2 English reference Danshen injection [Chinese medicine terminology examination and approval Committee. Terminology of Traditional Chinese Medicine (2004)]
3 national essential drugs and Danshen injection related national essential drugs retail guidance price information
Essential drug serial number
DirectoryNo. Drug name, dosage form and specification Retail unit refers to
Remarks on price category 633 49 Danshen injection 10ml 3.3 Chinese patent medicine part *△ 634 49 Danshen injection 2ml 0.74 Chinese patent medicine part 635 49 Danshen injection 20ml 6.3 Chinese patent medicine part Note:
1. The dosage form specifications marked with "*" in the remarks column in the table are representative products.
2. Specifications of dosage forms with "△" in the remarks column in the table, and other specifications of the same dosage form are tentative prices.
3. The dosage form specifications are indicated in the remarks column. The prices of other specifications in this dosage form are based on the same usage and dosage, and are calculated according to the drug price comparison rules.
4. The "honey pills" marked in the column of dosage form in the form include small honey pills and big honey pills.
To sum up, the main component of Danshen injection is Danshen [1]. Has the effects of promoting blood circulation, removing blood stasis, dredging collaterals and nourishing heart. Used for coronary heart disease, chest distress and angina pectoris.
The drug standards of People's Republic of China (PRC) and the Ministry of Health of the People's Republic of China contain the standards issued by the Ministry of Salvia Miltiorrhiza Injection.
5. Standard of Salvia Miltiorrhiza Injection issued by the Ministry of Traditional Chinese Medicine 5. 1 Pinyin Name Salvia Miltiorrhiza Injection
5.2 StandardNo. WS3-B-3766-98
This product is a sterile aqueous solution made of salvia miltiorrhiza.
5.3 Methods Take 65438 0.500 g of Salvia Miltiorrhiza, add water and decoct for three times, the first time is 2 hours, the second time and the third time are 65438 0.5 hours respectively, combine the decoctions, filter, and concentrate the filtrate under reduced pressure to 750ml. Adding ethanol for precipitation twice, the first time making the alcohol content 75% and the second time making the alcohol content 85%, refrigerating and standing for each time, filtering, recovering ethanol from the filtrate, concentrating to about 250ml, adding water for injection to 400ml, uniformly mixing, refrigerating and standing, filtering, adjusting the pH value to 6.8 with 10% sodium hydroxide solution, boiling for half an hour, and filtering.
5.4 Characteristics This product is a brown to reddish brown clear liquid.
5.5 Identification (l) Take 0.5ml of this product, add water to 500ml, shake well and determine by spectrophotometry (Appendix ⅴ a). The maximum absorption is at the wavelength of 28 1 3nm.
(2) Take 2 drops of this product, add 2 drops of water, shake well, and add 1 drop of ferric chloride test solution, which is green.
(3) Take 4ml of this product, put it in an evaporating dish, evaporate it to dryness, and add 1ml absolute alcohol to dissolve it as the test solution. Another protocatechuic aldehyde reference substance was added with absolute ethanol to prepare a solution containing 65438 0 mg per 65438 0 ml as the reference substance solution. According to the thin-layer chromatography test (Appendix ⅵ b), respectively absorb 2 ~ 5 μ l of the above two solutions and spot them on the same silica gel G thin-layer plate. Using ethyl phenylacetate formic acid (8:5:0.8) as developing agent, developing, taking out, air drying, and spraying 2% ferric chloride 1% potassium ferricyanide solution (1: 6544). In the chromatogram of the test sample, spots with the same color appear at positions corresponding to the chromatogram of the control sample.
5.6 Check that the pH value should be 5.0 ~ 7.0 (Appendix VII g). Pyrogen shall be inspected according to pyrogen inspection method (appendix ⅹ Ⅲ a), and the dosage shall be per 1kg rabbit body weight 1.5ml, which shall comply with the regulations. Preparation of 2% red blood cell suspension for hemolysis and coagulation test Take rabbit heart blood, put it in a container filled with glass beads, shake it evenly for several minutes, remove fibrinogen to make it into defibrinated blood, add normal saline, shake it evenly, centrifuge, pour off the supernatant, and wash the precipitated red blood cells with normal saline for 3-4 times until the supernatant does not turn red after centrifugation. Then, according to the obtained red blood cell volume, dilute it with normal saline into a 2% suspension (use it on the same day and shake it evenly when using it). Test method: Take 5 test tubes, add 0.3ml of this product and 2.2ml of normal saline into 1 ~ 3 tubes, add 2.5ml of normal saline into 4 tubes (as negative control), add 2.5ml of distilled water into 5 tubes (as positive control), then add 2.5ml of 2% red blood cell suspension respectively, shake well, and quickly put it in a constant temperature box, and keep it at 36. If there is condensation, it is recommended to shake the test tube into which the test sample is added, and the condensate should be evenly dispersed. Others shall comply with the relevant provisions under injections (Appendix I U).
5.7 The content shall be determined by high performance liquid chromatography (Appendix ⅵ d). Octadecylsilane bonded silica gel is used as a filler for chromatographic conditions and system suitability test. Methanol 0.2mol/L ammonium acetate (adjusted to pH 2.2 with sulfuric acid) (12: 88) as the mobile phase; The detection wavelength is 280 nm. According to the protocatechuic aldehyde peak, the theoretical plate number should be not less than 3000. Preparation of reference solution Accurately weigh a proper amount of protocatechuic aldehyde reference substance, put it in a measuring bottle, and add 5% methanol to make a solution containing 0.02mg per 1ml. Preparation of test solution Under different loading, take 2ml of this product, put it in a 25ml volumetric flask, dilute it with water to scale, and shake it evenly. The determination method accurately absorbs 65438 00μ l control solution and test solution respectively, and injects them into the liquid chromatograph for determination. This product contains protocatechuic aldehyde (C7H6O3) not less than 0.2mg per 1ml.
5.8 Functions and indications: promoting blood circulation, removing blood stasis, dredging pulse and nourishing heart. Used for coronary heart disease, chest distress and angina pectoris.
5.9 Administration and dosage: intramuscular injection, 2 ~ 4 ml at a time, 1 ~ 2 times a day; Intravenous injection, 4ml each time (diluted with 20ml 50% 50% glucose injection), 1 ~ 2 times a day; Intravenous drip, once 10 ~ 20 ml (diluted with 5% glucose injection 100 ~ 500 ml), once a day 1 time. Still follow the doctor's advice.
5. 10 specifications per package
(1) 2ml
(2 2) 10/0ml
5. 1 1 Storage is sealed and shaded.