【common name】    Yuye Jinhua Qingre Tablets

【Chinese Pinyin】    Yuyejinhua Qingre Pian
【Ingredients】    Jade Leaf Golden Flower, Andrographis paniculata, Gardenia, Upside Down Grass, Scrophularia, Artificial Bezoar.
【traits】    This product is a film-coated tablet, which shows brownish green to black color after removing the film coating; slight gas, bitter taste.
【Indications of function】    Clearing away heat and relieving the table, sore throat and swelling. For acute pharyngitis with wind-heat syndrome, symptoms include sore throat, dry and burning throat, pharyngeal mucosa, uvula, and lymphoid follicles in the posterior pharyngeal wall.
【Specification】    Each tablet weighs 0.4g.
【Dosage】    oral. 3 tablets at a time, 3 times a day. 5 days is a course of treatment.
【Adverse reactions】    uncertain.

【Taboo】    uncertain.

【Precautions】

  In clinical trials, red blood cells, hemoglobin, and leukopenia were occasionally seen, as well as a mild increase in serum alanine aminotransferase (ALT), but the relationship with the drug was suspicious.

【Clinical Trials】

  This product was approved for clinical trials by the State Drug Administration in October 2001. Phase II and Phase III clinical trials were conducted from February 2002 to August 2003. The clinical trial adopts parallel control, block randomization, blind method (double-dummy double-blind for phase II, single-blind for phase III), and multi-center trial design method to observe the effectiveness of Yuye Jinhua Qingre Tablets in the treatment of acute pharyngitis with wind-heat syndrome. and safety, the reference drug is a drug. The total number of cases completed in the phase II clinical trial was 239 cases, including 119 cases in the Yuye Jinhua Xiaore Tablet treatment group and 120 cases in the control group; the total number of cases in the Phase III clinical trial was 434 cases, and 326 cases in the Yuye Jinhua Qingre Tablet treatment group , 108 cases in the control group.
The inclusion criteria for Phase II and Phase III clinical trials are as follows: those who meet the diagnostic criteria for acute pharyngitis and the TCM syndrome differentiation criteria for wind-heat syndrome, have acute onset, and the course of the disease is within 48 hours. Subjects were excluded if they had a fever >38 degrees, or had pneumonia and bronchitis, or had suppurative tonsillitis. Medication method: the treatment group was given Yuye Jinhua Qingre Tablets, orally, 3 tablets at a time, 3 times a day. The control group was given a certain drug, orally, 2 tablets at a time (3 tablets for severe cases), 3 times a day. The course of treatment is 5 days.
The efficacy evaluation indicators are divided into primary efficacy indicators and secondary efficacy indicators. The main efficacy indicators were sore throat, dry and burning throat, pharyngeal mucosa and uvula, etc.; secondary indicators were fever, lymphoid follicles in the posterior pharyngeal wall, red and swollen lateral pharyngeal cord, and aversion to wind.
Efficacy: Phase II clinical trial: There was no significant difference between the groups in the main efficacy index (P>0.05). There was no statistical difference in the comprehensive efficacy between the two groups.
Efficacy of Phase III clinical trial: Main efficacy indicators: sore throat, dry and burning throat, pharyngeal mucosa, and uvula redness and swelling scores, the difference between the groups on the 5th day of treatment was statistically significant (P<0.05), and the treatment group was lower than the control group Group. There was a statistically significant difference between the groups in the decreasing value of the score on the second day after the treatment of dry throat and burning, and the treatment group was higher than the control group. The disappearance rate of positive symptoms and signs of sore throat, dry and burning throat, pharyngeal mucosa, and uvula redness and swelling were significantly different between groups after 5 days of treatment, and the treatment group was higher than the control group. The main symptom score, the difference between the groups on the 5th day of treatment was statistically significant, the treatment group was lower than the control group. Secondary efficacy indicators: the score of lymphatic follicles in the posterior pharyngeal wall, the difference between the groups was statistically significant on the 5th day of treatment, and the treatment group was lower than the control group. On the 5th day, the disappearance rate of lymphoid follicles in the posterior pharyngeal wall was significantly different between the groups, and the treatment group was higher than the control group. Symptoms and signs scores on the 5th day, the difference between the groups was statistically significant, the treatment group was lower than the control group. Comprehensive curative effect: There were statistically significant differences in comprehensive boil effect, cure rate and total effective rate between the two groups. The cure rate and total effective rate in the treatment group were higher than those in the control group. The results of PP analysis and ITT analysis were consistent.
Safety: The safety data set of Yuye Jinhua Qingre Tablets group is 456 cases. Physical and chemical tests include blood, urine, stool routine, liver function (ALT), renal function (BUN, Or), electrocardiogram. In clinical trials, erythrocyte, hemoglobin, and leukopenia were occasionally seen, as well as mild elevation of ALT. But the relationship with the drug is suspicious. There were no adverse events related to taking Yuye Jinhua Qingre Tablets.

【pharmacology and toxicology】    Non-clinical pharmacodynamic test results show that this product has inhibitory effect on Hep-2 cytopathies caused by Coxsackie virus B3 and B5 in vitro; In vitro antibacterial effect; can delay the time of death of mice infected with Staphylococcus aureus; inhibit the swelling of the feet of rats caused by carrageenan, peritonitis caused by acetic acid in mice, and the proliferation of subcutaneous cotton ball granulomas in mice. Mouse acetic acid has obvious analgesic effect on pain; it has antipyretic effect on rabbit fever caused by bacterial endotoxin; it can improve the function of mouse peritoneal macrophages and promote the production of serum hemolysin in mice induced by CRBC.

【storage】    seal.
【Package】    Polyvinyl chloride solid pharmaceutical hard tablets, aluminum foil packaging for pharmaceutical packaging, 12 pieces X2 board/box.
【valid period】    36 months.
【Executive standard】     CFDA standard YBZ00022014.
【Approval Number】     Chinese medicine approved word Z20090911.
【Drug Marketing Authorization Holder】
Name: Guangxi Chunzhengtang Pharmaceutical Co., Ltd.
Registered address: 3rd Floor, Standard Workshop, No. 8, Yangtang Industrial Park, Lingui Town, Lingui District, Guilin City
Phone number: 0773-5589395

【Entrusted production company】
Company name: Anhui Jiuhua Huayuan Pharmaceutical Co., Ltd.
Production address: No. 211 Chuangye Road, Chuzhou City
Postal Code: 239000
Phone number: 4008630880
Website address: http://www.hkjhhy.com