Method for evaluating ripdicaine emulsifiable paste

A technology for risprocaine and cream, which is applied in the field of evaluating samples developed for risprocaine cream, and can solve problems such as the inability to accurately evaluate the similarity and difference in results of transdermal experiments between self-developed samples and reference preparations

Pending Publication Date: 2022-04-26
苏州高迈药业有限公司
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Problems solved by technology

[0005] However, due to the individual differences in pigs, the differences in growth environment, the differences in pigskin processing, and the differences in different positions of the same individual in the methods in the prior art, the samples of Liprocaine cream were tested in parallel during the in vitro transdermal experiment. There are very large differences in the results, and it is impossible to accurately evaluate the similarity between the self-developed sample and the reference preparation transdermal test, so a new evaluation method is needed to solve the above problems

Method used

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  • Method for evaluating ripdicaine emulsifiable paste
  • Method for evaluating ripdicaine emulsifiable paste
  • Method for evaluating ripdicaine emulsifiable paste

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0046] Basic experiment example 1 Preparation of self-developed samples

[0047] The self-developed sample Liprocaine Cream is a local anesthetic and analgesic preparation for external use. It is suitable for all kinds of needle puncture and surgical anesthesia for superficial skin and mucous membranes. Each g contains lidocaine 25mg and prilocaine 25mg. The prescribing information is as follows:

[0048] materials effect Content (mg / g) Lidocaine active ingredient 25 Prilocaine active ingredient 25 carbomer thickener 8.0 Polyoxyethylene Hydrogenated Castor Oil Emulsifier 19.0 sodium hydroxide pH regulator 4.08 purified water solvent 918.92

[0049] Process flow chart such as figure 1 .

Embodiment 1

[0050] Embodiment 1 A kind of evaluation method of Liprocaine emulsifiable cream

[0051] The reference preparation in this example is EMLA cream, purchased from Aspen Pharma Trading Limited, Sweden, registration number H20100154.

[0052] (1) Preparation of mobile phase:

[0053] Weigh 3.03g of potassium dihydrogen phosphate and dissolve it in 700mL of water, adjust to pH 7.20±0.05 with 5mol / L sodium hydroxide, filter with 0.22μm water filter, take 630mL of filtrate, dilute to 1000mL with acetonitrile, shake Uniform, ultrasonic degassing, that is.

[0054] Diluent (receiving medium): 0.9% NaCl solution.

[0055]Reference substance solution preparation: take 20 mg of prilocaine reference substance and 20 mg of lidocaine reference substance respectively, accurately weigh them, put them in a 100mL measuring bottle, add diluent to dissolve and dilute to the mark, and shake well.

[0056] (2) The Franz vertical diffusion device was used in the transdermal experiment (the effect...

Embodiment 2

[0077] Embodiment 2 pigskin repeated utilization is to the transdermal experiment of Liprocaine emulsifiable cream

[0078] Get 6 pieces of pigskin, take the self-developed sample as the object of investigation, repeat the transdermal experiment 4 times (with reference to the initial transdermal experiment in Example 1), the results are shown in Figure 9-10 . Analyzing the 4 results, the ratio of the transdermal rate of prilocaine between the results of the subsequent three and the initial experiment was between 0.90-0.95, and the ratio of transdermal rate of lidocaine was 0.91-0.95.

[0079] In addition, 6 pieces of pigskin were taken, and the self-developed samples and the reference preparation were used as the investigation objects. Comparing preparations, comparing cross-loading, and repeated use of pigskin on the sample penetration rate, the results are shown in Figure 11-12 . The results showed that the ratio of prilocaine transdermal rate of the two self-developed ...

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Abstract

The invention provides a method for evaluating a riptacaine cream sample. The method at least comprises a primary transdermal experiment and a repeated transdermal experiment, the same transdermal material is selected for the primary transdermal experiment and the repeated transdermal experiment. According to the method, the pigskin is repeatedly and crossly used, and the self-researched sample and the reference preparation are sequentially used on the same pigskin to carry out the in-vitro transdermal experiment of the riptacaine cream, so that the difference caused by different pigskins is eliminated, and the influence of the difference between the pigskins on the in-vitro transdermal experiment of the riptacaine cream is reduced; therefore, the similarity between the self-developed dicaine cream and the reference preparation in vitro transdermal experiment can be evaluated more accurately.

Description

technical field [0001] The invention belongs to the technical field of drug detection, and in particular relates to a method for evaluating a developed sample of risprocaine cream. Background technique [0002] Liprocaine cream is a local rapid anesthetic, which can quickly anesthetize the skin after being applied, and is suitable for various types of needle puncture and surgical anesthesia on the skin and superficial mucosa. When Liprocaine cream is used on the skin or mucosal surface, it can release lidocaine and prilocaine to reach the cortex and subcutaneous layer, and then reach the whole body through blood vessel absorption. Therefore, in clinical experiments, the average drug absorption and metabolism curve in vivo can be used to determine Assess the bioequivalence (BE) of self-developed samples and reference preparations. In order to reduce the risk of BE failure, it is necessary to design an in vitro transdermal test of risprocaine cream to evaluate the comparison ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/15G01N33/50
CPCG01N33/15G01N33/5008
Inventor 张静杨镜
Owner 苏州高迈药业有限公司
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