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Sublingual tablet for anaesthesia and preparation method thereof

A sublingual tablet and prescription technology, applied in the field of anesthetized sublingual tablet and its preparation, can solve the problems of large increase in impurities, poor product stability, poor particle fluidity, etc. Over effect, simple and feasible preparation process, good fluidity

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 research on dexmedetomidine hydrochloride and ketamine in the prior art still cannot meet the needs of clinical use, and there is an urgent need to develop a compound anesthesia tongue that is convenient for clinical use, has a rapid onset of effect, and is well tolerated by patients. Sublingual tablets: At present, sublingual tablets still have technologies such as slow disintegration of the finished product, poor particle fluidity during the preparation process, resulting in large differences in tablet weight, large increase in impurities during storage of the finished product, poor product stability, and short shelf life. problem needs to be solved

Method used

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  • Sublingual tablet for anaesthesia and preparation method thereof
  • Sublingual tablet for anaesthesia and preparation method thereof
  • Sublingual tablet for anaesthesia and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] A sublingual tablet for anesthesia, prepared according to the following steps:

[0027] Element Dosage (parts by weight) Dexmedetomidine Hydrochloride 1 copy Ketamine hydrochloride 1100 copies lactose 1700 copies Mannitol 2950 copies Sodium carboxymethyl starch 600 copies Croscarmellose Sodium 1700 copies steviol glycoside 400 copies Povidone K30 200 copies 50% ethanol by volume 1250 copies Magnesium stearate 400 copies

[0028] Preparation process:

[0029] 1. Pre-treatment: Take the prescribed amount of dexmedetomidine hydrochloride, ketamine hydrochloride, lactose, mannitol, sodium carboxymethyl starch, cross-linked sodium carboxymethyl cellulose, and steviol glycoside, and place them in a universal grinder, Pulverize through a 100-mesh sieve, and set aside; get another prescribed amount of povidone K30 and dissolve it in an ethanol solution with a volume fraction of 50% of the presc...

Embodiment 2

[0063] A sublingual tablet for anesthesia, prepared according to the following steps:

[0064] Element Dosage (parts by weight) Dexmedetomidine Hydrochloride 1 copy Ketamine hydrochloride 900 copies lactose 1600 copies Mannitol 2800 copies Sodium carboxymethyl starch 500 copies Croscarmellose Sodium 1600 copies steviol glycoside 300 copies Povidone K30 150 copies 50% ethanol by volume 1200 copies Magnesium stearate 300 copies

[0065] Preparation process: It is prepared according to the preparation process of Example 1, and the Hugher angle of the particles is measured to be 35°.

[0066] According to the test method of Example 1, the sample stability test results of Example 2 show that the sample quality is stable in 6 months after acceleration, and the quality is stable for 24 months in a long-term, so the validity period of this product is at least 24 months; the disintegration time limit te...

Embodiment 3

[0068] A sublingual tablet for anesthesia, prepared according to the following steps:

[0069] Element Dosage (parts by weight) Dexmedetomidine Hydrochloride 1 copy Ketamine hydrochloride 1300 copies lactose 1800 copies Mannitol 3100 copies Sodium carboxymethyl starch 700 copies Croscarmellose Sodium 1800 copies steviol glycoside 500 copies Povidone K30 250 copies 50% ethanol by volume 1300 copies Magnesium stearate 500 copies

[0070] Preparation process: It is prepared according to the preparation process of Example 1, and the Hugher angle of the particles is measured to be 33°.

[0071] According to the test method of Example 1, the sample stability test results of Example 3 show that the sample quality is stable in six months after acceleration, and the quality is stable for 24 months in a long-term, so the validity period of this product is at least 24 months; the disintegration time limit...

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Abstract

The invention discloses a sublingual tablet for anaesthesia. The preparation method of the sublingual tablet comprises the following steps: taking dexmedetomidinehydrochloride and ketamine hydrochloride as raw materials, adding a certain amount of a filling agent, a disintegrating agent, a corrigent, an adhesive and a lubricant, and performing pretreatment, mixing, granulatinganddrying, total blending, aluminum plastic inner packaging, outer packaging and the likeseparately. The sublingual tablet does not require building a special administrationchannel, is directly dosed through sublingual veins, avoids the liver first pass effect, takes effect quickly and is good in effect; particle angles of the sublingual tablet are all smaller than 35 DEG C duringpreparation, so that the particle mobility of the sublingual tablet is good, finished products is rapid to disintegrate and can be completelydisintegrated within 3 minutes, the weight difference of finished products is small, the increment of impurities is small during storage, the stability is good, the shelf life reaches 24 months, the preparation technology is simple and practical, and the sublingual tablet is worthy of market promotion.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a sublingual tablet 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, acting on α2 receptors in the nucleus of the locus coeruleus of the brainstem to produce a good sedative effect, but alone 2ug / kg 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 doses...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4174A61K31/137A61K9/20A61P23/00
CPCA61K9/006A61K9/2059A61K31/137A61K31/4174A61K2300/00
Inventor 徐颖叶茂
Owner CHONGQING YUBEIHAI TECH CO LTD
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