Cefaclor compound, medicine composition of cefaclor compound and bromhexine hydrochloride, and preparation of cefaclor compound

A technology of bromhexine hydrochloride and cefaclor, applied in the field of medicine, can solve problems such as research on bioavailability of preparations, and achieve the effects of good clinical treatment effect, good stability and improved synergistic drug effect

Active Publication Date: 2015-11-25
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
8 Cites 3 Cited by

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Problems solved by technology

[0008] However, the above patents did not conduct in-d...
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Abstract

The invention relates to the field of medicines, in particular to a cefaclor trihydrate and a preparation thereof. The cefaclor trihydrate has a structural formula shown in formula (I). The invention further relates to a medicine composition prepared from the cefaclor trihydrate and bromhexine hydrochloride. The form of the medicine composition is selected from tablets, capsules and granules. Stability tests prove that the prepared cefaclor trihydrate is high in stability and bioavailability, and suitable for clinical application.

Application Domain

Antibacterial agentsOrganic active ingredients +1

Technology Topic

DrugDosage form +6

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  • Cefaclor compound, medicine composition of cefaclor compound and bromhexine hydrochloride, and preparation of cefaclor compound
  • Cefaclor compound, medicine composition of cefaclor compound and bromhexine hydrochloride, and preparation of cefaclor compound
  • Cefaclor compound, medicine composition of cefaclor compound and bromhexine hydrochloride, and preparation of cefaclor compound

Examples

  • Experimental program(14)
  • Comparison scheme(3)

Example Embodiment

[0039] Example 1 Preparation of Cefaclor Trihydrate
[0040] 1. Dissolve the crude cefaclor in water with a pH of 3.0 and a temperature of 40°C;
[0041] 2. While stirring, add a mixed solvent of diethyl ether and n-hexane in a volume ratio of 2:1; the stirring speed is 1200 rpm; the weight of the mixed solvent is 4 times the weight of the cefaclor aqueous solution, and the adding speed is 30 ml/min;
[0042] 3. After the mixed solvent is added, the temperature is lowered to -1°C, and the cooling rate is 4°C/hour; adjust the pH to 4.5 to obtain crystals and then stand for crystallization; filter, wash, and vacuum dry for 2 hours to obtain cefaclor III Hydrate.
[0043] The compound crystals were tested by high performance liquid chromatography, the purity was 99.96%, the yield was 94.0%; the X-ray powder diffraction pattern obtained by Cu-Kα ray measurement is as follows figure 1 As shown, the thermogravimetric analysis diagram is as figure 2 Shown; elemental analysis (%) measured value:
[0044] C (42.710), H (4.740), N (9.965), Cl (8.400), O (26.550), S (7.610).

Example Embodiment

[0045] Example 2 Preparation of Cefaclor Trihydrate
[0046] 1. Crude cefaclor is dissolved in water with a pH of 2.5 and a temperature of 35°C;
[0047] 2. While stirring, add a mixed solvent of diethyl ether and n-hexane with a volume ratio of 2:0.8; the stirring speed is 1000 rpm; the weight of the mixed solvent is 3 times the weight of the cefaclor aqueous solution, and the adding speed is 20 ml/min;
[0048] 3. After the mixed solvent is added, the temperature is lowered to 0°C, and the cooling rate is 5°C/hour; adjust the pH to 5.0 to obtain crystals and then stand for crystallization; filter, wash, and vacuum dry for 4 hours to obtain cefaclor trihydrate Things.
[0049] The compound crystals were tested by high performance liquid chromatography, and the purity was 99.95%, and the yield was 93.5%; the X-ray powder diffraction pattern obtained by Cu-Kα ray measurement is as follows figure 1 As shown, the thermogravimetric analysis diagram is as figure 2 Shown; elemental analysis (%) measured values: C (42.710), H (4.740), N (9.965), Cl (8.400), O (26.550), S (7.610).

Example Embodiment

[0050] Example 3 Preparation of Cefaclor Trihydrate
[0051] 1. The crude cefaclor is dissolved in water with a pH of 3.0 and a temperature of 38°C;
[0052] 2. While stirring, add a mixed solvent of diethyl ether and n-hexane with a volume ratio of 4:1; the stirring speed is 900 rpm; the weight of the mixed solvent is 3 times the weight of the cefaclor aqueous solution, and the adding speed is 20 ml/min;
[0053] 3. After the mixed solvent is added, the temperature is lowered to -1°C, and the cooling rate is 4°C/hour; adjust the pH to 4.5 to obtain crystals and then stand for crystallization; filter, wash, and vacuum dry for 3 hours to obtain cefaclor III Hydrate.
[0054] The compound crystals were tested by high performance liquid chromatography, the purity was 99.96%, the yield was 94.2%; the X-ray powder diffraction pattern obtained by Cu-Kα ray measurement is as follows figure 1 As shown, the thermogravimetric analysis diagram is as figure 2 Shown; elemental analysis (%) measured values: C (42.710), H (4.740), N (9.965), Cl (8.400), O (26.550), S (7.610).

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