Literature Research On The Safety Of Shandougen

Research purposes:Sophora subprostrata root is the dried root and rhizome of legumi nous plant Sophora tonkinensis Gagnep.It is bitter,cold,and toxic,with heat-clearing,detoxifying,detumescence and sore throat relieving effects.It can be used for sympt oms such as the accumulation of heat toxins,palatine tonsil redness and swelling pai n,swelling and pain in throat,gingival swelling and pain,and aphtha of the mouth and tongue.The routine dosage is 3-6 g.In recent years,a growing number of com pound decoction poisoning cases involving sophora subprostrata root or sophora subpro strata root contented compound decoction have been reported,raising widespread safet y concerns in the general public.Although scholars at home and abroad have conduc ted researches on the toxicity of sophora subprostrata root,the findings remain inconsi stent.In view of this,based on systematic review and analysis of past literatures on sophora subprostrata root's origins and toxicological records in ancient books,contemp orary toxicity studies,and clinical adverse reaction cases,the objective of this researc h is to have a clear knowledge of the use of sophora subprostrata root for toxicity a nd dosage in ancient books,acknowledge the status quo and problems of the sophora subprostrata root toxicity studies,summarize its primary toxicity characteristics and p atterns,thus facilitating safe and rational drug usage and providing basis and referen ces for further research directions.Research methods:(1)Ancient literature review:Retrieve relevant records in the”Kn owledge Base of Traditional Chinese Medicine Ancient Books" developed by Institute of Chinese medical history and literature of China Academy of Chinese Medical Scie nces.To supplement the insufficiencies of extant literatures on Materia Medica in the library,retrieve relevant information manually from the bibliographies listed in Shang Zhijun's The Essence of Chinese Traditional Medicine Literature.(2)Contemporaryliterature review:Retrieve information from journals,academic papers and conference papers from the day of database establishment to July 2017 in Chinese biomedical Ii terature database(Sino Med),China National Knowledge Infrastructure(CNKI),VIP Network(VIP),Wanfang Data(Wanfang),and Pub Med,and then manually check t he data involved in these documents.(3)Inclusive criteria:inclusive criteria of sophor a subprostrata root toxicology's literature i.Research material is sophora subprostrata root(Sophora tonkinensis Gagnep);ii.Research content is sophora subprostrata root's toxicity analysis.Inclusive criteria of adverse reactions:i.Clear use of sophora subpro strata root's single herb and sophora subprostrata root decoction;ii.Clinical reports;ii i.for a manuscript with two entries,the same author,or the same content,take themore comprehensive Iiterature.(4)Rejection criteria:i.Review articles;ii.Repeated ca se reports;iii.Use of sophora subprostrata root Chinese patent medicine;iv.Toxicity st udies on different extracts of sophora subprostrata root.Research results:(1)the ancient books:ancient books recorded that Sophora subprost rata root was "nontoxic",but its bitter and cold smell can cause discomfort in spleen and stomach.Thus,it is not recommended for people who have a small appetite an d complain of diarrhea or those who suffer from pathogen of deficient fire.In termsof usage and dosage,it is applied as "powder or grinding or holding in mouth then swallowing" as described in Broad Medical Notes in XianXingZhai,Volume ?,Broad Processing Methods,Herb Part.WoLing Materia Medica records the water decoction method,but its usage is "decoct with water and hold in mouth.Patients would be cu red after two or three of swallowing".And the treatment of throat swelling and painis mostly "cut it into inches or so,and hold it in mouth","hold in mouth then swa How the juice" or "mouthwash of water decoction".It is suggested that Sophora subp rostrata root should not be decocted when used,and if decocted,it should be strictly controlled within a low dosage.(2)Clinical adverse reactions in contemporary literatu re:sophora subprostrata root's adverse reactions occur in 15 minutes to 4 hours aftertaking medicine,but individual differences exist and are related to disease progressio n.The adverse reactions mainly affect the nervous system,digestive system and respi ratory system,and respiratory failure may be the direct cause of death.Adverse reac tions first appeared in the digestive system and nervous system with symptoms of he adache,dizziness,vomiting,nausea,abdominal pain,weakness in the extremities,palpi tations,and chest tightness.In severe cases,paleness,tremors in the extremities,conv ulsions,chills,rapid heartbeat,blood pressure drops,shock,and death from respirato ry failure.If taken in large doses for a long time,it may cause severe brain damage,especially in teenagers and children.(3)Toxicological studies of contemporary literat ure:Acute toxicity studies suggest that the toxicity of sophora subprostrata root is rel ated to the quality of the herbs and processing methods.The toxicity intensity of dec oction has a direct correlation with the decocting time.As the decoction time extends,the toxicity increases.Long-term toxicity studies suggest that sophora subprostrata ro ot can lead to liver damage and presents a dose-time-drug relationship,causing elevat ed biochemical indicator of ALT and changes in liver tissue.Suggestions:(1)Regulate the clinical usage of drugs to prevent patients from relying on folk or empirical prescriptions recklessly for colds and sore throats.(2)Strict ace ordance with the regulated usage and dosage prescribed by the Pharmacopoeia by th e clinicians is of immense importance to fully realize the efficacy and evade the risk of medication.(3)Clinical pharmacists should instruct the patient to take notice of a ny distress,dizziness,vomiting,and other discomforts after taking the drug.If there is any discomfort,instruct the patient to immediately stop taking the drug and seek medical advice if necessary.(4)There are no standardized and effective methods for sophora subprostrata root poisoning.Future attention should be paid to the study of r outine treatments for sophora subprostrata root poisoning.(5)The records of the ancie nt herbs and related drugs should be systematically searched prior to the toxicologica 1 research experimental design,and the sample preparation plan should be rationally designed in accordance with clinical practice.(6)Strengthen the researches on toxic s ubstances basic theories,toxicity mechanism,increasing efficacy and reducing toxicity,in order to make sophora subprostrata root exert its full effect while reducing clinica 1 adverse reactions and provide guidance for clinical safety.