Product Overview
Generic name: Xialiqi Capsules
Chinese Pinyin: Xialiqi Jiaonang
Product name: Yiling
Ingredients: Astragalus, Ligustrum lucidum, Talc, Prunella vulgaris, Lychee seeds, Amber, Cinnamon, Phellodendron amurense.
Properties: This product is a hard capsule, the content is brown to tan granules; slightly fragrant, bitter taste.
Functions and indications: To invigorate the spleen and kidneys, disperse swelling and hydration. Used for mild to moderate benign prostatic hyperplasia syndrome of spleen and kidney qi deficiency and phlegm stasis, symptoms include weakness in urination, inexhaustible drip, frequent nocturia, lower abdomen bulge, waist and knees, fatigue, etc.
Specification: 0.45g*24 capsules/box
Usage and dosage: Oral. 3 capsules at a time, 3 times a day. 4 weeks is a course of treatment.
Adverse reactions: Individual patients may experience stomach upset and other symptoms after taking the medicine.
Contraindications: Those who are allergic to the ingredients of this product should not take it.
Note: 1. Don't eat fat, sweet and greasy food.
2. Those with residual urine> 150ml, and those who have failed invasive treatment of benign prostatic hyperplasia, are not the indications for this product.
Pharmacology and Toxicology: The results of non-clinical pharmacodynamic tests show that this product can reduce the weight and index of the prostate of the mice implanted in the urogenital sinus of prostate hyperplasia, reduce the area of the prostate gland, and reduce the symptoms of prostate hyperplasia in mice; reduce castration and subcutaneous Injection of testosterone propionate experimental prostate hyperplasia model rat prostate wet weight and serum acid phosphatase to reduce the area of the prostate gland; reduce the prostate weight and the number of white blood cells in the prostatic fluid of the bacterial prostatitis rat, increase the lecithin body density and inhibit Bacteria multiply and inhibit inflammatory cell infiltration; reduce the weight of the prostate and the number of white blood cells in the prostatic fluid of rats with 1% carrageenan injected into the ventral lobe of the prostate, increase the density of lecithin bodies, and inhibit inflammation in the interstitium of the prostate Cell infiltration; increase the urine output of normal rats for 0-2 hours, and promote the excretion of Na+, K+, Cl-; improve mouse ear microcirculation; reduce xylene-induced acute ear swelling in mice and inhibit paper sheet method Chronic granuloma in mice, decreased xylene, increased permeability of abdominal capillaries in mice; decreased pain response caused by intraperitoneal injection of acetic acid and hot plate method.
Rats were given continuous intragastric administration (20, 10, 5g crude drug/kg) for 24 weeks long-term toxicity test results showed: after 12 weeks of administration, ALT and AST of each group were higher than the control group; after 24 weeks of administration, Cr was higher than the control group . He returned to normal 2 weeks after stopping the drug.
Clinical research: This product was approved for clinical research by the State Food and Drug Administration on July 14, 2005. Phase II and III clinical trials were conducted from December 2005 to February 2007. The experiment observed the effectiveness and safety of Xialiqi Capsule for benign prostatic hyperplasia with spleen and kidney qi deficiency and phlegm stasis syndrome. A randomized, double-blind, double-simulation, positive control, multi-center trial design method was adopted. The control drug was Qianlie Shule granules. A total of 240 cases were included in the phase II trial, 120 in the experimental group, and 120 in the control group; a total of 440 cases were included in the phase III trial, with 330 in the experimental group and 110 in the control group.
The criteria for the inclusion of cases in clinical trials is to meet the diagnostic criteria for benign prostatic hyperplasia, with a course of more than 3 months, and the syndrome of TCM is spleen and kidney qi deficiency combined with phlegm stasis. Drug usage: Test group: Xia Liqi capsules, 3 capsules at a time, 3 times a day + Qianlie Shule granules placebo, 1 bag at a time, 3 times a day; Control group: Qianlie Shule granules, 1 bag at a time, 1 day 3 times + Xialiqi capsule placebo, 3 capsules each time, 3 times a day. 4 weeks is a course of treatment.
The efficacy indicators of this product: TCM spleen and kidney qi deficiency and phlegm stasis syndrome score, I-PSS score, urinary symptom trouble score, maximum urine flow rate, residual urine, B-ultrasound, single main symptom score. Efficacy evaluation criteria: I-PSS score for prostate hyperplasia, efficacy of TCM syndromes, efficacy of single main symptoms, etc.
Effectiveness: Phase II: The two groups have statistically significant differences in the I-PSS score, the total effective rate of TCM syndromes, the urinary symptom trouble score, and the maximum urinary flow rate. The test group is better than the control group; There are statistically significant differences in single symptom urination weakness and nocturia frequency. The test group is better than the control group. There was no significant difference in prostate volume and residual urine volume between the two groups.
Stage III: Comparison of I-PSS score, total effective rate of TCM syndromes, urinary symptom trouble score, and maximum urine flow rate between the two groups were statistically significant. The test group was better than the control group; the two groups were urinating in single symptoms There were statistically significant differences in weakness, inexhaustible dripping, and frequent nocturia. The test group was better than the control group. There was no significant difference in prostate volume and residual urine volume between the two groups.
Safety: No less than 400 cases of blood routine, urine routine, liver function (ALT, AST), renal function (BUN, Cr), electrocardiogram were observed in the phase II and phase III test groups, and no less than 350 cases were observed. It is routine. In some cases, the blood routine, liver function, and renal function test indicators were normal before treatment, and slightly abnormal after treatment. Individual cases were abnormal before treatment, and slightly worsened after treatment. Most of the abnormalities had no clinical significance, and the judgment had nothing to do with drugs. One patient in the experimental group developed mild gastric discomfort after taking the medicine, which relieved spontaneously without treatment.
Storage: sealed.
Packing: Aluminum-plastic board. 2*12 grains/plate/box.
Validity period: 24 months
Executive standard: Standard YBZ00022012 of the State Food and Drug Administration
Approval number: National Medicine Zhunzi Z20123085
Company Name: Shijiazhuang Yiling Pharmaceutical Co., Ltd.
Company Address: No. 238, Tianshan Street, High-tech Development Zone, Shijiazhuang City
