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1、 Hydrophobic agent with the best application effect
1、 Preparation of antacid capsule
Glycerin 22.02kg, distilled water 34.13kg, dimethylsilicone oil 10kg, gelatin 43.85kg were added and dissolved in 70-80 ℃ under reduced pressure. The mixture of formaldehyde and acetone (1 / 60) is sprayed on the capsule. Due to the hydrophobic effect of dimethylsilicone oil, the capsule does not disintegrate in acid gastric juice for 2 hours and dissolves in alkaline intestinal solution for 200-620 seconds. It is stable for enzyme and temperature and has good mechanical strength.
2. Polishing of sugar coated tablets
In the polishing operation, Sichuan wax powder with 2% dimethylsilicone oil is added to the coated tablet for polishing. Compared with the tablet without dimethylsilicone oil, the sugar coated tablet has a bright and beautiful color surface and moisture-proof effect to ensure that the sugar coated tablet does not discolor or mildew during the storage period.
3. Film coating material
It can be used as plasticizer of film coating material. By using the hydrophobicity and oxygen resistance of dimethylsilicone oil, the chip core is isolated from the outside, free from moisture and oxygen in the air, moisture absorption deterioration, and the coating is firm and smooth.
2、 The best condensing agent for water soluble dropping pills
The possible behaviors of the drop in the condensing agent are spreading, forming drop and mixing. Generally, when the liquid with lower surface tension is put into the liquid with higher surface tension, the surface will spread, otherwise, it is easy to form droplets. Dimethylsilicone oil is the most common water-soluble pill condensing agent with the lowest surface energy (liquid paraffin 0.035n/m, vegetable oil 0.035n/m, dimethylsilicone oil 0.021 n / M).
There are many types and specifications of dimethylsiloxane oil. By adjusting the temperature and selecting different types of dimethylsiloxane oil, the forming and settling speed of liquid drops in the condensing agent can be adjusted to achieve the best process and quality conditions, and there is no hidden danger of polluting toxic substances of petrochemical products and water-borne dropping pills with water, discoloration and mildew, which cannot be guaranteed by liquid paraffin and vegetable oil.
Especially for the drop pills based on S-40 (polyoxyethylene monostearate) and poloxamer, dimethylsilicone oil must be used as the condensate instead of liquid paraffin, because the solution of water-insoluble active drugs can be increased by dikisiloil, which is beneficial to the absorption of drugs; poloxamer cannot be used as the condensate because of its hygroscopicity. (regular treatment technology of dimethylsiloxane oil in drop pill production; since the price of dimethylsiloxane oil is relatively expensive, it should be recycled as much as possible in production. The used dimethylsiloxane oil will mix with foreign matters. One of the most common foreign matters is the broken pills produced in the preparation of drop pills, which can be removed by filtration, static sedimentation or centrifugation. In addition, the common foreign matters are water, which uses dimethylsiloxane oil mixed with water When it is used as a condensing agent, the dropping pills may dissolve, deform or even not condense and harden. The method to remove the moisture in dimethylsilicone oil is: freeze the dimethylsilicone oil with moisture in the soul at - 4 ℃, take it out after the moisture condenses into ice, filter it quickly, and then remove it.
3、 The only effective antistatic agent in the production of micropowder and pellets
The pellets or pellets are Fluidized-bed in the fluidized bed. When the material passes through the spray area, the spray particles are sprayed on the surface of the coating, and a small piece of film is formed after bonding, spreading and drying. After repeated spraying, the coating film gradually expanded, and finally formed a continuous overall coating to achieve the purpose of coating. In order to ensure safe operation and complete dispersion of materials, powder is not adhered to agglomeration. Antistatic agent should be added to powder spray.
Dimethylsiloxane oil is the only pharmaceutical auxiliary material with antistatic effect at present, and the dosage used as antistatic agent is 0.1% of the weight of powder particles.
4、 Used as a lubricant in solid preparations
Lubricant refers to the general name of auxiliary materials which are added to the materials to be pressed before pressing to make them have or increase fluidity, anti adhesion and lubricity, so as to facilitate the pressing process. According to the action mechanism of lubricant, it can be divided into three kinds: lubricant refers to the auxiliary material which can reduce the friction between particles or tablets and die.
After the tablet die is cleaned, a layer of dimethylsiloxane oil can also be applied to solve the problem of sticking and punching of some varieties.
1. Sustained release aspirin tablets
Take 1000 g aspirin powder (crystal diameter is 0.1770 mm), 70 g ethoxyethyl cellulose (containing 12% ethoxy), dissolve in 300 ml (1:1) toluene dichloromethane solution and 30 g toluene solution containing dimethylsilicone oil, 400 g starch, 300 g glycerophosphatidic acid hard fatty acid ester, 50 g talcum powder, 100 g microcrystalline cellulose, and prepare tablets by the ordinary method.
2. Compound paracetamol capsule
The aspirin particles were heated to 50 degrees centigrade, coated with 1:1 methacrylic acid and methacrylate copolymer and 0.045%AF emulsion (defoamer), dried at 24h above 37.8 degrees in the boiling drying bed. Then 52.144g was added, adding sodium lauryl sulfate 0.203g, paracetamol 41.45g, two methicone oil 0.363g, polyoxyethylene dehydrated monoleate 0.145g mixed evenly. Yes. The weight of the capsule is 700mg, and each capsule contains 325mg of aspirin and 325mg of paracetamol.
3. Ibuprofen Sustained Release Tablets
Ibuprofen 58.25%, lactose 14.50%, dicalcium phosphate 12.60%, behenic acid glyceride 11.65%, magnesium stearate 1.0%, talcum powder + silicone oil (4:1) 2.0% were used as tablets.
5、 Used as release agent in the production process of suppository and other preparations
The preparation of suppository refers to a kind of cavity preparation which is melted between drug and matrix, poured into suppository mould while hot, cooled and shaped, scraped and taken out.
Demembrane agents of water-soluble suppository products are commonly used as dimethylsiloxane oil, liquid paraffin; dimethylsiloxane oil is not petrochemical products, which can reduce the possible risks of allergy, stimulation and other reactions.
The suppository based on poloxamer 188 must use dimethylsilicone oil as release agent, because poloxamer 188 has hygroscopicity.
6、 Safe defoamer in the process of extraction and refluxing of traditional Chinese medicine and bio fermentation
During the process of reflux and biological fermentation, a large number of bubbles often occur in the process of traditional Chinese medicine extraction, which leads to spills or exploding pots. The common way of usage is to add a small amount of defoamer, reduce the surface tension of the defoamer, change the surface tension of the bubble and break it, eliminate the reflux extraction and the gas remaining in the process of biological fermentation. The common defoamer is ether and two methylene oil. Or other; the components of ether and some compound defoamers have physiological activities, and their safety has not been recognized.
Dimethylsiloxane oil is the only defoamer approved by the pharmaceutical supervision department.
The amount of dimethylsiloxane oil is about 10ml per cubic extract (fermentation liquid), which has a significant defoaming effect.
7、 Main raw materials of medical defoamer emulsion
Formula 1 of silicon milk;
Dimethylsiloxane oil (500 type) 20ml, differential silica gel 10g, add a20,5% hydroxyphenethyl alcohol solution 2ml, purified water appropriate amount, make 1000ml.
It can also be used to eliminate abdominal distention caused by various reasons.
8、 Matrix composition of high-end cream products -- dimethylsilicone oil
As ointment matrix, it can improve the penetration ability of drugs to the skin, improve the efficacy, improve the comfort of patients, and improve the speed of drug dispersion.
It is a kind of high-end cream matrix with delicate, lubricating and Pearl like luster, cosmetic like sensory intuition and obvious advantages in drug release speed.
Common formula;
1. O / W cream matrix;
Active ingredients, oil phase; cetyl alcohol, dimethylsilicone oil, azone, stearic acid, spar-60; water phase; glycerin, purified water, etc., the proportion of dimethylsilicone oil is generally 6-10%. Such as ketoconazole cream.
2. W / O cream matrix;
Active ingredients, oil phase; dimethylsilicone oil, white vaseline, glycerin monostearate, plain A20, water phase; glycerin, purified water, etc., the proportion of dimethylsilicone oil is generally 1-5%.
Such as compound ketoconazole cream.
3. Sunscreen
Liquid paraffin 5, white beeswax 10, microcrystalline paraffin 5, two methicone 5, white vaseline 5, polyoxyethylene sorbitol laurate 1, dehydrated sorbitol half times oleic acid ester 5, flavour proper, isopropanol myristic acid 1, titanium dioxide 2 parts, purified water 21 parts, often made cream. Because there are ten different types of dimethylsiloxane oil products with the same properties, its density and viscosity can be flexibly adjusted to a physical and chemical properties. There is always a product or combination with the most appropriate specifications that can adjust the best product conditions, which is incomparable with any other similar pharmaceutical excipients.
It can be seen that dimethylsiloxane oil, as a pharmaceutical excipient and / or active ingredient, not only has excellent performance, but also is very safe.
9、 Application technology of dimethylsiloxane in medical devices and drug packaging products
Silicification refers to the process of evenly spraying dimethylsilicone oil (or dimethylsilicone oil diluent) on the surface of the appliance or material, and then drying, so that the surface of the appliance or material is coated with a thin layer of dimethylsilicone oil. The silicification degree is generally 0.012-0.02mg/c ㎡. After siliconization, the related properties of the products have been improved obviously.
1. The compatibility of dental materials will be improved after silicification.
2. After the surgical instruments and injection needles are silicified on the surface, the damage to the tissues can be reduced and the puncture is easy;
3. Due to the anticoagulant property of dimethylsiloxane oil, the surface of vacuum blood collection vessel, blood storage device and blood dialysis device can be silicified with this product to prolong the storage time of blood sample and the blood defoaming of blood circulation device.
4. The friction coefficient of the surface of butyl rubber plug is very high. It is necessary to treat the surface of rubber plug. Siliconization is a traditional method to overcome the operation and mechanical problems of rubber plug.
5. After the surface of the disposable dressing is silicified, such as gauze, medical cotton, etc., it can not be bonded with the wound;
6. Lubricating oil for medical devices, such as the lubrication of disposable syringe, is the safest lubricant;
7. Dimethylsilicone oil is the best non benzene lubricant for condoms;
8. Dimethylsiloxane oil can be directly used as first aid medicine (commonly used at home) for superficial burns and scalds and for scar prevention and treatment;
9. Dimethylsiloxane oil is a safe lubricant which can be used in human life of middle-aged and old people.
There are great differences between industrial dimethylsilicone oil and dimethylsilicone oil in raw materials, production process, production environment, quality monitoring, quality standards, and impurity composition, so the product quality is significantly different. Industrial dimethylsiloxane oil contains a variety of complex and harmful chemicals, and there is no relevant detection method in the conventional standard. Therefore, it is recommended that pharmaceutical, medical equipment, food and cosmetics manufacturers use dimethylsiloxane oil pharmaceutical grade raw and auxiliary materials to ensure the safety of such products directly related to people's life and health.
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