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Doxycycline hydrochloride dry suspension and preparation method thereof

A technology of doxycycline hydrochloride and dry suspension, which is applied in the directions of tetracycline active ingredients, pharmaceutical formulations, and non-active ingredients medical preparations, etc., can solve the problems of poor absorption and dispersion stability, difficult to swallow tablets, and poor palatability problems, to achieve the effect of improving palatability, fast absorption, and large distribution area

Inactive Publication Date: 2013-08-28
HEFEI JINYUE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the dosage forms involved in the doxycycline hydrochloride on the market are mainly tablets and capsules. However, tablets are difficult to swallow and are not suitable for children, the elderly and some patients with dysphagia.
At the same time, tablets and capsules also have defects such as poor absorption and dispersion stability, and poor palatability.

Method used

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  • Doxycycline hydrochloride dry suspension and preparation method thereof
  • Doxycycline hydrochloride dry suspension and preparation method thereof
  • Doxycycline hydrochloride dry suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Doxycycline hydrochloride dry suspension, 1000 mg per bag, the formula contains: 50 mg of doxycycline hydrochloride (crude drug, the same below), 935 mg of diluent, 10 mg of suspending agent, and 5 mg of flavoring agent.

[0021] Wherein, the diluent is glucose, the suspending agent is hydroxypropyl cellulose, and the corrective agent is banana essence.

[0022] Preparation method: dry mix doxycycline hydrochloride, diluent, suspending agent and flavoring agent for 10 minutes, pulverize, pass through a 120-mesh sieve, and fill to obtain.

[0023] The doxycycline hydrochloride dry suspension prepared in this example was checked for the sedimentation volume ratio according to the relevant regulations under the dry suspension inspection item in the appendix II of the Chinese Pharmacopoeia 2010 edition, and the result was 0.98. At the same time, the dispersion stability when taken is 90% higher than that of tablets and capsules.

Embodiment 2

[0025] Doxycycline hydrochloride dry suspension, calculated as 1000 mg per bag, the formula contains: 45 mg of doxycycline hydrochloride, 940 mg of diluent, 8 mg of suspending agent, and 7 mg of flavoring agent.

[0026] Wherein, the diluent is sucrose, the suspending agent is sodium carboxymethyl starch 6 mg, xanthan gum 2 mg, and the flavoring agent is fresh milk essence.

[0027] Preparation method: dry mix doxycycline hydrochloride, diluent, suspending agent and flavoring agent for 15 minutes, pulverize, pass through a 100-mesh sieve, and fill to obtain.

[0028] The sedimentation volume ratio is 0.97, and the dispersion stability when taken is 70% higher than that of tablets and capsules.

Embodiment 3

[0030] Doxycycline hydrochloride dry suspension, 2000 mg per bag, the formula contains: 130 mg of doxycycline hydrochloride, 1836 mg of diluent, 20 mg of suspending agent, and 14 mg of flavoring agent.

[0031] Wherein, the diluent is xylitol, the suspending agent is hydroxypropyl cellulose 10 mg, xanthan gum 10 mg, and the corrective agent is almond essence.

[0032] The preparation method is the same as in Example 1.

[0033] The sedimentation volume ratio is 0.97, and the dispersion stability when taken is 75% higher than that of tablets and capsules.

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Abstract

The invention discloses a pharmaceutical composition and in particular relates to doxycycline hydrochloride dry suspension and a preparation method thereof. The doxycycline hydrochloride dry suspension consists of the following materials in percentage by weight: 4%-10% of doxycycline hydrochloride, 89.6%-95% of diluents, 0.2%-1% of a suspending aid and 0.2%-1% of a flavoring agent. The doxycycline hydrochloride dry suspension disclosed by the invention is relatively high in settling volume and capable of realizing improving dispersing stability during a taking process. Compared with the traditional dosage form, the doxycycline hydrochloride dry suspension is a fine grain dosage form better than solid dosage forms including tablet, is large in distribution area of gastrointestinal tract, quick to absorb and high in bioavailability; meanwhile, the doxycycline hydrochloride dry suspension is capable of avoiding the defect that the tablet is difficult to swallow, and is suitable for the children, the old and partial patients with swallowing difficult. Besides, the dry suspension is stored in the form of solid and orally taken in the form of suspension, and therefore, the dry suspension is especially suitable for instable medicines in water.

Description

technical field [0001] The invention discloses a pharmaceutical composition, in particular to a doxycycline hydrochloride dry suspension and a preparation method thereof. Background technique [0002] The antibacterial spectrum of doxycycline hydrochloride is basically the same as that of tetracycline and oxytetracycline, and its antibacterial activity in vivo and in vitro is stronger than that of tetracycline. Microorganisms have close cross-resistance to this product with tetracycline and oxytetracycline. Oral absorption is good. It is mainly used for upper respiratory tract infection, tonsillitis, biliary tract infection, lymphadenitis, cellulitis, senile chronic bronchitis, etc. caused by sensitive gram-positive bacteria and gram-negative bacilli. disease, mycoplasma pneumonia, etc. It can still be used to treat cholera, and also to prevent falciparum malaria and leptospirosis infection. [0003] At present, the dosage forms involved in the doxycycline hydrochloride ...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/65A61K47/38A61K47/36A61K47/32A61P31/04
Inventor 赵栋磊杨波王旦刘延武吴小梅
Owner HEFEI JINYUE PHARMA
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