Very slight dissolution and slow dissolution in water can not meet the requirements of clinical medication, slow absorption and low bioavailability.Drug resistance is prominent and the clinical effect is not satisfactory.Residues of chloramphenicol and thiamphenicol are prone to occur.
2.1 Raw material and auxiliary materials
Fukexin used levoflorfenicol as raw material after strict purification process, and its impurities were controlled below 0.2%.
With the addition of imported auxiliary materials, the application of American preparation technology, scientific verification and strict quality control, the accuracy of Fukexin is consistent.
FUKEXIN(20% FLORFENICOL POWDER)
[VETERINARY DRUG NAME]
ENGLISH NAME: FLORFENICOL POWDER
COMMODITY NAME: FUKEXIN
White or off-white powder
[USAGE AND DOSAGE]
For oral administration:
Pig: per 1kg of body weight, should be 0.1 ~ 0.15g twice a day for 3-5 days,
Fish: 50 ~ 75mg, once a day for 3 ~ 5 days.
Used for bacterial diseases caused by pasteurella and escherichia coli.
(1) This product has a certain immunosuppressive effect when used over-dosage.
(2) Livestock should be used with caution during pregnancy and lactation because of embryonic toxicity.
- It is forbidden to use during eggs laying period.
- Animals with severe immune deficiency or vaccination period should not be allowed.
- The livestock with renal insufficiency need to reduce or extend the drug interval.
Airtight and in dry place
Ordinary florfenicol has the same left-handed and right-handed in the original molecule. Only left-handed is effective. Right-handed is completely useless or even toxic. The absorption rate of left-handed florfenicol is 2-3 times higher than that of ordinary florfenicol, and its activity is 8 times higher than that of right-handed florfenicol.
Fukexin thoroughly resolved three major problems existing in common florfenicol preparations
Perfect Solution of Water Dissolution Problem
Florfenicol itself is almost insoluble in water, and domestic preparations can greatly destroy the active ingredients and reduce the curative effect by adding acid, alkali and other cosolvents. Fukexin uses American pharmaceutical technology to make flufenicol fully soluble in water and uniformly distributed, and can ensure 99% non-degradation in water for 12 hours.
Validation of solubility: accurately weigh Fukexin, imported products and domestic products of the same kind 0.3 grams, add 100 ml water (equivalent to 600 grams of pure florfenicol per ton of water) and stir for 30 minutes. The dissolution of each product is shown in Figure 1.
Fig. 1 Field dissolution test of Fukexin and similar products at home and abroad
Note: A-Fukexin; B-Imported similar products; C-domestic similar products
Conclusion: Compared with similar products, Fukexin dissolves in water more quickly and completely, which is very beneficial to group drinking water.
Efficient: fast absorption, high blood concentration
Fukexin uses the process-purified L-florfenicol raw materials and imported excipients, and uses the American pharmaceutical technology to achieve a peak plasma concentration of 1 hour after administration, which is 1.8 times higher than the domestic preparations, so that the florfenicol can be bactericidal action.
Bioequivalence validation: 30-day-old broilers were given the same dose of Fukexin, imported products and domestic products. Blood samples were collected at different time points after administration, and the plasma drug concentration was determined by HPLC. Blood drug concentrations at different time points are shown in Figure 2.
Fig 2 The pharmacokinetic curve of Fukexin and similar products at home and abroad in broilers
Conclusion: The pharmacokinetic curve of Fukexin and imported powder is basically the same. The peak concentration of blood is reached in 1 hour, and the peak concentration is about 1.8 times that of domestic powder.
Safe, no residue
Fukexin selected the raw material of florfenicol and purified it strictly, which fundamentally solved the problem of residual chloramphenicol and thiamphenicol that customers worried about.
Fukexin residue detection test: Fukxin was given to chickens through water at recommended dosage for 3 days. Chest muscle, liver and kidney were taken from chickens 1, 3, 5 and 7 days after drug withdrawal, and the contents of florfenicol and chloramphenicol were detected respectively. The results are shown in Table 1.
Table 1 Results of the residue test of Fukexin
|Drug withdrawal time (days)||Residual concentration of Florfenicol mg·kg-1||Residual concentration of chloramphenicol mg·kg-1|
The residues of florfenicol in breast muscle were less than 50 g/kg on the 5th day after discontinuation of Fukexin in poultry for 3 consecutive days. No residues of florfenicol were detected in liver and kidney. No residues of chloramphenicol were detected in breast muscle, liver and kidney on the 1st, 3rd, 5th and 7th day after application of Fukexin.
Table 2 Fukexin usage program
|Applicable animal||Usage and dosage||Compatible drugs||Mainly controlled disease|
|Chickens||Water medication: Every 500g of this product dissolves in 2000 kg of water. For 3-5 days||Neomycin Sulfate, Doxycycline Hydrochloride, Colistin Sulfate, etc.||Escherichia coli, white diarrhea and typhoid fever|
|Ducks||Escherichia coli disease and infectious serositis in ducks|
Validity: 2 years
Packaging and storage: 500g/bottle *12 bottles/box. Keep in a sealed, dry place
Function: It is used to prevent infection caused by sensitive bacteria of pigs and chickens.
SHANDONG HUACHEN PHARMACEUTICAL CO.,LTD. was established in June 2001 and registered capital is RMB 50 million. It is a modern pharmaceutical enterprise with two subsidiaries, names SHANDONG HUACHEN PHARMACEUTICAL CO.,LTD. and SHANDONG HWATSON BIOCHEM CO., LTD., which specializes in the production of pharmaceutical preparations and raw chemical materials.
HUACHEN PHARMACEUTICAL has a professional production workshop and testing laboratory in China. In 2016, the GMP pharmaceutical preparations workshop was built according to international standards, which passed the GMP Certification of the Ministry of Agriculture and provided a guarantee for the reliable pharmaceutical preparations combining with the strict production management and quality control system.
Providing customers with the higher-quality products has always been the unremitting striving direction for HUACHEN PHARMACEUTICAL CO., LTD. The company introduced the preparations technology, using the higher-quality customized raw materials and the stable imported ingredients to guarantee the quality of veterinary medicine from the source. HUACHEN veterinary drug preparations inherit the quality of brand drugs to achieve the highest level in quality and efficacy. Its bioequivalence is consistent with the imported drugs, which can effectively replace the imported products, and the price has been greatly reduced.
HUACHEN not only produce the high quality products but rely on the professional disease diagnosis and testing center to provide timely and thoughtful service for the majority of breeding enterprises, which solved the problem of after- sales service.
In 2018, HUACHEN has invested RMB 1 billion to build a Pharmaceutical Production Park which covers a total area of more than 34 hectares in the littoral area, creating the research development and manufacturing base for Vitamin B series. On the basis of the existing business trading, the company also involves the generic drugs for human and the innovative drugs.
HUACHEN PHARMACEUTICAL CO., LTD. will become a comprehensive modern pharmaceutical enterprise with international competitiveness in the future