有限公司 | Carbazochrome sodium sulfonate freeze-dried powder injection and preparation method thereof |
| CN107382818A (en) * | 2017-08-03 | 2017-11-24 | 江苏汉斯通药业有限公司 | A kind of synthetic method of high cleanliness Carbazochrome Sodium Sulfonate |
| CN108938626A (en) * | 2018-07-27 | 2018-12-07 | 四川联成迅康医药股份有限公司 | A kind of good and highly-safe Carbazochrome sodium sulfonate pharmaceutical composition and its preparation method and application of stability |
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| CN102210656A (en) * | 2011-04-12 | 2011-10-12 | 罗诚 | Medicinal composition containing carbazochrome sodium sulfonate compound and preparation method thereof |
| CN102757378A (en) * | 2012-07-06 | 2012-10-31 | 江苏汉斯通药业有限公司 | Preparation method of carbazochrome sodium sulfonate |
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| CN1562001A (en) * | 2004-03-29 | 2005-01-12 | 南昌弘益科技有限公司 | Carbazochrome sodium sulfoate dripping pill and its preparing method |
| CN102210656A (en) * | 2011-04-12 | 2011-10-12 | 罗诚 | Medicinal composition containing carbazochrome sodium sulfonate compound and preparation method thereof |
| CN102757378A (en) * | 2012-07-06 | 2012-10-31 | 江苏汉斯通药业有限公司 | Preparation method of carbazochrome sodium sulfonate |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104800172A (en) * | 2015-05-26 | 2015-07-29 | 成都天台山制药有限公司 | Carbazochrome sodium sulfonate powder injection for injection and preparation method thereof |
| CN105434371A (en) * | 2015-12-29 | 2016-03-30 | 江苏吴中医药集团有限公司 | Carbazochrome sodium sulfonate freeze-dried powder injection and preparation method thereof |
| CN108743550A (en) * | 2015-12-29 | 2018-11-06 | 江苏吴中医药集团有限公司 | A kind of preparation method of carbazochrome sodium sulfonate freeze-dried powder injection agent |
| CN107382818A (en) * | 2017-08-03 | 2017-11-24 | 江苏汉斯通药业有限公司 | A kind of synthetic method of high cleanliness Carbazochrome Sodium Sulfonate |
| CN108938626A (en) * | 2018-07-27 | 2018-12-07 | 四川联成迅康医药股份有限公司 | A kind of good and highly-safe Carbazochrome sodium sulfonate pharmaceutical composition and its preparation method and application of stability |
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