CN105663035A - Lidocaine hydrochloride injection and preparation method thereof - Google Patents
Lidocaine hydrochloride injection and preparation method thereof Download PDFInfo
- Publication number
- CN105663035A CN105663035A CN201410658485.3A CN201410658485A CN105663035A CN 105663035 A CN105663035 A CN 105663035A CN 201410658485 A CN201410658485 A CN 201410658485A CN 105663035 A CN105663035 A CN 105663035A
- Authority
- CN
- China
- Prior art keywords
- lidocaine hydrochloride
- minutes
- hydrochloride injection
- injection
- xylotox
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention provides lidocaine hydrochloride injection. Each 1000ml of the lidocaine hydrochloride injection is prepared from the following components by weight: 20g of lidocaine hydrochloride (the theoretical weight, and the quantity of lidocaine hydrochloride needs to be determined according to the content as well as the water drying and the purifying condition), and 4.4-5.3 g of sodium chloride. According to the improved lidocaine hydrochloride injection and the preparation method of the lidocaine hydrochloride injection, the prescription composition is simple, and a few kinds of auxiliary materials is adopted, thus the clinical risks caused by lack of iso-osmia of a product are eradicated, and the various index including the pH of the product and related substances are stable and controllable, and meet the requirements in the exposure draft of the lidocaine hydrochloride injection in the China pharmacopeia 2015; the lidocaine hydrochloride injection is suitable for clinical application, and the product is safe and effective. A preparation method is simple, new cost is not increased, and the lidocaine hydrochloride injection is suitable for large-scale industrial production and has a large application value.
Description
Technical field
The present invention relates to pharmaceutical preparation, it is specifically related to process for preparing medicine, particularly relate to Xylotox injection and its preparation method.
Background technology
The main component of lidocaine hydrochloride injection is Xylotox, is local anaesthetics and anti-arrhythmic for this product. It is mainly used in infiltration anesthesia, epidural anesthesia, surface anesthesia (doing mucous membrane anesthesia when being included in thoracoscopy or abdominal operation) and nerve block. This product also can be used for ventricular premature contraction and ventricular tachycardia after acute myocardial infarction, also can be used for that digitalis is poisoning, ventricular arrhythmia that cardiac operation and heart catheter cause. But it is usually invalid for supraventricular arrhythmia.
Lidocaine hydrochloride injection indication is local anaesthetics and anti-arrhythmia, it is current clinical the most frequently used local anaesthesia medicine, it is mainly used in infiltration anesthesia, epidural anesthesia, surface anesthesia (doing mucous membrane anesthesia when being included in thoracoscopy or abdominal operation) and nerve block. This product also can be used for ventricular premature contraction and ventricular tachycardia after acute myocardial infarction, also can be used for that digitalis is poisoning, ventricular arrhythmia that cardiac operation and heart catheter cause. But, often be used to epidural retardance and canalis sacralis retardance due to clinical upper lidocaine hydrochloride injection, this route of administration is big to the risk of human body, such as liquid anisotonic, then can increase clinical application risk, the serious damage that patient even may be caused irrecoverable and even death. But the osmotic pressure of medicine is not carried out requirement by the existing version Chinese Pharmacopoeia standard of lidocaine hydrochloride injection, cannot avoid the risk because product anisotonic brings. Simultaneously, in existing version Chinese Pharmacopoeia, the pH standard of lidocaine hydrochloride injection is pH3.5～5.5, but lower pH value often makes medication patient produce excitement in medication process, and the anaesthetic effect of lidocaine hydrochloride injection is not obvious when lower ph, therefore before Clinical practice medical matters personnel often by lidocaine hydrochloride injection pH regulator be 5.0～7.0 (clinical study shows that the anaesthetic effect of lidocaine hydrochloride injection raises with pH and promote, best in pH5.0～7.0). Also after having document to show that pH is greater than 6.0, stability of solution is deteriorated relatively, has particulate to precipitate out, and joins it is thus desirable to face with facing, but this process is owing to lacking necessary detection means and the impact by peopleware, it is possible to can increase the risk of clinical application to a great extent.
Based on clinical drug safety and the validity of lidocaine hydrochloride injection, the quality standard of lidocaine hydrochloride injection has been revised by China's version pharmacopeia exposure draft in 2015, it is mainly reflected in osmotic pressure molar density and pH value index, pH value is adjusted to pH4.0～6.0, and osmotic pressure molar density standard is decided to be 285～310mOsm/Kg.
Existing lidocaine hydrochloride injection Recipe:
| Sequence number | Composition | The theoretical formula ratio of 1000ml |
| 1 | Xylotox | 20g |
| 2 | Sodium-chlor | 8.5g |
| 3 | Purified water | Add to 1000ml |
Remarks: Xylotox main medicine amount need to by content, moisture give money as a gift pure throwing material.
1, prepare: take sodium-chlor, Xylotox by formula ratio, Medicinal Charcoal, for subsequent use.
2, baking bottle is washed: use sonic washing machine to be cleaned by ampoule.
3, dosing:
3.1, water for injection by 70% formula ratio puts into Agitation Tank, adds the sodium-chlor of formula ratio, opens stirrer and stir 5 minutes.
3.2, the Xylotox of formula ratio is added in Agitation Tank, stir 5 minutes.
3.3, add formula ratio Medicinal Charcoal, stir 5 minutes.
3.4, add water for injection, open stirrer and stir 5 minutes.
3.5, solution titanium filter circulating filtration 10 minutes.
3.6, solution titanium filter, 0.45 μm of microporous membrane core strainer and 0.2 μm of microporous membrane core strainer circulating filtration 15 minutes.
3.7, adjust ph is 4.0～5.0.
4, embedding: regulate loading amount, carry out embedding under A level laminar flow hood.
5, sterilizing: 116 DEG C of sterilizings 30 minutes.
6, lamp inspection: use Manual light inspection or automatic lamp-checking machine to carry out lamp inspection.
7, printing package, warehouse-in.
And as, under existing lidocaine hydrochloride injection formula and processing condition, its osmotic pressure is about 415mOsm/Kg, much larger than the isotonic requirement of 285mOsm/Kg～310mOsm/Kg.
Summary of the invention
Technical problem to be solved by this invention is to overcome above-mentioned weak point, and all the processing quality in controlled range is stable for research and design osmotic pressure molar density and pH, the prescription of safer effectively clinical lidocaine hydrochloride injection and compound method.
The present invention provides a kind of lidocaine hydrochloride injection.
Described injection liquid is grouped into (every 1000ml) by the one-tenth of following weight proportion:
| Sequence number | Composition | The theoretical formula ratio of 1000ml |
| 1 | Xylotox | 20g |
| 2 | Sodium-chlor | 4.4-5.3g |
| 3 | Purified water | Add to 1000ml |
Remarks: Xylotox main medicine amount need to by content, moisture give money as a gift pure throwing material.
Having it is a further object of the present invention to provide the preparation method of above-mentioned lidocaine hydrochloride injection, the method comprises the following steps:
(1), prepare: take sodium-chlor, Xylotox, Medicinal Charcoal, for subsequent use;
(2) baking bottle, is washed: use sonic washing machine to be cleaned by ampoule;
(3), dosing:
(3.1), by the water for injection of 70% formula ratio put into Agitation Tank, add sodium-chlor, open stirrer and stir 5 minutes;
(3.2), by Xylotox add in Agitation Tank, stir 5 minutes;
(3.3), add Medicinal Charcoal, stir 5 minutes;
(3.4), add water for injection, open stirrer and stir 5 minutes;
(3.5), solution titanium filter circulating filtration 10 minutes;
(3.6), solution titanium filter, 0.45 μm of microporous membrane core strainer and 0.2 μm of microporous membrane core strainer circulating filtration 15 minutes;
(3.7), adjust ph is 4.0～6.0; Adjustment osmotic pressure is 292mOsm/Kg～310mOsm/Kg;
(4), embedding: regulate loading amount, carry out embedding under A level laminar flow hood;
(5), sterilizing: 116 DEG C of sterilizings 30 minutes;
(6), lamp inspection: use Manual light inspection or automatic lamp-checking machine to carry out lamp inspection;
(7), printing package, warehouse-in.
Step of the present invention (3.7) adjust ph is 4.0～6.0; Preferred adjust ph is 5.0～5.5; Select sodium hydroxide, potassium hydroxide or sodium-acetate, Potassium ethanoate adjust ph.
Step of the present invention (3.7) regulates osmotic pressure to be 285mOsm/Kg～310mOsm/Kg; Preferably osmotic pressure is regulated to be 292mOsm/Kg～310mOsm/Kg.
The present invention provides lidocaine hydrochloride injection and its preparation method of improvement, not only eradicate the clinical risk that product causes because of not isotonic, make product pH more be conducive to Clinical practice simultaneously, before avoiding Clinical practice, medical matters personnel regulate pH, reduce the clinical adverse because of the improper initiation of medical matters human users, it is ensured that product safe and effective. The inventive method is simple, does not increase new cost, is suitable for large-scale industrial to be produced, has bigger using value.
Embodiment
Following examples are raw materials used commercially available to be obtained.
Example 1 prepares lidocaine hydrochloride injection:
| Sequence number | Composition | 1000ml formula ratio |
| 1 | Xylotox | 21.565g |
| 2 | Sodium-chlor | 4.9g |
| 3 | Purified water | Add to 1000ml |
(1), prepare: take sodium-chlor, Xylotox by formula ratio, Medicinal Charcoal, for subsequent use.
(2) baking bottle, is washed: use sonic washing machine to be cleaned by ampoule.
(3), dosing:
(3.1), by the water for injection of 70% formula ratio put into Agitation Tank, add the sodium-chlor of formula ratio, open stirrer and stir 5 minutes.
(3.2), the Xylotox of formula ratio is added in Agitation Tank, stir 5 minutes.
(3.3), add formula ratio Medicinal Charcoal, stir 5 minutes.
(3.4), add water for injection, open stirrer and stir 5 minutes.
(3.5), solution titanium filter circulating filtration 10 minutes.
(3.6), solution titanium filter, 0.45 μm of microporous membrane core strainer and 0.2 μm of microporous membrane core strainer circulating filtration 15 minutes.
(3.7) it is, 5.0～5.5 by aqueous sodium hydroxide solution (10%) adjust ph; Adjustment osmotic pressure is 292mOsm/Kg～310mOsm/Kg. The content of sampling and measuring intermediate, content controls in the 97.0～103.0% of labelled amount.
(4), embedding: regulate loading amount, carry out embedding under A level laminar flow hood.
(5), sterilizing: 116 DEG C of sterilizings 30 minutes.
(6), lamp inspection: use Manual light inspection to carry out lamp inspection.
(7), printing package, warehouse-in.
Example 2 prepares lidocaine hydrochloride injection:
| Sequence number | Composition | 1000ml formula ratio |
| 1 | Xylotox | 21.565g |
| 2 | Sodium-chlor | 4.4g |
| 3 | Purified water | Add to 1000ml |
Remarks: Xylotox by content, moisture give money as a gift pure throwing material.
(1), prepare: take sodium-chlor, Xylotox by formula ratio, Medicinal Charcoal, for subsequent use.
(2) baking bottle, is washed: use sonic washing machine to be cleaned by ampoule.
(3), dosing:
(3.1), by the water for injection of 70% formula ratio put into Agitation Tank, add the sodium-chlor of formula ratio, open stirrer and stir 5 minutes.
(3.2), the Xylotox of formula ratio is added in Agitation Tank, stir 5 minutes.
(3.3), add formula ratio Medicinal Charcoal, stir 5 minutes.
(3.4), add water for injection, open stirrer and stir 5 minutes.
(3.5), solution titanium filter circulating filtration 10 minutes.
(3.6), solution titanium filter, 0.45 μm of microporous membrane core strainer and 0.2 μm of microporous membrane core strainer circulating filtration 15 minutes.
(3.7) it is, 4.0～4.5 by aqueous sodium hydroxide solution (15%) adjust ph; Adjustment osmotic pressure is 280mOsm/Kg～290mOsm/Kg. The content of sampling and measuring intermediate, content controls in the 97.0～103.0% of labelled amount.
(4), embedding: regulate loading amount, carry out embedding under A level laminar flow hood.
(5), sterilizing: 116 DEG C of sterilizings 30 minutes.
(6), lamp inspection: automatic lamp-checking machine carries out lamp inspection.
(7), printing package, warehouse-in.
Example 3 prepares lidocaine hydrochloride injection:
| Sequence number | Composition | 1000ml formula ratio |
| 1 | Xylotox | 21.565g |
| 2 | Sodium-chlor | 5.3g |
| 3 | Purified water | Add to 1000ml |
Remarks: hydrochloric acid benefit card by content, moisture give money as a gift pure throwing material.
(1), prepare: take sodium-chlor, Xylotox by formula ratio, Medicinal Charcoal, for subsequent use.
(2) baking bottle, is washed: use sonic washing machine to be cleaned by ampoule.
(3), dosing:
(3.1), by the water for injection of 70% formula ratio put into Agitation Tank, add the sodium-chlor of formula ratio, open stirrer and stir 5 minutes.
(3.2), the Xylotox of formula ratio is added in Agitation Tank, stir 5 minutes.
(3.3), add formula ratio Medicinal Charcoal, stir 5 minutes.
(3.4), add water for injection, open stirrer and stir 5 minutes.
(3.5), solution titanium filter circulating filtration 10 minutes.
(3.6), solution titanium filter, 0.45 μm of microporous membrane core strainer and 0.2 μm of microporous membrane core strainer circulating filtration 15 minutes.
(3.7) it is, 5.5～6.0 by potassium hydroxide aqueous solution (10%) adjust ph; Adjustment osmotic pressure is 292mOsm/Kg～310mOsm/Kg.
The content of sampling and measuring intermediate, content controls in the 97.0～103.0% of labelled amount.
(4), embedding: regulate loading amount, carry out embedding under A level laminar flow hood.
(5), sterilizing: 116 DEG C of sterilizings 30 minutes.
(6), lamp inspection: use automatic lamp-checking machine to carry out lamp inspection.
(7), printing package, warehouse-in.
The lidocaine hydrochloride injection that embodiment 1-3 produces is carried out every index investigation, and result is as follows:
Result illustrates, the every index of lidocaine hydrochloride injection that embodiment 1-3 produces is conformance with standard regulation all, and pH, osmotic pressure all meet Clinical practice requirement, and production process is controlled, meet mass-producing continuous and stable production requirement.
Comparative example: the following is the product produced by existing preparation technology,
Existing lidocaine hydrochloride injection Recipe:
| Sequence number | Composition | The theoretical formula ratio of 1000ml |
| 1 | Xylotox | 20g |
| 2 | Sodium-chlor | 8.5g |
| 3 | Purified water | Add to 1000ml |
Remarks: Xylotox main medicine amount need to by content, moisture give money as a gift pure throwing material.
1, prepare: take sodium-chlor, Xylotox by formula ratio, Medicinal Charcoal, for subsequent use.
2, baking bottle is washed: use sonic washing machine to be cleaned by ampoule.
3, dosing:
3.1, water for injection by 70% formula ratio puts into Agitation Tank, adds the sodium-chlor of formula ratio, opens stirrer and stir 5 minutes.
3.2, the Xylotox of formula ratio is added in Agitation Tank, stir 5 minutes.
3.3, add formula ratio Medicinal Charcoal, stir 5 minutes.
3.4, add water for injection, open stirrer and stir 5 minutes.
3.5, solution titanium filter circulating filtration 10 minutes.
3.6, solution titanium filter, 0.45 μm of microporous membrane core strainer and 0.2 μm of microporous membrane core strainer circulating filtration 15 minutes.
3.7, adjust ph is 4.0～5.0.
4, embedding: regulate loading amount, carry out embedding under A level laminar flow hood.
5, sterilizing: 116 DEG C of sterilizings 30 minutes.
6, lamp inspection: use Manual light inspection or automatic lamp-checking machine to carry out lamp inspection.
7, printing package, warehouse-in.
It is as follows that the 3 every indexs of batch sample investigate result:
Finding out from upper table, three sample pH value are lower, and osmotic pressure is far superfine oozes requirement, and product can not meet Clinical practice requirement, and the security of clinical application can not be guaranteed.
Example 4 prepares lidocaine hydrochloride injection
Composition and preparation are with example 1
Example 5 prepares lidocaine hydrochloride injection
Composition and preparation are with example 2
Example 6 prepares lidocaine hydrochloride injection
Composition and preparation are with example 3
Lidocaine hydrochloride injection prepared by above-described embodiment 4-6 all meets lidocaine hydrochloride injection (Chinese Pharmacopoeia version in 2015 two third time exposure draft) (see following)
Lidocaine hydrochloride injection quality standard
Chinese Pharmacopoeia version in 2015 two exposure drafts
This product is the sterile water solution of Xylotox, should be the 95.0%～105.0% of labelled amount containing Xylotox (C14H22N2O HCl).
[proterties] this product is colourless clear liquid.
This product is got in [discriminating] (1), according to the discriminating (1) under Xylotox item, the test of (3) item, and aobvious identical result.
(2), in the color atlas recorded under assay item, the retention time of need testing solution main peak should be consistent with the retention time of reference substance solution main peak.
[inspection] pH value should be 4.0～6.0 (annex VIH).
It is appropriate that [having related substance] precision measures this product, is quantitatively diluted in every 1ml about containing the solution of Xylotox 2mg by moving phase, as need testing solution; Precision measures 1ml, is placed in 100ml measuring bottle, is diluted to scale by moving phase, in contrast solution; Separately get 2,6-xylidine reference substance, accurately weighed, add moving phase dissolving and quantitatively dilute the solution made and about contain 0.8 μ g in every 1ml, product solution in contrast. According to the chromatographic condition under assay item, determined wavelength is 230nm, gets contrast solution 20 μ l, injection liquid chromatography, regulates detection sensitivity, makes the peak height of principal constituent chromatographic peak be about the 20% of full range; Precision measures each 20 μ l of above-mentioned three kinds of solution again, injection liquid chromatography respectively, record color atlas is to 3.5 times of principal constituent peak retention time, if any with 2 in the color atlas of need testing solution, the chromatographic peak that 6-xylidine retention time is consistent, its peak area must not be greater than reference substance solution main peak area (0.04%), other single impurity peak area must not be greater than contrast solution main peak area 0.5 times (0.5%), other each impurity peak area and contrast solution main peak area (1.0%) must not be greater than.
Bacterial endotoxin gets this product, checks (annex XIE) in accordance with the law, and the amount containing intracellular toxin in every 1mg Xylotox should be less than 0.040EU.
Osmotic pressure molar density gets this product, checks (annex IXG) in accordance with the law, and osmotic pressure molar density should be 285～310mOsm0l/Kg.
Other every regulations relevant under should meeting injection item (annex IB)
[assay] measures according to high performance liquid chromatography (annex VD).
Chromatographic condition and system suitability test octadecylsilane chemically bonded silica are weighting agent; (1mol/L sodium dihydrogen phosphate 1.3ml and 0.5mol/L disodium phosphate soln 32.5ml is got with phosphate buffered saline buffer, put in 1000ml measuring bottle, it being diluted with water to scale, shakes even)-acetonitrile (50:50) is moving phase by phosphoric acid adjust ph to 8.0;Determined wavelength is 254nm. Theoretical plate number calculates by lignocaine peak should be not less than 2000.
Assay method precision measures this product appropriate (being about equivalent to Xylotox 100mg), puts in 50ml measuring bottle, is diluted to scale by moving phase, shakes even, and precision measures 20 μ l injection liquid chromatographies, record color atlas; Separately get lignocaine reference substance and it is about 85mg, accurately weighed, put in 50ml measuring bottle, add 1mol/L hydrochloric acid soln 0.5ml and make dissolving, be diluted to scale by moving phase, shake even, be measured in the same method. By external standard method with calculated by peak area, and it is multiplied by 1.156, to obtain final product.
[classification] same to Xylotox.
[specification] (1) 2ml:20mg (2) 2ml:40mg (3) 3.5ml:35mg (4) 5ml:50mg (5) 5ml:0.1g (6) 10ml:0.2g (7) 20ml:0.4g
[storage] airtight preservation.
The data of lidocaine hydrochloride injection finished product prepared by above-mentioned example 4-6 examine result entirely.
Claims (7)
1. a lidocaine hydrochloride injection, it is characterised in that, described injection is grouped into by the one-tenth of following weight proportion:
Every 1000ml
Xylotox 20g
Sodium-chlor 4.4～5.3g
Purified water adds to 1000ml;
Described Xylotox amount by content, moisture give money as a gift pure throwing material.
2. a lidocaine hydrochloride injection, it is characterised in that, described lidocaine hydrochloride injection is grouped into by the one-tenth of following weight proportion:
Every 1000ml
Xylotox 20g
Sodium-chlor 4.9g
Purified water adds to 1000ml;
Described Xylotox amount by content, moisture give money as a gift pure throwing material.
3. prepare the method for a kind of lidocaine hydrochloride injection as claimed in claim 1 or 2, it is characterised in that, the method comprises the following steps:
(1), prepare: take sodium-chlor, Xylotox, Medicinal Charcoal, for subsequent use;
(2) baking bottle, is washed: use sonic washing machine to be cleaned by ampoule;
(3), dosing:
(3.1), by the water for injection of 70% formula ratio put into Agitation Tank, add sodium-chlor, open stirrer and stir 5 minutes;
(3.2), by Xylotox add in Agitation Tank, stir 5 minutes;
(3.3), add Medicinal Charcoal, stir 5 minutes;
(3.4), add water for injection, open stirrer and stir 5 minutes;
(3.5), solution titanium filter circulating filtration 10 minutes;
(3.6), solution titanium filter, 0.45 μm of microporous membrane core strainer and 0.2 μm of microporous membrane core strainer circulating filtration 15 minutes;
(3.7), adjust ph is 4.0～6.0; Adjustment osmotic pressure is 292mOsm/Kg～310mOsm/Kg;
(4), embedding: regulate loading amount, carry out embedding under A level laminar flow hood;
(5), sterilizing: 116 DEG C of sterilizings 30 minutes;
(6), lamp inspection: use Manual light inspection or automatic lamp-checking machine to carry out lamp inspection;
(7), printing package, warehouse-in.
4. method according to claim 3, it is characterised in that, described step 3.7 adjust ph is 4.0～6.0, and pH adjusting agent is selected from sodium hydroxide or potassium hydroxide.
5. method according to claim 4, it is characterised in that, described step 3.7 adjust ph is 5.0～5.5.
6. method according to claim 3, it is characterised in that, described step 3.7 osmotic pressure molar density is 285mOsm/Kg～310mOsm/Kg.
7. method according to claim 6, it is characterised in that, described step 3.7 osmotic pressure molar density is 292mOsm/Kg～310mOsm/Kg.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410658485.3A CN105663035A (en) | 2014-11-18 | 2014-11-18 | Lidocaine hydrochloride injection and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410658485.3A CN105663035A (en) | 2014-11-18 | 2014-11-18 | Lidocaine hydrochloride injection and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105663035A true CN105663035A (en) | 2016-06-15 |
Family
ID=56944386
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201410658485.3A Pending CN105663035A (en) | 2014-11-18 | 2014-11-18 | Lidocaine hydrochloride injection and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN105663035A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110590590A (en) * | 2019-10-18 | 2019-12-20 | 海南顿斯医药科技有限公司 | 1A1/5Lidocaine hydrochloride hydrate compound |
| CN111208236A (en) * | 2020-03-05 | 2020-05-29 | 遂成药业股份有限公司 | Method for measuring related substances of lidocaine hydrochloride by high performance liquid chromatography |
| CN112375009A (en) * | 2020-11-27 | 2021-02-19 | 山东华鲁制药有限公司 | Production method and application of lidocaine hydrochloride |
| CN112933041A (en) * | 2021-03-05 | 2021-06-11 | 遂成药业股份有限公司 | Preparation method of lidocaine hydrochloride injection |
-
2014
- 2014-11-18 CN CN201410658485.3A patent/CN105663035A/en active Pending
Non-Patent Citations (3)
| Title |
|---|
| 国家药典委员会: "关于盐酸利多卡因注射液标准的公示", 《国家药典委员会征求意见稿》 * |
| 朱建明: "碱化的利多卡因作为局麻药有效期的研究", 《冶金医药情报》 * |
| 李晓瑞等: "活性炭在注射液配制中对主药含量的影响研究", 《亚太传统医药》 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110590590A (en) * | 2019-10-18 | 2019-12-20 | 海南顿斯医药科技有限公司 | 1A1/5Lidocaine hydrochloride hydrate compound |
| CN111208236A (en) * | 2020-03-05 | 2020-05-29 | 遂成药业股份有限公司 | Method for measuring related substances of lidocaine hydrochloride by high performance liquid chromatography |
| CN112375009A (en) * | 2020-11-27 | 2021-02-19 | 山东华鲁制药有限公司 | Production method and application of lidocaine hydrochloride |
| CN112933041A (en) * | 2021-03-05 | 2021-06-11 | 遂成药业股份有限公司 | Preparation method of lidocaine hydrochloride injection |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN103940929B (en) | A kind of detection method for the treatment of the traditional Chinese medicine injection of cardiovascular and cerebrovascular disease | |
| CN105663035A (en) | Lidocaine hydrochloride injection and preparation method thereof | |
| HUE034059T2 (en) | Process for manufacturing a pharmaceutical preparation containing glatiramer acetate | |
| CN103463565B (en) | Zedoary oil injection and preparation method thereof | |
| CN106539753A (en) | A kind of phloroglucinol injection and preparation method thereof | |
| CN104069063B (en) | Fasudic hydrochloride pharmaceutical composition and preparation method thereof | |
| CN103159710B (en) | Antiviral decalin derivate | |
| CN103202805B (en) | Vinpocetine-containing pharmaceutical composition for injection and preparation method thereof | |
| CN114652675A (en) | Preparation method of urapidil hydrochloride injection | |
| CN1751691A (en) | Small volume intravenous injection of gastrodine and its prepn. method | |
| CN104997728A (en) | Nalmefene hydrochloride injection medicinal composition and preparation method thereof | |
| CN101011409B (en) | Collunarium containing vitamin B12 | |
| CN1830434A (en) | Preparation method of troxerutin injection | |
| CN107375208A (en) | A kind of composition for injection containing Tropisetron | |
| CN105434453B (en) | A kind of clindamycin phosphate for injection pharmaceutical composition and preparation method thereof | |
| CN104688675B (en) | A kind of preparation method of lidocaine hydrochloride injection | |
| CN116585451B (en) | Lidocaine hydrochloride spray containing antibacterial and antioxidant moringa seed polypeptide for pets and preparation method of lidocaine hydrochloride spray | |
| CN102423295B (en) | Small volume injection composition containing vinpocetine and preparation method thereof | |
| CN102861000B (en) | Preparation process of dimethyl sulfoxide flushing fluid | |
| CN105001202A (en) | Esomeprazole sodium compound and drug composition thereof | |
| CN106074366A (en) | Injection of disturbance of consciousness and preparation method thereof after treatment cerebral trauma and brain surgery | |
| CN105769776A (en) | Freeze-dry composition for treating NHL (non-hodgkin lymphoma) and preparation method thereof | |
| CN106474056A (en) | A kind of medicinal composition for injections improving phylloxanthin drug injection preparation stability | |
| CN107334729B (en) | Monosialotetrahexosyl ganglioside sodium oral liquid and application thereof | |
| CN106580884A (en) | Garden burnet sapogenin solid dispersion as well as preparation method and application thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20160615 |