Dan Seven Analgesic Cream Quality Control And Clinical Studies

Soft tissue injury is a frequently-occurring disease, the common diseases, as a result of increase in the number of traffic, the development of the constructionin dustry and the strength -ening of sports, and so on, may all types of soft tissue injuries have also increased, on the treatment of the disease drug for many in the country is broadly divided into tinctures, Paste, powder Cream etc. four categories, Cream to more foreign agent so that the current domestic use is the most common tincture, followed by the powder and ointment, in recent years, Cream agent is widely used in clinical practice, however, no matter what kind of preparations have certain limitations, and some poor results Some of the short-acting, some expensive, some significant side effects, and so on. This paper developed by the Tan seven Plaster, in the election on prescription drugs in Chinese medicine theory, combined with modem medicine and pharmacology knowledge and experience in clinical and repeated studycarefully selected from, using the traditional method of preparation, made Paste.Objective:Experiment TLC method of preparation for the main drug identification, According to "Chinese Pharmacopoeia"(2000 version a) Preparation, quality control, Stability test for observation o Dan through seven Plaster treatment of acute soft tissue injury, gouty arthritis Effect, animal testing, efficacy testing, to clear its pharmacology efficacy and side effects of the role, Dan for seven plaster in the clinical application of the theoretical basis and the security coefficient..Experimental Methods : 1. Initial quality control and stability in the initial quality control and stability in these two areas, the main drug on March 7, Salvia, rhubarb respectively TLC, TLC finished by the three batches of experimental observation, TLC, Prescriptions main drug on March 7, Salvia, rhubarb Tastes of the main ingredients stability, and conforms to quality standards. In seven Plaster Dan TLC analysis of the standard set based on Dan 7 Plaster three batches of med- icines, the stability of the initial test results showed that the drug with Chinese Pharmacopoeia 2000 version of an appendix IR ointment under the provisions of good stability.2. Which are in effect the pilot test, we set up a test group, sensitized group and the control group, the control group consisted of helping him Lin (Beijing Pharmaceutical Company Limited expressing his production batches: 03, 187), sensitized group Ma is 20% soybean oil 20% ethanol and related reagents. Test methods for mice is 36, each divided into 12 7 Dan Plaster; Lin, who supported his control group; sensitized three groups of the swelling and anti-inflammatory test results show Pellets seven plaster in the swelling. Anti—inflammatory effect helping him better than Lin, analgesic tests Dan seven Plaster analgesic effect and help him and there was no significant difference, equally obvious analgesic effect, P＜0.01.3. Skin irritation and allergy test(1)Skin irritation test; From 24 mice were divided into six groups, each four, the establishment of a complete skin and skin injury two groups to Dan seven Plaster and helping him lain for normal control group, Vaseline used for the negative control group, During the experiment, observation of animal activities, response to outside stimuli, respiratory and skin changes. Results of the two groups of mice test the integrity of he skin and skin damage observed animal behaviors are normal no irritability. Somnolence, lethargy, and other performance outside reaction, normal diet. Normal skin irritation no erythema and edema, and other anomalies, skin lesions wound healed, No septic infection.(2)Skin allergy test: Let Dan seven Plaster group, ensitized agent group and the control group Vaseline. Mouse 18, divided into three groups, each of six. The results, Than 7 analgesic ointment and Vaseline control group has no allergic reactions, erythema and edema, and sensitized animals have obvious skin erythema, but no edema, allergic reaction rate 100%. Through the above certification test animals Pellets seven Plaster right mouse skin irritation and allergic reactions Damage to the skin and the prevention of infection and promote wound healing.4. clinical observation:In the clinical observation of 704 cases of inpatients and outpatient cases of Clinical Observation, acute soft tissue injury of 680 cases, gout, 24 cases found in the total efficiency of over 97%. with the help of other drugs he Lin (Beijing Pharmaceutical Company Limited expressing his production batches : 03, 187) control found that the Danish seven Plaster significantly better than the control group, by the clinical observation, found that the drug for acute soft tissue injury, gout external application to a significant effect.Results :1. quality control and stability observation, the use of TLC other side of the main characteristics of drug identification, After repeated treatment can eliminate interference, after three batches of finished TCL experimental observation, drug agents major components stable good performance. 2. Efficacy: In the swelling analgesic effect set up a pilot test group and control group. The results showed Dan seven Plaster better swelling analgesic effect, while better than the control group.3. toxicity: skin irritation test, the test animals receive no animal skin of any abnormal behavior.4. clinical observation: Clinical observation shows that the drug is of Chines emedicine, the swelling analgesic efficacy, acute soft tissue injury, gout a significant effect and found that the drug rapidly swelling pain, role durable feature of the treatment of acute soft tissue injury, gout good topical drug..Conclusions:The paper on Dan 7 Plaster of clinical observation, animal testing, Quality control and stability test of the preliminary study, the drug was found on acute soft tissue injury, gouty arthritis significant efficacy, toxicity has not yet been found worthy of further research and development, marketing application.