[Main Ingredients] Rhizoma Corydalis (Yanhusuo), Asarum (Xixin), Cloves (Dingxiang), Radix Angenicae Sinensis (danggui),etc.
[Indications] Dysmenorrhea, stomachache.
[Specification] 0.35g /capsule ? 12 capsules/socket ? 2 sockets
[Cautions] Oral administration, two days before or when menstrual cycle starts.
[Contraindication] Contraindicated for children and pregnant women.
[Side Effects] No side effect.
[Storage] Tightly sealed and kept in a cool and dry place. Keep from moisture.
[Term of validity] 2 years
--------------------------------------------------------------------------------
[Pharmacological Actions]
1. Pharmacological tests conducted by Clinical Research Institute of Sichuan Provincial Academy of Traditional Chinese Medicine and Drugs explained and interpreted the acesodyne principles of Flow Qi Tablet to cure dysmenorrhea and stomach ache.
(1) Hot plate test on mice demonstration:
Large dose of Flow Qi Tablet (equal to 25 times of clinical dosage) can remarkably raise the level of pain threshold, presenting certain effect of abirritation that has obvious relationship between dosage and effects. Though abirritation of this medicine is not as strong as morphia injection of 10mg/kg, the duration it acts is longer than morphia.
(2) Flow Qi Tablet can obviously reduce times of body-twist reaction caused by acetic acid in mice in 15 minutes (P<0.01) and prolong the latent period of body twist reaction to certain extent.
The tests also proved that Flow Qi Tablet has obvious suppressive actions on the strong contraction of uterine smooth muscles isolated from normal rabbits or rabbits administered with ocytocin.
2. According to theories of traditional Chinese medicine, the abirritation principle of Flow Qi Tablet is the promotion of the circulation of qi and blood to remove stasis. The Clinical Research Institute of Sichuan Provincial Academy of Traditional Chinese Medicine and Drugs verified this principle in the tests of microcirculation improvement and the actions of anti thrombosis and anti inflammation of the drug.
(1) The tests of the effect on thrombogenesis demonstrated that dose group of 2.5g (raw drug) / kg?D*3 present an obvious action of anti thrombogenesis in comparison with the control group. The dose of 1.25g (raw drug) / kg?D*3 has also a tendancy of anti thrombogenesis but with no significant difference statistically.
(2) Tests of the effects on ear-mircocirculation in mice demonstrated that Flow Qi Tablet ( 2.4g , 1.2g , 0.6g/kg . D*2) has actions to enlarge markedly the diameters of micrangium of both arteries and veins and increase the velocity of blood flow. These actions all own dose-effect relationship and are similar to the actions of the positive drug of dinitrosorbide.
(3) The anti inflammation tests demonstrated that Flow Qi Tablet has an obvious suppressive action on the turgescence of ears induced by dimethylbenzene in mice, but the action is less than hydrocortione. It also has an obvious suppressive action on the raised permeability of capillaries induced by histamine phosphate. The above two tests prove that the remedy has an action to antagonize inflammation.
[Toxicity Tests]
Clinical Research Institute of Sichuan Provincial Academy of Traditional Chinese Medicine and Drugs conducted long term toxicity tests and acute toxicity tests on Flow Qi Tablet and results are listed as follows:
1. Long term toxicity tests
Administration of Flow Qi Tablet was performed to rats at the doses that are 120, 60 and 30 times of clinical dosage once daily and continuously for 4 weeks. Except the amount of ingestion became a little less, all other behaviors and eccresis of rats were quite normal. The gaining of weight, hemogram, indexes of biochemistry (e.g. those of liver functions and kidney functions) and the visceral system of liver, spleen, kidney, adrenal gland, testicle, ovary and uterus all present no significant differences in comparison with those in control group (P>0.05). The observation of visceral organs witnessed no presentation of inflammation, necrosis and lesion caused by other medicines. The tests demonstrate that Flow Qi Tablet is safe.
2. Acute toxicity tests
The maximum dose of tolerance was given to mice once daily (3.3g raw drug/ml of suspension of Flow Qi Tablet, 1ml/20g weight) and twice daily (equal to 330 and 660 times of the clinical daily dosage of Flow Qi Tablet). During 7 days of experiment, no mouse was found dead and their furs were lustrous and their reactions were sensitive. All behaviors and eccrisis were normal. After the mice were put to death, no abnormalities were witnessed with naked eyes on their main viscera such as hearts, livers, spleens, lungs and kidneys.
[Clinical Verification]
From Jul 1992 to May 1994, clinical observations on curative effect of Flow Qi Tablet to treat dysmenorrhea were performed in the No.3 People?s Hospital of Sichuan Province and the No.4 People?s Hospital of Chengdu. The results proved that among 120 patients, 49 cases were fully recovered, the highly effective cases numbered 42 and effective cases numbered 18 with highly effective rate of 75.00% and total effective rate 90.80%. In all recovered cases, 25 belonged to the type of the stagnancy of qi and blood stasis and among them highly effective cases were 22 and effective cases 10 with highly effective rate of 75.8% and total effective rate of 91.94%. There were 24 cases that belonged to the type of the stagnancy of cold and dampness and among them highly effective cases accounted for 20 and effective cases for 8 with the highly effective rate of 75.86% and total effective rate of 89.66%. The clinical trials prove that Flow Qi Tablet have good curative effects on both types of dysmenorrhea.
[Adverse Reaction]
There were among 120 patients only 3 cases who had slight symptom of naupathia at beginning of the administration, which disappeared in consequent course of medication. No withdrawal of intolerance occurred and no abnormalities were ever witnessed in patients? liver and kidney functions.