CN101036654B - Stable cefoperazone sulbactam medicine compound preparation - Google Patents
Stable cefoperazone sulbactam medicine compound preparation Download PDFInfo
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- CN101036654B CN101036654B CN2006100343153A CN200610034315A CN101036654B CN 101036654 B CN101036654 B CN 101036654B CN 2006100343153 A CN2006100343153 A CN 2006100343153A CN 200610034315 A CN200610034315 A CN 200610034315A CN 101036654 B CN101036654 B CN 101036654B
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Abstract
The invention discloses a stable compound preparation of cefoperazone-sulbactam drug, which is comprised by cefoperazone acid, sulbactam and latent solvent, which weight ratio is 8~1:1:6~0.06. The latent solvent is preferred selected from sodium carbonate and sodium bicarbonate. Related substances of the compound preparation in the invention are lower than standard of Chinese pharmacopoeia (2005 edition) in influencing factor and accelerated test in 40 DEG C, labelled content accords with the standard of the pharmacopoeia and changes very little in the experiment, and the product quality is more stable than cefoperazone sodium and sulbac during period of validity.
Description
Technical field
The present invention relates to the drug compound preparation of cefoperazone, specifically relate to the stable cefoperazone for inj sulbactam compound preparation that clinical use has synergistic function.
Technical background
The compound recipe of cefoperazone for inj sodium and sulbactam sodium enters China the nineties, now recorded in Chinese Pharmacopoeia (2005 editions).Because cephalo is sent the less stable of ketone sodium,, must preserve at the cold place of drying for guaranteeing that product is qualified before the deadline.And after being combined into compound recipe with sulbactam sodium, stability does not improve, so change the preservation condition of Chinese Pharmacopoeia (2000 editions) into Chinese Pharmacopoeia (2005 editions) " preserving at cold place " by " dark dry place preserves in cold ", this is the weak point of all compound preparations of cefoperazone sodium.
At present, cefoperazone acid is because its water-fast characteristic, generally use clinically.But, can draw cefoperazone acid ratio cefoperazone stable sodium by on the contrast test to cephalo piperazine keto acid and cefoperazone sodium.Because playing the main component of curative effect effect clinically is cefoperazone, therefore,, makes cefoperazone acid and cosolvent after share, reach the clinical efficacy of cefoperazone sodium, and meet the safety of clinical administration requirement by the effect of cosolvent to cephalo piperazine keto acid.
In addition, cosolvent commonly used clinically mainly is: natrium carbonicum calcinatum, arginine.The sodium bicarbonate aseptic powder is carried out aseptic mixed powder as medicine as cosolvent and cephalo-type or penicillins, does not see the relevant report of clinical use.But from the experiment of the study on the stability of cephalo piperazine keto acid and cosolvent, and the technological operation of mixed powder flow path is simple and feasible draws most preferably that cosolvent is: sodium bicarbonate.
Summary of the invention
At this weak point of cefoperazone sodium poor stability, the object of the invention is to provide the compositions of cefoperazone acid and sulbactam and cosolvent, and it preserves steady quality at room temperature, and clinical use dissolving rapidly.
Technical solution of the present invention is: stable cefoperazone sulbactam medicine compound preparation, it is characterized in that mainly forming by cefoperazone acid, sulbactam and cosolvent, and three's weight ratio is: 8～1: 1: 6.0～0.06.
Described cefoperazone sulbactam medicine compound preparation is characterized in that sulbactam is sulbactam acid or sulbactam sodium.
Described cosolvent is one or several a mixture of sodium carbonate, sodium bicarbonate, arginine, sodium hydroxide, sodium phosphate, sodium hydrogen phosphate.
Described cosolvent preferentially is selected from sodium carbonate, sodium bicarbonate, especially preferentially is selected from sodium bicarbonate.
Compound preparation of the present invention also comprises pharmaceutically useful stabilizing agent, as EDTA etc.
PH value with the control product during prescription of screening compound preparation is a standard, and pH value is low excessively, and cefoperazone dissolving not exclusively; PH value is too high, and the product solution color is obviously deepened, and influences product stability, is unfavorable for clinical practice simultaneously.Therefore add the amount of cosolvents such as sodium carbonate or sodium bicarbonate, cefoperazone is dissolved rapidly, can make its solution reach stable suitable pH value again, simultaneously, also will take into account the drug safety of product.General injection pH requires between 3～10, can not peracid or cross alkali, otherwise can cause the stimulation pain or the necrosis of local organization.Require pH between 4～9 for a large amount of intravenous fluids, otherwise after a large amount of intravenous injection the acid of causing, alkalotic danger are arranged.Guaranteeing safety, effectively, under stable, the quality controllable prerequisite of product, the scope of the pH value of this product is decided to be 5.5～7.5.
Obtain technical scheme of the present invention according to above-mentioned pH value scope screening pharmaceutical formulation:
Cefoperazone sulbactam medicine compound preparation is characterized in that cefoperazone acid: sulbactam sodium: the weight ratio of sodium bicarbonate is: 8～1: 1: 2.4～0.13.
Cefoperazone acid in the above-mentioned prescription: sulbactam sodium: the preferred weight ratio of sodium bicarbonate is: 2～1: 1: 0.54～0.13.
Further preferred weight ratio is: 1: 1: 0.25～0.13 or 2: 1: 0.54～0.28.
Preferred weight ratio is 1: 1: 0.1 8 or 2: 1: 0.38.
Described cefoperazone sulbactam medicine compound preparation is characterized in that cefoperazone acid: sulbactam sodium: the weight ratio of sodium carbonate is: 8～1: 1: 1.0～0.08.Preferable range is: 1: 1: 0.115～0.082 and 2: 1: 0.22～0.17, and preferred 1: 1: 0.09 and 2: 1: 0.18.
Cosolvent also can be selected pharmaceuticals industries such as arginine, sodium hydroxide cosolvent commonly used for use in the technical solution of the present invention, and the prescription of selected above-mentioned its compound preparation of cosolvent is: cefoperazone acid: sulbactam sodium: arginic weight ratio is: 8～1: 1: 2.3～0.27; Cefoperazone acid: sulbactam sodium: the weight ratio of sodium hydroxide is: 8～1: 1: 0.5～0.06; Cefoperazone acid: sulbactam sodium: the weight ratio of sodium phosphate is: 8～1: 1: 3.4～0.4; Cefoperazone acid: sulbactam sodium: the weight ratio of sodium hydrogen phosphate is: 8～1: 1: 4.5～0.5.
Sulbactam can be selected from sulbactam acid in the technical solution of the present invention, and described cefoperazone sulbactam medicine compound preparation is characterized in that cefoperazone acid: sulbactam acid: the weight ratio of sodium bicarbonate is: 8～1: 1: 4.7～0.5; Preferred 2～1: 1: 1.16～0.6; More preferably 2: 1: 1.08 or 1: 1: 0.64.
Above-mentioned cefoperazone sulbactam medicine compound preparation, the proportioning when being selected from sodium carbonate and being cosolvent is cefoperazone acid: sulbactam acid: the weight ratio of sodium carbonate is: 8～1: 1: 3.6～0.3; Preferred 2: 1: 0.6 or 1: 1: 0.34.
When selecting other cosolvent for use, described cefoperazone sulbactam medicine compound preparation is characterized in that cefoperazone acid: sulbactam acid: arginic weight ratio is: 8～1: 1: 3.0～1.0; Cefoperazone acid: sulbactam acid: the weight ratio of sodium hydroxide is: 8～1: 1: 0.7～0.2; Cefoperazone acid: sulbactam acid: the weight ratio of sodium phosphate is: 8～1: 1: 4.6～1.6; Cefoperazone acid: sulbactam acid: the weight ratio of sodium hydrogen phosphate is: 8～1: 1: 6.0～2.0.
Above-mentioned compound preparation component is sterile preparation.Promptly under the sterile production environmental condition, with degerming, remove thermal source aseptic component fully mixed, by mechanical packing, preparation 0.5 gram, 0.75 gram, 1 gram, 1.5 grams, 2 grams, 2.5 grams, 3 grams or 4 gram dress injectable powder.During clinical use, add injection water dissolved dilution and get final product.
To mix the powder pH value be feature to control in the preparation of above-mentioned compound preparation, and mixing powder dissolving back pH value is 5.5～7.5, and preferred pH value is 6.0～7.0.
Described cefoperazone sulbactam medicine compound preparation is characterized in that the preparation for a kind of parenterai administration, is preferably a kind of injection.
The present invention also comprises the application of described cefoperazone sulbactam medicine compound preparation in the medicine of preparation bacterial infection.
Preparating mechanism of the present invention is cosolvents such as cefoperazone acid-utilising sodium bicarbonate, and water-fast cefoperazone acid can be reacted rapidly in water with cosolvent, generates water-soluble cefoperazone sodium.
With the sodium bicarbonate is example, the relation of the addition of the sodium bicarbonate of cefoperazone compositions of the present invention, pH value, dissolution velocity:
1) addition of pH value and sodium bicarbonate is proportionate, and the amount that sodium bicarbonate adds is many more, and pH value is high more.
2) addition of dissolution time and pH, sodium bicarbonate is negative correlation, and the amount that adds sodium bicarbonate is many more, and pH value is high more, and the dissolving required time is just short more, helps more shortening the clinical pharmacy time.
3) addition of appearance luster and pH value, sodium bicarbonate is proportionate, and the amount that adds sodium bicarbonate is many more, and pH value is high more, and solution colour is dark more, illustrates that pH value is high more, and sample is just unstable more in aqueous solution.
Cefoperazone compositions of the present invention is respectively in cephalo piperazine keto acid: sulbactam sodium: the ratio of sodium bicarbonate is fed intake in 1: 1: 0.18 and 2: 1: 0.38 preparation of making 1.0g specification (cefoperazone 0.5g+ sulbactam 0.5g) and the preparation of 1.5g (cefoperazone 1.0g+ sulbactam 0.5g), carries out tests such as influence factor's test, accelerated test according to Chinese Pharmacopoeia with the compound preparation product of existing " cefoperazone for inj sodium and sulbactam sodium " and obtains following correction data.
Subordinate list 1 influence factor's experimental examination data
Annotate: A is cefoperazone sodium+sulbactam sodium, and specification is 1.0g (cefoperazone 0.5g+ sulbactam 0.5g); B is cefoperazone acid+sulbactam sodium+NaHCO
3, specification is 1.0g (cefoperazone 0.5g+ sulbactam 0.5g).
2 40 ℃ of accelerated tests of subordinate list (40 ± 2 ℃, relative humidity 60% ± 5%) testing data
Annotate: injection .. cefoperazone acid sulbactam sodium preparation specification is: 1.0g (cefoperazone 0.5g+ sulbactam 0.5g); The preparation specification of cefoperazone for inj sodium and sulbactam sodium is: 1.0g (cefoperazone 0.5g+ sulbactam 0.5g).
Subordinate list 3 influence factor's experimental examination data
Annotate: C is cefoperazone sodium+sulbactam sodium, and specification is 1.5g (cefoperazone 1.0g+ sulbactam 0.5g); D is cefoperazone acid+sulbactam sodium+NaHCO
3, specification is 1.5g (cefoperazone 1.0g+ sulbactam 0.5g).
4 40 ℃ of accelerated tests of subordinate list (40 ± 2 ℃, relative humidity 60% ± 5%) testing data
Annotate: above cefoperazone for inj acid sulbactam sodium specification is 1.5g (cefoperazone 1.0g+ sulbactam 0.5g); The specification of cefoperazone for inj sodium and sulbactam sodium is 1.5g (cefoperazone 1.0g+ sulbactam 0.5g).
Can sum up from above-mentioned subordinate list, in influence factor's test, the related substance of cefoperazone sodium+sulbactam sodium obviously rises, and indicates content and obviously descends.Be higher than 05 edition standards of pharmacopoeia at 60 ℃ of related substances 10 days the time, indicated content and descended about 9%.The related substance of cefoperazone acid+sulbactam sodium+sodium bicarbonate and sign content then change not quite, illustrate that it is more stable than cefoperazone sodium+sulbactam sodium.Quicken in the contrast test at 40 ℃, cefoperazone sodium+sulbactam sodium is along with the time, and related substance is high more, and sign content is low more.When 3 months and 6 months, related substance has exceeded standards of pharmacopoeia; Indicate content in the time of 6 months and more be lower than 90%.Cefoperazone acid+sulbactam sodium+sodium bicarbonate quickens in the contrast test at 40 ℃, and related substance and sign content also increase to some extent and reduces, but still meet standards of pharmacopoeia, and 6 months related substance is about 2.2%; Indicate content and be about 99%, illustrated that cefoperazone acid+sulbactam sodium+sodium bicarbonate is more stable.The compound preparation that proves cefoperazone acid+sulbactam sodium of the present invention+cosolvent thus is stable than the compound preparation of cefoperazone sodium+sulbactam sodium before the deadline.
Specific embodiment
Be the specific embodiment of the invention below, but the present invention is not limited thereto.
The different proportionings of cefoperazone of the present invention acid and sulbactam and cosolvent, and correlation circumstance (pH value, dissolution time, solution colour).
As seen from the above table: what dissolution time was the shortest is: sodium bicarbonate, sodium carbonate, sodium hydroxide.Medicine dissolution is fast more clinically, can shorten time of compounding more, is convenient to clinical practice.Therefore, analyze from the dissolution velocity of medicine, the stability and the drug safety each side of medicine: sodium bicarbonate is the best cosolvent of preparation cefoperazone for inj sulbactam compound preparation.
Embodiment 1:
Cefoperazone acid is 1: 1 o'clock with the sulbactam sodium mass ratio, the proportioning of sodium bicarbonate and the pH value of hydrotropy:
| Cefoperazone acid: sodium bicarbonate (mass ratio) | PH value | Appearance luster | Dissolution time |
| 1∶0.12 | － | － | － |
| 1∶0.13 | 5.52 | Be not deeper than yellow No. 1 color | 60S |
| 1∶0.14 | 6.16 | Be not deeper than yellow No. 1 color | 58S |
| 1∶0.15 | 6.28 | Be not deeper than yellow No. 1 color | 50S |
| 1∶0.16 | 6.33 | Be not deeper than yellow No. 1 color | 50S |
| 1∶0.17 | 6.46 | Be not deeper than yellow No. 1 color | 45S |
| 1∶0.18 | 6.51 | Be not deeper than yellow No. 1 color | 30S |
| 1∶0.19 | 6.76 | Be not deeper than yellow No. 1 color | 30S |
| 1∶0.21 | 6.88 | Be not deeper than yellow No. 1 color | 28S |
| 1∶0.22 | 6.91 | Be not deeper than yellow No. 2 colors | 25S |
| 1∶0.23 | 7.07 | Be not deeper than yellow No. 2 colors | 25S |
| 1∶0.25 | 7.48 | Be equivalent to yellow No. 2 colors | 20S |
| 1∶0.26 | 7.64 | Be equivalent to yellow No. 2 colors | <20S |
As seen from the above table, press pH scope 5.5～7.5, cefoperazone acid: sulbactam sodium: the span of sodium bicarbonate: 1: 1: 0.25～0.13.Its color all is not deeper than yellow No. 3 colors, and dissolution time is not more than 60S.
Embodiment 2:
Cefoperazone acid is 1: 1 o'clock with the sulbactam sodium mass ratio, the proportioning of sodium carbonate and the pH value of hydrotropy:
| Cefoperazone acid: sodium carbonate (mass ratio) | PH value | Appearance luster | Dissolution time (second) |
| 1∶0.080 | 4.86 | Be not deeper than yellow No. 1 color | 60S |
| 1∶0.082 | 5.54 | Be not deeper than yellow No. 1 color | 58S |
| 1∶0.083 | 5.82 | Be not deeper than yellow No. 1 color | 58S |
| 1∶0.086 | 6.04 | Be not deeper than yellow No. 1 color | 50S |
| 1∶0.087 | 6.22 | Be not deeper than yellow No. 1 color | 50S |
| 1∶0.088 | 6.30 | Be not deeper than yellow No. 1 color | 48S |
| 1∶0.090 | 6.51 | Be not deeper than yellow No. 1 color | 40S |
| 1∶0.091 | 6.68 | Be not deeper than yellow No. 1 color | 38S |
| 1∶0.093 | 6.79 | Be not deeper than yellow No. 1 color | 38S |
| 1∶0.105 | 6.88 | Be not deeper than yellow No. 1 color | 25S |
| 1∶0.115 | 7.25 | Be not deeper than yellow No. 2 colors | 20S |
| 1∶0.120 | 7.56 | Be not deeper than yellow No. 2 colors | <20S |
As seen from the above table, press pH scope 5.5～7.5, cefoperazone acid: sulbactam sodium: the span of sodium carbonate: 1: 1: 0.115～0.082.Its color all is not deeper than yellow No. 2 colors, and dissolution time is not more than 60S.
Embodiment 3:
Cefoperazone acid is 2: 1 o'clock with the sulbactam sodium mass ratio, the proportioning of sodium bicarbonate and the pH value of hydrotropy:
| Cefoperazone acid: carbon acid sodium (mass ratio) | PH value | Appearance luster | The dissolving situation |
| 2∶0.27 | － | － | － |
| 2∶0.28 | 5.78 | Be not deeper than yellow No. 1 color | 60S |
| 2∶0.30 | 6.14 | Be not deeper than yellow No. 1 color | 40S |
| 2∶0.32 | 6.27 | Be not deeper than yellow No. 1 color | 40S |
| 2∶0.34 | 6.36 | Be not deeper than yellow No. 1 color | 35S |
| 2∶0.38 | 6.58 | Be not deeper than yellow No. 1 color | 30S |
| 2∶0.42 | 6.88 | Be not deeper than yellow No. 1 color | 29S |
| 2∶0.46 | 6.98 | Be not deeper than yellow No. 1 color | 25S |
| 2∶0.50 | 7.12 | Be not deeper than yellow No. 1 color | 20S |
| 2∶0.54 | 7.48 | Be not deeper than yellow No. 2 colors | <20S |
| 2∶0.55 | 7.67 | Be equivalent to yellow No. 2 colors | <20S |
As seen from the above table, press pH scope 5.5～7.5, cefoperazone acid: sulbactam sodium: the span of sodium bicarbonate: 2: 1: 0.54～0.28.Its color all is not deeper than yellow No. 3 colors, and dissolution time is not more than 60S.
Embodiment 4:
Cefoperazone acid is 2: 1 o'clock with the sulbactam sodium mass ratio, the proportioning of sodium carbonate and the pH value of hydrotropy:
| Cefoperazone acid: sodium carbonate (mass ratio) | PH value | Appearance luster | Dissolution time |
| 2∶0.16 | 4.48 | Be not deeper than yellow No. 1 color | 80S |
| 1∶0.17 | 5.57 | Be not deeper than yellow No. 1 color | 60S |
| 1∶0.18 | 6.48 | Be not deeper than yellow No. 1 color | 30S |
| 1∶0.19 | 6.76 | Be not deeper than yellow No. 1 color | 25S |
| 1∶0.20 | 6.88 | Be not deeper than yellow No. 1 color | 25S |
| 1∶0.21 | 6.93 | Be not deeper than yellow No. 1 color | 25S |
| 1∶0.22 | 7.23 | Be not deeper than yellow No. 2 colors | 20S |
| 1∶0.23 | 7.58 | Be not deeper than yellow No. 2 colors | <20S |
As seen from the above table, press pH scope 5.5～7.5, cefoperazone acid: sulbactam sodium: the span of sodium carbonate: 2: 1: 0.22～0.17.Its color all is not deeper than yellow No. 3 colors, and dissolution time is not more than 60S.
Embodiment 5:
Cefoperazone acid is 1: 1 o'clock with sulbactam acid mass ratio, the proportioning of sodium bicarbonate and the pH value of hydrotropy:
| Cefoperazone acid: sulbactam acid: sodium bicarbonate (mass ratio) | PH value | Appearance luster | Dissolution time |
| 1∶1∶0.59 | 5.00 | Be not deeper than yellow No. 1 color | 150s |
| 1∶1∶0.60 | 5.58 | Be not deeper than yellow No. 1 color | 100s |
| 1∶1∶0.62 | 6.18 | Be not deeper than yellow No. 1 color | 80s |
| 1∶1∶0.64 | 6.55 | Be not deeper than yellow No. 1 color | 60s |
| 1∶1∶0.66 | 6.62 | Be not deeper than yellow No. 1 color | 60s |
| 1∶1∶0.68 | 6.70 | Be not deeper than yellow No. 1 color | 50s |
| 1∶1∶0.70 | 6.95 | Be not deeper than yellow No. 1 color | 30s |
| 1∶1∶0.75 | 7.11 | Be not deeper than yellow No. 1 color | 30s |
| 1∶1∶0.80 | 7.23 | Be not deeper than yellow No. 2 colors | 25s |
| 1∶1∶0.85 | 7.56 | Be equivalent to yellow No. 2 colors | <20S |
As seen from the above table, press pH scope 5.5～7.5, cefoperazone acid: sulbactam acid: the span of sodium bicarbonate: 1: 1: 0.8～0.6.Its color all is not deeper than yellow No. 3 colors, and dissolution time is not more than 100S.
Embodiment 6:
Cefoperazone acid is 1: 1 o'clock with sulbactam acid mass ratio, the DH value of the proportioning of sodium carbonate and hydrotropy:
| Cefoperazone acid: sulbactam acid: sodium bicarbonate (mass ratio) | PH value | Appearance luster | Dissolution time |
| 1∶1∶0.29 | － | － | － |
| 1∶1∶0.30 | 5.52 | Be not deeper than yellow No. 1 color | 100s |
| 1∶1∶0.32 | 6.00 | Be not deeper than yellow No. 1 color | 100s |
| 1∶1∶0.33 | 6.28 | Be not deeper than yellow No. 1 color | 80s |
| 1∶1∶0.34 | 6.50 | Be not deeper than yellow No. 1 color | 60s |
| 1∶1∶0.35 | 6.66 | Be not deeper than yellow No. 1 color | 60s |
| 1∶1∶0.36 | 6.71 | Be not deeper than yellow No. 1 color | 50s |
| 1∶1∶0.37 | 6.91 | Be not deeper than yellow No. 1 color | 30s |
| 1∶1∶0.38 | 7.01 | Be not deeper than yellow No. 1 color | 30s |
| 1∶1∶0.40 | 7.11 | Be not deeper than yellow No. 2 colors | 25s |
| 1∶1∶0.41 | 7.76 | Be equivalent to yellow No. 2 colors | <20S |
As seen from the above table, press pH scope 5.5～7.5, cefoperazone acid: sulbactam acid: the span of sodium carbonate: 1: 1: 0.4～0.3.Its color all is not deeper than yellow No. 3 colors, and dissolution time is not more than 100S.
Claims (2)
1. stable cefoperazone sulbactam medicine compound preparation, it is characterized in that described compound preparation contains cefoperazone acid, sulbactam sodium and sodium bicarbonate or sodium carbonate, the three's of described cefoperazone acid, sulbactam sodium and sodium bicarbonate weight ratio is 2～1: 1: 0.54～0.28, or described compound preparation contains cefoperazone acid, sulbactam sodium and sodium carbonate, three's weight ratio is 2～1: 1: 0.22～0.17, and the above compound preparation is that pH reaches 5.5～7.5 injection.
2. stable cefoperazone sulbactam medicine compound preparation, it is characterized in that described compound preparation contains cefoperazone acid, sulbactam acid and sodium bicarbonate or sodium carbonate, the three's of described cefoperazone acid, sulbactam acid and sodium bicarbonate weight ratio is 1: 1: 0.8～0.6, or described compound preparation contains cefoperazone acid, sulbactam acid and sodium carbonate, three's weight ratio is 1: 1: 0.4～0.3, and the above compound preparation is that pH reaches 5.5～7.5 injection.
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| CN101912403B (en) * | 2010-08-02 | 2012-01-11 | 陶灵刚 | Cefoperazone sodium and tazobactam sodium medicinal composition microsphere injection |
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