Bromhexine hydrochloride oral liquid for livestock and poultry, and preparation method and application thereof
A technology of bromhexine hydrochloride and oral liquid, which is applied in the field of bromhexine hydrochloride oral liquid for livestock and poultry and its preparation, can solve the problems that the therapeutic effect needs to be improved, and achieve the improvement of drug safety, low price and simple preparation method Effect
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Embodiment 1
[0031] Embodiment 1 A kind of preparation method of bromhexine hydrochloride oral liquid for livestock and poultry
[0032] Present embodiment prepares 10L bromhexine hydrochloride oral liquid for livestock and poultry, comprises the following steps of carrying out successively:
[0033] 1) Dissolve 0.01kg of sodium bisulfite, 0.03kg of ammonium acetate, and 0.0015kg of ethylenediaminetetraacetic acid disodium (hereinafter referred to as EDTA-2Na) in 6L of purified water (denoted as the first use of purified water). After stirring and mixing, the aqueous solution A 1 ;
[0034] 2) Take 2L of propylene glycol and heat it to 65°C, add 0.1kg of bromhexine hydrochloride and stir to dissolve to obtain solution B 1 ; the solution B 1 Cool down to 35°C, add 0.8kg polyethylene glycol 6000 and stir evenly to obtain a mixture C 1 ;
[0035] 3) Mixture C 1 Add aqueous solution A while stirring, and after stirring evenly, adjust the pH value to 4.4 with 0.315kg glacial acetic acid, ...
Embodiment 2~6
[0038] Embodiment 2~6 bromhexine hydrochloride oral liquid for livestock and poultry and preparation method thereof
[0039] Embodiments 2 to 6 are respectively a bromhexine hydrochloride oral liquid for livestock and poultry and its preparation method. Their steps are basically the same as those in Example 1, the only difference being the difference in raw material consumption and process parameters. See Table for details. 1:
[0040] List of various process parameters in table 1 embodiment 2~6
[0041]
[0042] The content of other parts of embodiment 2~6, is identical with embodiment 1.
Embodiment 7
[0043] Example 7 Quality and Stability of Bromhexine Hydrochloride Oral Liquid for Livestock and Poultry
[0044] Get the commercially available bromhexine hydrochloride oral liquid for livestock and poultry prepared in embodiment 1~6, according to Chinese Veterinary Pharmacopoeia 2015 edition one annex 9001 raw material drug and preparation stability test guiding principle requirement, measure its stability, and Use high performance liquid chromatography to detect the content of related substances. Test conditions: commercially available packaging, 25 ° C ± 2 ° C, RH60% ± 10%, placed for 24 months, the test results of related substances are shown in Table 2:
[0045] Table 2 List of content detection results of related substances in bromhexine hydrochloride oral liquid for livestock and poultry prepared in Examples 1-6
[0046]
[0047] In Table 2, the impurity is N-methyl-N-cyclohexyl-2-amino-3-chloro-5-bromobenzylamine or / and N-methyl-N-cyclohexyl-2-amino-5-chloro Impur...
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