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Method for preparing ciprofloxacin hydrochloride time-release capsule

A technology of ciprofloxacin hydrochloride and sustained-release capsules is applied in the directions of medical preparations containing active ingredients, pharmaceutical formulas, urinary system diseases, etc., to achieve the effects of avoiding sudden release, smoothing the shape of the time curve and slowing the absorption

Inactive Publication Date: 2009-08-26
西安远大德天药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The technical problem to be solved by the present invention is to overcome the above-mentioned shortcoming of ciprofloxacin hydrochloride, and provide a kind of ciprofloxacin hydrochloride that has little stimulating effect on the gastrointestinal tract, good coating effect, particles are not easy to fall off, the coating liquid is easy to adhere, and the environment is polluted in the production process. The preparation method of small ciprofloxacin hydrochloride sustained-release capsules

Method used

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  • Method for preparing ciprofloxacin hydrochloride time-release capsule
  • Method for preparing ciprofloxacin hydrochloride time-release capsule
  • Method for preparing ciprofloxacin hydrochloride time-release capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Take the production of 1000 ciprofloxacin hydrochloride sustained-release capsule products as an example, and its preparation method is as follows:

[0054] 1. Ingredients

[0055] Weigh the medicinal active ingredients and auxiliary materials according to the following mass:

[0056] Ciprofloxacin Hydrochloride 292g

[0057] Microcrystalline Cellulose 58.4g

[0058] Lactose 58.4g

[0059] Citric acid 8.3g

[0060] The mass ratio of the medicinal active ingredients and auxiliary materials of the above-mentioned medicine is:

[0061] Ciprofloxacin Hydrochloride 70%

[0062] Microcrystalline Cellulose 14%

[0063] Lactose 14%

[0064] Citric acid 2%

[0065] 2. mix

[0066] Grind ciprofloxacin hydrochloride through a 120-mesh sieve, crush lactose through an 80-mesh sieve, and ciprofloxacin hydrochloride through an 80-mesh sieve, weigh ciprofloxacin hydrochloride, lactose, and citric acid according to the above mass ratio and mix them with a mixer Evenly, prepare a...

Embodiment 2

[0091] Take the production of 1000 ciprofloxacin hydrochloride sustained-release capsule products as an example, and its preparation method is as follows:

[0092] In the step 3 of preparing the plain pill, the polishing time is 3 minutes, and the other steps of this step are the same as in Example 1. In the coating step 4, when the coating amount of 1000g of plain pills is 1.2%, the coating solution is made from the raw materials of the following mass ratio:

[0093] Aqueous dispersion of ethyl acrylate-methyl methacrylate copolymer 14.26g

[0094] Aqueous dispersion of methacrylic acid-ethyl acrylate copolymer 14.26g

[0095] Talc powder 7.13g

[0096] Polyethylene glycol 6000 1.78g

[0097] Sodium Lauryl Sulfate 1.43g

[0098] Water 317.64mL

[0099] The mass percent of coating solution is:

[0100] Aqueous dispersion of ethyl acrylate-methyl methacrylate copolymer 4%

[0101] Aqueous dispersion of methacrylic acid-ethyl acrylate copolymer 4%

[0102] Talc 2%

[01...

Embodiment 3

[0108] Take the production of 1000 ciprofloxacin hydrochloride sustained-release capsule products as an example, and its preparation method is as follows:

[0109] In the step 3 of preparing the plain pill, the polishing time is 4 minutes, and the other steps of this step are the same as in Example 1. In the coating step 4, when the coating amount of 1000g of plain pills is 1.2%, the coating solution is made from the raw materials of the following mass ratio:

[0110] Aqueous dispersion of ethyl acrylate-methyl methacrylate copolymer 24.96g

[0111] Aqueous dispersion of methacrylic acid-ethyl acrylate copolymer 24.96g

[0112] Talc powder 17.83g

[0113] Polyethylene glycol 6000 2.85g

[0114] Sodium Lauryl Sulfate 2.50g

[0115] Water 283.40mL

[0116] The mass percent of coating solution is:

[0117] Aqueous dispersion of ethyl acrylate-methyl methacrylate copolymer 7%

[0118] Aqueous dispersion of methacrylic acid-ethyl acrylate copolymer 7%

[0119] Talc 5%

[0...

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Abstract

The invention relates to a method for preparing a ciprofloxacin hydrochloride time-release capsule. The method comprises the steps of matching materials, mixing, preparing a prime pill, coating and encapsulating. The invention prepares ciprofloxacin hydrochloride into a time-release preparation, thereby delaying the absorption of the ciprofloxacin hydrochloride in vivo; blood concentration-time curve shape becomes more smooth, thereby avoiding the occurrence of burst release; and the ciprofloxacin hydrochloride time-release capsule is obviously better than ordinary ciprofloxacin hydrochloride pellet in maintaining the stability of the blood concentration and has the effect of time-release. The ciprofloxacin hydrochloride time-release capsule prepared by the invention has the antiphlogistic and antibacterial functions and is used for general urinary tract infection, urinary tract mixed infection, complex urinary tract infection, chronic upper urinary infection, uncomplicated acute cystitis, intractable urinary tract infection, prostatitis, etc.

Description

technical field [0001] The invention belongs to the technical field of medical preparations containing inorganic active ingredients, in particular to ciprofloxacin hydrochloride sustained-release capsule preparations. Background technique [0002] Ciprofloxacin Hydrochloride (Ciprofloxacin Hydrochloride) is an excellent representative of the third-generation fluoroquinolone synthetic antibacterial drugs. It has the characteristics of broad antibacterial spectrum, strong antibacterial activity, complete oral absorption, and wide distribution in the body. Satisfactory curative effect. But along with being widely used, various adverse reactions are frequently reported, and the incidence of adverse reactions caused by oral preparations is 9.6% to 15.0%, and some reactions are even serious. concern. According to literature reports, ciprofloxacin hydrochloride has unique double bactericidal effect, low effective bacteriostatic concentration, and MIC for most pathogenic bacteria....

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/56A61K31/496A61P29/00A61P31/04A61P13/00
Inventor 唐星黄惠锋任延成宋莹王亚轩
Owner 西安远大德天药业股份有限公司
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