A kind of scopolamine butylbromide injection and preparation method thereof

A technology of scopolamine and injection, applied in the field of scopolamine butylbromide injection and preparation thereof, can solve the problems of temperature, light sensitivity, less research on injection, complicated preparation process, etc., and achieves stable quality, low adverse reaction rate, Component simple effect

Active Publication Date: 2022-03-15
朗天药业(湖北)有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because scopolamine butylbromide contains ester bonds, it is more sensitive to pH, temperature, and light, and has poor storage stability; currently, the injection preparations are mainly freeze-dried powders, and there are few related studies on injections
However, the freeze-dried powder has the disadvantages of complex preparation process, reconstitution and cumbersome operation during use.

Method used

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  • A kind of scopolamine butylbromide injection and preparation method thereof
  • A kind of scopolamine butylbromide injection and preparation method thereof
  • A kind of scopolamine butylbromide injection and preparation method thereof

Examples

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Embodiment 1

[0025] A scopolamine butylbromide injection, containing scopolamine butylbromide 200mg, glutathione 4.2mg, water for injection added to 10ml, pH value is 5.05.

[0026]The preparation method comprises: (1) taking 70% of the prescribed amount of water for injection, and adjusting the pH value to 5.1 with 0.1M hydrochloric acid; (2) adding the prescribed amount of scopolamine butylbromide and stirring at 150 rpm for 30 minutes; (3) adding the prescribed amount of glutathione The peptide and the remaining water for injection were stirred for 25 minutes, filtered through a 0.22 μm microporous membrane, filled, filled with nitrogen protection during the entire preparation and filling process, and sterilized at 121 ° C for 12 minutes to obtain the product.

Embodiment 2

[0028] A scopolamine butyl bromide injection, containing 200 mg scopolamine butyl bromide, 15 mg tryptophan, 3 mg phenylalanine, 19 mg disodium hydrogen phosphate, 7 mg citric acid, added to 10 ml of water for injection, the pH value is 4.92.

[0029] The preparation method comprises: (1) taking 60% of the prescribed amount of water for injection, adding disodium hydrogen phosphate and citric acid in the prescribed amount, stirring at 180 rpm for 12 minutes to completely dissolve it; (2) adding the prescribed amount of scopolamine butylbromide, and stirring at 120 rpm 30min; (3) Add the prescribed amount of tryptophan, phenylalanine and the remaining water for injection, control the pH to 4.9, stir for 20min, filter through a 0.22μm microporous membrane, fill, and fill in the whole preparation and filling process Nitrogen protection, sterilized at 121°C for 12 minutes, ready to use.

Embodiment 3

[0031] A scopolamine butylbromide injection, containing scopolamine butylbromide 200mg, tryptophan 15mg, phenylalanine 3mg, disodium hydrogen phosphate 19mg, citric acid 7mg and water for injection is added to 10ml, pH value is 4.9.

[0032] The water for injection of scopolamine butylbromide injection is pretreated, and other operations are the same as in Example 2. The pretreatment is as follows: the stirred tank is pre-filled with nitrogen, heated to 62°C after adding water for injection, vacuumed to 0.035Mpa, and stirred under reduced pressure for 30 minutes; slowly lowered to 4°C at a speed of 8°C / h, and passed to the stirred tank Inject nitrogen gas to 0.25Mpa, pressurize, stir for 30min, and place at room temperature and pressure for later use.

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PUM

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Abstract

The invention provides a scopolamine butylbromide injection and a preparation method thereof. The scopolamine butylbromide injection comprises 200 mg of scopolamine butyl bromide, a pH buffer of 10-100 mg, a stabilizer of 1.2-36 mg, water for injection to 10 ml, and the injection The pH value is 4.8-5.4, and the following method is used for preparation: (1) Take 60-80% of the formula amount of water for injection, add the prescribed amount of pH buffer pair, stir for 10-30min to completely dissolve it, and control the pH to 4.8-5.2 (2) Add the prescribed amount of scopolamine butylbromide, stir and dissolve; add the prescribed amount of stabilizer and remaining water for injection, and stir for 15-45min; (3) Filter through a 0.22 μm microporous membrane, fill, and prepare and fill Fill it with nitrogen protection during the loading process, and sterilize it at 121°C for 12 minutes. The scopolamine butylbromide injection of the invention can effectively promote smooth muscle spasmolysis of patients, has little adverse reaction, high storage stability, simple process and low production cost.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a scopolamine butylbromide injection and a preparation method thereof. Background technique [0002] Scopolamine is an alkaloid extracted from plants such as Dajinhua, Belladonna, and Scopolamine, and its hydrobromide and brominated butyl derivatives are commonly used clinically. Among them, scopolamine butyl bromide is a cholinergic receptor blocker, and its chemical name is: 6β bromide, 7β-epoxy-3α-hydroxyl-8-butyl-1α-H, 5αH-tropane (-) - Tropic acid ester, molecular formula: C21H30BrNO4, developed by Boehringer Company in Germany in 1950, and listed in February 1956. In addition to the antispasmodic effect of smooth muscle, the compound can also inhibit the conduction of ganglion, act on the parasympathetic nervous system, and be used for gastrointestinal spasm, biliary colic, renal colic or gastrointestinal motility hyperactivity caused by various etiolog...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/12A61K47/02A61K47/18A61K47/26A61K47/04A61K31/46A61P1/06
CPCA61K9/08A61K9/0019A61K47/12A61K47/02A61K47/183A61K47/26A61K31/46A61P1/06
Inventor 蔡翔黎翩陈景丽李平陈从富伍从旭胡宏林蔡和霖方贤贵张显强
Owner 朗天药业(湖北)有限公司
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