CN101596168A - Lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection and preparation method and packing method thereof - Google Patents
Lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection and preparation method and packing method thereof Download PDFInfo
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- CN101596168A CN101596168A CNA2009100321891A CN200910032189A CN101596168A CN 101596168 A CN101596168 A CN 101596168A CN A2009100321891 A CNA2009100321891 A CN A2009100321891A CN 200910032189 A CN200910032189 A CN 200910032189A CN 101596168 A CN101596168 A CN 101596168A
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Abstract
The invention discloses a kind of lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection and preparation method and packing method thereof.Be dissolved in the water for injection by corresponding local anaesthetics-glucose, add activated carbon adsorption, decarbonization filtering, 0.22 μ m filtering with microporous membrane, gained filtrate is sub-packed in aseptic cillin bottle or the easy cut ampule by specification under aseptic condition again, gets lyophilized powder through vacuum lyophilization; Adopt plastic cement aluminium lid cillin bottle to seal then or cassette bottle closure or easy cut ampule technology with ampule sealing, labeling, the lumbar anesthesia dedicated offices of must sterilizing anaesthetic-glucose lyophilized powder injection; A lumbar anesthesia medication unit is dressed up in the outsourcing of sterilizing again after lyophilized injectable powder and coordinative solvent take pre-encapsulated injector technology to pack.Advantage is to reduce anesthesia doctor's workload to greatest extent, avoids taking out that oxidation Decomposition and impurity produce under the generation of medicine mistake and accident and the High Temperature High Pressure.
Description
Technical field
A kind of lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection preparation method and technology of the package thereof.It is characterized in that it provides a kind of preparation method that contains four kinds of local anaesthetics-glucose lyophilized powder injections clinical commonly used (the special-purpose bupivacaine-glucose of lumbar anesthesia, chirocaine-glucose, ropivacaine-glucose or tetracaine-glucose lyophilized powder injection, cillin bottle or easy cut ampule packing) of lumbar anesthesia dosage; Solvent is water for injection 3ml (cillin bottle or cassette bottle or an easy cut ampule packing); And adopt the sterilization outsourcing to dress up a lumbar anesthesia medication unit.A lumbar anesthesia medication unit is dressed up in the outsourcing of sterilizing again after lyophilized injectable powder and coordinative solvent also can take pre-encapsulated injector technology to pack, for using in clinical lumbar anesthesia or the waist-hard combined anesthesia.
Background technology
The spinal anesthesia neural complication is with local anaesthetics dosage form, concentration, pH value, proportion (cerebrospinal fluid relatively) and whether contain the closely related of other composition such as preservative.There is following defective in homemade commercially available local anaesthetics injection at present: 1. be injection dosage form stability relative mistake.For increasing the stability of injection dosage form, take to regulate the method for pH or adding stabilizing agent with hydrochloric acid more.And the low pH value of local anaesthetics may be one of reason that causes spinal nerve injury, and therefore homemade local anaesthetics injection description all marks and is not proposed to be used in the ridge fiber crops.2. be that the aseptic packaging design is not all taked in the outer package of injection ampoule, the aseptic medicine inconvenience of taking out in the ridge fiber crops implementation process.3. the defective of non-easy cut ampule is, opening Shi Junyou behind the husky wheel saw increases glass granules and fall into possibility in the local anaesthesia medicinal liquid.4. commercially available local anaesthetics minimum package dosage all is unsuitable for the ridge fiber crops, adds diluent in addition after all needing to extract, and has prolonged the operation time-histories, has increased infection chance.
Clinical lumbar anesthesia prescription commonly used is: 1. 0.75% bupivacaine 2ml (15mg)+10%GS 1ml (anharmonic ratio heavy) or directly extract 1ml cerebrospinal fluid (waiting proportion) dilution; 2. 0.75% chirocaine 2ml (15mg)+10%GS 1ml (anharmonic ratio heavy) or directly extract 1ml cerebrospinal fluid (waiting proportion) dilution; 3. 0.75% ropivacaine 2ml (15mg)+10%GS 1ml (anharmonic ratio heavy) or directly extract 1ml cerebrospinal fluid (waiting proportion) dilution; 4. 1% tetracaine 1ml (10mg)+10%GS 1ml+1ml ephedrine (30mg) dilution (anharmonic ratio is heavy).It is loaded down with trivial details relatively when these medicines face with preceding extraction; And add in the local anaesthesia medicinal liquid sometimes that the vascular effect that contracts after vaso-excitor material thing epinephrine or the ephedrine has the hidden danger of potential anterior spinal artery ischemia and the spinal nerves toxicity that increases local anaesthetics.
Summary of the invention
For overcoming the drawback of above-mentioned lumbar anesthesia, the invention provides a kind of lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection and preparation method, adopt sterilizing packing process that its sterilization packaging is used to make things convenient for directly to open in the anesthesia process to place to extract fast on the anesthetic puncture platform in an aseptic package bag, reduce anesthesia doctor's workload to greatest extent, avoid taking out that oxidation Decomposition and impurity produce under the generation of medicine mistake and accident and the High Temperature High Pressure.
The present invention realizes with following technical scheme: a kind of lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection, be dissolved in the water for injection by corresponding local anaesthetics-glucose, add activated carbon adsorption, decarbonization filtering, 0.22 μ m filtering with microporous membrane, gained filtrate is sub-packed in aseptic cillin bottle or cassette bottle or the easy cut ampule by specification under aseptic condition again, gets lyophilized powder through vacuum lyophilization; Adopt plastic cement aluminium lid cillin bottle to seal then or cassette bottle closure or easy cut ampule technology with ampule sealing, labeling, lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection obtains sterilizing; Described corresponding local anaesthetics-glucose is bupivacaine-glucose or chirocaine-glucose or ropivacaine-glucose or tetracaine-glucose.
Described lumbar anesthesia bupivacaine-glucose lyophilized powder injection, its hydrochloric bupivacaine 5-15mg, glucose 100-150mg.
Described lumbar anesthesia chirocaine-glucose lyophilized powder injection, its hydrochloric chirocaine 5-15mg, glucose 100-150mg.
Described lumbar anesthesia ropivacaine-glucose lyophilized powder injection, its hydrochloric ropivacaine 5-15mg, glucose 100-150mg.
Described lumbar anesthesia tetracaine-glucose lyophilized powder injection, its hydrochloric tetracaine 5-10mg, glucose 100-150mg.
A kind of preparation method of lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection, by the prescription proportioning corresponding local anaesthetics-glucose is dissolved in the water for injection, add activated carbon adsorption, decarbonization filtering, 0.22 μ m filtering with microporous membrane, gained filtrate is sub-packed in aseptic cillin bottle or cassette bottle or the easy cut ampule by aforementioned dose specification under aseptic condition again, gets lyophilized powder through vacuum lyophilization; Adopt plastic cement aluminium lid cillin bottle to seal then or cassette bottle closure or easy cut ampule technology with ampule sealing, labeling, lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection obtains sterilizing; Described vacuum freeze-drying method is: 1. elder generation's quick-freeze pre-freeze under-40 ℃～-60 ℃ ultralow temperature became tiny crystallization in 2 hours; 2. under vacuum, be warming up to-20 ℃ of constant temperature sublimation dryings again 12 hours; 3. be warming up to 20 ℃ of continuation vacuum dryings then 12 hours.
A kind of packing method of lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection, adopt plastic cement aluminium lid cillin bottle to seal the above-mentioned lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection or cassette bottle closure or easy cut ampule technology with ampule sealing, labeling; Its local anaesthetics solvent is water for injection 3ml, and sterilization is sub-packed in the aseptic cillin bottle (or easy cut ampule) seals labeling.Special-purpose bupivacaine-glucose lyophilized powder injection of the lumbar anesthesia of preparation and sterilized water for injection each 1 bottle (propping up) are attached together lumbar anesthesia medication unit of formation in a medical sterilization packaging bag (box); Oxirane or illumination sterilization, signature.
A kind of packing method of lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection, also above-mentioned lyophilized injectable powder of preparing and coordinative solvent can be taked pre-encapsulated injector technology packing: lyophilized powder and solvent are separated technology packing and sterilization in a syringe, time spent is aseptic takes the back apart as long as one push away the push rod of syringe, and solvent and lyophilized powder are that compounding is spared after lumbar anesthesia puncture needle direct injection.
Owing to adopted technique scheme, the invention has the beneficial effects as follows: the local anaesthetics lyophilized injectable powder of vacuum dehydrating at lower temperature technology preparation has been avoided oxidation Decomposition and impurity generation under the High Temperature High Pressure.Its medicine loading amount specifications design rationally, can not cause the mistake of lumbar anesthesia dosage, is convenient to check effect duration and receives medicine and check (outer package can observably identify), makes things convenient in the lumbar anesthesia art aseptic unlatching to get it filled to extract rapidly and uses.
The specific embodiment
Embodiment 1
Prescription: bupivacaine hydrochloride 1.5g
Glucose 10g
Water for injection 300ml
Special-purpose 100 bottles of the bupivacaine-glucose lyophilized powder injections (propping up) of lumbar anesthesia
Preparation method: take by weighing bupivacaine hydrochloride 1.5g, glucose 10g is dissolved in the 300ml water for injection fully, adds activated carbon adsorption, decarbonization filtering, 0.22 μ m filtering with microporous membrane; Gained filtrate equalization under aseptic condition is sub-packed in 100 bottles of (propping up) aseptic cillin bottles (or easy cut ampule), vacuum lyophilization: 1. first ultralow temperature quick-freeze pre-freeze 2 hours (40 ℃～-60 ℃) becomes tiny crystallization, 2. be warming up to-20 ℃ of constant temperature sublimation dryings under the vacuum 12 hours, 3. be warming up to 20 ℃ of continuation vacuum dryings 12 hours; 4. adopt plastic cement aluminium lid cillin bottle to seal or cassette bottle closure or easy cut ampule technology with ampule sealing, labeling; Its local anaesthetics solvent is water for injection 3ml, and sterilization is sub-packed in 100 bottles of (propping up) aseptic cillin bottles (or cassette bottle or easy cut ampule) seals labeling.Special-purpose bupivacaine-glucose lyophilized powder injection of the lumbar anesthesia of preparation and sterilized water for injection each 1 bottle (propping up) are attached together lumbar anesthesia medication unit of formation in a medical sterilization packaging bag (box); Oxirane or illumination sterilization, signature.
Embodiment 2
Prescription: levobupivacaine hydrochloride 1.5g
Glucose 10g
Water for injection 300ml
Special-purpose 100 bottles of the chirocaine-glucose lyophilized powder injections (propping up) of lumbar anesthesia
Preparation method: take by weighing levobupivacaine hydrochloride 1.5g, glucose 10g is dissolved in the 300ml water for injection fully, adds activated carbon adsorption, decarbonization filtering, 0.22 μ m filtering with microporous membrane; Gained filtrate equalization under aseptic condition is sub-packed in 100 bottles of (propping up) aseptic cillin bottles (or cassette bottle or easy cut ampule), vacuum lyophilization: 1. first ultralow temperature quick-freeze pre-freeze 2 hours (40 ℃～-60 ℃) becomes tiny crystallization, 2. be warming up to-20 ℃ of constant temperature sublimation dryings under the vacuum 12 hours, 3. be warming up to 20 ℃ of continuation vacuum dryings 12 hours; 4. adopt plastic cement aluminium lid cillin bottle to seal or cassette bottle closure or easy cut ampule technology with ampule sealing, labeling; Its local anaesthetics solvent is water for injection 3ml, and sterilization is sub-packed in 100 bottles of (propping up) aseptic cillin bottles (or cassette bottle or easy cut ampule) seals labeling.Special-purpose chirocaine-glucose lyophilized powder injection of the lumbar anesthesia of preparation and sterilized water for injection each 1 bottle (propping up) are attached together lumbar anesthesia medication unit of formation in a medical sterilization packaging bag (box); Oxirane or illumination sterilization, signature.
Embodiment 3
Prescription: Ropivacaine HCL 1.5g
Glucose 10g
Water for injection 300ml
Special-purpose 100 bottles of the ropivacaine-glucose lyophilized powder injections (propping up) of lumbar anesthesia
Preparation method: take by weighing Ropivacaine HCL 1.5g, glucose 10g is dissolved in the 300ml water for injection fully, adds activated carbon adsorption, decarbonization filtering, 0.22 μ m filtering with microporous membrane; Gained filtrate equalization under aseptic condition is sub-packed in 100 bottles of (propping up) aseptic cillin bottles (or easy cut ampule), vacuum lyophilization: 1. first ultralow temperature quick-freeze pre-freeze 2 hours (40 ℃～-60 ℃) becomes tiny crystallization, 2. be warming up to-20 ℃ of constant temperature sublimation dryings under the vacuum 12 hours, 3. be warming up to 20 ℃ of continuation vacuum dryings 12 hours; 4. adopt plastic cement aluminium lid cillin bottle to seal or cassette bottle closure or easy cut ampule technology with ampule sealing, labeling; Its local anaesthetics solvent is water for injection 3ml, and sterilization is sub-packed in 100 bottles of (propping up) aseptic cillin bottles (or cassette bottle or easy cut ampule) seals labeling.Special-purpose ropivacaine-glucose lyophilized powder injection of the lumbar anesthesia of preparation and sterilized water for injection each 1 bottle (propping up) are attached together lumbar anesthesia medication unit of formation in a medical sterilization packaging bag (box); Oxirane or illumination sterilization, signature.
Embodiment 4
Prescription: tetracaine hydrochloride 1g
Glucose 10g
Water for injection 300ml
Special-purpose 100 bottles of the tetracaine-glucose lyophilized powder injections (propping up) of lumbar anesthesia
Preparation method: take by weighing tetracaine hydrochloride 1g, glucose 10g is dissolved in the 300ml water for injection fully, adds activated carbon adsorption, decarbonization filtering, 0.22 μ m filtering with microporous membrane; Gained filtrate equalization under aseptic condition is sub-packed in 100 bottles of (propping up) aseptic cillin bottles (or cassette bottle or easy cut ampule), vacuum lyophilization: 1. first ultralow temperature quick-freeze pre-freeze 2 hours (40 ℃～-60 ℃) becomes tiny crystallization, 2. be warming up to-20 ℃ of constant temperature sublimation dryings under the vacuum 12 hours, 3. be warming up to 20 ℃ of continuation vacuum dryings 12 hours; 4. adopt plastic cement aluminium lid cillin bottle to seal or cassette bottle closure or easy cut ampule technology with ampule sealing, labeling; Its local anaesthetics solvent is water for injection 3ml, and sterilization is sub-packed in 100 bottles of (propping up) aseptic cillin bottles (or cassette bottle or easy cut ampule) seals labeling.Special-purpose tetracaine-glucose lyophilized powder injection of the lumbar anesthesia of preparation and sterilized water for injection each 1 bottle (propping up) are attached together lumbar anesthesia medication unit of formation in a medical sterilization packaging bag (box); Oxirane or illumination sterilization, signature.
Claims (8)
1, a kind of lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection, it is characterized in that: be dissolved in the water for injection by corresponding local anaesthetics-glucose, add activated carbon adsorption, decarbonization filtering, 0.22 μ m filtering with microporous membrane, gained filtrate is sub-packed in aseptic cillin bottle or cassette bottle or the easy cut ampule by specification under aseptic condition again, gets lyophilized powder through vacuum lyophilization; Adopt plastic cement aluminium lid cillin bottle to seal then or cassette bottle closure or easy cut ampule technology with ampule sealing, labeling, lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection obtains sterilizing; Described corresponding local anaesthetics-glucose is bupivacaine-glucose or chirocaine-glucose or ropivacaine-glucose or tetracaine-glucose.
2, lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection according to claim 1 is characterized in that: lumbar anesthesia bupivacaine-glucose lyophilized powder injection, its hydrochloric bupivacaine 5-15mg, glucose 100-150mg.
3, lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection according to claim 1 is characterized in that: lumbar anesthesia chirocaine-glucose lyophilized powder injection, its hydrochloric chirocaine 5-15mg, glucose 100-150mg.
4, lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection according to claim 1 is characterized in that: the lumbar anesthesia hydrochloric ropivacaine 5-15mg of ropivacaine-glucose lyophilized powder injection, glucose 100-150mg.
5, lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection according to claim 1 is characterized in that: the lumbar anesthesia hydrochloric tetracaine 5-10mg of tetracaine-glucose lyophilized powder injection, glucose 100-150mg.
6, a kind of preparation method of lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection, it is characterized in that: corresponding local anaesthetics-glucose is dissolved in the water for injection by the prescription proportioning, add activated carbon adsorption, decarbonization filtering, 0.22 μ m filtering with microporous membrane, gained filtrate is sub-packed in aseptic cillin bottle or cassette bottle or the easy cut ampule by aforementioned dose specification under aseptic condition again, gets lyophilized powder through vacuum lyophilization; Adopt plastic cement aluminium lid cillin bottle to seal then or cassette bottle closure or easy cut ampule technology with ampule sealing, labeling, lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection obtains sterilizing; Described vacuum freeze-drying method is: 1. earlier under-40C～-60 ℃ ultralow temperature quick-freeze pre-freeze became tiny crystallization in 2 hours; 2. under vacuum, be warming up to-20 ℃ of constant temperature sublimation dryings again 12 hours; 3. be warming up to 20 ℃ of continuation vacuum dryings then 12 hours.
7, a kind of packing method of lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection, it is characterized in that adopting plastic cement aluminium lid cillin bottle to seal the above-mentioned lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder or cassette bottle closure or easy cut ampule technology with ampule sealing, labeling; Its local anaesthetics solvent is water for injection 3ml, and sterilization is sub-packed in aseptic cillin bottle or cassette bottle or the easy cut ampule seals labeling; Special-purpose bupivacaine-glucose lyophilized powder injection of the lumbar anesthesia of preparation and sterilized water for injection are attached together lumbar anesthesia medication unit of formation in a medical sterilization packaging bag or box for each 1 bottle; Oxirane or illumination sterilization, signature.
8, a kind of packing method of lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection, it is characterized in that: lyophilized injectable powder and coordinative solvent are taked pre-encapsulated injector technology packing: be about to lyophilized powder and solvent comparting packaging and sterilization in a syringe, time spent is aseptic takes the back apart as long as one push away the push rod of syringe, and solvent and lyophilized powder are that compounding is spared after lumbar anesthesia puncture needle direct injection.
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| CNA2009100321891A CN101596168A (en) | 2009-07-10 | 2009-07-10 | Lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection and preparation method and packing method thereof |
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| CNA2009100321891A CN101596168A (en) | 2009-07-10 | 2009-07-10 | Lumbar anesthesia dedicated offices anaesthetic-glucose lyophilized powder injection and preparation method and packing method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102038651A (en) * | 2010-12-25 | 2011-05-04 | 山东新时代药业有限公司 | Ropivacaine mesylate freeze-dried powder injection |
| CN106177970A (en) * | 2016-07-12 | 2016-12-07 | 扬子江药业集团有限公司 | Ropivacaine injection preparation and its preparation method and application |
-
2009
- 2009-07-10 CN CNA2009100321891A patent/CN101596168A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102038651A (en) * | 2010-12-25 | 2011-05-04 | 山东新时代药业有限公司 | Ropivacaine mesylate freeze-dried powder injection |
| CN102038651B (en) * | 2010-12-25 | 2013-04-03 | 山东新时代药业有限公司 | Ropivacaine mesylate freeze-dried powder injection |
| CN106177970A (en) * | 2016-07-12 | 2016-12-07 | 扬子江药业集团有限公司 | Ropivacaine injection preparation and its preparation method and application |
| CN106177970B (en) * | 2016-07-12 | 2019-09-17 | 扬子江药业集团有限公司 | Ropivacaine injection preparation and its preparation method and application |
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Open date: 20091209 |