TWI281400B - Herbal composition for angina pectoris, method to prepare same and uses thereof - Google Patents

Abstract

This invention provides compositions comprising extracts of Radix Salviae Miltiorrhizae, Radix Notoginseng and Borneol. Said compositions comprise notoginsenoside R1 and ginsenoside Rg1 which are active components for therapeutic applications. This invention also provides a method of preparation of the said compositions and a method of identification and determination of the amount of individual effective components of said compositions. Finally, this invention provides various uses of the compositions.

Description

1281400 A7 B7 V. INSTRUCTIONS (/ ) ... (Please read the notes on the back and then fill out this page.) Various references to this patent application are placed at the end of the specification, prior to the claims. The disclosure of the present invention is incorporated herein by reference in its entirety for the purpose of the present disclosure. Chronic stable angina is caused by myocardial ischemia. Aspirin, organic nitrates, /3 receptor blockers, and calcium antagonists are often used alone or in combination to treat angina pectoris. Aspirin as an antithrombotic drug can only be symptomatic for chronic stable angina. Organic nitrates are used in the onset of angina and can be prevented in patients with predictable symptoms. For sensitive patients, headaches caused by nitrates can prevent them from taking them. Although sputum adrenergic receptor blockers have an irreplaceable role in the treatment of angina pectoris, their contraindications are numerous, including tracheal block disease and severe ventricular dysfunction, including non-specific diabetes, peripheral blood vessels. Disease and bradycardia or heart block. The Central Standards Bureau of the Ministry of Economic Affairs, the employee consumption cooperative, printed calcium antagonists has a good effect in the treatment of angina pectoris. It is through the relaxation of coronary heart disease patients with vascular smooth muscle, affecting peripheral circulation, increasing myocardial oxygen supply, reducing myocardial work. Realized. Although many patients have begun to use a combination of organic nitrates, calcium antagonists and /3 adrenergic blockers to treat angina, and have made some progress, but still need to be long-term, low toxicity and high efficiency , a drug for the treatment of chronic stable angina. This paper scale applies to China National Standard (CNS) A4 specification (210X297 mm) 1281400 A7 B7 _ V. Invention description (2 ) ... (Please read the note on the back and fill out this page) In view of these problems of the above drugs, it is necessary Strive to find new ways to use Chinese herbal medicine to treat chronic stable angina. Traditional Chinese medicine can play its unique role in this respect. U.S. Patents (Nos. 5,288,485 and 5,433,957) teach the use of small forsythia (a reduction in the treatment and prevention of diseases caused by circulatory disorders such as angina. US Patent No. 5 776463 mentions oral administration of borage petals or extracts thereof. The composition can be used to prevent and treat stress tension caused by heart rash disease including angina pectoris. In addition to small forsythia ereciw/w and borage petals, many other herbs are also used to treat angina. It is broadleaf sedge /α^>//·α). Yang Guiyun et al (1 994) reported that 82 patients with angina pectoris (50 patients with ischemic manifestations in the ST-T segment of the electrocardiogram) were treated with broad-leaved grass. The total effective rate of angina pectoris (S Τ - 无 无 no ischemia) was 8.80%; the effective rate of angina pectoris with ST-T segment is 8.0 0%. In addition, it has also been found that valerian can reduce plasma lipid levels. Non-toxic to liver, kidney and hematopoietic tissue. Printed by the Consumers' Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs Wu Yiliang· (1 990) reported that 267 patients with angina pectoris were treated with “Xintongkang” capsules with an effective rate of 93.3%. Another herbal preparation, Shenqi Tongguan Tablet, is used for the treatment of angina pectoris. » 〆 In 990, Hu Jinxin et al reported that “Shenzhen Tongguan Tablet” consisted mainly of saponins extracted from the stems and leaves of ginseng and white peony. The total effective rate of treating angina was 9 4.7 1%. The ECG improvement rate was 63.3 8%. In addition, laboratory experiments show that ___ 2 ____ this paper scale applies to China National Standard (CNS) Α 4 specifications (210X297 mm) 1281400 at B7 V. Invention Description (3) ... "Shenzhen Tongguan Tablet" has. Improve left ventricle The function of the output 'reduces blood viscosity and inhibits platelet aggregation and other functions. Acute toxicity test and long-term toxicity test prove that “Shenzhen Tongguan Tablet” has no toxic side effects. "Expanding Crown Granules" is another herbal preparation for the treatment of angina pectoris. Li Yingdong et al (1 990) reported that in patients with coronary heart disease angina pectoris before taking "expanding crown particles" and one month after taking the drug, the plasma zinc, copper, red blood cells, glutathione were determined by atomic absorption spectrometry and D TNB method. And the content of peroxidase. The results showed that the levels of zinc, red blood cells, glutathione and peroxidase in the treatment group were higher than those in the control group, and the level of copper was lower than that in the control group (P < 〇.〇1). The plasma zinc was treated in the treatment group after taking the drug. The levels of red blood cells, glutathione and peroxidase were significantly lower than those of the control group, and the level of copper was significantly higher than that of the control group (P < 〇.〇1). These conditions indicate that the mechanism of “wide crown granules” for treating angina pectoris may be related to the regulation of trace elements in the body. Hedgehog is another herb that treats angina. Printed by the Consumers' Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs (please read the notes on the back and fill out this page). Fufang Wan# is a commonly used prescription for the treatment of chronic stable angina due to coronary ischemia. Since its publication in the Chinese Pharmacopoeia in 1977, it has been used clinically for decades. Compound Danshen Tablets is an extract of Chinese herbal medicine Radix Salviae Miltiorrhizae and Sanqi (www.g), and contains various effective ingredients. Danshen and Sanqi were first recorded in the "Shen Nong's Herbal Classic" in the 2nd year of the second year. In addition, Feifang's ginseng tablets also contain synthetic borneol. Natural borneol was first recorded in the "Tang Bencao" in 659 AD. This paper scale applies to China National Standard (CNS) A4 specification (210X2973 mm) 1281400 at B7 Ministry of Economic Affairs Central Sample Bureau employee consumption cooperative printing 5, invention description (sheep) ... Li Chengzhu et al [1 979 noon, Shanghai First Medicine Journal of the hospital] reported that experimental studies have shown that Salvia miltiorrhiza has antithrombotic effects. The blood plate aggregation function of rabbits was observed in vitro, indicating that it has a fibrinolysis effect. After injection of Salvia miltiorrhiza, three points were found to play an important role in in vitro thrombosis: (1) inhibition of platelet function; (2) inhibition of platelet aggregation; and (3) increased fibrin dissolution. The first two of these roles are more important. The results confirmed the role of Danshen in the treatment of thrombosis, especially arterial thrombosis. Jiang Wende et al [1 1982, Journal of Shanghai First Medical College] reported the effects of water-soluble components of Danshen and other Salvia miltiorrhiza on canine ischemic myocardium and isolated porcine coronary arteries. 3 new water-soluble ingredients such as Danshensu (DS-182, D(+)_3,4-dihydroxyphenyllactate), protocatechuic aldehyde (pcAD) and crude dibasic acid isolated from Salvia miltiorrhiza (DS- 187), compared with dipyridamole. The results showed that: (1) DS-182 had obvious anti-hypoxia effect in PC test, but PC AD had no obvious effect; (2) DS-1 82 on electrocardiogram ischemic ST-induced pituitary vasopressin The rise in T has a significant improvement and has no effect on heart rate. DS_ 187, PC AD and dipyridamole showed only incomplete protection; (3) Ligation of the left anterior descending artery of the dog coronary artery, an acute infarction model, and intravenous injection of DS-182. The results showed that DS-182 was superior to DS-187 and PCAD in terms of left ventricular function, left ventricular maximum systolic pressure (LVPSP), and left ventricular end diastolic pressure (LVEDP). In contrast, PCAD* has an opposite effect on left ventricular systolic pressure (LVPSP) and left ventricular end diastolic pressure (LVEDP). Dipyridamole intravenous administration, although it can not change LVEDP, but significantly reduced LVPSP and showed significant antihypertensive effect (please read the back note first and then fill out this page) This paper scale applies Chinese National Standard (CNS) A4 specification ( 210X297 mm) 1281400 A7 ______B7 __ V. Description of invention (f ) ... All components of Dan * ginseng and dipyridamole can reduce the range of myocardial infarction (N-Bt evaluation); Ds_182 is the most effective, dipyridamole Mo, and PCAD is the worst; (4) DS-182 can significantly reduce coronary vascular resistance in the isolated rat coronary artery model, while DS -1 8 7 , PC AD or another Salvia miltiorrhiza component - tanshinone II-A sulfonate can increase this resistance. In the ex vivo ^ M f Mo, the inhibitory effects of morphine and propranolol can be antagonized by pre-administered DS-182. All of this suggests that Danshensu may be the main component of Danshen's treatment of ischemic heart disease and may be beneficial in combination with morphine or propranolol. Li Chengzhu et al [1 1983, Journal of Integrative Medicine] reported the anti-coagulation effect of Salvia miltiorrhiza. Danshensu is a water-soluble monomer extracted from Salvia miltiorrhiza Bunge. It is also the main component of the commercially available Salvia miltiorrhiza injection. Modern studies have shown that Danshensu inhibits thrombosis in vitro, inhibits ADP-induced platelet aggregation and in vitro and in vivo agglutination, reduces platelet count, and accelerates fibrin or fibrinogen degradation. After the injection of Salvia miltiorrhiza injection at 20 m g / k g, the rabbit reached the strongest effect for 30 minutes and continued to recover for 1 hour. Printed by the Consumer Standards Agency of the Central Bureau of Standards of the Ministry of Economic Affairs (please read the notes on the back and fill out this page) Cheng Zhanghua et al [1 987, Journal of Shanghai First Medical College] reported the effect of Danshensu on experimental microcirculation and plasma lactate concentration . Natural Danshensu is a water-soluble monomer extracted from Danshen. In a model of microcirculation disorder induced by injection of macromolecular dextran in rabbits, Danshensu (dose 4-6 mg/kg), sputum can be significantly increased> and the number of capillaries in the microcirculation of the bulbar conjunctiva is significantly reduced. Plasma lactate levels. In a model of mesenteric microcirculatory disorder caused by instillation of norepinephrine (4g) in mice, Danshensu has a dilated artery that accelerates blood flow--------5---- This paper scale applies to Chinese national standards (CNS) A4 size (210X 297 mm) 1281400 A7 B7 V. Invention description (6) ... (Please read the note on the back and fill out this page) The effect of speed, therefore, can eliminate the blood circulation of the microcirculation. Synthetic Danshensu can also be found to have a similar effect in the experiment. This indicates that there is no significant difference between natural Danshensu and synthetic Danshensu in alleviating microcirculatory disorders. In 1991, Sun Ximing et al reported that the extract of Salvia miltiorrhiza has a new pharmacological effect. The paper reported that the Salvia miltiorrhiza extract containing sodium danshensu (D(+)-3,4-dihydroxyphenyl lactate) has a pharmacological effect of inhibiting intracellular cholesterol biosynthesis and anti-lipid peroxidation by cell culture. Compared with the control group, the electrophoretic mobility was significantly reduced, and MD A and cytotoxicity were significantly reduced. The results indicate that Danshensu sodium has an effective function in preventing and treating arteriosclerosis. Zheng Ruoxuan et al [1, 992, Journal of Integrative Medicine] reported that salvia miltiorrhiza has protective effects on myocardial ischemia caused by coronary artery ligation in mice. Intraperitoneal injection of water-soluble extract of Salvia miltiorrhiza (5g crude drug / kg), compared with the control group, it has a significant protective effect on acute myocardial ischemia caused by coronary artery ligation, the ST segment of the electrocardiogram caused by myocardial ischemia in the treatment group The height was significantly reduced, the left ventricular ischemic area was reduced, and the survival rate was significantly increased. Wu Yizhong and other reports (Journal of Nanjing University of Traditional Chinese Medicine, 1 9 9 5, 11 (6): Printed by the Consumer Standards Agency of the Central Bureau of Standards of the Ministry of Economic Affairs 3 5 -3 6 ) The role and mechanism of Danshen's blood circulation and phlegm. The authors believe that the pharmacological studies of Salvia miltiorrhiza are more common, but the blood rheology of Salvia miltiorrhiza, such as prostacyclin 12, ET, and thromboxane A2 produced by blood platelets are rare. 〆 They studied the thrombosis, platelet aggregation and changes of PT, KPTT, FG, ESR and HCT in rabbits. The results showed that Salvia miltiorrhiza can inhibit the synthesis of TXA2 and reduce platelet aggregation and thrombosis. ' ----~--6-------- This paper scale applies to China National Standard (CNS) A4 specification (210X297 mm) 1281400 Λ7 B7 Ministry of Economic Affairs Central Bureau of Standards Staff Consumer Cooperatives Printing 5, Invention Explanation (f) ... Shi Lin reports (Chinese Journal of Pelican, 1 9 9 0, (1): 2 9 - 3 2 ) Panax notoginseng f has elevated carotid prostacyclin 12 and decreased platelet thromboxane A2 effect. The rabbits were fed with 100 mg of Panax notoginseng total f/(kg·day) for 8 consecutive weeks, and the formation of aortic atherosclerotic plaques was significantly inhibited compared with the control group. Radioimmunoassay was used to determine the effect of Panax notoginseng saponins on the content of cervical prostacyclin 12 and thromboxane A2. The rabbits were fed with 25, 50, 100 mg of Panax notoginseng/(kg·day), and after 10 consecutive days, the carotid prostacyclin 12 content and thrombopoietin A2 content were decreased compared with the control group. These results show that Panax notoginseng total soap f achieves anti-atherosclerosis by correcting the imbalance of prostacyclin 12 and thromboxane A2. Li Xing reports (Chinese Journal of Pharmacology, 1990, (1): 26-29) The protective effect of Panax notoginseng on experimental myocardial ischemia-reperfusion injury in rats. The authors investigated the effects of Panax notoginseng saponins and ginseng soap f Rb 1 purified from Panax notoginseng saponins and ginsenoside Rg 1 on experimental myocardial ischemia reperfusion injury in vivo and in vitro. The rats were anesthetized with pentobarbital, the left descending coronary artery was ligated for 40 minutes, and then reperfused for 1 20 minutes. Compared with the control group, the Panax notoginseng total f treatment group (100 mg/kg and 200 mg/ Kg) can significantly reduce the extent of myocardial infarction. The isolated heart of the rat was subjected to spheroid ischemia for 40 minutes, and after reperfusion for 15 minutes, compared with the control group, the total saponin f 12.5 mg/L group and the panax notoginseng f 25 mg/L group were compared. The ginseng soap f Rbl 10mg/L group and the ginseng saponin Rgl10 mg/L group can significantly inhibit the release of cardiac creatine phosphokinase, reduce the myocardial calcium ion and malondialdehyde levels, and improve ------Ψ--- -- This paper size is applicable to China National Standard (CNS) A4 specification (210X297 mm) (please read the note on the back and fill out this page) 1281400 A7 B7 V. Inventive Note (") ... Superoxide dismutase activity . The results showed that Panax notoginseng total soap f, ginseng lane f Rb 1 and ginseng soap and other Rg 1 have the effect of preventing myocardial ischemia, which may be related to inhibition of lipid peroxidation. Huang Cong reports (Chinese Pharmacological Bulletin, 1 9 9 1, (3)·· 1 9 0 · 1 9 3 ) Sanqi total soap f protective effect on myocardial ischemia-reperfusion injury in rabbits. The authors investigated the effects of Panax notoginseng saponins f on electrocardiographic changes, creatine phosphokinase and lactate dehydrogenase, and myocardial ischemic area after myocardial ischemia-reperfusion injury in rabbits. The myocardial ischemic area was significantly reduced in the dose group of 5 0 m g / k g and 100 m g / k g. The results showed that Panax notoginseng saponins f had protective effects on myocardial ischemia-reperfusion injury. Mo Qizhong reports (Chinese patent medicine research, 1 982, (8): 5-7) 3 H-Ice Film Economics Department Central Standards Bureau employee consumption cooperative printing (please read the back of the note and fill in this page) Dynamics The study. In order to explore the mechanism of borneol aroma, the authors used venous injection or oral methods to study the dynamics of sputum-labeled borneol. The half-life of SH-ice tablets alone for 2 · 8 minutes suggests that the drug is quickly distributed to the relevant organs and tissues and can work quickly. Organs and tissues with high concentration in the body have blood, heart, lung, liver, kidney, brain, etc., which provide a theoretical basis for clinical application. The half-life of borneol after oral administration was 5.3 hours, suggesting that oral borneol does not cause accumulation, but the bioavailability is poor. And pointed out that further research should be to explore the relationship between dosage and dosage form. Chen Tiezhen reports (Chinese Journal of Pharmacology, 199 〇, (1): 42_44) Synthetic borneol promotes the absorption of cypropyrazine. Intramuscular injection of borneol (5mg/kg) in SD rats (with no injection as a control group), intramuscular injection of tetramethylpyrazine phosphate (5mg/kg), analysis of plasma tetramethylpyrazine concentration by gas chromatography This paper scale applies to China National Standard (CNS) A4 specification (210X29^^7" ' 1281400 Ministry of Economic Affairs Central Bureau of Standards Bureau employee consumption cooperatives print A7 B7_5, invention description (^) ... and use NONLIN program to process the data. The Cmax of the two groups were 931 and 562, respectively (p<〇.〇l), and the AUC were 68849 and 3 7 1 74 (P<0.05), respectively, suggesting that borneol can promote the absorption of tetramethylpyrazine instead of accelerating its elimination. Xu Wei et al. (Pharmacology and Clinical Medicine of Chinese Medicine, 199 5,11(6): 31-33) Effects of menthol and borneol on the distribution of sulfadiazine and Evans blue in the brain. Menthol (1.5g/kg, Ig) and borneol (1.5g/kg, ig) can significantly prolong the distribution phase half-life of sulfadiazine in rats. The above dose can also increase the concentration of sulfadiazine in rat brain. Menthol (〇.5g/kg, Ig, three days) and borneol (〇.5g/kg, ig, three days) can increase Evans blue in mice The concentration within the brain was significantly lower than that in the brain of mice with ischemia-reperfusion injury. The above results suggest that menthol and borneol may have the effect of promoting the passage of sulfadiazine through the blood-brain barrier without damage to the blood-brain barrier structure. In the United States, coronary atherosclerotic heart disease is the most common cause of cardiovascular dysfunction and death. Atherosclerosis is a yellow plaque with cholesterol, lipids, and cell debris deposited on the inner wall of the large and middle arteries. Characteristic arterial dysfunction. At the beginning, fatty streaks appear, gradually becoming fibrous plaque or atheromatous lesions, thickening of blood vessels, fibrosis, calcification, narrowing of the lumen of the blood vessels. Many atheromatous plaques remain stable or gradually Development, others can rupture and cause bleeding, platelet activation, and intravascular thrombosis. Coronary thrombosis can lead to partial or complete vascular occlusion, poor blood flow, and instability of angina or myocardial infarction. Broken plaque may be (please read the notes on the back and fill out this page). This paper scale applies to the Chinese national standard. (CNS) A4 specification (210X 297 mm) 1281400 Λ7 B7 Ministry of Economic Affairs Central Bureau of Standards Bureau employee consumption cooperative printing 5, invention description (/〇) ... Stabilized, often greedy leads to more serious stenosis. Sports and mental stress Causes an increase in myocardial aerobics. Under normal physiological conditions, increased blood flow through small arteriolar expansion is sufficient to meet the need for increased myocardial aerobics. In the case of atherosclerosis, the small arteries have expanded to the limit to meet basic oxygen supply. The increased oxygen demand can no longer be met. When aerobic excess exceeds oxygen supply, myocardial ischemia occurs. Severe vascular occlusion, blockage of blood flow, can also lead to myocardial ischemia. The clinical manifestation of transient myocardial ischemia is angina, manifested as sudden chest pain, often radiating to the arm, especially the left arm, or with a sense of suffocation. Angina is subdivided into two types: stability and instability. In most cases, stable angina is caused by an increase in oxygen demand. The factors that increase aerobics are exercise, mental stress, etc. The frequency and duration of seizures are often predictable. On the contrary, it is difficult to find the triggering factor for the unstable angina pectoris, which is often caused by the decrease of myocardial oxygen supply. The rupture of atheromatous plaque, platelet congestion, and coronary thrombosis can reduce myocardial oxygen supply. Methods for treating angina include medication, surgery, coronary artery bypass grafting, balloon angioplasty, and stent placement. Therapeutic stability of angina is the first to reduce myocardial aerobics, which is also a preventive measure. Treatment of acute unstable angina is first considered to inhibit platelet activity and thrombolysis. Current drugs for the treatment of chronic stable angina include nitroglycerin, other nitrates, dance channel blockers, and /3 - adrenergic receptor blockers. Taking these drugs or combination alone can relieve and prevent angina, rather than treating angina. '"This paper scale applies to China National Standard (CNS) A4 specification (210X29Y mm) (please read the note on the back and fill out this page) 1281400 A7 B7 Ministry of Economic Affairs Central Bureau of Standards Staff Cooperatives Printed 5, Invention Description (/ / ) ... When angina pectoris occurs, sublingual nitroglycerin can relieve symptoms, as well as prevent angina pectoris caused by fatigue and tension. Nitrate can also prevent angina attacks. Nitroglycerin and nitrates reduce the myocardial aerobics by relaxing the vascular smoothing machine and reducing myocardial activity. The side effects include inflammatory headache, dizziness, weakness, orthostatic hypotension, and palpitations. /3 - Adrenergic blockers such as propranolol prevent angina by reducing myocardial aerobics during exertion and stress. The main contraindications are bronchial stenosis, slow pulse arrhythmia, and obvious heart failure. Applying a sputum-adrenergic receptor blocker to patients with asthma and other airway obstructive disorders may worsen the condition. Calcium antagonists prevent angina by reducing myocardial aerobics. The myocardium plays a normal function by relying on the influx of calcium. Calcium antagonists prevent angina by inhibiting the influx of calcium to relax vascular smooth muscle, reduce myocardial activity, and reduce myocardial oxygenation. Adverse reactions of calcium antagonists include flushing, edema, dizziness, and nausea. Excessive inhibition of calcium influx into the myocardium can lead to serious side effects such as cardiac arrest, bradycardia, and congestive heart failure. When used in combination with /3 - adrenergic receptor blockers, side effects of calcium antagonists are often aggravated. Since the 200th year of the AD, Sanqi and Salvia have been used in China to treat cardiovascular diseases. Sanqi is used to treat angina pectoris, and salvia miltiorrhiza is used to promote blood stasis. Xu * 〆 Many preclinical studies and clinical studies have demonstrated the efficacy and safety of Panax notoginseng and Salvia miltiorrhiza. Traditional Chinese medicine is generally a mixture of several Chinese herbal medicines. Treatment of coronary heart ________π___ This paper scale applies to Chinese National Standard (CNS) A4 specification (210X297 mm) (Please read the note on the back and fill out this page) 1281400 A7 _____B7_ V. Invention Description (/JZ) - (Please first Read the precautions on the back and fill out this page. In the traditional Chinese medicine, the dosage of Fufang Danshen Tablet has been improved. It is a large oily tablet with a diameter of up to 1cm. Compound Danshen Tablets is composed of Salvia miltiorrhiza extract, Panax notoginseng powder and synthetic borneol. It was included in the Pharmacopoeia of the People's Republic of China in 1977 and has been used to treat cardiovascular diseases for decades. The compound Danshen Drip Nine (also known as Huxin Dan) disclosed in the present invention is a new generation of traditional Chinese medicine for treating coronary heart disease. Traditional Chinese medicines are not only different depending on the medicinal taste of the composition, but also vary with the ratio between the medicinal tastes and the amount of the formulation. In order to control the quality, the compound Danshen Dijiu is produced in a standardized formula, and its therapeutic ingredients contain 10~3〇% (usually about 20%) of water-soluble extract of Salvia miltiorrhiza, 2~6% of water-soluble extract of Panax notoginseng and 1 ~ 3% of borneol. In addition, in order to achieve rapid onset, the compound Danshen Drop Nine is made into a small nine that can be quickly dissolved and absorbed under the tongue. It can quickly enter the bloodstream, reach the heart muscle, and quickly relieve angina. The preclinical study and clinical study of compound Danshen Dianjiu confirmed that the treatment of cardiovascular disease caused by coronary ischemia is safe and effective. Moreover, both preclinical studies and clinical studies have confirmed the compound Danshen drip therapy. Cardiovascular disease is superior to compound Danshen tablets. Printed by the Consumers' Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs. Compound Danshen Dianjiu 199S was included in the Supplementary Edition of the Pharmacopoeia of the People's Republic of China. Since the approval of the Ministry of Health of the People's Republic of China in 993, the compound Danshen Distillation has reached more than 5 million. The compound Danshen Drip Nine (D SP ) disclosed in this patent is a new generation of traditional Chinese medicine for treating coronary heart disease, which is produced according to a standardized prescription. Compound Danshen Drop 9 includes Panax notoginseng, Salvia miltiorrhiza extract and borneol. The _______12 ____ paper scale applies to the Chinese National Standard (CNS) A4 specification (21〇'乂297 mm) 1281400 at B7 V. Invention Description (/J) Sanqi is used to relieve and prevent the onset of angina pectoris; Platelet aggregation prevents the formation of coronary thrombosis, thereby improving blood circulation; borneol is the main component of myocardial therapy. Compound Danshen Drop Nine is a round small nine 'every nine weights of about 25m § ‘ sublingual dissolution, so it can make it more effective. The efficacy of Compound Danshen Dropping Nine in preventing and relieving angina pectoris has been confirmed in clinical and _ clinical studies. The invention discloses a dropping machine which can produce compound Danshen dropping pills or other small nine agents. The present invention also discloses a method for quality control of such a drug, which comprises the use of analytical techniques such as thin layer chromatography and high performance liquid chromatography to identify and quantify the effective components of the drug. 1 Schematic description of the figure Figure 1 · Fingerprint (batch number: 1 9990806) Ministry of Economic Affairs, China Bureau of Standards and Staff, Consumer Cooperatives, printing, r, clearing the back of the stains, please fill out this page) Location of the fingerprint peak: Group I includes 1 #, 2# peak (retention time from 7 to 15 minutes); Π group includes 3#, 4# peak (retention time from 15 to 2 minutes); melon group including 5#, 6#, 7# and 8# Peak (retention time from 20 to 40 minutes). Overall, the peaks of the I groups are the most abundant, so the peak heights of the 1# and 2# peaks are almost the same. The peaks of the Π group stand side by side, the peak height is almost the same, and the abundance is very low. The m group consists of 4 peaks whose peak height is stepped up. These two sets of peaks contain the characteristic peaks of the compound Danshen Drip. _;___ 13_____ This paper scale applies to China National Standard (CNS) A4 specification (210X 297 mm) Printed by the Consumer Standards Agency of the Central Bureau of Standards of the Ministry of Economic Affairs 1281400 V. Invention Description (/4 ) ... Figure 2 · Fingerprint (batch number: 1 9 9 9 0 8 1 5 ) Figure 3·Fingerprint (batch number: 1 9 9 90 82 3 ) The compound compound Danshen Dripping Pill disclosed in the present invention has the following composition: (a) Salvia miltiorrhiza [water-soluble] extract, Sanqi [Water-soluble] extracts, and borneol; (b) Salvia, Panax notoginseng, borneol and adjuvants; (c) Salvia, Panax notoginseng, borneol and medicinal adjuvants; Danshen and Sanqi used in the above drugs, in China It has been used in the treatment of coronary heart disease since 200 AD. Among them, Sanqi is used to treat angina pectoris, Salvia miltiorrhiza is used to improve blood circulation, and borneol is used to promote the effective ingredients to reach the organs of Geba as soon as possible. Natural borneol has been used since the year 2000. Due to its transitional mining, synthetic borneol is now used in the compound Danshen Drop 9. The invention discloses the following effects of the compound Danshen Dianjiu: (a) treatment of coronary heart disease; (b) treatment of coronary heart disease in combination with other drugs; (〇 is preferred for prevention of coronary heart disease; (d) preferred combination with other drugs for prevention Coronary heart disease; (e) Indirect use for prevention of coronary heart disease; 14 This paper scale applies to China National Standard (CNS) A4 specification (210X297 mm) (please read the note on the back and fill out this page) -I# order 1281400 A7 B7 V. Inventive Note (/jf), (f) Indirect use of a combination of drugs to prevent coronary heart disease; (g) Reduce the use of organic nitrates in patients; (h) Reduce blood cholesterol levels. Compound Danshen drops The indications for Nine are coronary atherosclerotic diseases (not limited to this), such as relieving angina pectoris, preventing angina caused by fatigue and tension, and preventing the formation of coronary thrombosis by inhibiting platelet aggregation and promoting blood circulation. Drip Nine can reduce the amount of nitroglycerin that often has the effect of relieving and preventing angina. The application of Compound Danshen Drop 9 can lower the level of cholesterol in plasma. Therefore, coronary atherosclerosis can be prevented from causing damage. Atherosclerosis should be caused by deposition of cholesterol in the blood vessel wall. The present invention discloses a quality control method for such a drug, and the active ingredient is applied by applying techniques such as analysis and identification. Analysis makes the composition and content of the active ingredients in the drug more standardized. The steps are as follows: (a) * Analyze the drug using analytical methods; Printed by the Consumer Standards Agency of the Central Bureau of Standards of the Ministry of Economic Affairs (please read the notes on the back and fill in the form) (b) Identification and determination of therapeutic components by comparison with corresponding purified standards. The above analysis techniques mainly include thin layer chromatography, high performance liquid chromatography/spectroscopy, etc. The purification of the drug is effective. The ingredients are considered to be active ingredients. For example, the therapeutic ingredients purified in the compound Danshen Drop No. 9 include (not limited to this): saponins, phenolic acids such as Danshensu and borneol, etc. Compound Danshen drops in the middle of ______15 ___ This paper scale applies to the Chinese National Standard (CNS) A4 specification (210, / 297 mm) " 1281400 A7 B7 DESCRIPTION OF THE INVENTION (/6) ,. (Please read the notes on the back and then fill out this page.) The retention time in the effect liquid phase, or the color and position in the thin layer chromatography are compared with the purified standard. It is identified. The quantitative determination of the active ingredient is obtained by comparing the therapeutic part of the compound Danshen Dropping Nine with a known amount of the reference substance. For example, the content of the saponin in the compound Danshen Drop No. 9 is obtained by using a known amount of pure saponin. The compound standard curve is obtained by comparison. The compound Danshen Drop 9 contains 5-40% of the water-soluble phenolic acid component of Salvia miltiorrhiza, 1-10% of the water-soluble saponin of Panax notoginseng and 1-5% of borneol. Nine contains 10-30% of the water-soluble phenolic acid component of Salvia miltiorrhiza, 2-6% of the water-soluble saponin component of Panax notoginseng and i-3% borneol. The present invention discloses a drip nine machine for producing a small nine-agent, which can rapidly dissolve to reach a target organ. The drip machine includes the following parts: (a) The drip tank temperature range is 60-100 ° C (preferably temperature: 89-93 V); (b) The condensate liquid dendrite temperature is lower than 8 ° C; (c) The dripper has an inner diameter of 1.8 mm and an outer diameter of 2.35 mm. (c) The distance between the dripper and the condensate surface is approximately 15 cm. The Central Bureau of Standards and Staff of the Ministry of Economic Affairs prints a small size produced by the above-mentioned drip machine. Nine doses, quickly dissolved after taking. The characteristics of the nine doses are as follows: (a) The diameter is 〇.3 3 -0.3 4 cm; (b) The weight of IX is 2 1.2 5 -2 8.75 mg; (c) The density is 1.13-1.40 mg/mm3. _______16 ____ This paper scale applies to China National Standard (CNS) A4 specification (210X297 mm) 1281400 Ministry of Economic Affairs Central Bureau of Standards Staff Consumer Cooperatives Print A7 B7___ V. Invention Description (, 7) ... Details of the production of compound Danshen Dianjiu The compound Danshen Drop Nine is a small nine doses, each weighing about 25mg, and its active ingredients include water-soluble extracts of Salvia miltiorrhiza and Panax notoginseng and synthetic borneol. Compound Danshen Dropping Nine is produced according to the following method: Sanqi and Salvia miltiorrhiza are separately extracted with boiling water, filtered, and the filtrate is concentrated under reduced pressure, filtered and precipitated. The concentrate is refined with a resin and concentrated under reduced pressure. The purified water-soluble extract is mixed with synthetic borneol and medicinal excipients, and a special nine-dose machine is used to make a small nine-dosage. The quality of the compound Danshen drip is controlled by controlling the main The proportion of therapeutic ingredients is controlled, including saponins, phenolic acids such as Danshensu and borneol. The methods used for the identification and determination of compound Danshen Drop Nine include thin layer chromatography, liquid chromatography, fingerprinting and other analytical methods. Production of Compound Danshen Drip Nine 1. Extraction of water-soluble components of Panax notoginseng: (a) Add 5-7 times the amount of water to the medicinal material; (b) Put the notoginseng into the extraction tank and keep the air pressure at 〇〇4_〇〇6mPa , boiling for 2 hours, extracting its water-soluble ingredients; (Ο re-extracting for 1.5 hours; (d) extract through a 100 mesh sieve; 〆 (e) purifying the filtrate with macroporous adsorption resin, eluting with ethanol; The eluent is concentrated under reduced pressure to a density of Km35, of which the _____17______ paper size applies to the Chinese National Standard (CNS) A4 specification (21〇X: 297 羡1 ~" (please read the notes on the back and fill in the form) This page)

1281400 A7 B7____ V. INSTRUCTIONS (A?) ... The air pressure is 0 04-0 06 mPa 'The vacuum is -0.076~-0·088 mP a ° (Please read the back note first and then fill in this page) 2 · Extraction of water-soluble components of Salvia miltiorrhiza (a) Add 5-7 times of water to the medicinal material; (b) Put the salvia miltiorrhiza into the extraction tank, keep the air pressure at 0.04-0.06 mPa, and decoct for 2 hours to extract the water-soluble components; (c) Extract for another 1.5 hours; (d) Filter the extract through a 100 mesh sieve; (e) Concentrate the filtrate in vacuo to a crude dose of 1: 1 (W/V); (f) Concentrate with ethanol to precipitate; (g) The alcohol precipitation liquid was filtered through a 100 mesh sieve; (h) The filtrate was concentrated under vacuum, the inlet pressure was 0.04-0.06 mPa, and the vacuum was 0.076-0.088 mPa; (i). Purified by dextran gel chromatography and eluted with ethanol. (j) The eluent is concentrated to a density of 1.33 to 1.35. Printed by the Consumers' Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs 3. Production of Compound Danshen Dianjiu (a) Weighed Salvia miltiorrhiza extract, Sanqi extract, synthetic borneol and polyethyl b. by 4·〇:20.6:1.9:79·5 Glycol-6000, mixed; (b). The mixture is heated and melted; ... (The mixture is made into a compound Danshen drop nine with a drip machine, and the technical parameters of the drip nine machine are as follows: drip irrigation temperature is maintained at 89_93, condensate liquid stone temperature 18 1281400 A7 B7 V. INSTRUCTIONS (The temperature is less than 8 ° C, the inner diameter of the dripper is 1.8 mm, the outer diameter of the dripper is 24 mm, and the distance of the dripper from the surface of the liquid stone is 15 cm 6 (d) Centrifugal, rotation speed SOO-llOOrpm,; ^ minutes, remove sarcophagus. Compound Danshen Drop Nine Quality Control Compound Danshen Drop 9 includes known therapeutic ingredients such as protocatechuic aldehyde and saponin and many other ingredients. The composition of the drug varies very much. In order to ensure the content of the active ingredients of the compound Danshen Drop No. 9, the quality control is carried out, and the method involves identification and content determination. The specific process is as follows: (a) Take 30 drops of 9 dissolved in 3 ml of methanol, ultrasound Treatment for 1 minute; (b) centrifugation 5 (c) Take the sputum and use it as a sample solution for thin-layer chromatography and liquid chromatography; (please read the precautions on the back and fill out this page.) Aldehyde tea complexes on the original, serotonin and ginseng Xiaodan Daxu, such as the line of products into the position of the pair of points and the intermediate effect of the product has a trial color in the comparison of the nine-glycosides drip soap and the Danish Ministry of Economic Affairs Central Bureau of Standards staff consumption cooperatives The product side is tested and re-supplied; the color is more than the color of the color and the color of the pass and the other is in the middle of the product and the effect is in the nine drops of the Shen Dan Xiao Jian Da Xing, the placement of the phase of the nine drops Peak /. Participate in the Chinese map of the spectrum of the complex map of the complex map of the standard to the standard of the nine sides of the peak of the peak of the pair of Dan. The square and the division of the complex time ratio than stay. Have a guarantee of the pass If / f / (\ moderate one尺 I张一纸一 I PCT A7 1281400 B7 _ 5, invention description U〇) ... Compound Danshen Drop nine thin layer chromatography identification (please read the back of the note before filling this page) One can treat chronic stable angina Traditional Chinese medicine composition, identified by thin layer chromatography, containing Danshensu The method of protocatechuic aldehyde consists of the following steps: a) The following steps are carried out: 1. Take 30 parts of the composition, add 3 m of sterol, dissolve it by ultrasonic for 1 ; minutes; centrifuge for 5 minutes, take The above solution was taken up 1 〇 / / 1 point on a gelatin G plate containing 0.5% carboxymethylcellulose nano; • chloroform-acetone-formic acid (10: 4: 1.6) as a developing agent; Dry, smear with ammonia, and check for 15 minutes. • Check under ultraviolet light. The chromatogram of the test sample will show the same color spot at the position corresponding to the chromatogram of the reference. b) Take Danshensu sodium and protocatechuic aldehyde as reference. The Central Bureau of Standards of the Ministry of Economic Affairs, the Consumers' Cooperatives, printed 2 kinds of traditional Chinese medicine compositions capable of treating chronic stable angina. The method for identifying the soaps contained by thin layer chromatography consists of the following steps: a) The test has the following steps: Take the composition 3 granules, add 5 ml of ammonia water, dissolve in the ultrasonic; '. Over-porous resin column, elution rate is 〇.5 / min; ____ 20 ______ This paper is again applicable to Chinese national standards (CNS A4 size (210X297 mm) 1281400 A7 B7 V. Invention description) .... First rinse with 1 ml of distilled water and then with 2 ml of methanol; collect the eluent; (please read the precautions on the back) Fill in this page) • Draw the above solution 1 0 // 1 point on a silicone G plate containing 5. 5 % carboxymethylcellulose; • chloroform-acetone-water (6: 2: 1) at l〇° The lower layer solution after 2 hours of C is used as a developing solvent, and unrolled; • air-dried, sprayed with 10% sulfuric acid ethanol solution, and baked at l〇5 °C for several minutes; ♦ under visible light, 'in the chromatogram of the test sample Spots of the same color are displayed at positions corresponding to the chromatogram of the reference substance. b) Total saponin, notoginsenoside: f R 1 and ginseng soap: f r g 1 as reference substance. Compound Danshen Drop Nine Fingerprints 1. Preparation of Fingerprints (1) Chromatographic System and System Suitability Conditions The Ministry of Economic Affairs, Central Bureau of Standards, Staff Consumer Cooperatives, printed octadecyl decane bonded tantalum as a stationary phase sputum; A and B were gradient eluted as mobile phase, a was methanol, b was water _ Ν, Ν-dimethylamine-glacial acetic acid (1 〇〇: 45: 4), gradient condition was 0-> 25 min, A: 5% - 30%; detection wavelength is 281nm. The number of theoretical plates should be no less than 2000 by Danshen Sufeng. 1 Instruments and reagents 2 HP 1100 High Performance Liquid Chromatograph 1281400 A7 B7 V. Inventions (22 ) ’ HP VWD-stile UV Detector

Alltech ODS column (5u, 250x4.6mm) (please read the notes on the back and fill out this page)

Alltech Corporation Alltima C 18 Precolumn (5u)

Column temperature: 30 °C (3) Preparation of reference solution to take salvianolic acid B, Danshensu and protocatechuic aldehyde reference substance, prepared with sterol to form 50 // g, 40 // g per lml and 10 / g solution, as a reference solution. (4) Preparation of the test solution: Take 10 pieces of 10 drops, put in a 25ml volumetric flask, add 20ml of methanol, dissolve it by ultrasonic 20 μm, let cool, add methanol to dilute to the mark, centrifuge, and take the sputum For the test. (5) Measurement Printed by the Consumer Standards Agency of the Central Bureau of Standards of the Ministry of Economic Affairs. The precision sample solution and the reference solution are each 1 〇 # 1, respectively injected into the chromatograph, and the chromatogram is recorded and calculated. 2. Compound Danshen Dropping Nine Different Batch Fingerprints Twenty batches of compound Danshen Drips were measured according to the above method. The results are shown in Tables 1, 4, 15 and 16. The measured data showed that the compound Danshen Drop Nine has its own unique fingerprint map, and 8 peaks coexist in the different batch numbers of the compound Danshen Drop. The reference value of the original tea aldehyde peak (relative retention time ____22_____) This paper scale applies Chinese National Standard (CNS) Α4 specification (210Χ297 mm)^ '1281400 at B7 V. Invention description Us) ... is 1), measured The relative retention times of the eight peaks were 〇.6 72,1 ·00 ^ 1.417, 1.512, 2.016, 2.2 35, 2.407, 2.757, and their relative retention times and peak areas were quite stable in different batches. Among the 8 peaks, the 1st peak is Danshensu, the 2nd peak is protocatechuic aldehyde, and the 7th peak is salvianolic acid B, and their relative peak area ratios are 0.476-0.668: 1: 0.3 9 1 · 0.6 4 1. The fingerprints of the three batches of samples are shown in Figures 1, 2 and 3. (Please read the notes on the back and fill out this page.) Printed by the Consumer Standards Agency of the Central Bureau of Standards of the Ministry of Economic Affairs 23 Paper scale applicable to China National Standard (CNS) A4 specification (210X297 mm) 1281400 A7B7 V. Invention description U4) M N) K) N) K) K) -JOCN〇^0^.〇^.〇U)〇l〇〇lOOOO — OlOOOOlsJ C\〇aN〇w〇NJ〇〇N〇〇j〇〇s〇c\〇 ^v〇〇〇〇〇〇〇〇〇— * O v〇 ,

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1281400 A7 ----------B7_ V. Description of invention (Xi Yu) ...

Alltech Evaporative Light Scattering Detector Alltech Corporation 〇ds Column. (5u, 25 0x4.6mm)

Alltech Corporation Alltima C18 Precolumn (5u)

Column temperature: 30 °C (3) Preparation of reference solution Take ginseng 笮Rg 1 and notoginseng saponin R R i reference substance, and prepare a solution containing 98.98mg and 〇.25mg per lml, respectively. Reference solution. (4) Prepare the test solution by taking 90 capsules, place it in a 5mi volumetric flask, add 4% ammonia to the mark, and pre-treat the Ci8 cartridge (STRATA C18-E column of Phenomenex Company, 500) Mg and 3 cc tube), eluted with 10 ml of water. 'The eluate was discarded and eluted with 2 ml of methanol. The eluate was collected to a volume of 2 ml. In the bottle, add methanol to the mark to serve as the test solution. (5) Determination Accurately draw the test solution and the reference solution each 10 / 1, 1 into the respectively, v chromatograph, record the chromatogram, calculate, that is. (ό) Results Printed by the Consumers' Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs (please read the notes on the back and fill out this page). The 20 batches of compound Danshen Drips were measured according to the above method. The results are shown in Table 4. As shown in the table, the content of Panax notoginseng saponin R 1 is between 0.41% and 0.71%, with an average of 0.550%; the content of ginsenoside Rgl is between 2.06% and 4.04%. The average is 2.847%. - This paper scale applies to Chinese National Standard (CNS) Α4 specification (210 X 2 PCT 1281400 A7 B7 V. Invention Description (3丨),, Table 4·Combined Danshen Drop ginseng saponin Rgl and notoginsenoside R1 • Content notoginsenoside R1 ginsenoside Rgl Lot number _( μ g/pill)_( β g/pill ) 20000106 1 7 • 22 80 .93 20000216 1 6 .92 80 .78 20000323 1 5 .16 7 0 • 76 20000406 1 3 .65 62 • 51 20000422 1 4 .24 68 .72 20000513 1 5 .27 7 1 • 16 20000606 1 4 • 86 68.21 20000726 1 4 • 59 72 • 35 20000728 1 4 .25 57 .37 20000804 1 5 .30 70 .55 Average 値1 5 .15 70 .33 RSD % 戸7. 53 9. 67 Not less than 1 2 .12 56 .26 (Please read the notes on the back and fill out this page) Central Standards of the Ministry of Economic Affairs The compound Danshen Drips produced by the Bureau of Staff Consumer Cooperatives has the following characteristics: (a) Compound Danshen Drip 9 contains 3,4 dihydroxyphenyl lactic acid, sodium danshensu, saponin and borneol; / (b) Bacterial examination: lower than 1 000 ; (c) . Fungal examination: less than 100; (d) Heavy metal inspection: lower than the safety amount prescribed by the Chinese government. e) Under normal temperature preservation, the effective period of compound Danshen Drip Nine is 4 years. The clinical study of compound Danshen Dianjiu usually uses the history of angina pectoris, lipid level in blood stasis, ECG/figure, exercise electrocardiogram and internal flash method. Ischemic conditions, coronary angiography and other methods to evaluate the condition of angina pectoris. These methods were used to evaluate the efficacy of compound Danshen Dianjiu, suggesting that Compound Danshen Drip Nine has a definite therapeutic effect on the treatment of angina pectoris. This paper scale applies to Chinese national standards (CNS) A4 size (210X297 mm) 1281400 A7 ________B7_ V. Invention description, nine treatment of angina pectoral effect 1 5 7 patients with coronary heart disease oral compound salvia miltiorrhiza drip nine, 10 capsules / time, 3 times / (please read the back Note: Please fill in this page again. Take 4 weeks. Observe the frequency, intensity and duration of angina pectoris, as well as chest tightness and palpitations. The results show that the above symptoms disappear or the remission rate is 95.3. Dianjiu compound scorpion scorpion 妫 妫 compound Danshen tablets is another Chinese patent medicine for treating angina in China today. Compound Danshen Drip Nine and Compound Dan Efficacy compared sheet. One hundred and seven patients with coronary heart disease were randomly divided into two groups, including 10 in the treatment group (combined Danshen Drops Group 9) and 5 in the control group (combined Danshen Tablets). Compare the frequency of angina pectoris and the amount of organic nitrates taken. The results showed that in the treatment of angina pectoris, compound Danshen drip is more effective than compound Danshen tablets. See the table printed by the Ministry of Economic Affairs' Central Standards Bureau employee consumption cooperative. The above suggests that the compound Danshen drip is more effective than the compound Danshen tablets. The following is a comparison between the efficacy of Fufang Danshen Dropping Nine and the drugs used in modern America for the treatment of chronic and stable angina. The ratio of compound Danshen Drop Nine to nitroglycerin One nitroglycerin is a commonly used drug for relieving angina pectoris. The effect of compound Danshen drip in relieving angina pectoris was compared with nitroglycerin. In the onset of angina pectoris, the patients were treated with compound Danshen Drop Nine or Nitroglycerin, and the two drugs were compared. Table 5. Compound Danshen Drip Nine and Compound Danshen Tablets compared the total number of patients. Effective Compound Danshen Drip Nine 107 1 02 (9 5.3 %) Compound Danshen Tablets 50 3 8 (7 6%) This paper scale applies to China National Standard (CNS) A4 Specification (210X297 mm) 1281400 Ministry of Economic Affairs Central Bureau of Standards Staff Consumer Cooperatives Print A7 ____B7 V. Invention Description (Η ) ... the time required to relieve angina. The time required for the above two drugs to relieve angina was within 15 minutes, and the effect of compound Danshen Drip Nine was slightly lower than that of nitroglycerin. See Table · Table 6. Comparison of Compound Danshen Drops Nine and Nitroglycerin Effective Number of Patients 1 - 5 minutes Within 6-10 minutes Within 11-15 minutes Compound Danshen Drops 9 11 14 5 Nitroglycerin 17 12 1 Total: Per The group of 30 patients with Lingfang Danshen Drop 9 did not change heart rate data, indicating that Compound Danshen Drop Nine can effectively relieve angina pectoris. Investigate whether the compound Danshen Drop 9 increases heart rate while relieving angina. After taking Fufang/Fang Dan Shen Jiu Jiu, its heart rate was consistent with that before taking it, indicating that Compound Danshen Drop Nine had no effect on heart rate while relieving angina pectoris. (See Table 7), Table 7· Compound Danshen Drop 9 does not affect heart rate ^ $ ' After treatment, compound Danshen 淌 84 84·3 zL 23.1 82.8 ± 22.8 Effect of compound Danshen dripping pills and isosorbide dinitrate hh _ It is proved that the effect of compound Danshen Drop 9 on relieving angina is equivalent to that of nitric acid/glycerin. Compare the compound Danshen drip with isosorbide dinitrate to see if the compound Danshen drip has the effect of preventing angina pectoris. Isosorbide dinitrate is a commonly used drug for preventing chronic stable angina in modern America. The paper size applies to the Chinese National Standard (CNS) A4 specification (210/2# 公羡1 ' ' -- (Please read the back note and fill out this page)

1281400 A7 _____B7 V. INSTRUCTIONS (舛) Oral compound Danshen drip nine, three times / day, 1 capsule / time, or isosorbide dinitrate ' 3 times / day, 10 mg / time. Investigate its cardiac function and electrocardiogram. The cardiac function increases the heart's output (c Ο ) by the amount of each heart (SV), the ejection fraction (EF), the left ventricular short-axis shortening rate score (FS), and other factors. The efficacy of the function is stronger than isosorbide dinitrate. See Table 8. Table 8. Comparison of the efficacy of compound Danshen drip and isosorbide dinitrate. Compound salvia miltiorrhiza octahydrate diisosorbide a 刖 After SV 7 5.3 8 + 8.32 83.45 ^ 9.11 74.96 ± 8.44 79.47 8.72 CO 5.61 + 1.34 6.9 4 ±_ 1.36 6.54 ^ 1.36 6.12 ±_ 1.4 1 . EF 0.5 7 ± 0.02 0.79 ±_ 0.02 0.59 t 0.03 0.70 +_ 0.03 FS 17.14 ± 3.4 16.6 9 it 3.6 17.32 ^ 3.1 18.46 9 4.2 Employees of the Central Bureau of Standards of the Ministry of Economic Affairs Printed by the consumer cooperative (please read the precautions on the back and fill out this page). Compound Danshen Drop 9 improves the ECG function. By recording the changes in the ST segment of the ECG, the effectiveness of the compound Danshen Drop 9 on the patient's ECG is evaluated. Compound Danshen Drop Nine and Isosorbide Dinitrate can significantly reduce the number of patients with ST-T changes. Among them, the compound Danshen drip effect is more comfortable. See Table 9. This paper scale applies to China National Standard (CNS) A4 specification (210X2 public Τ 1281400 A7 B7 V. Invention description) Table 9. Comparison of electrocardiogram energy between compound Danshen drip and isosorbide dinitrate. ST-modified disease Number of patients before treatment, compound Danshen drip nine 13 1 3 5 diisosorbide dinitrate 129 4 2 gather the 坷 表 table (please read the notes on the back and then fill out this page) Printed by the Central Bureau of Standards and Staff of the Ministry of Economic Affairs Compound Danshen Dripping Pills and Aspirin inhibit platelet aggregation than hemorrhage caused by atherosclerotic lesions can cause platelet aggregation, coronary thrombosis and blood stagnation, resulting in poor blood flow. Therefore, in order to improve blood flow, patients with angina must take long-term use of the platelet aggregation inhibitor, spironin. By evaluating Hb, Lb, P, and airflow, the efficacy of the compound ginseng and aspirin in improving blood flow was compared. Results: The effect of compound Danshen Drop 9 on improving blood flow is consistent with aspirin. See 10 ° Table 10. Comparison of compound Danshen drip and aspirin to improve blood flow Compound Danshen drip nine aspirin, after gossip Hb 6.23 + 1.67 4.35 + 1.02 6.12 on 1.56 4.28 + 1.07 LB 10.92 + 2.2 1 8.30 + 1.14 10.38 + 1.96 8.21 + 0.3 P 1.95 + 0.08 1.77 + 0.08 1.89 + 0.12 1.67 + 0.7 Air flow 1.79 ±_ 0.13 1.39 + 0.11 1.82 on 0.17 1.40 on 0.10 Total number of patients: Compound Danshen drops nine groups: 2 5 Example; Aspirin group: 28 cases of compound Danshen dripping pills inhibited blood clotting alkane § 2 (TXB 2) to initiate platelet activity by inhibiting platelet activity. The activated platelets release a large amount of substances, including /3 platelet microglobulin, which can cause blood stagnation and damage blood flow. Investigate the standard of this paper on the inhibition of platelet aggregation by Compound Danshen Dropping Nine. Apply Chinese National Standard (CNS) A4 Specification (210X 23⁄4 mm) ^ 1281400 A7 ___B7_ V. Invention Description (36 ) ... (Please read the notes on the back and fill in this section) Page) function. Compound Danshen Drop 9 can reduce the concentration of thromboxane B 2 and effectively inhibit platelet aggregation. Isosorbide dinitrate has no platelet inhibition function, can not reduce the concentration of thromboxane B2 or inhibit the activity of platelets, so it can only be used for the control of angina pectoris. See Table 1 1. Table U. Compound Danshen Drops 9 inhibits platelet aggregation treatment before treatment β PM Compound Danshen Drop 9 62.44 ^ 14.37 45.65 t 12.25 Nitrate 5 9.89 : L 15.42 5 4.3 6 + 13.18 TXB2 Compound Danshen Drop 9 13 12 7 53 5 73 8 ±.3 84 Nitrate 13 15 t 5 07 12 18 ±. 445 Compound Danshen Drop 9 Reduces Plasma Cholesterol Levels Increased plasma cholesterol levels are associated with arteriosclerosis. It is recommended to reduce plasma cholesterol levels and prevent atherosclerotic damage by foraging or taking drugs. Investigate whether the compound Danshen Drop Nine has reduced plasma cholesterol and alcohol levels. RESULTS: Compound Danshen Drop 9 could lower cholesterol by 0.3 mmol/L, with statistically significant differences. See Table 12. Table 12. Compound Danshen Drops Reduces Plasma Cholesterol Level

Plasma cholesterol (mmol/L) After treatment, compound Danshen drip nine 5.15 ±_0.\6 4.84 ± 0.2J Number of patients: 8 0 Ministry of Economic Affairs, Central Bureau of Standards, Staff Consumer Cooperatives, Printing Compound Danshen Drops, Blood Stasis for Coronary Heart Disease Patients Lipid peroxide (LPO) and the paper scale apply to China National Standard (CNS) A4 specification (210X@7 mm) 1281400 A7 ______B7 _ _ V. Invention Description of the effect of superoxide dismutase (SOD): treatment group Twenty-four cases were diagnosed in accordance with the revised reference standard for coronary heart disease revised in China in 1979. The compound Danshen drip nine 10 capsules/time, one for three times. Twenty patients in the normal group were healthy and were not treated with drugs. Conclusion: The LPO of patients with coronary heart disease is significantly higher than that of healthy people, and the S OD of patients with coronary heart disease is significantly lower than that of healthy people (P &lt; 〇. 〇1 =. The patients with coronary heart disease after treatment with compound compound Danshen drip nine, LPO Compared with the treatment before treatment (P < 0.01 =, and the SOD content increased significantly after treatment (P < 0.01). See Table 1 3 _ Table 13 Comparison of blood SOD and LPO content between the two groups (X soil s)

Group case SOD (ng/ml) LPO, ._ number (nmol/ml) is concealed and 2 0 348±106 4.64±1.52 treatment group 24 before treatment 267±76* 7. 16±1.48* ______ after treatment 3 0 9 ± 8 7 △_4.68±1.72δ δ 杳·· Compared with the normal group, *Ρ &lt;0.05; compared with before treatment, ^ Ρ &lt; 0.05 △ △ Ρ &lt; 0·01 Conclusion.: Coronary heart disease Due to the chronic ischemic state of the myocardium, the tissue is hypoxic, resulting in the decrease of S OD activity, especially extracellular s OD, and the increase of oxygen g from the base, resulting in an increase in LPO and an increase in SOD consumption. In this group of patients, the application of compound Danshen Dianjiu treatment decreased blood LPO significantly and blood and sputum SOD levels increased significantly, which proved that compound Danshen Dianjiu has a good role in the elimination of oxygen free radicals, which is one of the mechanisms for the treatment of coronary heart disease. . Ministry of Economic Affairs, Central Bureau of Standards, Staff Consumer Cooperatives, Print C, please read the notes on the back and fill in the tribute. Effect of Compound Danshen Dropping Nine on LPO and Antioxidant Activity in the Treatment of Pulmonary Heart Disease: Method: 48 Cases of Pulmonary Heart Disease , randomly divided into 3钽. In the conventional treatment group, the patients were treated with anti-inflammatory and anti-inflammatory oxygen to improve cardiopulmonary function, etc.; Compound Danshen's drip nine groups of 14 cases, compound Danshen drip nine times / day, 10 capsules / time; Group 18 cases, using glycoside 20 Omg in 5% glucose solution 25 0ml static 'drop, 1 time / day, 10 days for a course of treatment. This paper scale applies to Chinese National Standard (CNS) A4 Specification 7:21 (^23⁄4 mm) 1281400 A7 B7 V. Description of Invention (%) Result: GSH-Px increase after treatment of Compound Danshen Drip Nine, LPO drop and The increase in GSH-Px/LPO was significantly different from that in the conventional treatment group. See Table 14 ° Table 1 4 Changes in indicators before and after treatment GSH-P CAT SOD LPO GSH- X (U/gHb (U/gHb) (nmol Px (U/mg Hb) ) /ml) /LPO 140.6 soil 3 1 2 · 7 soil 5799.8 soil 4.2 soil 34.2 35.2 58.1 948 1 .2 8.7 treatment-1 刖101.3 soil 300.4+ 5740.5 soil 5 · 6 soil 20.4 23.6 107.7 93 9.0 1.9 8.8 post-treatment 120.6 soil 3 90 soil 6076.8 soil 4.3 soil 3 1.3 20.6δ 1 84·3δ 109 1 1.2 Δ Δ soil 15.1 Δ Δ treatment. 1 gossip 108.8 soil 233.1 soil 5863.3 soil 5.9 soil 18.5 28.3 70.2 1072.7 2.0 7.6 158.2 soil 3 2 8.4 soil 5 5 8 2.8 soil 4 soil 36.4 After IP 40.7 Δ Δ * s|i 78.5 Δ △ 氺 1 094.7 Δ 氺 1.6 Δ △ 氺氺 6.7 Δ Note: Comparison before and after treatment in each group △ P> 〇.05 δδΡ&lt;0·05 before and after treatment *Ρ&gt;〇 .〇5 **Ρ&lt;〇.〇5 Conclusion: Compound Danshen Drop Nine has anti-oxidation effect, relieves lipid over-v oxidation reaction and enhances the body's antioxidant capacity. Compound Danshen Dropping Nine Treatment of Essential Hypertension The Central Bureau of Standards of the Ministry of Economic Affairs, the Consumer Consortium, the Printing Health Group, the Regular Group, the Compound Danshen Dropping Group (please read the notes on the back and fill out this page) Method··(1) Case Choice: Select patients with primary hypertension I and sputum, and exclude secondary hypertension, heart, liver and kidney dysfunction. (2) Administration method: The patients in the test were stopped with Chinese and Western medicines (except antihypertensive drugs) for 2 weeks, and their blood pressure and blood rheology indexes were measured at the 3rd week. The clinical manifestations were recorded. 'Combined Danshen Drop Nine Group' Oral Compound Danshen Drop 9 10 capsules/time, 3 times a day; Compound Danshen Tablets' Oral Compound Danshen Tablets 5 · tablets/time, 3 times a day; control group taking placebo, course of treatment _ __________________^------- This paper scale applies to China National Standard (CNS) A4 specification (21〇&gt;&lt;297 public Chu) 1281400 A 7 B7 V. Description of invention (external) ... for 6 weeks. Results: (1) The effect on the viscosity of whole blood. After treatment, the whole blood viscosity of the compound Danshen Decoction Group 9 and Fufang Danshen Tablets group decreased significantly, while the whole blood viscosity of the compound Danshen Drop 9 group was more significant than that of the compound Danshen Tablets. See Table 1 5. (2) Effects on red blood cell deformation and aggregation. After treatment, the deformability of red blood cells in the compound Danshen drip group was significantly higher than that before treatment. After treatment, the area of aggregation and aggregation index of compound Danshen sap was significantly lower than that before treatment, and the degree of decline was significantly higher than that of compound Danshen tablets (P &lt; 0.0 1 =. See Table 16. 6. (3) Effect on blood pressure. Compound Danshen The systolic blood pressure and diastolic blood pressure of patients with Dianjiu and Fufang Danshen tablets were significantly lower than those before treatment (P &lt; 0.0 1 =. There was no significant difference in the degree of decline between the two groups. See Table 17. 7. (4) Symptoms of hypertension The effects of headache, dizziness and limb numbness were significantly improved after treatment in patients with compound Danshen Dianjiu and Fufang Danshen tablets (P &lt; 0.0 1 =, the symptoms of insomnia were not obvious. See Table 18. Read the notes on the back and fill out this page.) Department of Economics, Central Bureau of Standards, Staff Consumer Cooperatives, Printed Table 15 Effect of Compound Danshen Drops on Whole Blood Viscosity (mPas, X Soils) Group 3.83s1 38.3s'1 192s_i Compound Salvia Treatment 1 8.27±2.85 5.82±0.93 4.54±0.78 Before the drop of the nine groups (30 cases) Treatment 1 1.79 Soil 4.78 Soil 3.98 Soil 3 7 5 氺*△ △ ▲ ▲ 0.65** △ △ ▲ ▲ ▲ Compound Danshen treatment 1 7.69±1 .96 5.86+0.79 4.69±0.54 Before the group (30 cases) Treatment 1 4.68 Soil 5. 69 ± 0 . 8 1 * 4.42 After the soil 3 4 1 * * ▲ ▲ ▲ 0.59**AA ^ . Treatment 1 7.6 5 ± 2.0 7 5.69 ± 0.79 4.75 ± 0 · 5 8 before (15 cases) Treatment 1 8.02 ± 2.32 5.71 ± 2.76 4 · 86 ± 0 · 65 This paper scale is suitable for Guanjia County (CNS) M secret ( 2lG&gt;&lt;2g public 羡) 1281400 A7 V. Description of invention (;. Έ Έ 粗 粗 、, * ρ&lt; 0.05~~ 口-ρ-&lt; ο.οΠ- Compared with compound Danshen tablets, ΡΡ&lt;〇·05 △△Ρ&lt;0·01 (Please read the note on the back and fill out this page) Compared with the control group, ▲ Ρ &lt; 0 · 0 5 ▲ ▲ Ρ &lt; Ο · Ο 1 $ 1 6 gastric force Danshen drip nine effects on red cell deformation and aggregation (X ± s) red blood cell deformation red blood cell aggregation red blood cell aggregation surface index index product (integration) compound salvia treatment 0.4115 soil 4.06 soil 0.39 841 ·12±67.68 Before the group 0.0360 (30 cases) Treatment 0.4274 soil 3.41 soil 683.52 after 0.034*a 0·36**Δ ▲ ▲ 69.09**Δ ▲ ▲ Compound Danshen treatment 0.4066 soil 3.98±0.34 806·90±66·30 before the tablet group 0.0290 (30 cases) Treatment 0.4180 soil 3.64 soil 716.12 after 0.0 2 8 1 “ 〇39**α α 8 4.2 9 * * Α Group treatment 0.4091 soil 4.02 soil 0.41 812·52±65.64 '刖0.0376 (1 5 cases) Treatment 0.4001 soil 4.01 soil 0.39 804·44±68·06 after 0.0381: compared with before treatment, * P &lt; 〇. 〇5 * * P &lt; 0.0 1 ; Compared with the compound Danshen tablet group, △Ρ&lt;0·05 Δ Δ Ρ &lt; 0.01 compared with the control group, ▲ Ρ &lt; 0.0 5 ▲ ▲ P &lt; 0 · 0 1 Ministry of Economic Affairs, Central Bureau of Standards, Staff Consumer Cooperatives, Printed Table 17, Effect of Compound Danshen Dropping Nine on Blood Pressure (mmHg, x±s) Group systolic and diastolic blood pressure, compound Danshen drip before treatment 155·00±8·08 90.70± 7·93 Nine groups (190 cases after treatment of 190.20 ± 86.59 8 · 8 9 * * ▲ ▲ 8 · 3 0 * * ▲ ▲ Compound Danshen tablets before treatment 152·93±9.59 92.5 9±8.30 This paper scale applies to China National Standard (CNS) A4 Specification (210X21^Metric Γ1281400 A7 ______ B7__ V DESCRIPTION OF THE INVENTION (羊羊) ... group (30 cases) After treatment * 1 46.02 ± 8 8.5 5 soil (please read the notes on the back and fill out this page) 1 0.2 0 * * AA 7.22 * * Α Α Before treatment 1 5 4.0 6 ± 7.0 5 9 0.9 0 ± 9 . 1 0 (1 5 cases) After treatment 1 5 2.0 8 ± 9.2 5 9 1 . 1 0 ± 8.7 0 &quot;1 Master: Compared with before treatment in this group, * * p &lt; 〇. 〇1 ; Compared with the control group after treatment, ▲ ▲ P &lt; 0.0 1 Table 18 The effect of compound Danshen drip on clinical symptoms of hypertension (example) Group headache, dizziness, limb insomnia, Μ Μ 有Μ川,有&gt;fnT- Μ Compound Danshen treatment 2 1 1 1 1 1 8 2 Drop nine groups —, gossip 0 0 6 4 2 8 2 (3 0 cases) Treatment 7 2 2 2 3 2 4 2 After 3 8 7 6 * * * 氺 compound Danshen treatment 2 8 1 1 1 2 6 2 tablets, name 7 2 7 3 0 0 4 (3 0 cases). Treatment 1 1 8 2 3 2 6 2 after 5 5 2 7 4 氺* 氺 control group treatment 8 7 6 9 4 1 4 1 -Λ&quot; gossip 1 1 (1 5 cases) treatment 7 8 5 1 3 1 2 1 after 0 2 3 Note: Compared with before treatment, * P &lt; 0.0 1 Printed by the Consumer Standards Agency of the Central Bureau of Standards of the Ministry of Economics Conclusion: There is a clear abnormality in the rheological properties of red blood cells in patients with essential hypertension, and the red blood cell deformability is significantly reduced and the red blood cell aggregation is significantly increased. This experiment proves that compound Danshen Drip Nine has a significant reduction in whole blood viscosity and drop _4J___ This paper scale applies Chinese National Standard (CNS) A4 specification (210X297 mm) 1281400 A7 B7 V. Invention description (β) .... Low red blood cell aggregation index And the area, significantly improve the role of red blood cell deformability 'and can lower blood pressure, so the clinical symptoms of patients, so the compound Danshen drip nine is beneficial to prevent or delay the occurrence of essential hypertension and heart and brain syndrome . Toxicity Compound Danshen Drop 9 is safe and non-toxic. In China, more than 5 million patients have been treated with Compound Danshen Dianjiu, and there have been no serious side effects, but only a few have mild side effects such as headache or dizziness. Clinical research summary Compound Danshen Drop Nine is a new generation of traditional Chinese medicine for treating coronary heart disease. Clinical trials have shown that Compound Danshen Drop 9 relieves and prevents angina from improving heart function, reducing myocardial ischemia, inhibiting platelet aggregation, reducing blood stasis and lowering plasma cholesterol levels. The therapeutic effect of compound Danshen Dianjiu is better than other Danshen preparations, such as compound Danshen tablets. Compound Danshen Drip Nine has the same effect as the drug used in the United States. Compound Danshen Drops 9 relieves angina and functions similarly to nitroglycerin. Prevention of coronary heart disease is equivalent to long-acting sorbitan dinitrate, and inhibition of platelet aggregation is comparable to that of aspirin. Compound Dan> Ginseng Nine has no toxicity: more than 5 million people have received the treatment of compound Danshen Dianjiu, and most of them have no serious side effects. Printed by the Consumers' Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs (please read the notes on the back and fill out this page) Preclinical Studies The preclinical study reveals the mechanism by which Compound Danshen Drop 9 relieves and prevents angina pectoris. + ' Compound Danshen Drop 9 relieves the heart by increasing blood flow -

Wistar rats, weighing about 260g, urethane anesthesia, open the chest, remove the heart, placed in Langendorff solution at 37 ° C, on the 65cm water column of the standard paper size applicable to China National Standard (CNS) A4 specifications (210X297 mm) 1281400 A7 --- -__B7______ --- V. Description of the invention (shirt) ... under the force of coronary perfusion. After the heart rate was stabilized, different doses of compound Danshen Dianjiu and Fufang Danshen tablets were administered through the lateral branches of the aorta, and then the coronary flow and heart rate were measured. The results showed that the dose range of the compound Danshen Drop 9 was wider, while the range of the Compound Danshen Tablet was narrower. See Table 2 0. ^ 20. Compound Danshen Dropping Nine Increases Coronary Flow Coronary Flow Dosage (mg/ml) Before Treatment, None 7.0 ± _ 1 · 1 7.1 ± _ 〇. 97 Compound Danshen Drop 9.5. 8 7.2 ± IA 7.0 ± _ 1.4 290 6.7 ±1.6 8.7 i 1.4 5 80 6.7 ±1.5 9.3 +2.9 Compound Danshen Tablets 5. 8 6.7 ±1.4 7.1 ±.1.5 290 7.3 ±1.7 9.1 t 2. 1 580 6.8 ±1.4 7.1+1.5 The compound salvia miltiorrhiza was examined. The effect of Dijiu and Compound Danshen Tablets on heart rate. Results&gt; Printed by the Consumers' Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs (please read the notes on the back and fill out this page) Compound Danshen Drip Jiuhe and Compound Danshen Tablets have no effect on heart rate. See Table 2 Table 2 1 Compound Danshen Drop 9 does not increase heart rate heart rate dose (mg/ml) Before treatment Before treatment 1 None 1 94 ± _ 1 7 193 ± _ 12 Compound Danshen drops 9 5.8 18 0 ± _ 1 1 1 89 ± _ 9 This paper scale applies to China National Standard (CNS) A4 specification (210X297 mm) 1281400 Α7 ______Β7 V. Invention description (external) 290 18 8 ±7 1 84 ±_ 8 580 T73 ^ 14 167+13 Compound Danshen Tablet 5.8 180 ^ 1 1 1 89 ±_ 9 290 T89 +16 1 83 Death 14 5 80 1 8 6 九 2 3 17 1 ±_ 8 (Please read the notes on the back and fill out this page) Repeat 9 to relax the vascular smooth muscle The effect of Guantian compound Danshen drip on the contraction of rabbit aortic strip induced by potassium in the venous flow. Compound Danshen Drop Nine has the effect of relaxing the smooth muscle and dilating blood vessels. The same effect was observed on the porcine coronary artery ring. The effect of compound Danshen Drop 9 on inhibiting platelet aggregation The effect of Compound Danshen Drop 9 on platelet aggregation was investigated, and the therapeutic effect of Compound Danshen Drop N on rabbit platelet aggregation was observed. Compound Danshen Drop Nine can significantly inhibit platelet aggregation. See Table 22. Table 2 2 · The effect of compound Danshen Drop 9 on inhibiting platelet aggregation - Compound Danshen Drop Nine (mg/ml) Animal number aggregation rate (%) Inhibition rate (%) 0 6 6.7 Soil 4.4 0 1.8 6 42.7±2.5 8 · 3 ± 4.5 3.5 6 33.4 Soil 3.4 2 3.6 ± 6 · 7 * 7 6 匕 5.3 ± 2.1 ^ 7.6 5.9 * 14 6 15.8 Soil 3.0 6 9 . Gentleman 6.9 * Printed by the Central Bureau of Standards and Staff of the Ministry of Economic Affairs by Table 2 3 It can be seen that the micronucleus rate of mice at different times after the treatment of compound Danshen Drops (8400 mg/kg) Table 23 Time (h) Micronucleus rate of erythrocyte micronuclei cells This paper scale applies Chinese National Standard (CNS) A4 specification (210χ297 public) PCT) 1281400 A7 _ B7 V. Description of invention (private) (〇/〇 (x soil SD) 1 2 6,000 9 1 · 5 士 · 8 2 4 6,000 11 1 .8 士 0.7 3 6 6,000 11 1.8 士 1.2 48 6,000 11 1.8 soil 1 · 5 72 6,000 13 2.2 soil 0.7 solvent 2 4 6,000 9 1 .5 士 1.4 Table 2 4 shows that taking compound Danshen drops nine hours after 24 hours of mouse micronucleus table 24 time (h) erythrocyte micronucleus Cell micronucleus rate (%) (x soil SD) 8,400 6,000 12 2.0 ± 0.6 840 , 6,000 9 1.5 ± 1.0 84 6,000 11 1 .8 ± 1.0 Solvent 6,000 9 1.5士 1.4 CP (80mg/kg) 6,000 13 8 23.0 soil 4.0* Compared with the solvent pair and the photo group P&lt;0.01. Printed by the Consumer Standards Agency of the Central Bureau of Standards of the Ministry of Economic Affairs (please read the notes on the back and fill out this page) Table 25 shows the evaluation criteria for different levels of efficacy of the test drug. Table 25 Parameters\Efficacy efficacy Non-Normal effect Highly effective Ineffective red blood cell aggregation does not have a significant significant onset time &lt;90 90-180 180-300 &gt;3 00 ---45_ This paper scale is applicable to China National Standard (CNS) A4 specification (210X297 mm) 1281400 A7 B7 V. Invention description) Microcirculation blood flow state is better than usual · Turn normal improvement Deterioration duration (min) &gt;15 15-10 10-5 &lt;5 Compound Danshen Dropping Nine Improves the Circulation Observation The effect of Compound Danshen Dropping Nine on the microcirculation of hamsters. In the ill-dose administration of all animals for ill minutes, after the administration of the compound Danshen drops on the cheeks, all the animals took effect within 11 minutes, and the effect of improving the microcirculation was 23 minutes. See Table 2 ό 〇 Table 2 6. Compound Danshen Dropping Nine Improves Microcirculation Initiation Time (min) Duration (min) Efficacy (%) Compound Danshen Turns Nine 111 23 100 Table 27 shows the levofin-induced myocardium Protection of Injury (Phase 2) Printed by the Consumer Standards Agency of the Central Bureau of Standards of the Ministry of Economic Affairs (please read the notes on the back and fill out this page) Table 27 (n = 8) After dose administration (g/ Kg 刖 after pituitary administration of pituitrin 40) After vasopressin seconds to 15 minutes, the number of rats with abnormal electrocardiogram appeared/normal before normal 7 paper size applicable to Chinese National Standard (CNS) Α4 specification (210Χ297 mm) 1281400 A7 ___ _B7 V. Description of invention (47) Group compound Danshen drip nine groups 0.4 Normal normal 3 * 0.8 Normal normal 1 * * , 1.2 Normal normal 1 * * Compound Danshen tablets group 铤 0.4 Normal normal 4 0.8 Normal normal Λ \ Γ . 3k sic ^ 1 * * (Please read the notes on the back and fill out this page) Printed by the Central Bureau of Standards, Department of Blood Economics, Consumer Cooperatives ^ 28 Forms Protective effect of ginseng drop nine pairs of vasopressin-induced heart muscle. Table 28 Group dose (g/kg) Inhibition rate (%) Compound Danshen Drop Nine Group 0.4 7 1.4* 0.8 85.7* 1.2 7 1.4* Compound Danshen Tablets 0.4 42.8* 0.8 85.7* Compared with the control group, *p&lt;0.05 . Table 29 shows the protective effect of compound Danshen Decoction on myocardial ischemia induced by vasopressin in rats____42_---- This paper scale applies Chinese National Standard (CNS) A4 specification (210X297 mm) Consumer Cooperatives Printed 1281400 A7 _______ B7 V. Description of the Invention (Winter f) Table 2 9 Group Dose (g/kg Changes in the first stage of electrocardiogram T-ST) After administration, administration of vasopressin in the pituitary 40 ) 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 0.8 Normal normal 1 1 2* Group 1.2 Normal normal 2 1 3 * Compound 0.4 Normal normal 3 2 5 7T Septal group 0.8 Normal normal 1 1 2* Compared with the control group, the oxygen free radical elimination effect of compound Danshen drip嘌呤——The xanthine oxidase system produces superoxide anion, H202-Fe2 + P system produces hydroxyl radicals, and uses electron paramagnetic resonance and cyclotron capture technology to study compound The oxygen free radical elimination of Salvia miltiorrhiza. Method: (1) Formation of free radicals. According to the Fenton reaction principle, an experimental type is built. H2O2, ferrous sulfate and DMPO ( 5, ______4S_____ This paper scale applies to Chinese National Standard (CNS) A4 specification (210X297 mm) (please read the back note before filling out this page)

1281400 A7 _____B7__ V. Inventive Note), S-dimethyl-l-pyrroiine-boxide) After mixing, EPR was detected, and the obtained signal was added as a control/treatment group to the compound Danshen Drop 9. (Please read the precautions on the back and fill out this page) (2) Formation of superoxide anion. An experimental model was established based on the jaundice-xanthine oxidase reaction. The scutellaria, Dietrylene triamine Pent acetic ace d, DMPO and xanthine oxidase were mixed and subjected to epr detection as a control. The treatment group was added to the compound Danshen Drop 9. One of the above four groups was tested for one sample, and the results were expressed as mean, and statistical analysis was performed by t test. Results: (1) Compound Danshen Drop 9 eliminated the hydroxyl radical generated by H2〇2-Fe2 + system. The hydroxyl radical was captured by DMPO to form DMPO-OH adduct. The peak height of the adduct in the control group was 11. 8 ± 0.6 relative units, and the compound Danshen drip group was 4.1 ± 0.5 relative units. The difference is highly significant (P &lt; 〇. 0 1 ), the elimination rate of compound salvia miltiorrhiza drops is 65% 〇 (2) compound Danshen drip nine pairs of jaundice---xanthine oxidase system The removal of superoxide anion. The superoxide anion was captured by DMPO to form DMPO-OOH adduct. The peak height of the adduct in the control group was 10.6 ± 0.67 relative units, and the signal of the adduct of the compound Danshen drip group completely disappeared. Compared with the control group, the difference was highly significant (P < 0.01) + compound Danshen drip. The elimination rate of nine pairs of superoxide anion reached 100%. Printed by the Consumers' Cooperatives of the Central Bureau of Standards of the Ministry of Economic Affairs From the above experiments, it is known that the compound Danshen Drip Nine produces a superoxide anion and a H2〇2 —Fe2 + system to produce hydroxyl radicals from the Astragalus membranaceus oxidase system. In addition to the effect. Effect of Compound Danshen Decoction on Free Radical of Experimental Rats with Cerebral Ischemia Reperfusion Injury: 300 SD rats, randomly divided into 3 groups, respectively, sham operation group (surgery, but no ligation of blood vessels and nerves) , cerebral ischemia-reperfusion model group 'complex Danshen drip nine groups (4g / kg). Ip was administered for 3 consecutive days. On the third day __45-------- This paper scale applies Chinese National Standard (CNS) A4 specification (210X297 mm) 1281400 A7 B7 V. Invention description (沁) 2 hours after drug 'at 2〇% Under the anesthesia of urethane, the common carotid arteries and vagus nerves were isolated from both sides of the rat, reperfused for 30 min, and then the brain was decapitated. Take about 500 mg of the left cerebral cortex and the hippocampus on both sides, and mix them in liquid nitrogen. Make a homogenate with frozen saline, centrifuge, and take the sputum to measure the activity of catalase (C AT ). S Ο D activity, MD A content and GS Η content. Results: See Table 30. (1) The effect of compound Danshen Decoction on CAT activity and GSH content in brain tissue. The CAT activity and GSH content in the cerebral cortex and hippocampus of the ischemic reperfusion model group were significantly lower than those in the sham operation group. The CAT activity and the GSH content of the hippocampus in the compound Danshen drip group were significantly higher than those in the model group. (2) The effect of compound Danshen Decoction on the activity of S〇D and MDA in brain tissue. The SOD activity in the brain tissue of the model group was significantly lower than that in the sham operation group, while the MD A content was significantly increased. The SOD activity in the cerebral cortex and hippocampus of the compound Danshen drip group was significantly increased, while the MDA content was significantly decreased. · Table 30 Changes in CAT activity, SOD activity, MDA content and ___GSH content in brain tissue of each group (mPas, x soil s) (n=l〇)_ CAT activity G~SH SOD live g MDA~~_ group Do not (u/mg eggs (// (u/mg eggs (nmol/mg white.) mol) mg protein) _______ white) —___ (please read the notes on the back and fill out this page) Central Standards of the Ministry of Economic Affairs Bureau staff consumption cooperative printed hand-type β ginseng nine and fake model - Fudan drip - cerebral cortex 2.94 soil 0.17 2.17 soil 0.24 氺 2.55 soil 0.35 hippocampus 2.78 soil 0.14 1.97 soil 0.23 * 2.79 soil 0.2 1 cerebral cortex 18.4 9 Soil 0.70 14.7 6 soil 1.12 * 17.1 4 soil 0.76 hippocampus 16.8 7 soil 0.92 13.8 0 soil 0.74 15.7 6 soil 1.18 cerebral cortex 14.2 4 soil 0.90 10.4 4 soil 0.79 氺 13.3 1 soil 0.77 hippocampus 2 0.3 4 soil 0.74 18.1 8 soil 0.62 * 20.5 9 soil 0.59 cerebral cortex 0.50 2 soil 0.05 4 0.71 8 soil 0.07 hippocampus 1.08 4 soil 0.11 7 1.44 3 soil 0.14 0 * 0.48 1.06 3 soil 9 soil 0.06 0.13 5δ 1δ This paper scale applies to China National Standard (CNS) A4 specification ( 210 X 297 mm) 50 1281400 A7 B7 V. Invention (诃) ... Note: Compared with the sham operation group * P &lt; 0.0 5 ; compared with the model group △ P &lt; 0 · 0 5 Conclusion: Rat brain tissue ischemia and reperfusion, increased MDA content in brain tissue The level of GSH decreased, and the activities of CAT and SOD, two important enzymes for deoxygen free radicals in tissues, decreased significantly, indicating that during the process of ischemia and reperfusion in the brain, free radicals eliminated systemic dysfunction, resulting in a large number of oxygen free radicals. Produced, causing lipid peroxidation, causing damage to brain tissue. Compound Danshen Dianjiu can decrease the MDA content in cerebral cortex and hippocampus of rats with ischemia-reperfusion, increase the level of GSH, and increase the activity of CAT and SOD, indicating that it has significant inhibition of oxygen free radical reaction and reduced lipid peroxidation. The role of protection against brain cell damage caused by ischemia-reperfusion. Antioxidant effect of compound Danshen Dianjiu in chronic liver injury Method: A mild chronic liver injury model of Wister rats was induced by CC14 high fat and low protein complex method. The compound Danshen drip group was re-irrigated with 4g/kg rats. The normal sputum and the model were administered by the same amount of normal saline. The SOD activity was measured by the xanthine oxidase method and the MDA content was determined by the modified thiobarbituric acid method. Results: See Table 31. Compared with the normal group, the SOD activity decreased and the MDA increased. The compound Danshen drip group increased SOD and decreased MDA, which made it normal. Printed by the Consumer Standards Agency of the Central Bureau of Standards of the Ministry of Economic Affairs (please read the notes on the back and fill out this page) Table 31 Changes in SOD and MDA in Liver Injury (x±s) Groups in Rats (only) SOD (NU/mg.pr) MD A (nM/mg . pr ) Normal group 12 1·717±0.521 15·21±4.35,- Module 12 1.3 26±0.321* 19.3 9±4.62* Compound Danshen Drop 11 1.710±0.415δ 1 5 . 6±4.29δ Nine groups Note: Compared with the normal group, *Ρ &lt; 0.05. Compared with the test group, the paper scale is applicable to the Chinese National Standard (CNS) A4 specification (210X297 mm) 1281400 A7 B7 V. Invention Description (0 Δ P &lt; 0.05 Conclusion: MDA is the main degradation product of lipid peroxidation, which can seriously damage the cell membrane structure and lead to liver cell damage. S OD is a scavenger for superoxide anion radicals and inhibits free radical initiated lipid peroxidation. Compound salvia miltiorrhiza can significantly increase SOD activity, significantly reduce MDA, reduce lipid peroxidation level, and reduce liver damage. Compound Danshen Drop No. 9 has no mutagenic effect. Through the Ames test, it is investigated whether the compound Danshen Drop Nine is really mutagenic. The results showed that the compound Danshen Drop No. 9 had no mutagenic effect. See Table 32. Table 32. Mutagenic effects of compound Danshen Drips (Ames test) (Please read the notes on the back and fill out this page) Department of Economics Central Bureau of Standards Staff Cooperatives Prints the number of colonies per dish S9 TA97 Ta98 TA1 00 TA1 02 Compound Danshen Drop Nine 0.0 - 141±13 3 6士3 1 6 1土2 1 3 03 士44 0.5 - 140土17 3 5 土2 148土2 1 2 8 8土15 5 1 3 6 土1 4 34士4 1 54土26 280士1 6 50 _ 13 3土20 3 3 土5 142士25 292土3 7 500 109土1 5 34士士3 154土1 6 3 1 1士32 5 000 67 土8 * 3 0士4 1 49士27 298土32 0.0 + 1 4 1 ± 1 3 44 士6 176土1 9 296士3 9 0.5 + 148 soil 13 42 士9 161土27 296土3 7 _______52_ The paper scale Applicable to China National Standard (CNS) A4 specification (210X297 mm) 1281400 at B7 V. Invention description (G) 5.0 + 152 soil 1 1 44 士 7 161 soil 16 292 soil 3 8 50.0 + 140 soil 1 8 3 7 soil 6 16 6土 9 3 07 soil 5 5 5 00.0 + 1 3 5 ± 2 1 42 ± 7 152 soil 22 287 soil 16 5 000.0 + 1 19 soil 17 3 8 ± 7 162 soil 17 363 soil 57 D ex ο η 50 - 2155 soil 81 952 soil 1 8 831 soil 1 1 15 10 soil 2 1 2-AF 40 - 125 soil 18 3 8±3 * 161 soil 16 + 1404 soil 64 4 * 1 5 9 8 soil 1 24 1222 soil 3 09 DAN 100 - 364 soil 50 + * 943 soil 102 氺 (please Read the notes on the back and fill out this page. The Ministry of Economic Affairs, the Central Bureau of Standards, the staff of the Consumer Cooperatives, the production of printed pharmaceutical materials. 1 · Danshen · (1) Quality Control Collect samples from the Salvia miltiorrhiza medicinal herbs produced in various parts of China, and The analysis of chemical composition showed that the quality of Salvia miltiorrhiza produced by Shangluobai was the best, and the content of active ingredients such as tanshinone A in Salvia miltiorrhiza B. was the highest, which proved that the climate of Shangluo is most suitable for the birth of Salvia miltiorrhiza. 1 0 8 ° 3 4 ' 2 0 ”~1 1 1 ° 1 ' 2 5 ”, north latitude 3 3 . ——_____q__ This paper scale is applicable to China National Standard (CNS) A4 specification (210X297 mm). The phenolic sample in this area is 1281400 at B7. 5. Description of invention (舛) ... ~34° 24'40”, average elevation 900 meters. The region is surrounded by low-lying mountains, no pollution, and no pollution environment is an ideal place for the growth of Salvia miltiorrhiza. (3) Climate The climate is mild and moderate in humidity. It is a typical subtropical to temperate transitional foothill. Under the influence of the southeast monsoon, there are obvious four seasons with abundant rainfall. The annual rainfall is about 73 3.9~899mm, and the annual light is about 1 874.1~2185 hours, which is equivalent to 119.57~1 24.36 kcal/cm2. The temperature is 18 ° C ~ 40.8 ° C, the annual non-frost period of 198 ~ 218 days. (4) 80% of the soil in the Shangluo area of the soil is sandy, most of which are neutral and weakly alkaline cultivables of pH 値 6.5 ~ 8. The soil, nutritious tillage layer reaches 0~20cm, and its nutrient composition includes: 1.36% organic matter, 0.085% nitrogen, 18ppm active phosphorus, Γ3 6 ppm active 绅, 60 ppm hydrolyzed nitrogen, soil/heavy metal And other harmful substances It has passed the national agricultural standards. The local crops use organic fertilizer. * - &gt; (5) Printed by the Consumer Standards Agency of the Central Bureau of Standards of the Ministry of Heavy Metals (please read the notes on the back and fill out this page). Lead, cadmium, mercury, arsenic, etc., as well as pesticide residues, air quality, water quality, etc. are in line with national environmental protection standards. (6) Standardized production of Danshen cultivation and cultivation according to GAP specifications. Technical points and steps for the production of Danshen are compiled. In the book, the planting base Danshen producers have a handbook. During the Danshen planting season, the technicians will go to the field for on-site guidance and technical support to standardize and standardize the large-scale planting of Danshen. -_- _____ This paper scale applies to Chinese national standards. (CNS) A4 specification (210X297 mm) 1281400 Α7 Β7 V. Invention description (π) ... (7) At the Shangluo Danshen base, 20 different varieties of Salvia miltiorrhiza were cultivated and planted, their growth status>J, yield The appearance, chemical composition and observation were compared for 3 years. Finally, the best quality Salvia miltiorrhiza varieties were selected for large-scale cultivation. (8) Apply tissue cultivation and cloning techniques in the cultivation of Salvia miltiorrhiza to accelerate production and shorten the growth cycle. (9) After 30 days of test tube culture, there is a 40-day rapid propagation process before the long roots, followed by 1 0 days is the growth and growth of the roots, the rooting rate reaches 90% or more, and then transferred to a computer-controlled breeding room with advanced sprinkler irrigation facilities and facilities, and then transplanted to the outside after one month of cultivation. (1 〇) As the experts said, Salvia miltiorrhiza cultivated at Shangluo Danshen Base is high in quality and high in yield, rich in rhizomes (more than 50% more than other parts of Salvia miltiorrhiza) and high in chemical content (more than other parts of Salvia miltiorrhiza) The active pharmaceutical ingredient content is higher than 70%). 2 · Natural borneol (1) Growth conditions / Printed by the Consumer Standards Agency of the Central Bureau of Standards of the Ministry of Economic Affairs (please read the notes on the back and fill out this page) The natural borneol growth base is located in Xinhuang County, Hunan Province, China. The height of the hilly area, 300 to 600 meters above sea level, forest coverage of 60%, is yellow and red sandy soil of p Η値 5~6, no air and water pollution. (2) The biological characteristics of the tree ^ For the low shrubs with extremely strong growth ability, 300 to 400 plants per mu, collecting the above branches and leaves, the net can be 1 000 kg per mu. - -5S-:—— This paper size applies to Chinese National Standard (CNS) Α4 size (210 X 297 mm) 1281400 Δ7 A 7 B7 V. Invention Description (α) (3) Reproduction and transplantation (please read the back) Precautions: Please fill in this page. Use the grafting and planting techniques to breed. In the first year, grow in the breeding room, and in the second year, transplant to the field. The field needs regular fertilization and dressing. (4) Plants can grow to 80~100 (: 111 high, the maximum diameter can reach 3〇mm. Different parts of the tree such as leaves, branches, stems, roots, etc. contain different natural camphor, and the content of leaves is the highest. (5) The borneol-type camphor tree in Xinhuang area is a variant of Cirnamonium glandullferm (wall) Noes. The content of camphor trees on camphor and borneol is different, some borneol content is low, camphor content is high, and others On the contrary, after a large sample test and many times of high performance liquid chromatography analysis, we finally chose a variety with a borneol content of more than 8 〇% and less impurities. 3 · Sanqi A · Plant seeds (1) three Seven Identification of the Ministry of Economic Affairs Central Bureau of Standards Staff Employees Cooperatives printed the application of molecular mass labeling polymerase chain reaction to observe the staining of Panax notoginseng, Sanqi has its own unique DNA fingerprinting. (2) Shape and characteristics of the seeds of Sanqi Round, ring, according to different growth period, can be divided into two-year and two-year seeds. The two-year seed diameter is 0.45 〇.55cm, dry weight Φ5~103 g; three-year seed 0.54~0.65cm ,dry 9 8 ～1 0 9 g 〇本纸标准Applicable to China National Standard (CNS) A4 Specification (210X297 mm) 1281400 A7 B7 V. Invention Description U7) ... (3) Suitable temperature for seed germination The optimum temperature for seed germination is 10~3〇°C, ideal temperature is 15~20〇c. (4) Moisture The moisture content should be 60 to 70%. If it is less than 20% for a long time, the seed will be inactivated. (5) Hibernation Seeds undergo a hibernation period of 4 5 to 60 days after collection. (6) Lifespan The life in the natural state after seed picking is 15 days. (7) Requirements for storage of seeds The seeds to be stored and stored should be collected from the aerial parts of plants that have been grown for more than two years and are free from pests and foliage. It is recommended to harvest from three-year plants.

(8) Management of seed reserve field V Printed by the Central Bureau of Standards and Staff Consumer Cooperative of the Ministry of Economic Affairs (please read the notes on the back and fill out this page) The management of the seed reserve field is stricter than the general production field, no matter when it is polluted The seeds must be removed, and there must be no pests during the germination period. In budding and long leaves, 3 000 00 YunDa-120 and 400-fold diluted YangKang bio-fertilizer were sprayed twice; during flowering and fruiting, cytokinin was sprayed. (9) Harvesting of seeds The harvesting period of the seeds of Panax notoginseng is from the end of October to the beginning of December. This paper scale applies to China National Standard (CNS) A4 specification (210X 297 mm) 1281400 A7 __B7_____ V. Description of invention (W) ... (1 0 ) Seed collection method determines whether to collect according to the maturity level of the seed, from strong growth Seeds are collected on the plants and stored separately. It is strictly forbidden to collect from immature plants. (· 1 1 ) Preliminary treatment Immediately after seed collection, the seeds are washed, the flesh and the withered seeds are removed, and the washed seeds are dried in the sun. (1 2) The solution was diluted 300 times with 58% metalaxyl manganous zinc, and the seeds of Panax notoginseng were treated for 30 minutes to make the surface of the seeds dry and stored in wet sand with a water content of 20%. An important step. (13) Packaging Final • The product is loaded in a non-contaminating container with the date of collection, the process of processing, and the lot number of the product. (14) Transportation Printed by the Consumer Standards Bureau of the Central Bureau of Standards of the Ministry of Economic Affairs (please read the notes on the back and fill out this page). Use clean, waterproof and well-ventilated transportation tools and equipment / prevent products from being contaminated with toxic substances. If the transport time exceeds 8 hours, the seeds should be placed in wet sand. (1 5) Seed vigor test The test was carried out by the TTC method: lg tetrazolium powder was accurately weighed and dissolved in 100 ml of steamed water to make a 0.1% TTC solution. The sample was immersed in the solution for 24 hours, taken out, cut in half, and half of it was placed in a Petri dish. The sample was stained for 30 minutes with a pre-prepared 1. 1% TTC solution. The degree of vigor of the seed can be determined based on the color of the seed. _|___SR _____ This paper scale applies to Chinese National Standard (CNS) A4 specification (210X297 mm) 1281400 at B7 V. Invention description (θ) ,, (1 6 ) Pest inspection ' I. Put on white paper or glass 5 00 to 1 样品 sample, observed with the naked eye, if there are unusual spots or pests appear on the surface of the sample, it can be confirmed as contamination. Contaminated samples should be separated and their contamination level identified. II. Incision examination: Two sets of samples (100 seeds per set) were cut with a scalpel, and the number of contaminated seeds was counted to determine the degree of contamination. III. Odor check: Place the sample on the hand, sniff it with the nose, see if there is a mildew smell, or put the sample into a cup containing 60~70 °C hot water, cover the lid and soak 2~3 Minutes, then pour out the water, smell the smell of the seeds, and the seeds should emit a light aroma. If not, it may be contaminated. (1 7) Color check Uncontaminated seeds should be yellowish white. (1 8) Microscopic examination Randomly select 5 groups of samples (no less than 50 seeds in each group), place them in a Petri dish for 24 hours, and then observe under the microscopic microscope to see if there is oxygen pathogen, if any , calculate the extent of its pollution. Printed by the Consumers' Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs (please read the notes on the back and fill out this page) B · Plant seedlings (1) Germination temperature The temperature of the germination of germination is 1~2 0 °C, ideal temperature It is 1 5 °C. (2) The moisture content is suitable for the growth of soil with a moisture content of 20~2 5% ° (3) Storage _____^--~~-- - This paper scale applies Chinese National Standard (CNS) A4 specification (210X297 mm) 1281400 A7 B7_ V. Inventive Note) ... There are 90 days of hibernation before the germination of Panax notoginseng, and 100 ppm of gibberellin can help shorten the hibernation period of Panax notoginseng. (Please read the notes on the back and fill out this page) (4.) Featured The selection period of Sanqi is from the end of December to the beginning of January. When selecting, the roots should be carefully treated and planted immediately after selection. (5) Transportation Sanqi is not suitable for long-distance transportation, otherwise it will be damaged. If long-term transportation cannot be avoided, the Sanqi should be placed in a well-ventilated, soil-containing container that cannot be directly exposed to sunlight. (6) Quality inspection I·Unit weight: 300~500 seedlings are selected as samples, one for each seedling, and the weight is weighed on the balance to calculate the unit weight. II. Insecticide inspection: Select 4 groups of samples, 100 seedlings per group, place the sample on a glass plate, or observe with a magnifying glass 5 to 10 times to see if there is any pesticide. III. Microscopic examination: 4 groups of samples were selected, 100 seedlings per group, and the samples were cut - 'v pieces and placed under a microscope for observation. Printed by the Consumers' Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs c · Cultivation of narrow seedlings (1) Tentative conditions The seedlings of Panax notoginseng need to be cultivated in well-conditioned areas. The Sanqi Base should use the methods of center cultivation and large-scale cultivation. 1281400 A7 B7_ V. INSTRUCTIONS (έί) 厂· (3) Water source' (Please read the notes on the back and fill out this page) The water source in this area is composed of rainwater, groundwater and natural flowing water. GB. 5 0 84- 92 Conduct water quality monitoring. (4) The soil soft soil is not suitable for the planting of Panax notoginseng. The content of heavy metals in the soil of the planting of Panax notoginseng should not exceed the relevant national standards. (5) The ideal soil is to obtain the best effect expected. We choose the slope with the slope not exceeding 15 degrees. The soil is acidic, the pH is 5.5~7.0, and the light is 8~12% below 1600 meters. 10~20% of the light above 16〇0 meters. (ό) Temperature During the hair bud period, the atmospheric temperature should be 20~25t, and the soil temperature should be 1 0~1 5 °C. During the seeding period, the optimum atmospheric temperature is 20 to 2 5 ° C, and the optimum soil temperature is 15 to 20 ° C. (7) Water content; soil moisture content should be 25~30%. Printed by the Consumers' Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs (8) Soil tillage Before planting, the soil should be ploughed three times to expose the soil to the sun, which helps to kill the bacteria in the soil. (9) The location of the soil To prevent damage to the roots of the Panax notoginseng, 75 to 100 g of lime should be added per square meter of soil before transplantation. This paper scale applies to China National Standard (CNS) A4 specification (210X297 mm) 1281400 A7 B7 _ V. Invention description (") ... (10) Shading building and its 'management shades are 1. 8 meters from the ground, 2 underground The depth of the ditch in the depth of the rice is 16 海拔. The transmittance of sunlight below the glutinous rice is preferably 8 to 10%, and the temperature above 1 600 is 10 to 15%. The ground should be flat, the deep soil is loose, and the surface soil is hard. The season is best from the end of December to the end of January. Before planting, the seeds should be soaked in a solution of 58% metalaxylic zinc diluted 500-800 times or 1.5% anti-mycin dilution (diluted concentration 200ppm). ~50 minutes, remove, dry, so as to protect plants from disease (the coated seeds do not have to do the above procedure). Planting density is 4 X 5cm or 5x5cm, 10~200,000 seeds per acre. Special tools for ploughing shallow ditch, and then planting or planting with machinery or artificially, the seeds should be completely covered with refined soil. After the above, fertilization, irrigation, weeding should be carried out. Weeding should be carried out at all times. If the sunshade is damaged, it should be repaired in time. To Ensure the appropriate light transmittance. Natural fertilizers include livestock and poultry fertilizer, ash, and ashes, but it is not suitable to use human cockroach fertilizer. D · Cultivation of Sanqi (1) Printed by the Central Bureau of Standards and Staff of the Ministry of Economic Affairs (please read first) Precautions on the back side. Fill in the page. The ground is preferably sloped at less than 15 degrees and has good illumination. 1281400 A7 B7____ Five 'Inventions (0), can be pre-planted with grain, wheat, beans in Xintian Avoid soil damage. (Please read the note on the back and fill out this page.) (5.) The altitude above 1 400~1 800 meters above sea level and 23.5 degrees north latitude is most suitable for the growth of Panax notoginseng. (6) Illumination Panax notoginseng is a plant that requires only 8 to 20% of light. The amount of light should increase gradually with the growth period, but excessive light will cause growth to stagnate. (7) Water content The soil moisture content should be 2 5~3 0 °/... (8) Fertilizer - Organic fertilizer is applied together with compound fertilizer, micronutrient fertilizer, and trace element fertilizer. (9) Temperature ^ Ministry of Economic Affairs, Central Bureau of Standards, Staff Consumer Cooperative, Printed Sanqi The average temperature of the planting base is 15~18. (: During the budding, the atmospheric temperature is optimally 20~25 °C, the soil temperature is best 15t; in the rapid growth and flowering period, the temperature is preferably 25 °. C. If the temperature is lower than 15 °C, the flowering will be affected. (1 〇) Field soil spoon ploughing, one field should be ploughed and soiled 3 times before planting, so that the soil is powdery. —_ This paper The scale applies to China National Standard (CNS) A4 specification (210X297 public celebration) 1281400 A7 B7_ V. Invention description (6f) ... (11) Soil treatment (please read the notes on the back and fill in this page) Before sowing and transplanting Add 75~100g of lime per square meter of soil for bactericidal action. (1 2) Specifications of the field bed Level the ground so that the soil bed is 20 to 25 cm high, inclined 15 to 20 cm, and 120 to 140 cm wide, in a tile shape. The soil in the lower part of the soil bed is looser and the upper soil is harder, which will result in better permeability. _( 13 ) Seed soaking Before transplanting, the seeds should be immersed in a solution of 58% metalaxyl diluted 500 ~ 6,000 times for 3 〇 ~ 5 〇 minutes, taken out, dried, so as to prevent diseases and eliminate pests . (1 4) Planting Density Planting 'density is 10x12.5cm~10x15cm, 2.6~3.2 每 per mu. (1 5) Transplantation method Printed by the Consumers' Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs In order to facilitate management, the narrow seedlings should be planted in the same direction. If it is a sloping field, the seedlings are planted from the low side to the high side, with the first row facing up and the second row going down, with the buds facing up and bottom facing down. (1) Soil cover completely covered with seedlings in powdery, soft and moist soil, do not expose roots or buds - 苞. ' (1 7 ) Fertilizer uses special fertilizers such as livestock and poultry, ash, ashes, calcium, magnesium and phosphorus. 11_________ ^4___ - This paper scale applies to China National Standard (CNS) Α4 specification (210X297 mm) Printed by the Central Bureau of Standards and Staff of the Ministry of Economic Affairs 1281400 A7 A7 ____B7 V. Invention Description (Μ) References 1. US Pat. N〇 5 2 8 84 8 5 “vasodilating agent” 2. US Pat. No. 5 4 3 3 9 5 7 “vasodilating agent” 3. US Pat. No. 5 7 7 6 4 6 3 “Method of reducing stress and circulatory Heart disease with freeze-dried borage petalextracts” 4. Yang Guiyuan et al. Clinical study on the treatment of coronary heart disease with broadleaf valerian. Chinese Journal of Integrated Traditional Chinese and Western Medicine, 1994, 14(9): 540-542 5 · Wu Yuliang. Xintongkang Capsule Treatment Coronary heart disease angina pectoris effect observation. Inspection. Integrated Chinese and Western medicine Beach, 1 9 9 0, (7): 3 9 5 - 3 9 8 6. Liu Kangyong et al. Clinical observation of 45 cases of coronary heart disease with angina pectoris. Chinese Journal of Traditional Chinese Medicine Combined with the magazine, 1 995, 1 5 ( 1 1 ): 649-65 1 • ' &gt; 7 . Hu Jinxin / Shenqi Tongguan Tablets for the treatment of coronary heart disease with angina pectoris clinical and experimental research. Chinese Journal of Integrated Traditional and Western Medicine, 1990, (10): 596-599 8. Li Yingdong · crown-expanding agent for plasma of patients with angina pectoris Effects of Zinc and Copper and Erythrocyte Glutathione Enzyme Activity · Chinese Journal of Integrated Traditional and Western Medicine, 1 9 90, (6): 3 4 8 -3 5 0 ... 9·Wang Bowen. 蒺藜 soap f treatment of coronary heart disease angina 4〇 6 cases of clinical observation. Chinese Journal of Integrated Traditional and Western Medicine, 1 990, (2): 85-87 _ ._____^ ____ This paper scale applies Chinese National Standard (CNS) A4 specification (210X297 mm) (please read the notes on the back first) Fill in this page again)

1281400 A7 B7 V. Description of the invention (I) 1 0. Jin Qi. Effect of Astragalus membranaceus on sodium content and sodium transport in erythrocytes of patients with coronary heart disease. Chinese Journal of Integrated Traditional and Western Medicine, 1 9 9 1, (1 1 ) : 6 5 1 - 6 5 3 (Please read the precautions on the back and then fill out this page) 1 1 . Qian Zhenhuai. Clinical observation of qi and blood granules in the treatment of angina pectoris with qi deficiency and blood stasis type. Chinese Journal of Integrated Traditional and Western Medicine, 1 992, (1 1): 663 -665 12. Wang Xiaofang. Clinical observation of 82 cases of spontaneous angina pectoris treated by Wenxin Decoction. Chinese Journal of Integrated Traditional and Western Medicine, 1 996,1 6(4): 20 1 -203 1 1 2 3 · Lei Zheng First-class. Effect of Astragalus on cardiac function in patients with angina pectoris. Chinese Journal of Integrated Traditional and Western Medicine, 1 994,1 4(4): 1 99-202 1 4. He Wei. Coronary heart disease angina pectoris Research. Journal of Traditional Chinese Medicine, 1 9 8 9,( 2 ) : 2 3 - 2 6 1 4 ·Chen Yi·Shu Xuening Tablets for the treatment of coronary heart disease. Chinese Journal of Integrated Traditional and Western Medicine, 1 996,1 6 ( 1 ): 24-26 1 5 · Zhang Hua. Clinical study of Buyang Huanwu Decoction in the treatment of coronary heart disease and its mechanism--Discussion. Chinese Journal of Integrated Traditional and Western Medicine, 1 994, 14(4): 213-2 15 Department of Economics, Central Bureau of Standards, Staff Consumer Cooperatives, Printing 1 7 . Zhang Xiulan·Rose Shuxin Oral Liquid for the treatment of angina pectoris with qi stagnation and blood stasis type. Chinese Journal of Integrated Traditional and Western Medicine, 1 9 9 2, ( 7 ) : 4 1 4 - 4 1 6 1 8 · Zhu W et al., "Protective effect of danshen 2 during myocardial ischemia and reperfusion: an 3 isolated rat heart study" American Journal of Clinical 4 _____66 ____ 5 This paper scale applies to Chinese national standards (CNS ) A6^洛 (210X297 mm) 6

Medicine, 1 8( 1 -2): 1 9-24, 1 990. 1281400 at Β7 5, invention description (0), 1 9. Li Yiyi. Clinical observation and experimental study of Xuemaitong in the treatment of coronary heart disease. Integrative Chinese and Western medicine Journal, 1 989, (2): 79_81 2 0 · Cai Peiyuan et al. Clinical study of Hehuan Decoction in the treatment of coronary heart disease. Chinese Journal of Integrated Traditional Chinese and Western Medicine, 1 996,1 6(4): 204_206 2 1. Lin Qiucheng·Cronical Treatment Clinical study of coronary heart disease. Chinese Journal of Integrated Traditional and Western Medicine, 1 98 9; (5): 280-282 2 2. Clinical observation of Li Shuqing et al. in the treatment of ischemic heart disease. Chinese Journal of Integrated Traditional and Western Medicine, 195.02.20 15(2): 77-80 23 · Lu Baojing et al. Anti-lipid peroxidation of Shengmaisan in patients with acute myocardial infarction. Chinese Journal of Integrated Traditional and Western Medicine, 1 9 9 4, 1 4 ( 1 2 ) : 7 1 2 - 7 1 4 24·Wang Shuoren·Dangshen's effect on the synthesis of thromboxane A1 2 and prostacyclin' Journal of Integrated Traditional Chinese and Western Medicine, 1 9 9 ; ( 7 ) : 3 9 1 - 3 9 4 2 5 · Guan Mansheng ♦ Expanding the crown Qi Ling's treatment of coronary heart disease. Journal of Traditional Chinese Medicine; 1989, (6): 27-29 Printed by the Consumer Standards Agency of the Central Bureau of Standards of the Ministry of Economic Affairs (please read the notes on the back and fill out this page) 26· Compound Fufang Danshen Tablets. Pharmacopoeia of the People's Republic of China (English version), p. 280 1 7. Zhu Hougang et al. Treatment of asymptomatic myocardial ischemia in coronary heart disease 2 察·中ίψ西医联合杂志,1994,14 (4): 213-215 n Ministry of Economic Affairs Central Bureau of Standards Staff Consumer Cooperatives Printed 281400 A7 A7 B7 V. Description of the Invention (from) 1982; (1): 31-20 2 9 · Sun Ximing. The new pharmacological effects of Danshensu. Chinese herbal medicine, 1 9 9 1,( 1 ) ·· 20-23 3〇. Cheng Zhanghua. Experimental study on the effects of Danshensu on microcirculatory disorders and plasma lactic acid content. Journal of Shanghai Medical University, 1 9 8 7,(1): 25 _2 9 3 1. Huang Cong. Protective effect of Panax notoginseng saponins on myocardial ischemia-reperfusion injury in rabbits. Chinese Journal of Pharmacology, 1991; (3): 190-193 3 2 . Shi Lin. Total soap f increased carotid prostaglandin 12 and decreased platelet thromboxane A2. Chinese Journal of Pharmacology, 1990, (1): 29-32 3 3 · Xu Wei et al. Menthol and borneol on sulfadiazine and Evans blue The influence of distribution in the brain · Chinese medicine pharmacology and clinical, 1 99 5,1 1 (6) 彳 3 1-33 3 4 · Chen Tiezhen. Borneol promotes tetramethylpyrazine Chinese Journal of Pharmacology, 1990, (1): 42-44 3 5. Protective effect of Lixing·Sanqi Soap F on experimental myocardial ischemia-reperfusion injury in rats. Chinese Journal of Pharmacology, 1990, (1): 26-29 3 6 ·Pan Shuguang·Ai Ye volatile oil chemical research ·Chinese Journal of Traditional Chinese Medicine, 1992, (12): 741-744 3 7 ·Wu Yuzhong·etc. Danshen's effect on promoting blood circulation and phlegm. Journal of Nanjing University of Traditional Chinese Medicine, 1995 ,11(6): 35-36 3 8 ·Wang Ningsheng et al. The borneol "the ambassador is active, the experimental study of Chinese medicine miscellaneous paper scale applies to the Chinese National Standard (CNS) A4 specification (210X297 mm) (please read first Note on the back side of this page) 1281400 A7 _ B7 V. Inventive Note (θ ) ... 志,1994, 35(1): 46-47 3 9·Li Chengzhu. Study on the anticoagulant effect of Danshensu. Chinese and Western Medicine Journal of Integrative Medicine, 1983, (5): 297-299 4〇·Li Chengzhu. Experimental study on the inhibition of thrombosis in vitro by Salvia miltiorrhiza. Journal of Shanghai First Medical College, 1979, (3): 146-149 41·Mo Qizhong· Study on the dynamics of 3H-ice flakes: a preliminary discussion on the mechanism of aromatic opening of traditional Chinese medicine borneol. Chinese patent medicine research, 1 9 8 2, (8) : 5 - 7 42·Zheng Ruoxuan. Preventive effect of salvia miltiorrhiza on myocardial ischemia caused by coronary artery ligation in rats·Chinese Journal of Integrated Traditional Chinese and Western Medicine, 1992, (7): 424-426 Ministry of Economic Affairs, Central Bureau of Standards, Staff Consumer Cooperatives, Printing Standards I use moderate scale in i country|sheet paper ¥1 public 7 ^ 9 (please read the notes on the back and fill out this page)

Claims (1)

1281400 Pickup, patent application scope: 1 · A traditional Chinese medicine composition for treating chronic stable angina pectoris, the cow's inch sign is that '匕 is prepared by the following steps: (1) Preparation of Salvia miltiorrhiza extract: a) Extraction: Place the salvia in a multi-purpose extraction tank, add water to 15~20cm beyond the medicinal material (about 5~7 times the amount of the medicinal material); steam heating 'the inner pressure of the tank is kept at 〇.〇4~〇〇6mPa In between, extract twice, the first 2 hours, the second 1.5 hours; collect the extract, filter through 10 mesh; discard the residue; (b) Concentrate: transfer the extract to the vacuum tank, Control the vapor pressure below 0.05mPa, and adjust the vacuum to be 0.076~0.088mPa, keep the boiling in the pot; concentrate to the weight ratio of the liquid to the drug is 1 liter: 1 kg; (c) Alcohol: After concentration, concentrate Transfer to an alcohol-tank, slowly agitate and add 95% ethanol, measure with alcohol until the ethanol concentration drops to 70%, and place for 24 hours; (d) Recover ethanol: transfer the alcoholic supernatant Adjust the input air pressure to the vacuum tank 〇·〇4~0.〇6mPa, vacuum degree 0.076~0.088mPa, keep boiling; concentrated to the ratio of the volume of the liquid to the weight of the medicine is 1 liter: 1 kg; (e) Polyamide chromatography purification: the step ( d) The obtained solution is placed on a pre-treated polyamide column, the loading volume is 5 ml sample per 1 g of polyamide; after 3 times the amount of water is rinsed, it is eluted with 5 to 10 times the amount of 9 5 % ethanol, and used The method of the step (d) recovers the ethanol 'concentrated eluate to a relative density of 1. 3 3~1 . 3 5 ; 70 1281400 (2) Preparation of the extract of Panax notoginseng: U) Extraction: placing the three-seven in the multifunctional In the extraction tank, add water to 15~20cm over the medicinal material (about 5~7 times the amount of medicinal material); heat to generate steam'. The gas pressure in the tank is kept between 〇.〇4~0.06mPa, and this state is maintained 7 points twice. Extraction, the first 2 hours, the second time 1 · 5 hours; collect the extract, filter through 1 mesh, discard the residue, and concentrate the filtrate properly; (b) Refining the macroporous resin: the step (a) The concentrate is applied to the column, the ratio of the sample to the resin is 1 ··1, the flow rate is 0.5~5cm/cm2/min, and the sample is finished, washed with water. Until it is bright; elute with 70% ethanol at a flow rate of 5.5~5 (:111/(:]112/111丨11, collect the eluent; (c) Concentrate the Sanqi eluate · Open the vacuum pump, filter the eluent with 100 mesh and add it to the vacuum tank; adjust the inlet air pressure to 0.04 ~ 0.06mPa, the vacuum degree is 0.076~0.08 8mPa, keep it boiling and not bump; the recovered ethanol is concentrated to its relative density. 1. 3 3~1 . 3 5, extract of notoginseng; (3) preparation of traditional Chinese medicine composition drip: (a) taking 5% to 40% by weight of the above-mentioned salvia miltiorrhiza extract, the weight percentage is 1%~10% of the above extract of Panax notoginseng, the weight percentage is 1%~5% borneol, the remaining amount is the auxiliary material polyethylene glycol 6000, put into the chemical tank, mix well, and heated to 80~85 ° with steam C, last for 30~40 minutes, until the mixture is uniform without any agglomeration; (b) Add the evenly mixed material into the drip tank of the drip machine, keep the temperature at 89~93 °C, and carry out the dropping; condensation The agent is liquid paraffin, 1281400, the temperature is lower than 8C, the inner diameter of the dripper is i.7mm, the outer diameter is 2.4mm; the liquid medicine and the dripper The distance is 5~6cm; the distance between the dripper and the condensate surface is 26~3 1cm; the depth of the condensate is im; the dropping speed is 60~80 particles/min; (c) the nine is taken out from the condensate, and the oil is removed by centrifugation. That is, the Chinese medicine composition is dripped nine. 2. The traditional Chinese medicine composition according to claim 1, wherein the (3) composition is prepared by taking 10% to 30% by weight of the above-mentioned salvia miltiorrhiza extract, weight percentage The above-mentioned Panax notoginseng extract is from 2% to 6%, and the weight percentage is from 1% to 5% of borneol, and the rest is an auxiliary material, which is uniformly mixed to prepare a composition. The Chinese medicine composition according to claim 1 or 2, wherein the macroporous resin adsorption resin in the preparation of the (2) Panax notoginseng extract is made of porous polymer, tannin, alumina, Polyamide, activated carbon, cellulose or cross-linked dextran is substituted. 4. The Chinese medicine composition according to claim 1 or 2, wherein the eluate is concentrated under reduced pressure at 60 ° C to a relative density of 1 in the preparation of the (2) Panax notoginseng extract. , 3 3~1. 3 5. 5. The Chinese medicine composition according to claim 1 or 2, wherein the pretreatment of the macroporous resin in the preparation of the (2) notoginseng extract is: soaking in 95% ethanol for 24 hours. Add non-polar macroporous 72 I 1281400 resin ZTC -1 to the resin column, the particle size is ο · 3~1 . 2 mm, the gap is 130~300A; elute with equal amount of water and ethanol until Eluent is bright, or washed with 0.1~lmol/L Na〇H and HCL until there is no taste of ethanol or near neutrality of the eluent; regeneration of macroporous resin is: wash with 95% ethanol Remove the resin until the eluent is bright and colorless, then rinse with water until there is no taste of ethanol. 6. The traditional Chinese medicine composition according to claim 1, wherein the drip is a reddish brown or brownish black sphere, uniform in size, fragrant, slightly bitter, and the weight difference is about ±15. %, the range is between 21.25 and 2 8.75mg, the density is 1.13~l.40mg/mm3, the average diameter is 0.33~0.34cm; every nine contains Danshensu 0.14~0.18mg, and the notoginsenoside R1 is greater than 12.12//g, Ginsenoside Rgl is greater than 56.26 / / g. 7. The Chinese medicine composition according to claim 1 or 2, wherein the fingerprint is as shown in the following table: peak number retention time relative retention time occurrence ratio peak area peak area ratio peak area ratio Range 1 8.289 0. 672 100% 1034.276 0. 572 0. 572±0. 096 2 12. 343 1.000 100% 1817.065 1.000 1.000±0. 000 3 17. 493 1.417 100% 376. 547 0.208 0. 208±0. 040 4 18. 664 1.512 100% 328.011 0. 181 0.181±0. 059 5 24. 883 2.016 100% 486. 626 0. 267 0. 267±0. 097 6 27. 586 2. 235 100% 525. 432 0 289 0. 289 ± 0. 052 7 29.714 2.407 100% 940. 963 0.516 0· 516±0· 125 73 1281400 Q 34.030 2.757 100% 1547.495 0.850 0.850±0. 163 • Chinese medicine as claimed in item 7 of the patent application Composition Drop No. 9, characterized in that the fingerprint is obtained by the following method: a) pretreatment: 1) dissolving an appropriate amount of the composition in a solution using p-aminobenzoic acid as an internal standard; ii. adding methanol Ultrasound for 15 minutes; iii. Let cool, add methanol to dilute, centrifuge; iv. Collect the upper sputum as a sample solution; b) The appropriate amount of sodium danshensu reference substance is dissolved in a solution containing p-aminobenzoic acid as an internal standard, and dissolved in methanol as a reference solution; c) High performance liquid chromatography conditions are as follows: i · Mobile phase: methanol··water : glacial acetic acid = 8 ·· 91 : 1 ; ii. column temperature: 30 ° C; ii i. injection amount: 1 0 // 1 ; iv . detection wavelength: 2 8 1 nm; ν · theoretical plate number The calculation of Danshensu sodium peak should not be lower than 2000; d) Inject the sample solution and the reference solution into the high-performance liquid solution separately, and determine by HPLC, the relative retention time and peak area of the reference product are calculated as 1 Retention time and relative peak area, that is, a fingerprint is obtained. 74