Rifampicin freeze-dried powder injection and preparation process thereof

A technology of freeze-dried powder injection and rifampicin, which is applied in the field of medicine and can solve problems such as poor controllability

Active Publication Date: 2014-08-13
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, rifampicin sterilized powder intravenous preparations have problems such as product quality stability and safety. In addition, considering factors such as transportation and storage, both powder intravenous preparations and capsules have poor controllability.

Method used

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  • Rifampicin freeze-dried powder injection and preparation process thereof
  • Rifampicin freeze-dried powder injection and preparation process thereof

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Embodiment Construction

[0009] A best implementation of the present invention, a preparation of rifampicin freeze-dried powder for injection and its preparation process, adopts conventional technology to mix rifampicin and necessary materials into aqueous solution, rifampicin 450g, sodium thiosulfate (Na 2 S 2 o 3 .5H 2 O) 14.1g, sodium hydroxide 15.3g, medicinal charcoal 6g, water for injection 6 L. Among them, rifampicin is fed according to 102.5% after conversion according to the moisture and content (used to offset the residual loss when the material is transferred to the liquid mixing tank after weighing, the adsorption of medicinal charcoal and fine filtration adsorption), and the content of the intermediate is used for filling. The calculation is based on 100% filling. Sodium thiosulfate 14.1g is equivalent to 9g Na 2 S 2 o 3 , the concentration is 0.15%, and the dosage of 6g of medicinal charcoal is 0.1% of the volume of the liquid medicine, which is finally removed. The preliminary pr...

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Abstract

The invention discloses a rifampicin freeze-dried powder injection and a preparation process thereof, and the preparation process is as follows: weighing rifampicin raw material drug and water for injection for standby use, adding sodium thiosulfate, stirring for dissolving, adding into a liquid mixing tank; filling nitrogen into the liquid mixing tank, adding rifampicin, stirring into a suspension, adding a sodium hydroxide solution, mixing evenly, taking medicinal carbon, adding the water for injection to prepare into paste to add into the material mixing tank, stirring evenly, and standing for adsorption; using a titanium stick to filter for remove carbon; opening a sterile liquid storage tank for circulating mixing in a filling material liquid circulating pump, sampling and testing the pH value, using filtered and sterilized nitrogen for pressure maintaining; filling the drug liquid in an injection bottle, pressing until a plug is semi-closed, placing in a lyophilizer for freeze drying. The rifampicin freeze-dried powder injection has the advantages of longer shelf life, higher quality stability and safety, more convenient transportation and storage, and can be widely used in rifampicin freeze-dried powder injections and the preparation process thereof.

Description

Technical field: [0001] The invention relates to the technical field of medicine, in particular to a rifampicin freeze-dried powder for injection and a preparation process thereof. Background technique: [0002] At present, the incidence of tuberculosis in the world is on the rise, and tuberculosis has become one of the serious public health problems. Rifampicin plays an important role in tuberculosis control. However, oral administration of rifampicin capsule preparations to patients with gastrointestinal tract malabsorption cannot exert its due anti-tuberculosis effect, while rifampicin intravenous preparations can maximize the strengths and circumvent weaknesses, which not only speeds up the disease control of tuberculosis patients, but also reduces adverse reactions happened. Rifampicin sterilized powder intravenous preparation has a remarkable curative effect in the treatment of tuberculosis, has a strong anti-tuberculosis effect, has low adverse reactions, and has a s...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/496A61K47/04A61P31/06
Inventor 周利
Owner REYOUNG PHARMA
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