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Erythromycin ethylsuccinate dry suspension and preparation method thereof

A technology of erythromycin ethylsuccinate and dry suspension, which is applied in the direction of pharmaceutical formulations, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., and can solve the problem of poor redispersibility and erythromycin ethylsuccinate To solve the problems of poor flocculation effect of plain dry suspension, to achieve the effect of improving clinical curative effect, rapid absorption in gastrointestinal tract, and improving compliance

Active Publication Date: 2018-08-17
山西皇城相府药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The invention well solves the problems of poor flocculation effect and poor redispersibility of the erythromycin ethylsuccinate dry suspension in the prior art; meanwhile, the mouthfeel and color of the preparation are improved to improve patient compliance

Method used

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  • Erythromycin ethylsuccinate dry suspension and preparation method thereof
  • Erythromycin ethylsuccinate dry suspension and preparation method thereof
  • Erythromycin ethylsuccinate dry suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Example 1 Erythromycin ethylsuccinate dry suspension

[0039] The raw material composition is shown in Table 1, where 1 part by weight = 1g.

[0040] The erythromycin ethylsuccinate dry suspension is prepared by the following method:

[0041] I. Prepare the components according to the weight ratio and crush them;

[0042] II. Take 1 / 3 of the weight of steviol, 1 / 2 of the weight of lemon yellow, sodium lauryl sulfate and erythromycin ethylsuccinate, 2 / 3 of the weight of sucrose powder, press Mix in equal increments, and granulate with a 20% ethanol aqueous solution (24ml) with a volume of 0.048 times the total mass of the mixed dry materials to obtain loose granules with hands that are clumped and loose and have burrs. And powder, part A, total 515g;

[0043] III. Take the remaining parts by weight of steviol, lemon yellow, sodium lauryl sulfate, erythromycin ethylsuccinate and sucrose powder, and the parts by weight of hydroxypropyl cellulose, sodium starch glycolate and sodium...

Embodiment 2

[0047] Example 2 Erythromycin ethylsuccinate dry suspension

[0048] The raw material composition is shown in Table 1, where 1 part by weight = 1g.

[0049] By the same method and steps as in Example 1, 940 bags of erythromycin ethylsuccinate dry suspension (0.1 g / bag based on erythromycin ethylsuccinate) were prepared.

[0050] The dry suspension of erythromycin ethylsuccinate prepared in this example is light yellow particles and a small amount of powder. After adding an appropriate amount of water, the container is slightly shaken to form a uniform suspension with good taste, aroma and moderate sweetness.

Embodiment 3

[0051] Example 3 Erythromycin ethylsuccinate dry suspension

[0052] The raw material composition is shown in Table 1, where 1 part by weight = 1g.

[0053] Through the same method and steps as in Example 1, 1045 bags of erythromycin ethylsuccinate dry suspension (0.1 g / bag based on erythromycin ethylsuccinate) were prepared.

[0054] The dry suspension of erythromycin ethylsuccinate prepared in this example is light yellow particles and a small amount of powder. After adding an appropriate amount of water, the container is slightly shaken to form a uniform suspension with good taste, aroma and moderate sweetness.

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Abstract

The invention provides erythromycin ethylsuccinate dry suspension and a preparation method thereof. The erythromycin ethylsuccinate dry suspension is prepared from the raw materials of 120 to 130 weight parts of erythromycin ethylsuccinate, 630 to 670 weight parts of saccharose powder, 10 to 20 weight parts of sodium alginate, 1 to 3 weight parts of steviosin, 5 to 15 weight parts of hydroxy propyl cellulose, 1 to 3 weight parts of lauryl sodium sulfate, 0.4 to 0.8 weight part of lemon yellow and 5 to 15 weight parts of sodium carboxymethyl starch. The sedimentation volume ratio F of the erythromycin ethylsuccinate dry suspension disclosed by the invention is very close to 1, a flocculation degree beta of the erythromycin ethylsuccinate dry suspension is about 6.0, and redispersibility ofthe erythromycin ethylsuccinate dry suspension is larger than or equal to 95%; thus, the suspension can be evenly dispersed in water, the problem that erythromycin ethylsuccinate dry suspension in theprior art can form much small micelle after water is added into the erythromycin ethylsuccinate dry suspension according to an instruction book is solved, clinical use experience is improved, and patient compliance is improved.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations, and specifically relates to a dry suspension of erythromycin ethylsuccinate and a preparation method thereof. Background technique [0002] Suspension refers to a non-uniform liquid preparation of poorly soluble solid drugs dispersed in a liquid medium with particles larger than colloidal particles. It is suitable for poorly soluble drugs that cannot be completely dissolved in a given solvent volume at the required dose, or Medicines that taste unpleasant and difficult to swallow. Suspension is a thermodynamically unstable system, which requires that the chemical properties of the drug itself should be stable, the sedimentation speed should be slow, there should be no agglomeration after sedimentation, and it should be quickly and evenly dispersed after gentle shaking. In the suspension, the drug is dispersed in a particulate state, with a large degree of dispersion, rapid absorption from t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/38A61K47/36A61K47/26A61K31/7048A61P31/04
CPCA61K9/1623A61K9/1652A61K31/7048A61P31/04
Inventor 马路军刘志红
Owner 山西皇城相府药业股份有限公司
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