CN102366399A - Procaine hydrochloride injection and its production technology - Google Patents
Procaine hydrochloride injection and its production technology Download PDFInfo
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- CN102366399A CN102366399A CN2011102949830A CN201110294983A CN102366399A CN 102366399 A CN102366399 A CN 102366399A CN 2011102949830 A CN2011102949830 A CN 2011102949830A CN 201110294983 A CN201110294983 A CN 201110294983A CN 102366399 A CN102366399 A CN 102366399A
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- procaine hydrochloride
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- hydrochloride injection
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Abstract
The invention belongs to the field of medicinal preparations, and provides a procaine hydrochloride injection and its preparation method. 1000 ml of the procaine hydrochloride injection provided by the invention contains 20g of procaine hydrochloride, 9g of common salt, 0.5g of medicinal charcoal and the balance being fresh injection water. The preparation method of the procaine hydrochloride injection is characterized by comprising the following steps of: a, adding common salt into injection water for dissolution, adding procaine hydrochloride, and stirring for dissolution; b, adjusting pH of a liquid medicine obtained from the step a to 4.0-4.5 by the use of 1 mol/L of hydrochloric acid; c, adding injection water into a liquid medicine obtained from the step b up to the full amount, adding medicinal charcoal, stirring for 10 minutes, standing for 20 minutes, and filtering through a titanium rod filter and 0.45 micron and 0.22 micron of a cartridge type filter; d, placing a sealed intermediate product into a sterilization cabinet, using circulating vapor of 100 DEG C, and sterilizing for 30 minutes. The procaine hydrochloride injection provided by the invention is more stable.
Description
Technical field
The invention belongs to field of medicine preparations, a kind of procaine hydrochloride injection and method for preparing are provided.
Background technology
The local anesthetic procaine hydrochloride is one of clinical medicine of domestic and international extensive use, by in being taken in, American and Britain, day, moral, method, meaning, state's pharmacopeia such as auspicious.
Procaine hydrochloride belongs to the esters local anaesthetics, can temporary interruption nerve fiber conduction and have anesthetic action, these article to skin, mucosa penetration power a little less than, be inappropriate for topical anesthesia.These article dispersivity and permeability are poor, and the combining form of its hydrochlorate discharges free alkali and brings into play the local anesthesia effect in tissue.These article suppress central nervous system's constant, excessive excitement.At first cause calmness, giddy, improve the threshold of pain, causes dizzy, disorientation, ataxia then, and maincenter suppresses to continue to deepen, and bradythesia, confusion occur and then gets into comatose state.Radiation dose further strengthens, and the poisoning symptom of central excitations such as muscular tremor, dysphoria and convulsions can occur.The low dose of effect that exciting sympathetic nerves is arranged of these article makes heart rate quickening, increased blood pressure, and dosage strengthens, because cardiac muscle suppresses, peripheral blood vessel is expanded, neuroganglion is slightly blocked and blood pressure drops increased heart rate.These article suppress the presynaptic membrane acetylcholine and discharge, and produce certain neuromuscular, can strengthen the effect of non-depolarizing muscular relaxant, and directly suppress smooth muscle, can remove smooth muscle spasm.
Procaine hydrochloride has several formulations, like injectable powder, injection, tablet, capsule etc.In addition, also has the procaine sodium chloride injection.The procaine hydrochloride injection is local anesthetic commonly used, and its effect is strong, and toxicity is low.But contain ester bond and fragrant primary amino radical in the structure of these article, so it is prone to be hydrolyzed the generation para-amino benzoic acid, its stability is relevant with multiple factor, like pH value, sterilising temp, time etc.
According to the reported in literature procaine hydrochloride injection is free permeable membrane material, and the character of its solution seemingly has osmotic pressure, but the blood cell film is not had osmotic pressure; That is to say; The molecule of procaine hydrochloride is as water permeate through cell membranes freely, it calculated by physics and chemistry be made into isosmotic solution, do not wait in fact; Thereby visible haemolysis, so should add sodium chloride furnishing etc.A lot of reported in literature sodium chloride not only have adjusting etc. to ooze effect to procaine hydrochloride injection, and Stabilization is arranged.Procaine hydrochloride injection sterilization back content has obvious decline, and add sodium chloride content descend few particularly add through the sodium chloride of charcoal treatment or add its content of calcium disodium edetate descend still less.
Summary of the invention
The present invention is in order to improve the stability of procaine hydrochloride injection, a kind of procaine hydrochloride injection and preparation method thereof to be provided.
The technical scheme that technical solution problem of the present invention is adopted is:
Procaine hydrochloride injection of the present invention is characterized in that with procaine hydrochloride, sodium chloride, medicinal charcoal and fresh water for injection be component.
Its characteristics also are to contain procaine hydrochloride 20g, sodium chloride 9g, medicinal charcoal 0.5g in the said procaine hydrochloride injection of every 1000ml, and all the other all are fresh water for injection.
The method for preparing of procaine hydrochloride injection of the present invention is characterised in that and comprises the steps:
A, sodium chloride is joined water for injection dissolving back add procaine hydrochloride, stirring and dissolving;
B, with pH value to 4.0～4.5 of 1mol/L hydrochloric acid regulating step a medicinal liquid;
The medicinal liquid of c, step b is mended and is added to the full amount of water for injection, and adds medicinal charcoal, stirs 10 minutes, leaves standstill 20 minutes.Filter through titanium rod filter, 0.45um, 0.22um cartridge filter.
D, with the intermediate products after the embedding in the sterilization cabinet in, with 100 ℃ of flowing steams, sterilized 30 minutes.
Compared with present technology, beneficial effect of the present invention is embodied in:
1. add sodium chloride in the prescription, improved the stability of procaine hydrochloride injection.
2. the pH value to 4.0 of regulating step 1 medicinal liquid～4.5, under this pH value condition, the hydrochloric acid Proca is the most stable.
3. select 100 ℃ of flowing steams, sterilize 30 minutes, contained the procaine hydrochloride hydrolysis to greatest extent as sterilising conditions.
The specific embodiment
Procaine hydrochloride injection provided by the invention is made up of procaine hydrochloride, medicinal charcoal and fresh water for injection; Wherein, Every 1000ml procaine hydrochloride injection contains 20g procaine hydrochloride, 9g sodium chloride and 0.5g medicinal charcoal, and all the other all are fresh water for injection.
Production technology of the present invention is: the reason bottle → bottle → preparation of washing, dry by the fire, go out → embedding → sterilization, leak detection → lamp inspection → packing → warehouse-in.
1. the bottle of washing, dry by the fire, go out: the bottle after will managing places bottle washer, slightly washes through ultrasound wave with purified water (50 ℃～60 ℃ of water temperatures), and the water for injection fine purifiation, in the tunnel baking oven, 300 ℃～320 ℃, sterilization time >=4 minute.
2. preparation: calculate the raw material use amount by labelled amount 100%, measure water for injection in preparing tank, be cooled to 50～60 ℃; Sodium chloride is joined water for injection dissolving back add procaine hydrochloride, stir and circulate and it was dissolved fully in 10 minutes, with 1mol/L hydrochloric acid adjust pH to 4.0～4.5; Benefit adds to the full amount of water for injection; Add medicinal charcoal, stirred 10 minutes, left standstill 20 minutes.Filter through titanium rod filter, 0.45um, 0.22um cartridge filter, the censorship intermediate products are qualified, hand over the embedding operation.
3. embedding: medicinal liquid by the embedding of embedding post operation rules, is checked seal quality through the aseptic filtration of 0.22um microporous filter membrane at any time; Whenever at a distance from selective examination in 60 minutes loading amount, visible foreign matters and a remaining oxygen, loading amount is controlled to be 2.00ml～2.15ml/ and props up, remaining oxygen≤2.0%.
4. sterilization, leak detection: the intermediate products after the embedding with 100 ℃ of flowing steams, were sterilized 30 minutes in the sterilization cabinet.It controls parameter: purified water pressure: 0.15MPa～0.3MPa, and compressed air pressure: 0.4MPa～0.8MPa, steam pressure: 0.3MPa～0.6MPa and vacuum (＞-80KPa).Be stored between transfer for inferior pot number by cabinet after offeing for sale.
5. lamp inspection:
Press lamp inspection post operation rules operations, lamp inspection case illumination should be at 1000～1500lx, and lamp inspection finishes the back clears out a gathering place by the rule of operation of clearing out a gathering place, Quality Inspector's passed examination after-discharge quality certification of clearing out a gathering place.
6. oven dry:
The dry house temperature is controlled at 30～40 ℃, and drying time is in 10 hours.
7. lettering and packing:
Check quantity by lettering and packaging operation rules lettering, dress box, vanning back by checking the people, can joint sealing after errorless.That conscientiously checks printing box, operation instructions etc. after packing finishes receives number, practical number, remainder and damage number, carries out material balance inspection back and puts in storage.
Protection domain of the present invention is not limited to the foregoing description, and every technology distortion of doing according to know-why of the present invention all falls within protection scope of the present invention.
Claims (3)
1. a procaine hydrochloride injection is characterized in that, this procaine hydrochloride injection is made up of procaine hydrochloride, sodium chloride, medicinal charcoal and fresh water for injection.
2. procaine hydrochloride injection according to claim 1 is characterized in that, contains procaine hydrochloride 20g, sodium chloride 9g and medicinal charcoal 0.5g in the said procaine hydrochloride injection of every 1000ml, and all the other all are fresh water for injection.
3. the method for preparing of procaine hydrochloride injection according to claim 1 is characterized in that comprising the steps:
A, sodium chloride is joined water for injection dissolving back add procaine hydrochloride, stirring and dissolving;
B, with pH value to 4.0～4.5 of 1mol/L hydrochloric acid regulating step a medicinal liquid;
The medicinal liquid of c, step b is mended and is added to the full amount of water for injection, and adds medicinal charcoal, stirs 10 minutes, leaves standstill 20 minutes;
Filter through titanium rod filter, 0.45um, 0.22um cartridge filter;
D, with the intermediate products after the embedding in the sterilization cabinet in, with 100 ℃ of flowing steams, sterilized 30 minutes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011102949830A CN102366399A (en) | 2011-09-28 | 2011-09-28 | Procaine hydrochloride injection and its production technology |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011102949830A CN102366399A (en) | 2011-09-28 | 2011-09-28 | Procaine hydrochloride injection and its production technology |
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| Publication Number | Publication Date |
|---|---|
| CN102366399A true CN102366399A (en) | 2012-03-07 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2011102949830A Pending CN102366399A (en) | 2011-09-28 | 2011-09-28 | Procaine hydrochloride injection and its production technology |
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| CN (1) | CN102366399A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105012233A (en) * | 2015-08-24 | 2015-11-04 | 段鹏静 | Composition for childbirth containing procaine and its preparation method |
| CN105919969A (en) * | 2016-05-27 | 2016-09-07 | 郑州瑞启生物技术有限公司 | Procaine hydrochloride micro-capsules and preparation method thereof |
-
2011
- 2011-09-28 CN CN2011102949830A patent/CN102366399A/en active Pending
Non-Patent Citations (3)
| Title |
|---|
| 傅敏东: "活性炭在制备盐酸普鲁卡因注射液中的应用", 《广东药学》 * |
| 国家药典委员会编: "《中华人民共和国药典2005年版一部》", 31 January 2005 * |
| 李林千: "不同配制方法对盐酸普鲁卡因注射液的稳定性观察", 《中国医院药学杂志》 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105012233A (en) * | 2015-08-24 | 2015-11-04 | 段鹏静 | Composition for childbirth containing procaine and its preparation method |
| CN105012233B (en) * | 2015-08-24 | 2018-04-20 | 段鹏静 | Composition for childbirth containing procaine and its preparation method |
| CN105919969A (en) * | 2016-05-27 | 2016-09-07 | 郑州瑞启生物技术有限公司 | Procaine hydrochloride micro-capsules and preparation method thereof |
| CN105919969B (en) * | 2016-05-27 | 2019-01-08 | 郑州百瑞动物药业有限公司 | Procaine hydrochloride micro-capsule and preparation method thereof |
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Application publication date: 20120307 |