Barium sulfate, this product is X-ray double contrast agent.It is a high-density gastrointestinal contrast agent, which can be made into suspensions of different proportions for separate use, but is usually used together with low-density gas to achieve the purpose of double contrast.It is often used for digestive tract radiography. According to domestic users, the uneven barium sulfate is better than the fine and uniform barium sulfate.Cautiously used for some intestinal diseases that are prone to perforation and fistula formation, such as appendicitis, diverticulum, ulcerative enteritis, parasitic infection, etc.[8]
Character: odorless and tasteless powder.Soluble in hot concentrated sulfuric acid, almost insoluble in water, dilute acid and alcohol.The aqueous suspension solution is neutral to litmus test paper.
Density: 4.25-4.5
barium sulfate
Melting point: 1580 ℃[8]
Boiling point: 330 ℃ (under 760mmHg pressure)[8]
Decomposition temperature:>1600 ℃
security information
Customs code: 2833270000[1]
Pharmacopoeia standard
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Barium sulfate (type I)
[Identification] Take about 0.3g of this product, add 10ml of sodium carbonate test solution, boil and filter;Identification reaction of sulfate after adding hydrochloric acid to filtrate to make it acidic (Appendix III);The residue was washed with water, dissolved with dilute acetic acid, filtered, and the filtrate showed barium salt identification reaction (Appendix III).
[Inspection] Porosity Take 5.0g of this product, place it in a 50ml measuring cylinder with a plug (the distance from the bottom of the cylinder to the highest scale should be 11 plugs, shake it forcefully for 1 minute to make the powder evenly suspended, and let it stand for 15 minutes. The top surface of the suspension should not fall below the 18ml scale.Acidity and alkalinity Take 1.0g of this product, add 20ml of water, put it in a water bath and stir it for 5 minutes, filter it, and the filtrate is divided into two equal parts: add one drop of bromothymol blue indicator solution in one part, and it shall not appear blue;Add one drop of bromocresol green indicator solution to the other, which should be blue.Dissolved matter in acid Take 10.0g of this product, place it in a beaker, add 10ml of dilute hydrochloric acid and 90ml of water, boil it for 10 minutes, add water to supplement the evaporated water, cool it, filter it with filter paper washed with hydrochloric acid solution (1 → 40), if the primary filtrate appears turbid, filter it again, take 50ml of clear filtrate, place it in a water bath, evaporate it dry, add 2 drops of hydrochloric acid and 10ml of hot water, mix it, and then use hydrochloric acid solution (1 → 40)Filter the washed filter paper, wash the filter residue with 10ml of hot water, combine the washing solution and filtrate, place them in an evaporating dish with constant weight at 105 ℃, evaporate them on a water bath, dry them at 105 ℃ to constant weight, and the residual residue shall not exceed 15mg (0.3%).Acid soluble barium salt: take the residue left under the item of dissolved matter in acid, add 10ml of water, stir, filter with filter paper washed with hydrochloric acid solution (1 → 40), add 0.5ml of dilute sulfuric acid to the filtrate, and let it stand for 30 minutes without turbidity.Sulfide Take about 10.0g of this product and check according to the law (Appendix Ⅷ C). The lead acetate test paper shall not change color.Loss on drying Take the product, dry it at 105 ℃ to constant weight, and the weight loss shall not exceed 1.0% (Appendix VIII L).Heavy metal Take 4.0g of this product, add 4ml of acetate buffer (pH3.5) and appropriate amount of water to make 50ml, boil for 10 minutes, cool it, add water to make 50ml, filter it, take 25ml of filtrate, and check according to the law (Appendix VII H Method 1), the content of heavy metal shall not exceed 10% per million.Arsenic salt Take 2.0g of this product, add 23ml of water and 5ml of hydrochloric acid, and check according to the law (Appendix VIII J, Method 1), which should meet the requirements (0.0001%).
[Content determination] Accurately weigh about 0.6g of this product, put it into a platinum crucible, add 10g of anhydrous sodium carbonate, mix it well, ignite it until melting, continue to heat it for 30 minutes, cool it, put the crucible into a 400ml beaker, add 250ml of water, stir it with a glass rod, heat it until the melt elutes from the crucible.Move the crucible out of the beaker, clean it with water, put the washing solution into the beaker, continue to wash the inside of the crucible with 2ml of 6mol/L acetic acid solution, and then wash it with water, and merge the washing solution into the beaker.Heat and stir until the molten matter disintegrates, put the beaker in an ice bath to cool, stand until the sediment is hard and the upper liquid is clear, pour out the supernatant, filter, carefully transfer the fine sediment to the filter paper, wash the contents of the beaker twice with cold sodium carbonate (1 → 50) solution, about 10ml each time, stir, as above, continue to filter the supernatant through the same filter paper,Carefully transfer the fine precipitate to the filter paper, then place the beaker containing large barium carbonate precipitate under the funnel, wash the filter paper with 3mol/L hydrochloric acid solution for 5 times, 1ml each time, and then wash it with water (note: the solution may be slightly turbid).Add 100ml of water, 5ml of hydrochloric acid, 10ml of acetic acid solution (2 → 5), 25ml of potassium dichromate solution (1 → 10) and 10g of urea, cover them with a watch glass, heat them for 16 hours, filter them with a vertical melting crucible that has been dried to constant weight while hot, transfer all precipitates, wash the precipitates with potassium dichromate solution (1 → 200), finally wash them with about 20ml of water, dry them at 105 ℃ for 2 hours, cool them, weigh them,The weight of the precipitate obtained multiplied by 0.9213 is the weight of barium sulfate.
[Category] Diagnostic drugs.
[Storage] Sealed storage.
Barium sulfate (type II)
[Identification] Take about 0.3g of this product, add 10ml of sodium carbonate test solution, boil and filter;Identification reaction of sulfate after adding hydrochloric acid to filtrate to make it acidic (Appendix III);Clean the residue with water, add dilute acetic acid to dissolve it, filter it, and identify the barium salt in the filtrate (Appendix III).
[Inspection] Acidity and alkalinity Take 2.0g of this product, add 20ml of water, fully stir it to make a suspension, and determine according to the law (Appendix VI H), the PH value should be 3.5~10.0g.Dissolved matter in acid Take 10.0g of this product, place it in a beaker, add 10ml of dilute hydrochloric acid and 90ml of water, boil it for 10 minutes, add water to supplement the evaporated water, cool it, and filter it with filter paper washed with hydrochloric acid solution (1 → 40). If the primary filtrate appears turbid, filter it again, take 50ml of clear filtrate, evaporate it on a water bath, add 2 drops of hydrochloric acid, mix it with 10ml of hot water, and then use hydrochloric acid solution (1 → 40)Filter the washed filter paper, wash the filter residue with 10ml of hot water, combine the washing solution and filtrate, place them in an evaporating dish with constant weight at 105 ℃, evaporate them on a water bath, dry them at 105 ℃ to constant weight, and the residual residue shall not exceed 15mg (0.3%).Acid soluble barium salt: take the residue left under the item of dissolved matter in acid, add 10ml of water, stir, filter with filter paper washed with hydrochloric acid solution (1 → 40), add 0.5ml of dilute sulfuric acid to the filtrate, and let it stand for 30 minutes without turbidity.Sulfide Take about 10.0g of this product and check according to the law (Appendix Ⅷ C). The lead acetate test paper shall not change color.Loss on drying Take the product, dry it at 105 ℃ to constant weight, and the weight loss shall not exceed 1.0% (Appendix VIII L).Heavy metal Take 4.0g of this product, add 4ml of acetate buffer solution (PH3.5) and appropriate amount of water to make 50ml, boil for 10 minutes, cool, add water to make 50ml, filter, take 25ml of filtrate, and check according to the law (Appendix VII, Method 1, H), the content of heavy metal shall not exceed 10% per million.Arsenic salt Take 2.0g of this product, add 23ml of water and 5ml of hydrochloric acid, and check according to the law (Appendix VIII J, the first method), which should meet the requirements (0.0001%).Particle fineness: Take 0.5g of this product, add water to 50ml, shake it sufficiently to make it even, immediately take one drop on the glass slide, inspect three fields of vision under a 400 times microscope, and the particle diameter should be 0.5-50 μ m, and no more than two particles should be more than 50 μ m.
[Content determination] Accurately weigh about 0.6g of this product, put it into a platinum crucible, add 10g of anhydrous sodium carbonate, mix it well, ignite it until melting, continue to heat it for 30 minutes, cool it, put the crucible into a 400ml beaker, add 250ml of water, stir it with a glass rod, heat it until the melt elutes from the crucible.Move the crucible out of the beaker, clean it with water, put the washing solution into the beaker, continue to wash the inside of the crucible with 2ml of 6mol/L acetic acid solution, and then wash it with water, and merge the washing solution into the beaker.Heat and stir until the molten matter disintegrates, put the beaker in an ice bath to cool it until the sediment is hard and the upper liquid is clear, pour out the supernatant, filter it, carefully transfer the fine sediment to the filter paper, wash the contents of the beaker twice with cold sodium carbonate (1 → 50) solution, about 10ml each time, stir it, continue to filter the supernatant through the same filter paper,Carefully transfer the fine precipitate to the filter paper, then place the beaker containing large barium carbonate precipitate under the funnel, wash the filter paper with 3mol/L hydrochloric acid solution for 5 times, 1ml each time, and then clean it with water (note: the solution may be slightly turbid, add 100ml of water, 5ml of hydrochloric acid, 10ml of ammonium acetate solution (2 → 5), 25ml of potassium dichromate solution (1 → 10) and 10g of urea, and cover it with a watch glass,Heat it at 80~85 ℃ for 16 hours, filter it in a vertical melting crucible that has been dried to constant weight while it is hot, transfer all precipitates, wash the precipitates with potassium dichromate solution (1 → 200), finally wash them with about 20ml of water, dry them at 105 ℃ for 2 hours, cool them, weigh them, and multiply the weight of the precipitate by 0.9213, which is the weight of barium sulfate[2]。
[Category] Diagnostic drugs.
[Storage] Sealed storage.
Drug description
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pharmacology
This product is X-ray double contrast agent.It is a high-density gastrointestinal contrast agent, which can be made into suspensions of different proportions for separate use, but is usually used together with low-density gas to achieve the purpose of double contrast.It is often used for digestive tract radiography. According to domestic users, the uneven barium sulfate is better than the fine and uniform barium sulfate.
indication
It is suitable for upper and lower gastrointestinal radiography.
Usage and dosage
Due to different dosage forms and specifications, please read the drug manual carefully or follow the doctor's advice.
Adverse reactions
Generally, there is no reaction, and occasionally it is difficult to defecate (in order to prevent constipation, you should drink enough water after examination, and take laxatives or Kaiselu if necessary).
contraindication
A patient with digestive tract perforation is suspected.Patients with intestinal obstruction.Patients with acute gastrointestinal bleeding.Patients with general weakness.(Mannitol is prohibited for laxatives).
matters needing attention
Cautiously used for some intestinal diseases that are prone to perforation and fistula formation, such as appendicitis, diverticulum, ulcerative enteritis, parasitic infection, etc.
preparation
Dry suspension (type I, type II)
[2-5]
Barium sulfate (type I) dry suspension
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Common name: barium sulfate (type I) dry suspension
English name: Barium Sulfate for Suspension (Type I)
Hanyu Pinyin: Liuguanbei (yi xing) Ganhunxuanji
Main components and chemical name of the product:
The main component of this product is barium sulfate (type I), which is white fine particles, tasteless, insoluble in water and organic solvents, and slightly soluble in acid and alkali.This product is a dry suspension made of barium sulfate (type I) plus appropriate dispersant and flavoring agent.
Molecular formula: BaSO4
Molecular weight: 233.39
[Character]
This product is white loose fine powder with fragrance.The particle diameter is less than 2 μ m.
[Pharmacology and Toxicology]
Barium salt can absorb more X-ray, and form density contrast with surrounding tissue structures on X-ray images after entering gastrointestinal tract or respiratory tract and other cavities in the body, so as to show the position, contour, shape, surface structure and functional activity of these cavities.Fine and uniform barium is mostly synthetic barium, with fine and uniform particles, mostly round, light specific gravity, slow and consistent sedimentation, and is suitable for single and double contrast radiography of esophagus, stomach, duodenum, small intestine, and colon.Due to the low optimal development concentration of thin and uniform barium, it is not as good as the one with uneven thickness in showing the microscopic structure of gastric mucosa.
[Pharmacokinetics]
This product is not absorbed after oral administration or infusion into the gastrointestinal tract, but is discharged from the feces in its original form.After entering the bronchus, most of them coughed up, and a small amount of them entered the alveoli and deposited in the alveolar wall, or were phagocytosed by phagocytes and transported to the pulmonary interstitial and lymphatic system, but the speed was very slow, so it was not suitable for bronchography.
[Indications]
Barium sulfate dry suspension is suitable for single and double contrast examination of esophagus, stomach, duodenum, small intestine and colon, as well as double contrast examination of digestive tract.
[Usage and dosage]
Usually, oral administration, small intestine enema and colon enema are adopted.
1. Esophageal examination: oral administration of barium [60~250% (W/V)] 15~60ml can immediately observe the esophagus and its peristalsis;Before taking barium, take gas producing drugs first, and make a double contrast examination of the esophagus.
2. Double contrast examination of stomach and duodenum: Fasting for more than 6 hours, take gas producing drugs orally. After 300~500ml of CO2 gas is produced in the stomach, take 70~100ml of barium [concentration 200~250% (W/V, viscosity 150~300 millipascals)] orally first, make the patient turn over several times, and let the barium evenly spread on the gastric mucosa. If necessary, take another 150ml of barium;If the patient is given hypotonic drugs (such as anisodamine or atropine) 20 minutes before the contrast examination, and the gastric juice is washed with stomach clearing enzyme orally, then the double contrast examination is performed, the surface structure of the gastric mucosa can be more clearly displayed.
3. Gastrointestinal single contrast follow-up examination: Fasting for more than 6 hours, 240~480ml of oral 40~120% (W/V) barium can immediately observe the morphology and peristalsis of the stomach and duodenum;The shape and peristalsis of small intestine can be observed after 15~30 minutes;The morphology and peristalsis of all small intestines could be observed 1 and a half hours later;After 2-6 hours, the ileocecal area and the right large intestine can be observed.
4. Intestinal enema examination: Fasting for 8~12 hours, 800~2400ml barium with a concentration of 30~80% (W/V) was directly introduced into the duodenum or proximal jejunum through a special guided tube, and the small intestine was examined section by section.If necessary, double contrast examination shall be performed directly in single contrast examination.
5. Colon enema examination: feed liquid or half liquid one to three days before examination, use proper amount of laxatives if necessary, and clean the intestines one to two hours before examination.The colon was inserted through anus, and contrast agent was injected to fill the whole large intestine for imaging.After injection of 20~60% (W/V) barium, fluoroscopy and radiography were performed, which were single contrast radiography;Then, most of the barium was drained, and gas was injected to fill the large intestine, which was a double contrast radiography.When performing direct large intestine double contrast radiography, first inject 150~300ml of 60~80% (W/V) barium through the catheter, rotate the body position and inject gas to make barium and gas fill the entire large intestine, and perform double contrast radiography.In order to achieve good results, hypotonic drugs such as Glucagon or anisodamine are often injected intramuscularly or intravenously before the contrast agent is injected.
[Adverse reactions]
Oral barium can cause nausea, constipation, diarrhea and other symptoms;Improper use can also lead to intestinal perforation, followed by peritonitis, adhesion, granuloma, and even death in severe cases.After a large amount of barium enters the lung, it can cause mechanical stimulation and inflammatory reaction, and cause foreign body giant cells, epithelioid cells and monocytes to infiltrate in the early stage. Later, fibrosis occurs around the deposited barium inflammation, forming barium nodules.
[Contraindications]
This product is prohibited for oral gastrointestinal examination under the following circumstances:
1. Acute gastrointestinal perforation
2. Esophagotracheal fistula and suspected congenital esophageal atresia
3. Massive bleeding due to esophageal vein rupture in the near future
4. Colonic obstruction
5. Pharyngeal paralysis
[Precautions]
1. Barium sulfate must be checked in strict accordance with the provisions of the pharmacopoeia and must not contain soluble barium salts.
2. This product is prohibited for oral gastrointestinal examination under the following circumstances:
1) Acute gastrointestinal perforation;2) Esophagotracheal fistula and suspected congenital esophageal atresia;3) Esophageal vein rupture and massive bleeding in the near future;4) Colonic obstruction;5) Pharyngeal paralysis
3. Be careful to use this product for oral gastrointestinal examination in the following cases:
1) Acute gastroduodenal bleeding;2) Small bowel obstruction;3) Habitual constipation
4. Cautiously use this product for colon enema examination in the following cases:
5. Barium enema can be carried out 1~2 weeks after the live pathological examination of colon to avoid colon perforation.
[Medication for pregnant women and lactating women] It is forbidden for pregnant women.Data on drug safety of lactating women are still lacking.
[Children's medicine]
Esophagography;Take a small amount of it into a paste.Gastrointestinal radiography: use 100~200g of this product and 200~500ml of water to take it evenly.Barium enema: use 200g of this product and 1000ml of water to mix well for enema.
[Medication for elderly patients]
Elderly patients should be careful to use this product for barium enema.
[Drug interaction]
1. High atomic weight drugs such as bismuth agent and calcium agent shall be prohibited 3 days before the inspection;Drugs that affect the gastrointestinal tract, such as atropine, antacids and laxatives, should not be used 1 day before the examination.
[Drug overdose]
Excess can lead to intestinal obstruction and perforation.
Specification
Dry suspension: 100% (w/v)
[Term of Validity]
Storage
Keep away from light and sealed.[6]
Barium sulfate (type II) dry suspension
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[Name of drug]
Common name: barium sulfate (type II) dry suspension
Name used before:
Trade name:
English name: Barium Sulfate (Type II) for Suspension
Hanyu Pinyin: Liu or nbei (er xin) G or nhunxu or nji
The main ingredients of this product are: barium sulfate type II.Its chemical name is barium sulfate.This product is a dry suspension made of barium sulfate (type II) added with appropriate dispersant and taste correction agent.
Molecular formula: BaSO4
Molecular weight: 233.39
[Character]
It is white loose fine powder with fragrance.
[Pharmacology and Toxicology]
Barium salt can absorb more X-ray, and form density contrast with surrounding tissue structures on X-ray images after entering gastrointestinal tract or respiratory tract and other cavities in the body, so as to show the position, contour, shape, surface structure and functional activity of these cavities.The unevenness of thickness is good for showing the fine structure of gastric mucosa.
[Pharmacokinetics]
This product is not absorbed after oral administration or infusion into the gastrointestinal tract, but is discharged from the feces in its original form.After entering the bronchus, most of them coughed up, and a small amount of them entered the alveoli and deposited in the alveolar wall, or were phagocytosed by phagocytes and transported to the pulmonary interstitial and lymphatic system, but the speed was very slow, so it was not suitable for bronchography.
[Indications]
Barium sulfate dry suspension is suitable for single and double contrast radiography of esophagus, stomach, duodenum, small intestine and colon.
[Usage and dosage]
Usually, oral administration, small intestine enema and colon enema are adopted.
(1) Esophageal examination Oral barium [60%~250% (W/V)] 15~60ml, can immediately observe the esophagus and its peristalsis;Before taking barium, take gas producing drugs first, and make a double contrast examination of the esophagus.
(2) Double contrast examination of stomach and duodenum fasted for more than 6 hours, and took gas producing drugs orally. After 300~500ml of CO2 gas was produced in the stomach, 70~100ml of barium [concentration 200%~250% (W/V, viscosity 150~300 millipascals] could be taken orally first, so that the patient could turn over several times, and the barium could be evenly coated on the gastric mucous membrane. If necessary, 150ml of barium could be added;If the patient is given hypotonic drugs (such as anisodamine or atropine) 20 minutes before the contrast examination, and the gastric juice is washed with stomach clearing enzyme orally, then the double contrast examination is performed, the surface structure of the gastric mucosa can be more clearly displayed.
(3) After fasting for more than 6 hours and 240~480ml of 40%~120% (W/V) barium, the morphology and peristalsis of stomach and duodenum can be observed immediately;The shape and peristalsis of small intestine can be observed after 15~30 minutes;The morphology and peristalsis of all small intestines could be observed 1 and a half hours later;After 2-6 hours, the ileocecal area and the right large intestine can be observed.
(4) Intestinal enema examination fasted for 8~12 hours, and 800~2400ml barium with a concentration of 30%~80% (W/V) was directly introduced into the duodenum or proximal jejunum through a special guided tube, and then the small intestine was examined section by section.If necessary, double contrast examination shall be performed directly in single contrast examination.
(5) One to three days before the examination of colon enema, take a liquid or half liquid diet. If necessary, use an appropriate amount of laxatives, and clean the intestines 1 to 2 hours before the examination.The colon was inserted through anus, and contrast agent was injected to fill the whole large intestine for imaging.After injection of 20%~60% (W/V) barium, fluoroscopy and radiography were performed, which were single contrast radiography;Then, most of the barium was drained, and gas was injected to fill the large intestine, which was a double contrast radiography.When performing direct large intestine double contrast radiography, first inject 150~300ml of 60%~80% (W/V) barium through the catheter, rotate the body position and inject gas to fill the entire large intestine with barium and gas, and perform double contrast radiography.In order to achieve good results, hypotonic drugs such as Glucagon or anisodamine are often injected intramuscularly or intravenously before the contrast agent is injected.
[Adverse reactions]
Oral barium can cause nausea, constipation, diarrhea and other symptoms;Improper use can also lead to intestinal perforation, followed by peritonitis, adhesion, granuloma, and even death in severe cases.After a large amount of barium enters the lung, it can cause mechanical stimulation and inflammatory reaction, and cause foreign body giant cells, epithelioid cells and monocytes to infiltrate in the early stage. Later, fibrosis occurs around the deposited barium inflammation, forming barium nodules.
[Forbidden]
This product is prohibited for oral gastrointestinal examination in the following cases: ① acute gastrointestinal perforation; ②Esophagotracheal fistula and suspected congenital esophageal atresia; ③Esophageal vein rupture and massive bleeding in the near future; ④Colonic obstruction; ⑤Pharyngeal paralysis.
[Precautions]
1. Barium sulfate must be checked in strict accordance with the provisions of the pharmacopoeia and must not contain soluble barium salts.
2. This product is prohibited for oral gastrointestinal examination under the following circumstances: ① acute gastrointestinal perforation; ②Esophageal vein rupture and massive bleeding in the near future; ③Colonic obstruction;Pharyngeal paralysis.
3. Be careful to use this product for oral gastrointestinal examination in the following cases: ① acute gastric and duodenal bleeding; ②Small intestinal obstruction; ③Habitual constipation
4. Cautiously use this product for colon enema examination in the following cases: ① colonic obstruction; ②Habitual constipation; ③Megacolon; ④Severe ulcerative colitis; ⑤Colonic intussusception.
[Drugs for pregnant and lactating women]
Not for pregnant women.Data on drug safety of lactating women are still lacking.
[Children's medicine]
Esophagography: swallow with a small amount of paste.For gastroenterography, use 100-200g of this product and 200-500ml of water.For barium enema, use 200g of this product and 1000ml of water to mix well for enema.
[Medication for elderly patients]
Elderly patients should be careful to use this product for barium enema.
[Drug interaction]
Prohibit high atomic weight drugs such as bismuth and calcium 3 days before examination;Drugs that affect gastrointestinal tract, such as atropine, antacid and laxative, should be prohibited one day before examination.
[Drug overdose]
Excess can lead to intestinal obstruction and perforation.
