Lidocaine hydrochloride injection and preparation method thereof

A technology of lidocaine hydrochloride and lidocaine hydrochloride amount is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., which can solve the problem of insignificant anesthesia effect, poor solution stability, and increased risk of clinical medication. To reduce clinical adverse reactions, ensure safety and effectiveness, and eradicate clinical risks

Inactive Publication Date: 2016-06-15
SHANGHAI ZHAOHUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since lidocaine hydrochloride injection is often used clinically for epidural block and caudal block, this route of administration has a high risk to the human body. If the drug solution is not isotonic, it will increase the risk of clinical medication , serious and may even lead to irreversible damage or even death of the patient
However, the current version of the Chinese Pharmacopoeia Standard for Lidocaine Hydrochloride Injection does not require the osmotic pressure of the drug, which cannot avoid the risk of the product being not isotonic
At the same time, the pH standard of lidocaine hydrochloride injection in the current version of the Chinese Pharmacopoeia is pH 3.5 to 5.5, but lower pH values ​​often cause irritation in patients taking the drug, and li

Method used

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  • Lidocaine hydrochloride injection and preparation method thereof
  • Lidocaine hydrochloride injection and preparation method thereof
  • Lidocaine hydrochloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0047] Example 1 prepares lidocaine hydrochloride injection:

[0048] serial number

Element

1000ml recipe volume

1

Lidocaine Hydrochloride

21.565g

2

Sodium chloride

4.9g

3

purified water

Add to 1000ml

[0049] (1), preparation: take by weighing sodium chloride, lidocaine hydrochloride, medicinal charcoal according to formula quantity, for subsequent use.

[0050] (2) Washing and drying the bottle: use an ultrasonic washing machine to clean the ampoule.

[0051] (3), dosing:

[0052] (3.1), put the water for injection of 70% formula quantity into the liquid mixing tank, add the sodium chloride of formula quantity, turn on the mixer and stir for 5 minutes.

[0053] (3.2), add the lidocaine hydrochloride of formula quantity in the liquid mixing tank, stir for 5 minutes.

[0054] (3.3), add medicinal charcoal according to the formula, and stir for 5 minutes.

[0055] (3.4), add water for injection, turn on...

example 2

[0063] Example 2 prepares lidocaine hydrochloride injection:

[0064] serial number

Element

1000ml recipe volume

1

Lidocaine Hydrochloride

21.565g

2

Sodium chloride

4.4g

3

purified water

Add to 1000ml

[0065] Remarks: lidocaine hydrochloride is fed according to the content and water content of the dry product.

[0066] (1), preparation: take by weighing sodium chloride, lidocaine hydrochloride, medicinal charcoal according to formula quantity, for subsequent use.

[0067](2) Washing and drying the bottle: use an ultrasonic washing machine to clean the ampoule.

[0068] (3), dosing:

[0069] (3.1), put the water for injection of 70% formula quantity into the liquid mixing tank, add the sodium chloride of formula quantity, turn on the mixer and stir for 5 minutes.

[0070] (3.2), add the lidocaine hydrochloride of formula quantity in the liquid mixing tank, stir for 5 minutes.

[0071] (3.3), add medici...

example 3

[0080] Example 3 prepares lidocaine hydrochloride injection:

[0081] serial number

Element

1000ml recipe volume

1

Lidocaine Hydrochloride

21.565g

2

Sodium chloride

5.3g

3

purified water

Add to 1000ml

[0082] Remarks: Lidoca hydrochloride is divided into dry and pure according to the content and water content.

[0083] (1), preparation: take by weighing sodium chloride, lidocaine hydrochloride, medicinal charcoal according to formula quantity, for subsequent use.

[0084] (2) Washing and drying the bottle: use an ultrasonic washing machine to clean the ampoule.

[0085] (3), dosing:

[0086] (3.1), put the water for injection of 70% formula quantity into the liquid mixing tank, add the sodium chloride of formula quantity, turn on the mixer and stir for 5 minutes.

[0087] (3.2), add the lidocaine hydrochloride of formula quantity in the liquid mixing tank, stir for 5 minutes.

[0088] (3.3), add medic...

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PUM

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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 [0001] The invention relates to a pharmaceutical preparation, in particular to a preparation method of the medicine, in particular to a lidocaine hydrochloride injection and a preparation method thereof. Background technique [0002] The main component of Lidocaine Hydrochloride Injection is Lidocaine Hydrochloride, which is used in this product as a local anesthetic and an antiarrhythmic drug. It is mainly used for infiltration anesthesia, epidural anesthesia, topical anesthesia (including mucosal anesthesia during thoracoscopic examination or abdominal surgery) and nerve conduction block. This product can also be used for premature ventricular contractions and ventricular tachycardia after acute myocardial infarction, and for ventricular arrhythmias caused by digitalis poisoning, cardiac surgery and cardiac catheterization. But it is usually ineffective for supraventricular arrhythmias. [0003] The indications for lidocaine hydrochloride injection are lo...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/167A61P23/02A61P9/06
Inventor 王燕周建伟
Owner SHANGHAI ZHAOHUI PHARMA
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