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Compound doxycycline hyclate suspension injection and preparation method thereof

A technology of doxycycline hydrochloride and injection, which is applied in the field of compound doxycycline hydrochloride suspension injection and its preparation, can solve the problems of high tissue irritation, precipitation, oxidative decomposition and the like, and achieves low tissue irritation and biological The effect of improving the utilization and enhancing the therapeutic effect

Inactive Publication Date: 2012-05-09
TIANJIN RINGPU BIO TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, its preparations are prone to oxidative decomposition during preparation and storage, and there are precipitation phenomena, which are irritating to the tissue at the injection site.

Method used

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  • Compound doxycycline hyclate suspension injection and preparation method thereof
  • Compound doxycycline hyclate suspension injection and preparation method thereof
  • Compound doxycycline hyclate suspension injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Party:

[0031] Component Dosage

[0032] Doxycycline Hydrochloride 2000g

[0033] Tilmicosin Phosphate 2000g

[0034] Aluminum monostearate 200g

[0035] Soy Lecithin 10g

[0036] tert-Butyl-p-Hydroxyanisole 10g

[0037] Butylated hydroxytoluene 10g

[0038] Add soybean oil for injection to 10L

[0039] Preparation:

[0040] A. Weigh each component according to the prescription amount and set aside.

[0041] B. Mix soybean oil for injection and aluminum stearate, add it into a pressure cooker or an autoclave and heat it to 120-125°C for 3-4 hours to form a gel.

[0042] C. While stirring, add tert-butyl p-hydroxyanisole and dibutyl hydroxytoluene, and cool the gel to below 40°C to prepare an oil gel for later use.

[0043] D, get the prescribed amount of doxycycline hydrochloride and tilmicosin phosphate, add an appropriate amount of oil gel, and stir in a high-speed stirrer.

[0044] E. Transfer the above-mentioned stirred liquid to a quantitative container,...

Embodiment 2

[0047] Party:

[0048] Component Dosage

[0049] Doxycycline Hydrochloride 500g

[0050] Tilmicosin Phosphate 500g

[0051] Polyvinylpyrrolidone 50g

[0052] Tween-80 200g

[0053] Vitamin C Palmitate 1g

[0054] Add tea oil for injection to 10L

[0055] Preparation:

[0056]A. Weigh each component according to the prescription amount and set aside.

[0057] B. Mix soybean oil for injection and polyvinylpyrrolidone, put it into a pressure cooker or an autoclave cabinet and heat to 120-125°C for 3-4 hours to form a gel.

[0058] C. While stirring, add vitamin C palmitate, and cool the gel to below 40°C to prepare oil gel for later use.

[0059] D, get the prescribed amount of doxycycline hydrochloride and tilmicosin phosphate, add an appropriate amount of oil gel, and stir in a high-speed stirrer.

[0060] E. Transfer the above-mentioned stirred liquid to a quantitative container, add the prescribed amount of Tween 80 into the container, add the remaining oil gel to th...

Embodiment 3

[0063] Party:

[0064] Component Dosage

[0065] Doxycycline Hydrochloride 1000g

[0066] Tilmicosin Phosphate 1000g

[0067] Aluminum stearate 100g

[0068] Soy Lecithin 60g

[0069] Span-80 40g

[0070] tert-Butyl p-Hydroxyanisole 5g

[0071] Butylated hydroxytoluene 5g

[0072] Refined corn oil to 10L

[0073] Preparation:

[0074] A. Measure each component according to the prescription and set aside.

[0075] B. Mix refined corn oil and aluminum stearate, put it into a pressure cooker or an autoclave and heat it to 120-125°C for 3-4 hours to make a gel.

[0076] C. Under stirring, cool the gel to below 40°C, prepare oil gel, and set aside.

[0077] D. Take the prescribed amount of doxycycline hydrochloride, add an appropriate amount of oil gel, stir in a high-speed mixer, and add tert-butyl-p-hydroxyanisole and dibutylhydroxytoluene while grinding and stirring.

[0078] E. Transfer the above-mentioned stirred liquid to a quantitative container, add the prescribe...

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Abstract

The invention discloses a compound doxycycline hyclate suspension injection and a preparation process thereof. The suspension injection is prepared by taking doxycycline hyclate and tilmicosin phosphate as main medicines and adding appropriate medical accessories. The compound doxycycline hyclate suspension injection comprises the following components: 5-20 percent (W / V) of doxycycline hyclate, 5-20 percent (W / V) of tilmicosin phosphate, 0.5-2 percent (W / V) of a suspending aid, 0.01-0.2 percent (W / V) of an antioxidant, 0.1-2 percent (V / V) percent of a thickening agent and injection oil which supplements the balance to reach 100 percent. According to the invention, the doxycycline hyclate and the tilmicosin phosphate are evenly suspended into a solvent by a special process, and therefore the compound doxycycline hyclate suspension injection has good dispersibility and high bioavailability. Meanwhile, a feasible approach is provided for broadened production, and the advantages of increasing medical efficacy, reducing medication frequency and saving manpower and material resources are achieved.

Description

technical field [0001] The invention belongs to the field of veterinary drug preparations, in particular to a compound doxycycline hydrochloride suspension injection and a preparation method thereof. Background technique [0002] Doxycycline hydrochloride, also known as deoxyoxytetracycline hydrochloride, removes an oxygen atom at the R position of the chemical structure formula of oxytetracycline hydrochloride, and its chemical name is 6-methyl-4-(dimethylamino)-3,5 , 10, 12, 12a Pentahydroxy-1, 11-dioxo-1, 4, 4a, 5, 5a, 6, 11, 12a-octahydro-2-tetracenecarboxamide hydrochloride hemiethanol hemihydrate substance, the molecular formula is: C 22 h 24 N 2 o 8 , the molecular weight is 512.93. The core of polycyclic tetracene carboxamide is the necessary structure for antibacterial effect. Due to the different substituents of R1, R2, and R3 at the 5, 6, and 7 positions, they exhibit different antibacterial activities. The order of antibacterial activity is minocycline >...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/706A61K31/65A61K9/10A61P31/04
Inventor 魏德宝夏雪林刘桂兰刘爱玲
Owner TIANJIN RINGPU BIO TECH
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