| The prescription of Suhexiang Pill comes from Prescription of Peaceful Benevolent Dispensary. It contains kinds of aromatic drugs such as Styrax,Broneolum Syntheticum,olibanum,Lignum Santali Albi,Raidx Aristolochice,Moschus. It possesses fragrance,can wake up a patient from unconsciousness,run the functional activities of vital energy and warm the middle warmer. It refers to stroke which belongs to cold.Though iterative authenticate of successive dynasties'doctors,the Pill's therapeutic effect is conspicuous. After the Song Dynasty Muskone which is included in the Pharmacopeia of China many times is based on Suhexiang Pill that is the orthodox complex prescription. Muskone comprises Styrax,Broneolum Syntheticum,olibanum,Lignum Santali Albi,Raidx Aristolochice.It can wake up a patient from unconsciousness,run the functional activities of vital energy, promote blood flow and relieve pain.It applies to angina pectoris,chest distress,breath holding and myocardial infarct generally,especially to prevent and cure the insultus of angina pectoris.Both myocardial infarct and angina pectoris belong to thoracic obstruction and cardiodynia in traditional Chinese medicine. This disease's etiological factor is the stoppage of functional activities of vital energy and the stagnation of blood mainly. Muskone has many herbal medicine which can promote blood flow and run the functional activities of vital energy, meanwhile,compared with glycerol trinitrate, the patients have not conspicuous adverse reaction after eating the Muskone.So it is accepted to patients.But following the cognition of kidney damage in the traditional Chinese medicine,though questioning the patients'case history insistently,we discover gradually that patients who take this medicine for long-term can effect the function of kidney,even induce kidney damage. In the composition of Muskone, Raidx Aristolochice is the most possible medicine which can result in kidney damage.Because the primeval plant of Raidx Aristolochice is roots of Fructus Aristolochiae that includes aristolochic acid.People who take it long-standingly may lead to kidney damage.We call it aristolochic acid nephropathy (AAN) which is induced to aristolochic acid clinically. Owing to this cause,the clinical application has its limitation. Pill was recorded originally in Prescription of Peaceful Benevolent Dispensary, which had many disadvantages such as big dosage, slow absorption and low absorption rate, etc.But angina pectoris breaks out quickly.The virgin form of medication can not satisfy with the demand of pathogenetic condition.So we introduce this topic. Under the guidance of traditional Chinese medicine theory,based on Muskone we utilize modern technology of manufacturing medicine which removal Raidx Aristolochice and replace pill with drop pill to make a new medicine.It is named New Guanxinsuhe Drop Pill.New Guanxinsuhe Drop Pill which is prepared in the experiment is composed of four medicine such as Styrax,Broneolum Syntheticum,olibanum,Lignum Santali Albi.We abscise Raidx Aristolochice in order to avoid the kidney damage because of eating it long-termly.At the same time,we replace pill with drop pill because it has advantage ,for example: drop pill can cause the immediate effect or prolonged action,lente liberantes according to the demands of curing pains;though sublingual administration,it is absorbed by sublingual membrana mucosa blood vessel directly,enters blood fast to educe curative effect.It passes by the medical metabolism to liver, accordingly raises the time of drug action; it increases stability of the drug, decreases the stimulation, masking the dys-smell;because using water-solubility adjuvant to make base material such as polyethylene glycol(PEG),we elevate the bioavailability,the drop pill can effect quickly,its production is convenient and its cost is low.For approaching the mechanism of action of NGDP,we used AMI models of mice which were induced by Pit to study the pharmacodynamics in the experiment in order to replace Muskone with NGDP really.1 Studies on Preparation Process for NGDPObjective: To study the extracting process of herbal medicine in order to optimize the best conditions; To determine the clathration process usingβ–cyclodextrin of mixed volatile oil in order to optimize the best conditions;To explore the forming process of preparation for manufacturing NGDP.Methods:⑴The study on extracting process:Using orthogonal test,with the yield of volatile oil as indexes,to optimize the best extracting conditions.⑵The study on clathration process: Using orthogonal test,with the yield,clathration rate,oil content rate of clathrate as indexes, to optimize the best clathration conditions.⑶The study on forming process: Using orthogonal test, with the degree of circle and integrity,tailing,adhere of the drop pill as indexes,to optimize the best forming conditions.Results:⑴The study on extracting process:The best extracting process of mixed volatile oil of olibanum and Lignum Santali Albi is to add ten times amount of water into the mixture of crude drugs,to soak for 10 hours,to heat up to boil and recire 8 hours.⑵The study on clathration process:The optimized process isβ–cyclodextrin: mixed volatile oil in proportion as 8:1,to add 2 times amount of water,to grind 30 min.⑶The study on forming process:The water-bath temperature is 75℃, the proportion of drug and base material is 1:2, the proportion of PEG4000 and PEG6000 is 1:4,don't need clathration.Bases on this condition,the forming rate is the highest.Conclusions:To optimize the best extracting process,clathration process and forming process of NGDP.The method is simple,the efficiency is higher.So it applies to industrialized production.2 Studies on quality control of NGDPObjective: To establish a series of thin-layer chromatography (TLC) methods to identify traditional Chinese medicine in prescription such as Broneolum Syntheticum and olibanum. To establiah a reversed-phase HPLC method for determination of cinnamic acid in NGDP in order to provide exact,sensitive,fast,convenient guideline for their quality controls.Methods:⑴Studies on identification methods:To use TLC,selecting suitable extraction solvent,approach and eligible fixed phase,development system,colouration system ,Broneolum Syntheticum and olibanum in NGDP were identified with TLC.⑵The assaying of cinnamic acid:①Chromatogram conditions: Choose appropriate fixed phase, adjust different formulation and proportion of mobile phase and regulate flow rate and wavelength in order to separate the peak of cinnamic acid from others well.②Preparation of standard curve: Prepare a series of the reference solution,examine peak area, then the regress equation was obtained with the content of cinnamic acid as abscissa, the relevant peak area as ordinate.③Lowest detection limitation: Dilute the reference solution to the value of S/N was not less than 3. The relevant concentration was the lowest detection limitation.④Precision:Inject the same test solution into the chromatograph for six times, measure the responses of cinnamic acid, and then calculate the precision.⑤Stability: Prepare the test solution to measure the relevant responses at different time respectively in 48 hours,then determine the peak area.⑥Reproducibility: Prepare the test solution five shares in the same way respectively to determine the content of cinnamic acid.⑦Recovery: Transfer a portion of contents of NGDP, add a certain volume of reference solution of cinnamic acid to it, and mix. Prepare three shares parallelly. Inject and determine the content of cinnamic acid respectively, and caculate the average recovery in the end.⑧The content of cinnamic acid in NGDP was analyzed under above-mentioned conditions.Results:⑴Identification: TLC methods were established for the identification of Broneolum Syntheticum and olibanum. The principal spot in the chromatogram obtained from the test solution was similar in position, colour and intensity to the principal spot in the chromatogram obtained from the reference solution. But the negative control was non-interference.⑵Assay:①Chromatogram conditions:A ZORBAX Eclipse XDB-C18 column (250 mm×4.6mm,5μm) was used for HPLC. The mobile phase was a mixture consisted of methanol–acetonitrile-water-glacial acetic acid(10:22:55:0.5) at a flow rate of 1.0 ml·min-1 and the detective wavelength was set at 272nm. Column temperature was 25℃;pressure was 73Pa; sample size was 10μl.Under the system, the peaks of samples were separated well with the resolution of not less than 1.5. The retention time is about 7 min. The theoretical plates were more than 4000 and the tailing factor of the cinnamic acid peak was from 1.02 to 1.12.②The draw of standard curve: The liner range for cinnamic acid was 0.374～3.74μg·ml-1.Regress equation was Y=366.08091X-34.63637,r=0.99956(n=6).③The lowest detection limitation was 0.236ng·ml-1.④Precision:The sample's precision is fine. The RSD value in the precision test was 0.22%(n=6).⑤Stability:The sample was stable in 48 hours.⑥Reproducibility:The RSD value of repeatability was 0.70%(n=5).⑦Recovery:Average recovery is 100.488% and the value of RSD was 0.63%(n=5).⑧The average content of cinnamic acid was 0.11mg/g,the value of RSD was 0.20%(n=5).Conclusions: In identification, the relevant spots were clear and characteristic and could be used to differ them from others in NGDP. The RP-HPLC method was established to determine concentration of cinnamic acid in NGDP. The method was found to be accurate, sensitive, quick and stable. It can be used to control the quality of NGDP.3 The Experiment Studies of NGDP on Pit-induced AMI of MiceObjective:To observe the effect of NGDP on Pit- induced AMI of mice and discuss the mechanism of action.Methods:Injecting Pit to use the method of intraperitoneal injection in order to duplicate the model of experimental AMI of mice.To determine the content of NO,MDA and SOD in blood.To take the myocardium of apex of heart which were made into 10% homogenate with physiological saline to determine the content of NO,MDA and the activity of SOD.Results:NGDP can oppose Pit-induced AMI obviously,increase the contents of NO and the activity of SOD both in serum and in muscular tissues,decrease the contents of MDA.Conclusions:NGDP can prevent and cure Pit- induced AMI effectively.It possesses the role of protecting the cardiac muscle cell.
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