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Pharmaceutical composition, and preparation method and use thereof

A composition and drug technology, applied in the field of medicine, can solve problems such as non-compliance with drug administration, aggravating patients' nervousness, anxiety and fear, and delaying diagnosis and treatment.

Pending Publication Date: 2020-03-20
YICHANG HUMANWELL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Most of the above sedatives and anesthetics are administered intravenously, especially for some drugs, such as propofol, which can cause pain at the injection site (Chinese Journal of Practical Internal Medicine, 2010, 30 (7)), which will aggravate the tension, anxiety and fear of patients Psychology, do not cooperate with drug administration, especially young patients, this will delay the progress of diagnosis and treatment

Method used

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  • Pharmaceutical composition, and preparation method and use thereof
  • Pharmaceutical composition, and preparation method and use thereof
  • Pharmaceutical composition, and preparation method and use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0098] Embodiment 1 preparation contains sedative (formula (I), R 1 =CH 3 , R 2 =CH 3 , besylate) and alfentanil hydrochloride nasal microsphere formulation

[0099] 1. take by weighing 2g chitosan, be dissolved in the acetic acid aqueous solution of 5% in 100ml volume ratio, obtain the chitosan solution of 2% (g / 100ml); Take by weighing 50mg alfentanil hydrochloride and be dissolved in 10ml 2% ( g / 100ml) chitosan solution, adjust the pH to 2.9~3.7 with 1mol / L NaOH, as the water phase;

[0100] ② Take 100ml of liquid paraffin containing 2% (v / v) Span80 as the oil phase; when the stirring speed of electric stirring is 1200r / min, and the temperature is room temperature, slowly add the water phase to the oil phase through a syringe, Emulsify for 15 minutes to make a W / O emulsion;

[0101] ③At room temperature, with a stirring speed of 400r / min, slowly add 1ml of cross-linking agent glutaraldehyde, solidify for 90min, and let it stand until there are no bubbles; min and an o...

Embodiment 2

[0104] Example 2 Preparation of nasal microsphere preparations containing dexmedetomidine hydrochloride and dexketamine hydrochloride

[0105] ① Take 2g chitosan and dissolve it in 100ml volume ratio of 5% acetic acid aqueous solution to obtain 2% chitosan solution; weigh 46mg dexketamine hydrochloride and dissolve it in 10ml 2% (g / 100ml) chitosan Sugar solution, adjust the pH to 2.9-3.7 with 1mol / L HCl, as the water phase;

[0106] ② Take 100ml of liquid paraffin containing 2% (v / v) Span80 as the oil phase; when the stirring speed of electric stirring is 1200r / min, and the temperature is room temperature, slowly add the water phase to the oil phase through a syringe, Emulsify for 15 minutes to make a W / O emulsion;

[0107] ③At room temperature, with a stirring speed of 400r / min, slowly add 1ml of cross-linking agent glutaraldehyde, solidify for 90min, and let it stand until there are no bubbles; min and an outlet temperature of 75°C for spray drying to obtain dexketamine hy...

Embodiment 3

[0110] Embodiment 3 preparation contains sedative (formula (I), R 1 =CH 3 , R 2 =CH 3 , tosylate) and fentanyl citrate nasal microsphere formulation

[0111] 1. Take by weighing 2g chitosan, be dissolved in 100ml and be 5% (v / v) in the acetic acid aqueous solution, obtain the chitosan solution of 2% (g / 100ml); Take by weighing 56mg fentanyl citrate and dissolve in 10ml of 2% (g / 100ml) chitosan solution, adjusted to pH 2.8-3.5 with 1mol / L HCl, as the water phase;

[0112] ② Take 100ml of liquid paraffin containing 2% (v / v) Span80 as the oil phase; when the stirring speed of electric stirring is 1200r / min, and the temperature is room temperature, slowly add the water phase to the oil phase through a syringe, Emulsify for 15 minutes to make a W / O emulsion;

[0113] ③At room temperature, with a stirring speed of 400r / min, slowly add 1ml of cross-linking agent glutaraldehyde, solidify for 90min, and let it stand until there are no bubbles; min and outlet temperature of 75°C t...

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Abstract

This application discloses a pharmaceutical composition including a sedative and a narcotic. The pharmaceutical composition is suitable for a programmed controlled release drug delivery preparation indigestive endoscopic diagnosis and treatment, can be a nasal microsphere preparation containing the sedative and the narcotic. The sedative is quickly released and can relieve tension, anxiety and fear in patients firstly. The anesthetic wrapped in microspheres works later and can maintain anesthesia to facilitate checking. The preparation not only increases the compliance of a patient, but alsois given more conveniently, saves the diagnosis time, and improves the treatment efficiency.

Description

technical field [0001] The application belongs to the technical field of medicine, and specifically relates to a pharmaceutical composition, which includes a sedative and an anesthetic; in particular, the pharmaceutical composition can be used for gastrointestinal endoscopic diagnosis and treatment. Background technique [0002] Gastrointestinal endoscopic diagnosis and treatment techniques include gastroscopy, colonoscopy, enteroscopy, retrograde cholangiopancreatography, endoscopic mucosal resection, endoscopic submucosal dissection, etc. It is the most commonly used and most reliable diagnosis and treatment method for gastrointestinal diseases. However, most patients feel nervous, anxious and fearful about digestive endoscopy, and cough, nausea and vomiting, increased heart rate, increased blood pressure, arrhythmia, etc. are prone to occur during the examination, and even induce angina pectoris, myocardial infarction, stroke or Severe complications such as cardiac arrest...

Claims

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Application Information

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IPC IPC(8): A61K31/5517A61K31/4468A61K31/454A61K31/4535A61K31/451A61K31/661A61K31/137A61K31/4174A61K31/05A61P25/20A61P23/00
CPCA61K31/5517A61K31/4468A61K31/454A61K31/4535A61K31/451A61K31/661A61K31/137A61K31/4174A61K31/05A61P25/20A61P23/00A61K2300/00
Inventor 杨洁吴有斌曲龙妹田峦鸢汪淼吕金良杨玉萍张丽娜李莉娥李仕群杜文涛李杰符义刚郭建锋
Owner YICHANG HUMANWELL PHARMA
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