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Rectal suppository for anaesthesia and preparation method thereof

An anal suppository and prescription technology, which is applied in the field of anesthesia anal suppository and its preparation, can solve problems such as difficult control of product melting temperature, poor product content uniformity, and inaccurate drug dosage, so as to avoid liver first-pass effect and product stability Good, simple and easy preparation process

Inactive Publication Date: 2017-09-08
CHONGQING YUBEIHAI TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In summary, the prior art research on dexmedetomidine hydrochloride and ketamine can not meet the needs of clinical use, and there is an urgent need to develop an anal suppository for anesthesia that is convenient for clinical use, rapid onset, safe and effective; at present, anal The suppository still exists. The melting temperature of the product is not easy to control. That is, the suppository cannot be melted at a normal body temperature of 37°C, resulting in the drug being unable to be released. short shelf life

Method used

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  • Rectal suppository for anaesthesia and preparation method thereof
  • Rectal suppository for anaesthesia and preparation method thereof
  • Rectal suppository for anaesthesia and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] A kind of anal plug for anesthesia is prepared according to the following steps:

[0024] Element Dosage (parts by weight) Dexmedetomidine Hydrochloride 1 copy Ketamine hydrochloride 750 copies Glyceryl monostearate 2000 copies Poloxamer 1000 copies polyethylene glycol 2000 800 copies Tween 60 110 copies Span 60 190 copies White Vaseline 2650 copies glycerin 600 copies Benzyl alcohol 500 copies

[0025] Preparation process:

[0026] 1. Matrix melting: Take the prescribed amount of glyceryl monostearate, poloxamer, and polyethylene glycol 2000 in a suitable container, heat to 70-80°C to melt the matrix, keep it warm after melting, and obtain the matrix solution; take another prescribed amount of Tween 60, Span 60, white petrolatum, and glycerin in a suitable container, heat to 70-80°C, and add prescribed amounts of dexmedetomidine hydrochloride and ketamine hydrochloride under heat prese...

Embodiment 2

[0057] A kind of anal plug for anesthesia is prepared according to the following steps:

[0058] Element Dosage (parts by weight) Dexmedetomidine Hydrochloride 1 copy Ketamine hydrochloride 650 copies Glyceryl monostearate 1800 copies Poloxamer 900 copies polyethylene glycol 2000 700 copies Tween 60 100 copies Span 60 170 copies White Vaseline 2500 copies glycerin 500 copies Benzyl alcohol 400 copies

[0059] Preparation process: prepared according to the preparation process of Example 1, and its melting temperature was measured to be 33.7°C.

[0060] According to the test method of embodiment 1, the sample stability test result of embodiment 2 shows that the sample quality is stable in accelerated June, and the quality is stable in 24 months for a long time, so the validity period of this product is at least 24 months; the content uniformity test result shows that this product is A+ 1.8S is 5...

Embodiment 3

[0062] A kind of anal plug for anesthesia is prepared according to the following steps:

[0063] Element Dosage (parts by weight) Dexmedetomidine Hydrochloride 1 copy Ketamine hydrochloride 850 copies Glyceryl monostearate 2200 copies Poloxamer 1100 copies polyethylene glycol 2000 900 copies Tween 60 120 copies Span 60 200 copies White Vaseline 2800 copies glycerin 700 copies Benzyl alcohol 600 copies

[0064] Preparation process: prepared according to the preparation process of Example 1, and its melting temperature was determined to be 34.6°C.

[0065] According to the test method of embodiment 1, the sample stability test result of embodiment 3 shows that the sample quality is stable in accelerated June, and the long-term quality is stable in 24 months, so the validity period of this product is at least 24 months; the content uniformity test result shows that this product is A+ 1.8S is 7.23...

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Abstract

The invention discloses a rectal suppository for anaesthesia. The preparation method of the rectal suppository comprises the following steps: taking dexmedetomidinehydrochloride and ketamine hydrochloride as raw materials, adding a certain amount of matrix, a surfactant, a diluent, a humectant and a bacteriostat, and performing matrix melting, mixing, membrane injection, cooling shaping and packagingseparately. The rectal suppository does not require building a special administrationchannel, is directly dosed through arectum, avoids the liver first pass effect, takes effect quickly and is good in effect; the melting temperature of the rectal suppository is between 32EDG C to 35 EDG C, not only is beneficial to product storage, but also does not affect melting of the rectal suppository during use, meanwhile, the content of the rectal suppository is uniform and stable, A plus 1.8S of multiple products is smaller than 8, the product stability is good, the shelf life reaches 24 months, the increment of impurities is small during storage, the preparation process is simple and practical, and the rectal suppository is worthy of market promotion.

Description

technical field [0001] The invention mainly relates to the field of pharmaceutical technology, in particular to an anal suppository for anesthesia and a preparation method thereof. Background technique [0002] Pre-examination sedation, especially for children, is a clinical problem that needs to be solved urgently. The use of safe and effective drugs is the key to ensure that children can successfully complete various examinations. [0003] Dexmedetomidine hydrochloride is the dextro isomer of medetomidine, which is a derivative of imidazoles. It is a highly selective α2 receptor agonist, and its chemical name is: (+)-4-(S) -[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole hydrochloride acts on α2 receptors in the nucleus of the locus coeruleus of the brainstem to produce a good sedative effect, but 2ug / kg alone After sedation with dexmedetomidine, it is easy to be awakened by external stimuli, and the awakening rate can reach about 50%, resulting in failure of sedation; large d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4174A61K31/137A61K9/02A61P23/00
CPCA61K9/0031A61K9/02A61K31/137A61K31/4174A61K47/26A61K2300/00
Inventor 徐颖叶茂
Owner CHONGQING YUBEIHAI TECH CO LTD
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