A kind of bromhexine hydrochloride injection and its preparation method and application
A technology of bromhexine hydrochloride and bromhexine hydrochloride, which is applied in the field of bromhexine hydrochloride injection and its preparation, can solve the problem of unstable content of raw materials in injection, disulfiram-like reaction of patients, adverse effects of sterilization effect, etc. problems, to achieve the effect of stable and reliable product quality, safe use, safe and effective use
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Embodiment 1
[0030] Embodiment 1 bromhexine hydrochloride solubility research in water for injection
[0031] Accurately weigh 3 g of bromhexine hydrochloride sample, add 1000 ml of water for injection, shake for 20 minutes, no dissolution is seen, place it at room temperature, and observe bromhexine hydrochloride under 1500 lx fluorescent lamp at 30 minutes, 60 minutes, 120 minutes, 24 hours, 48 hours and 72 hours respectively. The new dissolution situation, the results are as follows:
[0032] The solubility of table 1 bromhexine hydrochloride in water for injection (1)
[0033]
[0034] + means bromhexine hydrochloride precipitation can be detected
[0035] - Indicates no precipitation of bromhexine hydrochloride detected
[0036] Precisely weigh 3g of bromhexine hydrochloride sample, add 1000ml of water for injection, heat in a water bath at 70°C (with reflux condenser), stir at 60 rpm for 30min, most of it dissolves, and there is a small amount of precipitate. 60min, 120min, ...
Embodiment 2
[0046] Embodiment 2 bromhexine hydrochloride solubility research in glucose solution
[0047]Accurately weigh 3g of bromhexine hydrochloride sample, add 1000ml of 5% glucose injection, shake for 10min, partly dissolve, there is sediment, place at room temperature, respectively in 30min, 60min, 120min, 24h, 48h, 72h under 1500lx fluorescent lamp Next, observe the bromhexine hydrochloride dissolution situation, the results are as follows:
[0048] The solubility of table 4 bromhexine hydrochloride in glucose solution (1)
[0049]
[0050] + means bromhexine hydrochloride precipitation can be detected
[0051] - Indicates no precipitation of bromhexine hydrochloride detected
[0052] Accurately weigh 3g of bromhexine hydrochloride sample, add 1000ml of 5% glucose injection, heat in a water bath at 70°C (with a reflux condenser), stir at 60 rpm for 30min, and dissolve completely; place it at room temperature for 30min, 60min, and 120min respectively , 24h, 48h, 72h under t...
Embodiment 3
[0058] Example 3 Ultrasonic Treatment Stability Research in Bromhexine Hydrochloride Glucose Solution
[0059] Accurately weigh 3 g of bromhexine hydrochloride sample, add 1000 ml of 5% glucose injection, and dissolve completely by ultrasonic treatment (25 kHz, 100 w) at 30-40 °C for 50 min. Place it at room temperature, and observe the dissolution of bromhexine hydrochloride under 1500lx fluorescent lamp at 30min, 60min, 120min, 24h, 48h, and 72h respectively. The results are as follows:
[0060] The stability of bromhexine hydrochloride glucose solution after ultrasonic treatment of table 6
[0061]
[0062] + means bromhexine hydrochloride precipitation can be detected
[0063] - Indicates no precipitation of bromhexine hydrochloride detected
[0064] This group of experiments shows that ultrasonic treatment can make the bromhexine hydrochloride glucose solution not precipitated for more than 72 hours, indicating that ultrasonic treatment has a strong stabilizing eff...
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