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Preparation method of scopolamine butylbromide injection

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: 2021-06-04
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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  • Preparation method of scopolamine butylbromide injection
  • Preparation method of scopolamine butylbromide injection
  • Preparation method of scopolamine butylbromide injection

Examples

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Embodiment 1

[0026] A scopolamine butylbromide injection, containing scopolamine butylbromide 200mg, glutathione 4.2mg, water for injection added to 10ml, pH value is 5.05.

[0027]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

[0029] 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.

[0030] 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

[0032] 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.

[0033] 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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Abstract

The invention provides a scopolamine butylbromide injection and a preparation method thereof. The scopolamine butylbromide injection comprises 200 mg of scopolamine butylbromide, 10-100 mg of a pH buffer pair, 1.2-36 mg of a stabilizer and the balance of water for injection, the pH value of the injection is 4.8-5.4, and the scopolamine butylbromide injection is prepared through the following steps: (1), 60-80% of the water for injection in the formula amount is added into the pH buffer pair in the formula amount, carrying out stirring for 10-30 min so that the water for injection can be completely dissolved, and controlling the pH value to 4.8-5.2; (2) adding scopolamine butylbromide in the formula amount, and performing stirring for dissolving; adding the stabilizer and the residual water for injection in the formula amount, and carrying out stirring for 15-45 min; and (3) performing filtering with a 0.22 [mu] m microfiltration membrane, carrying out filling, introducing nitrogen for protection in the whole preparation and filling process, and performing sterilizing at 121 DEG C for 12 min to obtain the scopolamine butylbromide injection. The scopolamine butylbromide injection can effectively promote spasmolysis of smooth muscles of a patient, and has small adverse reaction; and the storage stability is high, the process is simple and the production cost is low.

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 (-) - Tropinate, molecular formula: C21H30BrNO4, was developed by the German Boehringer company in 1950 and launched 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 etiologies...

Claims

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Application Information

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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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