2. Pharmacopoeia Standard of Fracture and Contusion Capsule 2. 1 Name Fracture and Contusion Capsule
Rhizoma drynariae capsule
2.2 Prescription: 250g pork bones, 200g fried cucumber seeds, 25g calcined pyritum, 25g safflower, 0/5g rhubarb/kloc-,0/5g angelica/kloc-,0g vinegar frankincense/kloc-,0g vinegar myrrh/kloc-,and 0/0g dragon's blood/kloc-.
2.3 Make the above ten ingredients, decoct pig bones to obtain glue, filter until it is clear, heat and concentrate with slow fire until the glue is impermeable to paper, add 1.25g crystal sugar and 3.75ml yellow wine, mix well and concentrate into glue; Degreasing cucumber seeds, mixing with the above eight ingredients such as pig bone glue and safflower, pulverizing into fine powder, sieving, mixing, and encapsulating to make 1000 capsule.
2.4 Properties This product is a hard capsule, and its contents are yellowish brown to brown powder; It tastes very spicy.
2.5 Identification (1) Take this product, and observe it under the microscope: the pollen grains are spherical or oval, with a diameter of about 60μm, with thorns on the outer wall and three germination holes (safflower). Calcium oxalate cluster crystals are larger, with a diameter of 60 ~ 140μ m (rhubarb). Body wall fragments are yellow or reddish brown, with round hair nests, 8 ~ 24 microns in diameter, and bristles of different lengths (Eupolyphaga sinensis) can be seen. Irregular fragments are brownish black (natural copper).
(2) Take 0.6g of the content of this product, add 20ml of methanol, soak it for 65438+/-0h, filter, evaporate the filtrate, add 65438+-00ml of water to dissolve the residue, add 65438+-0ml of hydrochloric acid, heat it in water bath for 30min, immediately cool it, extract it with ether twice, each time with 65438+-00ml, and combine the ether solutions. Then take rhein reference substance and emodin reference substance, respectively add methanol to make a solution containing 65438±0mg per 65438±0ml as reference substance solution. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia Part I, 20 10), 4μl of each of the above four solutions was absorbed and spotted on the same silica gel G thin-layer plate, and the upper solution of petroleum ether (30 ~ 60℃)- ethyl formate-formic acid (15: 5: 1) was used as the developing agent. In the chromatogram of the test sample, the same five orange-yellow fluorescent main spots are displayed at the corresponding positions of the chromatogram of the control medicinal materials; At the position corresponding to the chromatogram of the reference substance, the same orange-yellow fluorescent spots appeared, which turned red after being smoked in ammonia vapor.
(3) Take 6g of this product, add 30ml of ether, ultrasonic for 65438 00 minutes, filter, evaporate the filtrate, add 65438±05ml of 80% acetone solution to the residue, plug it, shake it evenly for 65438 05 minutes, let it stand, and take the supernatant as the test solution. In addition, 0.5g of Carthamus tinctorius was taken and a control drug solution was prepared in the same way. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia I, 20 10), 5μl of each of the above two solutions were absorbed, spread out, taken out and dried on the same silica gel H thin-layer plate with ethyl acetate-methanol-water-formic acid (7: 0.4: 3: 2) as the developing agent. In the chromatogram of the test sample, the spots with the same color appear at the positions corresponding to the chromatogram of the control medicinal materials.
2.6 the inspection shall comply with the relevant provisions of capsules (appendix Ⅰ L of Pharmacopoeia 20 10).
2.7 the content was determined by high performance liquid chromatography (appendix ⅵ D of pharmacopoeia I, 20 10).
2.7. 1 chromatographic conditions and system applicability test, using octadecylsilane bonded silica gel as filler; The mobile phase was acetonitrile -0.05 mol/L sodium dihydrogen phosphate solution (50: 50). The detection wavelength is 440nm；; The column temperature is 40℃. According to the peak of dracorhodin, the theoretical plate number should be no less than 4000.
2.7.2 Preparation of reference solution Take a proper amount of dracorhodin perchlorate reference substance, weigh it accurately, put it in a brown volumetric flask, and add 3% methanol phosphate solution to make a solution containing 8μg per 1ml, and get (dracorhodin weight/dracorhodin perchlorate weight/1.377).
2.7.3 Preparation of test solution Take 0.75g of content, weigh it accurately, put it in a 50ml brown volumetric flask, add 40ml of 3% methanol phosphate solution, perform ultrasonic treatment (power 200W, frequency 50kHz) 50k Hz)65438±00 minutes, cool, add 3% methanol phosphate solution to scale, shake well, filter and take continuous filtrate.
2.7.4 Determination method Accurately absorb 65,438+00μ l of control solution and test solution respectively, inject them into liquid chromatograph, and determine to obtain the product.
Each tablet of this product contains dracorhodin (C 17H 14O3), not less than 80μg g. ..
2.8 Indications: relaxing muscles and activating collaterals, reducing swelling and removing blood stasis, and setting bones to relieve pain. It is used for traumatic injury, lumbar sprain, tendon injury and fracture, and belongs to blood stasis blocking collaterals.
2.9 Usage and dosage Take it with warm yellow rice wine or warm boiled water. 4 ~ 6 capsules at a time, 3 times a day; Children should be reduced.
2. 10 Note that pregnant women are prohibited.
2. 1 1 specifications each containing 0.29g.
2. 12 storage seal.
2. 13 Note: Pig bone is the dry bone of Susscrofa dommestica Brisson.
2. 14 Edition First Supplement to China Pharmacopoeia 20 10 Edition
3. Standards issued by the Ministry of Traditional Chinese Medicine for Fracture and Contusion Capsule 3. 1 Pinyin Name Fracture and Contusion Capsule
3.2 standard number WS3B346598
3.3 Prescription pig bone (prepared) cucumber seed (prepared) Pyritum (calcined) safflower (calcined), rhubarb, angelica, frankincense (fried), myrrh (prepared) and ground beetle.
3.4 Properties This product is a capsule, and its contents are grayish brown powder; It tastes very spicy.
3.5 Identification (1) Take this product, and observe it under the microscope: the pollen grains are spherical or oval, with dentate processes on the outer wall, and some can see three germination holes. Irregular fragments are blood red, and the surrounding liquid is ginger and turns red gradually. Irregular fragments are yellowish and translucent, with oil droplets oozing out. When oil droplets are heated and melted, calcium oxalate crystals can be seen. The edges and corners of calcium oxalate cluster crystals are short and blunt, with a diameter of 60 ~140μ m ... The body wall fragments are yellow or brownish red, with round hair nests, with a diameter of 8 ~ 24μ m, and some with bristles of different lengths.
(2) Take 65438+/-0g of this product, add 50ml of water, heat in water bath for 30min, filter, add 2 drops of hydrochloric acid to the filtrate, extract with ether twice, 20ml each time, remove the ether layer, add 5ml of hydrochloric acid to the water layer, heat in water bath for 30min, cool, extract with 20ml of ether again, separate the ether layer, and add 65438 sodium bicarbonate test solution.
3.6 The inspection shall comply with the relevant regulations under Capsules (Appendix I L).
3.7 Functions and indications: relaxing muscles and activating collaterals, setting bones and relieving pain. Used for traumatic injury, detumescence, blood stasis, waist torsion and qi stagnation.
3.8 Usage and dosage Take it with warm yellow rice wine or warm boiled water. 4 ~ 6 capsules at a time, 3 times a day; Children should be reduced.
3.9 pay attention to pregnant women avoid taking or following the doctor's advice.
3. 10 specification 0. 29 grams per capsule.
3. 1 1 storage seal.
Drafted by Heilongjiang Institute for Drug Control
4 Description of Fracture Contusion Capsule 4. 1 Drug Name Fracture Contusion Capsule
4.2 dosage form capsules: 0.29g per capsule.
4.3 The main components of Fracture Contusion Capsule are pig bone (processed), cucumber seed (processed), native copper (calcined), safflower, rhubarb, angelica, frankincense (processed), myrrh (processed), dragon's blood and ground beetle.
4.4 The function of Fracture Contusion Capsule is to relax tendons and activate collaterals, set bones and relieve pain. Used for traumatic injury, detumescence, blood stasis, waist torsion and qi stagnation.
4.5 Precautions Pregnant women should not take it.
4.6 Usage and dosage of Fracture Contusion Capsule