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Wet granulation: in the raw and auxiliary powder to participate in the adhesive or wetting agent made of soft material, sifted and made of wet particles, wet particles after drying and then through the whole grain。 The granules made by wet method have the advantages of good surface modification, beautiful appearance, strong wear resistance and good compaction formability。
Wet granulation mechanism: firstly, the liquid in the binder wets the surface of the drug powder, causing adhesion between the powder particles, and then under the action of the liquid bridge and the external mechanical force to make a certain shape and size of the particles, after drying and finally consolidated by solid bridge.
Wet granulation mainly includes soft material processing, wet granulation, wet particle drying and whole grain process。
One system of soft materials: according to the prescription of fine powder of raw materials and accessories mixed (about three minutes), to participate in excessive wetting agent or adhesive mixing into soft materials.
Selection of wetting agents or adhesives
(1) Fine powder, loose texture, poor dryness and viscosity, low solubility in water; choose a strong adhesive, and the amount of adhesive is more。
(2) The solubility in water is high, the raw and auxiliary materials have strong viscosity; wetting agent or adhesive with low viscosity is selected, and the amount of adhesive is relatively small。
(3) It is sensitive to moisture and easy to hydrolyze; water can not be used as the solvent of the adhesive, and absolute ethanol or other inorganic solvent can be used as the solvent of the adhesive.
(4) It is sensitive to heat and easy to decompose; water is not used as the solvent of adhesive as far as possible, and ethanol with certain solubility is chosen as the solvent of adhesive to increase the drying time of particles and reduce the drying temperature。
金凤凰彩票app(5) fluctuations in moisture and heat; use lower cost water as binder solvent.
Soft wood should pay attention to the results:
金凤凰彩票app(1) the variety and dosage of adhesive should be determined according to the nature of the material.
(2) the concentration and stirring time of adhesives should be grasped by different types。
(3) soft material quality。 Because of the difference of raw materials and accessories, it is difficult to set a uniform norm。 Commonly mastered by experience, it can be agglomerated by squeezing with hands, and it can be split by gently pressing fingers。
(4) When making soft materials, the mixing and cutting time should be excessively mastered。 Commonly mastered by experience, it can be agglomerated without sticking hands when squeezed with hands, and the fingers can be split easily when pressed gently。 The cutting time is too long, the viscosity is too strong, the granulation is difficult, the cutting time is short, the viscosity is not strong, and the granulation is not good。
Two, wetting particles: make soft material after 14 mesh or 16 mesh mesh。
The results we should pay attention to when making wet granules:
金凤凰彩票app(1) If the particles fall from the sieve hole like growth strips, indicating that the soft wood is too wet, wetting agent or wetting agent too much. On the contrary, if the soft material is powdery after the sieve, indicating that the soft wood is too dry, it should be adjusted accordingly.
(2) If the sieve device is comparatively loose in granulation and the drum is rotated to and fro to stir and knead, the viscosity of the soft material can be added, and the wet particles produced are thick and tight. On the contrary, the particles are thin and loose. So in consumption, the tightness of the screen is excessive.
Common equipment: rocking granular machine; screen mesh: stainless steel screen.
Three, wet particles dry: wet sieve particles should be dry immediately, so as not to caking or compression deformation.
Dry temperature: the material must be determined by the nature of the ordinary 50-60 C; some of the wet, thermal fluctuations of drugs, the drying temperature can be appropriately increased to 80-100。
Boring level: After measuring the water content to stop control, according to the different types of each detail and preserve the appropriate moisture, usually about 3%.
Circulating oven: a multi-layer bracket is arranged in the dryer, a stainless steel plate is placed on the bracket, and the air is heated by the preheater and enters the drying chamber to stop the drying through the material surface in a degree direction. (Stainless steel discs can be used to open the wet particle stall and turn it over from time to time to deal with wet particle deposit caking and deformation results,)
Features: complex equipment, strong adaptability, but high rest intensity, slow drying speed and high heat consumption.
Boiling granulator: make hot air from bottom to top through lax granular or powder material layer to form a fluidized form and stop drying, also known as boiling dryer.
Features: Complex structure, easy operation, particle and hot air relative movement is intense, large contact area, fast drying.
4. Whole: Wet particles need to be sifted after drying to break up the agglomerated particles to meet the tablet pressing requirements.
Blank Granule Method: For drugs with small dosage and no fluctuation of humidity and heat, auxiliary granules and other drugs with fluctuation of dry and cold can be prepared by wet granulation first, then dry and whole granules, and then mixed with the granules evenly. The method of making dry granules from only auxiliary granules and then mixing the medicines with granules (pressing or partitioning) is called blank granules method.
Properties of raw materials
Wetting agents and adhesives
金凤凰彩票appMoistening agents: A liquid that wets a material to produce a strong enough viscosity to facilitate granulation. The wetting agent itself is non-sticky or non-sticky, but it can wet the material and induce the viscosity of the material itself, so that it can coalesce into soft materials and make particles. Such as distilled water and ethanol.
Adhesives: A viscous solid powder or thin liquid that agglomerates and binds materials that are non-viscous or less viscous to particles or to form compactly. Such as povidone (PVP), hydroxypropyl methylcellulose (HPMC), carboxymethyl cellulose (CMC-Na), syrup and so on.
Two concentrates and absorbents
Concentrates and absorbents are collectively referred to as fillers。 Their effects are as follows: 1。 Adding tablet weight and volume 2。 Increasing the dosage bias of the main ingredients 3。 Improving the drug's compact formability 4。 Improving the activity of small doses 5。 Containing more。