2. Standard issued by the Ministry of Traditional Chinese Medicine 2. 1 Pinyin name Maodongqing injection
2.2 standard number WS3B378698
This product is a sterile aqueous solution made of Ilex pubescens.
2.3 preparation method: Ilex pubescens is decocted with water for injection for three times, the first time is 2 hours, the second time and the third time is 65438 0 hours, the decoctions are combined, filtered, and the filtrate is concentrated under reduced pressure until the relative density is 65438 0.15 ~ 65438 0.18 (50℃ Add water for injection to the relative density of 1.08, adjust the pH value to 2.0-3.0 with 10% hydrochloric acid solution, stand for precipitation, filter, adjust the pH value of the filtrate to 6.0-6.5 with 20% sodium hydroxide solution, refrigerate for 12 hours, filter, and concentrate the filtrate under reduced pressure to the relative density of. Adding ethanol to make the alcohol content reach 75%, refrigerating for 24 hours, filtering, recovering ethanol from the filtrate under reduced pressure, measuring the content, adding water for injection to make it contain 20mg of Ilex pubescens extract per 65438±0ml, adjusting the pH value, filtering, filling and sterilizing.
2.4 Characteristics This product is a yellow-brown clear liquid.
2.5 Identification (1) Take this product 1 drop, put it on filter paper, and observe it under ultraviolet lamp (365nm). Spots show yellow-green fluorescence; 1% aluminum trichloride was sprayed into ethanol solution, dried and observed under ultraviolet lamp (365nm) to enhance fluorescence.
(2) Take this product 1 drop, add water 1ml and 20% phosphomolybdic acid ethanol solution 1 drop, which is green.
(3) Take this product 1 drop, add water 1ml and ferric chloride test solution 1 drop, and it turns green.
2.6 Check that the pH value should be 5.0 ~ 6.5 (Appendix VII g). In the hemolysis test, take 0.3ml of this product, add 2.2ml of normal saline and 2.5 ml of 2% rabbit red blood cell normal saline suspension, shake well, and put it in a constant temperature water bath at 36.5℃ 0.5℃ for half an hour. Hemolysis is not allowed. Others shall comply with the relevant provisions under injections (Appendix I U).
2.7 preparation of reference substance solution for content determination: accurately weigh an appropriate amount of rutin reference substance (another rutin reference substance is dried under reduced pressure at 120℃ to constant weight, and converted into dried product 20mg according to weight loss), put it in a 1002550ml volumetric flask, add 60% ethanol, heat it in a water bath at 80℃ until it is dissolved, cool it, and use 60% ethanol. Preparation of test solution Accurately measure 65438±0ml of this product, and prepare it according to the preparation method of reference solution under different loading amounts. Determination method: Accurately measure 4ml of test solution and 4ml of reference solution respectively, put them in a 10ml volumetric flask, add 0.3 ml of sodium nitrite solution (1→ 20) accurately, shake well, let stand for 6 minutes, and then add 0.3 ml of aluminum nitrate solution (/kloc-0 /→10) accurately. Take 4ml of test solution and 4 ml of reference solution, and dilute them with 30% ethanol to 65438±00ml respectively as a blank. According to the spectrophotometry (Appendix ⅴ b), the absorbance was measured at the wavelength of 5 10nm and calculated. The extract of Ilex pubescens in each branch of this product is anhydrous rutin (C27H30O 16), which should be 90.0 ~ 1 10.0% of the labeled amount.
2.8 Functions and indications for cardiovascular diseases, with vasodilating, antibacterial and anti-inflammatory effects. Used for coronary atherosclerotic heart disease, thromboangiitis obliterans, central retinitis and pneumonia in children.
2.9 usage and dosage intramuscular injection, 2ml at a time, 1 ~ 2 times a day.
2. The specification of10 contains 2ml each (containing 40mg of Ilex pubescens extract).
2. 1 1 Storage, shading and sealing.
Drafted by Guangdong Institute for Drug Control
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