Xiaobai (diphenol pseudoephedrine syrup) is a special symptomatic drug for children's colds. It is suitable for runny nose and stuffy nose caused by colds, with higher selectivity and less adverse reactions. Effective cough relieving, no addiction; Antipyretic and analgesic drugs are safe and effective; And because there is no caffeine, there is no central excitation; No chlorpheniramine, no drowsiness and little influence on appetite have been recognized by pediatricians in clinical application. In order to better evaluate the efficacy and safety of Xiaobai in the treatment of upper respiratory tract infection, summarize and exchange clinical application experience, and promote rational application. Editorial Department of Journal of Clinical Pediatrics, Shaanxi Dongsheng Pharmaceutical Co., Ltd. and 37℃ Professional Health Consulting Network will jointly hold the activity of "Award-winning Essay on Clinical Rational Application of Xiaobai (Bisphenol Pseudoephedrine Syrup)", hoping pediatricians will actively participate.
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Acetaminophen compound preparation (taken day and night, Qierbufeining, etc. )
Paracetamol compound preparation
Indications Acetaminophen can be combined with various drugs to form a compound preparation. The ingredients compatible with it have many functions, such as caffeine has sedative, hypnotic and anticonvulsant effects; Aspirin and ipratropium are antipyretic and analgesic drugs; Pseudoephedrine hydrochloride or phenylpropanolamine xanthate can cause vasoconstriction of swollen nasal mucosa, increase nasal patency and relieve cold symptoms; Chlorphenamine maleate or diphenhydramine hydrochloride is an antiallergic drug; Dextromethorphan hydrobromide has antitussive effect. The combination of acetaminophen and the above drugs can improve the curative effect and relieve related symptoms, so the indications of compound preparation are to relieve fever, cold, headache, cough, runny nose and stuffy nose.
Adverse reactions include mild dizziness, drowsiness, nausea, fatigue and epigastric discomfort.
For details of usage and dosage, please refer to the instructions or labels of each preparation.
Dosage forms: tablets, chewable tablets, granules, capsules, syrups, oral solutions and drops.
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Summary of pharmacological and toxicological research conclusions of Xiaobai syrup
Shanghai Second Medical University Department of Pharmacology
Bisphenol pseudoephedrine syrup is a cold antipyretic and antitussive drug developed by Qidong Gaitianli Pharmaceutical Co., Ltd. with reference to Contek JR (aqueous solution) produced by SmithKline Company of the United States. For children only, it can effectively relieve children's symptoms such as headache, fever, stuffy nose, runny nose, sneezing and coughing caused by cold. The pharmacological and toxicological experimental conclusions and literature reports of bisphenol pseudoephedrine syrup are summarized as follows:
1. Pharmacology
1. 1 paracetamol
This product has analgesic and antipyretic effects. After long-term clinical verification, it is a safe and effective antipyretic and analgesic widely used at home and abroad. It produces antipyretic effect through hypothalamic thermoregulation center. Can be used for treating headache, myalgia, arthralgia, chronic pain of cancer patients, postpartum and postoperative pain, and fever. A single dose 1g can achieve the maximum effect. Generally, the oral dose for adults is 0.5- 1g, once every 4-6 hours, and the maximum daily dose is 4g. The recommended dose for children is 60- 120mg for 3 months. 1 -5 years old,120-250 mg; 6 years old-12 years old, 500mg, this dose can be taken 3-4 times a day as needed. [ 1]
1.2 pseudoephedrine
A decongestant can relieve congestion and swelling of nasopharyngeal mucosa and relieve nasal congestion. After oral administration, it mainly stimulates the release of norepinephrine from sympathetic nerve endings, which indirectly plays a sympathetic role. Its vasoconstrictive effect is selective, mainly constricting the upper respiratory tract blood vessels, and has little effect on the whole body blood vessels and blood pressure. Adults take 60mg three times a day, and children take/kg body weight 1mg four times a day. [2][3]
1.3 dextromethorphan hydrobromide
Cough medicine, USP-2 1 Edition, 1988 WHO recommends an efficient and safe cough medicine that can replace codeine. Has no drug resistance and addiction, and is suitable for long-term drug treatment and children. Many countries' drug supervision and administration laws list dextromethorphan as the least restricted category, which directly inhibits the dual antitussive effect of cough center and periphery, and has a strong and lasting effect, and is praised as the safest antitussive drug in modern times by the US FDA. The dosage is 10-30 mg, once every 4-8 hours, usually the same dosage does not exceed 120 mg within 24 hours, and the dosage for children aged 6- 12 years is 5- 15 mg, once every 4-8 hours, and the dosage does not exceed 60mg within 24 hours. [4]
Bisphenol pseudoephedrine syrup is a compound preparation of the above drugs, and its main efficacy is determined in the Pharmacology Department of Shanghai Second Medical University. The results are as follows:
Antipyretic effect of 1.4 bisphenol pseudoephedrine syrup
Rabbit fever model was made with bacterial endotoxin. Rabbits were given 2.5%, 5%, 10% diphenol pseudoephedrine syrup 3ml/kg, namely 75 mg/kg, 150 mg/kg, 300mg/kg, corresponding doses of CTC (daily) and acetaminophen 108mg/kg respectively. The results showed that three doses of diphenol pseudoephedrine syrup had antipyretic effects on rabbits with fever, and the onset time and intensity were dose-dependent. Compared with CTC (Japan), the antipyretic effect is basically the same, and compared with acetaminophen, the antipyretic effect of bisphenol pseudoephedrine syrup is slightly stronger, but there is no statistical difference.
Analgesic effect of 1.5 bisphenol pseudoephedrine syrup
The tail of mice was irradiated with a bolometer to cause pain, and the tail flick time was measured as an index of pain response. The change of pain threshold after administration reflects the analgesic effect of the drug. The results showed that the tail flick time of mice was prolonged to varying degrees, the pain threshold was increased, and the duration and intensity of analgesia increased with the increase of dose. Compared with CTC (Japan), there is no obvious difference in analgesic effect between the two drugs, and the analgesic effect is basically the same as that of the same amount of acetaminophen.
Effect of 1.6 Bisphenol Pseudoephedrine Syrup on Capillary Permeability
Effect of 1.6. 1 diphenol pseudoephedrine syrup on capillary permeability of nasal mucosa in guinea pigs
Five groups of guinea pigs were given diphenol pseudoephedrine syrup, CTC (daily) 125 and 500mg/kg and normal saline respectively, and Evans blue was injected into femoral vein 30 mg/kg, 10 minute later, the guinea pigs were decapitated immediately, and the nasal mucosa was taken out to determine the Evans blue content. The results showed that the contents of Evans blue in the mucosa of two doses of diphenol pseudoephedrine syrup were significantly lower than those in the control group, while the contents of Evans blue in the large dose group were significantly lower than those in the small dose group, and there was no significant difference between the two drugs, which indicated that diphenol pseudoephedrine syrup could reduce the capillary permeability of the mucosa of guinea pigs through the vasoconstriction of pseudoephedrine hydrochloride.
1.6.2 Effect of Bisphenol Pseudoephedrine Syrup on Conjunctival Microvessels in Rabbits;
Intravenous injection of endotoxin dilates conjunctival vessels in rabbits, and then intraocular injection of bisphenol pseudoephedrine syrup and CTC (day) to observe the changes of microvascular caliber. The results showed that the two drugs had the same contractile effect on conjunctival microvessels in rabbits. The vasoconstrictive effect of bisphenol pseudoephedrine syrup is stronger than that of single pseudoephedrine and diphenhydramine.
The antitussive effect of 1.7 diphenol pseudoephedrine syrup
According to the principle of ammonia induced cough, the confidence limits of ET50 and 50% of each group were obtained, and the strength of antitussive effect was estimated by R value. The results showed that diphenol pseudoephedrine syrup had a dose-dependent antitussive effect. The antitussive effect of diphenol pseudoephedrine syrup is basically the same as that of CTC (Japan). Compared with dextromethorphan alone, the antitussive effect of diphenol pseudoephedrine syrup is obviously enhanced.
To sum up, in experimental animals, bisphenol pseudoephedrine syrup has effective and reliable antipyretic, analgesic, antitussive, capillary contraction and capillary permeability reduction effects. These effects increase with the increase of dose. Compared with the similar foreign product CTC (Japan), it has similar pharmacological effects and can effectively resist the symptoms such as headache, fever, stuffy nose, runny nose and conjunctival congestion caused by cold. It is an ideal anti-cold medicine. [5]
2. Toxicology
Acute toxicology test [6]: LD50 was determined by Bliss method. Fifty mice, half male and half female, weighed 18-22g, and were observed for 7 days after oral administration on an empty stomach. The results are shown in the following table.
medical science
LD50 (mg/kg)
95% confidence limit
Bisphenol pseudoephedrine syrup
1372.97
1 166.89 - 16 15.44
Carbon tetrachloride (days)
1262.22
1 178.8 1 - 135 1.52
Comparison between diphenol pseudoephedrine syrup and CTC (once a day): P > 0.05.
Bisphenol pseudoephedrine syrup: 252.5mg/kg is equivalent to 10ml/kg.
1mg/kg is equivalent to CTC (day) 1mg/kg.
refer to
Review of the function and use of 1 paracetamol -J, cokeweser New England Journal of Medicine1976,295, 1297.
Goodbye, Hill. Hughes and peck 1974
3C。 Drew and others. Clinical pharmacy 1978, 6, 22 1
4 martindale 29th Edition 1989908.
5 See item 5.
6 See item 7.
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