CN109718100B - Aseptic refining process for medicinal materials - Google Patents
Aseptic refining process for medicinal materials Download PDFInfo
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- CN109718100B CN109718100B CN201811637985.3A CN201811637985A CN109718100B CN 109718100 B CN109718100 B CN 109718100B CN 201811637985 A CN201811637985 A CN 201811637985A CN 109718100 B CN109718100 B CN 109718100B
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Abstract
The invention relates to the field of pharmaceutical preparation, and discloses a sterile refining process of a pharmaceutical raw material, which comprises the following steps: A. dissolving crude drug; B. crystallizing; C. drying; D. charging; in order to solve the problems that in the process of preparing a refined original drug in the prior art, the refined original drug is contacted with people so that impurities and bacteria can be doped in the refined original drug, the impurities and the bacteria in the original drug are removed or the original drug is prevented from being contacted with the impurities and the bacteria from the beginning to the end of the whole process of preparing the original drug, thereby achieving aseptic production and greatly reducing insoluble impurities.
Description
Technical Field
The invention relates to the technical field of pharmaceutical preparation, in particular to a sterile refining process of pharmaceutical raw materials.
Background
In general, a crude drug of a pharmaceutical used as an active ingredient of the pharmaceutical is directly administered into the body by, for example, subcutaneous, intradermal, or lode injection, or orally administered. Therefore, pharmaceutical raw materials are required to be free of impurities and to have high sterility or dust-free properties. For example, a drug substance for injection is produced by synthesizing a chemical substance as a target product in a synthesis step and subjecting the resultant to a purification step for removing impurities. The sterility or dustless property of the drug substance of the pharmaceutical product is achieved by a purification step after synthesis. In the purification step, the synthesized crude drug of a pharmaceutical is dissolved in a solvent, sterilized by sterile filtration, and then subjected to crystallization by a crystallization solvent, filtration, drying, filling into a container, and the like in this order to produce a purified drug of a pharmaceutical of desired quality.
For example, as a general pharmaceutical production apparatus, a production apparatus disclosed in patent document 1 is known. Patent document 1 discloses a configuration in which each process is performed in an independent working room (clean room) as much as possible; the structure of the manufacturing equipment can reduce pollution. Patent document 1, Japanese patent application laid-open No. 6-143067.
However, in the production process of a purified drug, when each process is performed in an independent working room as much as possible as in patent document 1, for example, when the drug is transferred between the processes, the drug may be exposed to the air outside the apparatus. In particular, in the step of taking out the dried powdered purified drug from the dryer and the step of filling the container with the powdered purified drug, the drug is easily exposed to the air outside the apparatus. In addition, in the step of taking out the dried powdered pharmaceutical purified drug from the dryer and the step of filling the powdered pharmaceutical purified drug into the container, the ginseng and the operation are often performed from the viewpoint of efficiency of the operation.
The purified drug substance of the drug is placed in the atmosphere outside each device, and the mixing of foreign substances or fine particles is also allowed. In addition, when ginseng is used in a work, foreign substances derived from living bodies such as fibers, hair, and skin pieces of clothes may be mixed. Further, the quality of the pharmaceutical may be degraded by decomposition or change of the drug substance due to oxygen or moisture in the environment outside the apparatus. Generally, in order to create a sterile and dust-free environment, clean air having a constant flow rate filtered by a HEPA filter is allowed to flow in one direction. However, since an apparatus for performing a purification process of a pharmaceutical raw material is very large, it is very difficult to manufacture all the working chambers in a highly sterile and dust-free environment. In addition, in order to efficiently deliver a powdered purified drug, a person needs to be involved directly.
Disclosure of Invention
The invention aims to provide a sterile and refined process of a pharmaceutical raw material, which can prevent a person from contacting the raw material and can ensure the aseptic and dustless production of the raw material.
The aseptic refining process of the technical scheme of the invention for the raw medicine of the medicine comprises the following steps:
A. dissolving crude raw medicines: putting the crude drug into a dissolving tank for dissolving; the liquid temperature was kept at 25 ℃; after dissolution, adding activated carbon, carrying out decolorization treatment for 10 minutes, and then cooling to 15 ℃;
B. and (3) crystallization: firstly, carrying out nitrogen replacement on a crystallization tank, then enabling the crude drug solution to pass through an activated carbon filtering filter, a1 st filter and a 2 nd filter at a specified filtering pressure, wherein the size of the 1 st filter is smaller than that of the activated carbon filtering filter, and the size of the 2 nd filter is smaller than that of the 1 st filter, and transferring the crude drug solution into the crystallization tank; setting the crystallization temperature to 10 ℃, adding acetone, crystallizing and curing at 5 ℃, and curing for 1-5 h to obtain original drug crystals;
C. and (3) drying: transferring the slurry containing crystallized raw drug into a filter dryer, and filtering; stopping stirring the slurry, feeding nitrogen gas into the filter dryer, and drying at 25 ℃ while rotating the stirring blade at a stirring speed of 2 rpm; after drying, carrying out nitrogen purging in a filtering dryer, and then discharging the refined raw pesticide from the filtering dryer;
D. charging: putting refined raw medicine into a conveying pipe, conveying the refined raw medicine into a hopper through a vibration conveying pipe, introducing nitrogen into a crushing box, sucking out the nitrogen in the crushing box, replacing gas in the crushing box, unloading the refined raw medicine into the crushing box from the hopper, introducing nitrogen into the crushing box, crushing for 40min, then discharging the crushed refined raw medicine into a medicine storage box, and storing the refined raw medicine by the medicine storage box.
The technical principle and the beneficial effects of the scheme are as follows:
1. according to the scheme, the production equipment is replaced by the inert gas, so that the interior of the production equipment is clean, sundries and dust are prevented from accumulating, and the sterility of the equipment is ensured, so that the prepared raw pesticide is cleaner; the refined raw medicine is dried and blown by inert gas, so that the raw medicine is dustless and aseptic.
2. The scheme performs multi-stage filtration on crude drugs, also performs multi-stage filtration on other added reagents, and can completely filter out impurities such as fibers, hair, skin pieces and the like in all substances, so that the prepared crude drugs are aseptic.
3. The scheme is characterized in that refined raw medicine crystals are conveyed in a fully-mechanized mode, the refined raw medicine crystals are crushed in a mode of combining nitrogen and a vacuum pump, the refined raw medicine crystals are prevented from contacting with air in the crushing process, the dryness of the refined raw medicine is guaranteed, the refined raw medicine is also prevented from contacting with dust, bacteria and the like, and the sterility of the refined raw medicine is further guaranteed.
4. The whole in-process of preparing former medicine of this scheme uses inert gas replacement production facility from the beginning, then carries out the multiple stage filtration to former medicine and the reagent that adds, also uses inert gas to carry out the drying to former medicine, and the mode that at last full mechanized transport and let in nitrogen gas and vacuum pump combination is broken to refined former medicine crystallization, and the combination of above mode is got rid of or is prevented the contact of former medicine and impurity, bacterium to impurity, bacterium in the former medicine all the time to reached aseptic production, the very big reduction of insoluble impurity.
Further, in step a, hydrochloric acid is used to adjust pH during the dissolution of the crude drug. Prevent the medicine from being too acidic or alkaline, so that the medicine has better quality.
Further, in step B, the crystallization tank was subjected to nitrogen substitution 5 times. The replacement of the crystallization tank is more complete, air residue is prevented, and the interior of the crystallization tank is more aseptic.
Further, in step B, the crystallization temperature was set at 10 ℃ and 2200L of acetone as the 2 nd solvent which had been subjected to sterile filtration was charged at a flow rate of 900L/h while stirring at a rotation speed of 10rpm of the stirring blade. The acetone is added with stirring, so that the acetone is easier to be uniformly mixed with the original medicine.
Further, in the step C, drying is carried out at the temperature of 25 ℃, and the drying time is 16-24 h. Drying for 16-24 h, so that the water content in the refined raw medicine is lower, and the refined raw medicine is more fully dried.
Further, in the step C, pressure filtration was performed at a pressure of 0.1 to 0.18 MPa. The pressure filtration enhances the filtering effect, so that the filtration is faster, and the accumulation of the original medicine is prevented.
Drawings
FIG. 1 is a front sectional view of an air ring cooling device according to an embodiment of the present invention;
fig. 2 is an enlarged schematic view at a1 in fig. 1.
Detailed Description
The following is further detailed by way of specific embodiments:
reference numerals in the drawings of the specification include: the device comprises a medicine containing box 1, a material conveying pipe 2, a hopper 3, a material discharging pipe 4, a slide valve 5, a slide valve 6, a magnet 7, an electromagnet 8, a motor 9, a cylinder 10, a crushing box 11, a nitrogen gas pipe 12, a medicine containing box 13, a material discharging valve 14, a medicine containing bottle 15, a piston cylinder 16, a first check valve 17, a second check valve 18, a bottle taking port 19, a striking hammer 20, a speed reducer 21, a first cam 22, a second cam 23, a first spline cylinder 24, a second spline cylinder 25, a speed reducer output shaft 26, a second spline shaft 27, a first external spline gear 28 and a second external spline gear 29.
Example (b): the aseptic refining process of medicinal products includes the following steps:
A. dissolving crude raw medicines: dissolving 100kg of crude drug in a dissolving tank filled with 400L of water; the liquid temperature was kept at 25 ℃ and stirring was carried out by means of a stirring blade at a stirring speed of 90 rpm. After dissolution, the pH was adjusted using hydrochloric acid, 4.5 to 5.5kg of activated carbon was added, and after 10 minutes of decolorization treatment, the mixture was cooled to 15 ℃.
B. And (3) crystallization: firstly, performing nitrogen replacement on a crystallization tank for 5 times, so that the crude drug solution passes through an activated carbon filtering filter, a1 st filter and a 2 nd filter at a specified filtering pressure, wherein the size of the 1 st filter is smaller than that of the activated carbon filtering filter, and the size of the 2 nd filter is smaller than that of the first filter, and is transferred into the crystallization tank; the crystallization temperature was set to 10 ℃, acetone was added as a 2 nd solvent, which was sterile-filtered and a total of 2200L, at a flow rate of 900L/h while stirring at a rotation speed of a stirring blade of 10rpm, and the crystals were aged at 5 ℃ for 1 to 5 hours to obtain crude crystals.
C. And (3) drying: the slurry containing the crystallized raw drug was transferred into a filter dryer, and after the cake surface was confirmed to be flat, pressure filtration was performed at a pressure of 0.1 to 0.18 MPa. After the mother liquor washing and the acetone washing (300L) were performed, the stirring blade was raised and stopped; drying the mixture at 25 ℃ under reduced pressure for 16 to 24 hours while feeding a predetermined amount (10 to 50L/min) of nitrogen gas to the stirring blade (air knife) and rotating the stirring blade at a stirring speed of 2 rpm; after drying, the purified crude drug was carried out from the filter dryer through a carrying-out port (gate valve) by blowing nitrogen gas at 0.01MPa and rotating the stirring blade at 2rpm and the nitrogen gas blowing and the stirring blade.
D. Charging: as shown in fig. 1 and fig. 2, a powder charging device is needed, the powder charging device comprises a powder charging box 1, an inclined material conveying pipe 2 is fixedly connected in the powder charging box 1, a striking hammer 20 is hinged at the bottom of the material conveying pipe 2, a first spring is connected between the striking hammer 20 and the material conveying pipe 2, a first spline shaft is rotatably connected in the powder charging box 1, a first cam 22 is fixedly connected with the first spline shaft, the first cam 22 abuts against the striking hammer 20, a fixed rod is slidably connected in the powder charging box 1, a first spline cylinder 24 and a second spline cylinder 25 are rotatably connected on the fixed rod, the first spline cylinder 24 is in spline connection with the first spline shaft, an air cylinder 10 is fixedly connected in the powder charging box 1, an output shaft of the air cylinder 10 is fixedly connected with the fixed rod, a second spline shaft 27 is rotatably connected in the powder charging box 1, the second spline shaft 27 is used for spline connection with the first spline cylinder 24, a first external spline gear 28 is fixedly connected on the second spline, a second external spline gear 29 is fixedly connected to the second spline cylinder 25, the first external spline gear 28 is meshed with the second external spline gear 29, the exterior of the medicine containing box 1 is fixedly connected with a motor 9, an output shaft of the motor 9 is fixedly connected with a speed reducer 21, an output shaft 26 of the speed reducer is in flat key connection with a second spline shaft 27, a third spline shaft is rotatably connected to the medicine containing box 1 and is used for being in spline connection with the second spline cylinder 25, a second cam 23 is fixedly connected to the third spline shaft, a piston cylinder 16 is fixedly connected to the interior of the medicine containing box 1, a piston is slidably connected to the piston cylinder 16, a piston rod is fixedly connected to the piston and abuts against the second cam 23, a second spring is connected between the piston and the bottom of the piston cylinder 16, a hopper 3 is fixedly connected to the interior of the medicine containing box, a material conveying pipe 2 is communicated with the hopper 3, a material discharging pipe 4 is communicated with the, a third spring is connected between a valve rod of the slide valve 6 and the discharge pipe 4, a magnet 7 is fixedly connected at the right end of the valve rod of the slide valve 6, an electromagnet 8 which is attracted with the magnet 7 is fixedly connected in the medicine charging box 1, the electromagnet 8 is positioned at the right side of the magnet 7, a crushing box 11 is also fixedly connected in the medicine charging box 1, a crushing hammer is rotationally connected in the crushing box 11, the crushing box 11 is communicated with the discharge pipe 4, a communicating pipe is communicated between the crushing box 11 and the piston cylinder 16, a first check valve 17 which admits air into the piston cylinder 16 is installed on the communicating pipe, the bottom of the piston cylinder 16 is communicated with an air outlet pipe, a second check valve 18 which gives out air from the piston cylinder 16 is installed on the air outlet pipe, the outlet of the air outlet pipe faces the motor 9, the bottom of the crushing box 11 is communicated with a nitrogen pipe 12, a medicine storage box 13, the bottom of the medicine storage box 13 is provided with a medicine storage bottle 15 for receiving medicine, and the medicine storage box 1 is provided with a bottle opening 19.
The refined raw medicine is introduced into the inclined conveying pipe 2, and the raw medicine which is just refined has larger volume and is not easy to slide in the conveying pipe 2, so the conveying pipe 2 needs to be vibrated to enable the refined raw medicine to slide in the hopper 3, the motor 9 is started, the motor 9 drives the second spline shaft 27 to rotate through the speed reducer 21, the second spline shaft 27 drives the first spline cylinder 24 to rotate, the first spline shaft drives the first spline shaft to rotate, the first spline shaft drives the first cam 22 to rotate, the first cam 22 drives the striking hammer 20 to strike the conveying pipe 2 in a reciprocating manner, so that the conveying pipe 2 vibrates, and the material is conveyed into the hopper 3; the second spline shaft 27 also drives the first external spline gear 28 to rotate, the first external spline gear 28 will drive the second external spline gear 29 to rotate, and the second external spline gear 29 will drive the third spline cylinder to rotate.
Introducing nitrogen into the crushing box through a nitrogen pipe 12, sucking out the nitrogen in the crushing box, replacing the gas in the crushing box, starting the air cylinder 10 when the weight of the refined raw pesticide in the hopper 3 is enough, enabling the air cylinder 10 to push the fixed rod to move leftwards, enabling the first spline cylinder 24 to be separated from the second spline shaft 27, enabling the first spline cylinder 24 and the first spline shaft to stop rotating, enabling the first cam 22 to stop rotating, enabling the striking hammer 20 to stop striking, enabling the second spline cylinder 25 to be combined with the third spline shaft, enabling the second spline shaft 27 to drive the third spline shaft to rotate, enabling the third spline shaft to drive the second cam 23 to rotate, enabling the second cam 23 to drive the piston rod to reciprocate, and enabling the piston rod to drive the piston to reciprocate; simultaneously to 8 circular telegrams of electro-magnet, electro-magnet 8 attracts magnet 7 to move right, and magnet 7 drives the valve rod and moves right, and slide valve 6 will be opened, and the medicine in the hopper 3 will enter into broken case 11 in, treat that the whole back that flow into broken case 11 of medicine in the hopper 3, stop to the circular telegram of electro-magnet 8, slide valve 6 will be closed, begin to carry out the breakage to the medicine.
Rotating the crushing blades, and crushing the medicine by the crushing blades; at broken in-process, continue to let in nitrogen gas in the nitrogen gas pipe 12, nitrogen gas enters into broken case 11 from broken case 11 bottom, and drive the medicine motion, strengthen the mutual motion of medicine and broken blade, thereby improve crushing effect, simultaneously when the piston downstream, form the negative pressure in the piston cylinder 16, will inhale the piston cylinder 16 to the nitrogen gas in broken case 11 in, when the piston upstream, the piston cylinder 16 will push nitrogen gas in the outlet duct, nitrogen gas flows along the outlet duct, and sweep motor 9, thereby play the effect of supplementary cooling to motor 9, the reciprocating motion of piston, can be intermittent type to broken incasement 11 nitrogen gas suction, strengthen the air current motion, thereby make the medicine motion more violent, further strengthen crushing effect.
After crushing for 40min, opening the discharge valve 14 on the discharge pipe after the crushing is finished, feeding the crushed raw medicines into the medicine storage box 13, and then loading the raw medicines into the medicine storage bottle 15 through the medicine storage box 13 for sealing and storing.
The foregoing is merely an example of the present invention and common general knowledge of known specific structures and features of the embodiments is not described herein in any greater detail. It should be noted that, for those skilled in the art, without departing from the structure of the present invention, several changes and modifications can be made, which should also be regarded as the protection scope of the present invention, and these will not affect the effect of the implementation of the present invention and the practicability of the patent. The scope of the claims of the present application shall be determined by the contents of the claims, and the description of the embodiments and the like in the specification shall be used to explain the contents of the claims.
Claims (5)
1. The aseptic refining process of the medicinal product is characterized by comprising the following steps:
A. dissolving crude raw medicines: putting the crude drug into a dissolving tank for dissolving; keeping the liquid temperature at 25 ℃, and then using hydrochloric acid to adjust the pH value so as to prevent the medicine from being too acidic or alkaline; after dissolution, adding activated carbon, carrying out decolorization treatment for 10 minutes, and then cooling to 15 ℃;
B. and (3) crystallization: firstly, carrying out nitrogen replacement on a crystallization tank, then enabling the crude drug solution to pass through an activated carbon filtering filter, a1 st filter and a 2 nd filter at a specified filtering pressure, wherein the size of the 1 st filter is smaller than that of the activated carbon filtering filter, and the size of the 2 nd filter is smaller than that of the 1 st filter, and transferring the crude drug solution into the crystallization tank; setting the crystallization temperature to 10 ℃, adding acetone, crystallizing and curing at 5 ℃, and curing for 1-5 h to obtain original drug crystals;
C. and (3) drying: transferring the slurry containing crystallized raw drug into a filter dryer, and filtering; stopping stirring the slurry, feeding nitrogen gas into the filter dryer, and drying at 25 ℃ while rotating the stirring blade at a stirring speed of 2 rpm; after drying, carrying out nitrogen purging in a filtering dryer, and then discharging the refined raw pesticide from the filtering dryer;
D. charging: relates to a powder charging device, which comprises a powder charging box, wherein an inclined delivery pipe is fixedly connected in the powder charging box, the bottom of the delivery pipe is hinged with a striking hammer, a first spring is connected between the striking hammer and the delivery pipe, a first spline shaft is rotationally connected in the powder charging box, a first cam is fixedly connected with the first spline shaft, the first cam is abutted against the striking hammer, a fixed rod is slidably connected in the powder charging box, a first spline cylinder and a second spline cylinder are rotationally connected on the fixed rod, the first spline cylinder is in spline connection with the first spline shaft, a cylinder is fixedly connected in the powder charging box, an output shaft of the cylinder is fixedly connected with the fixed rod, a second spline shaft is rotationally connected in the powder charging box, the second spline shaft is in spline connection with the first spline cylinder, a first external spline gear is fixedly connected on the second spline shaft, a second external spline gear is fixedly connected on the second spline cylinder, the first external spline gear is meshed with the second external spline gear, a motor is fixedly connected to the outside of the medicine charging box, a speed reducer is fixedly connected to an output shaft of the motor, an output shaft of the speed reducer is connected with a flat key of a second spline shaft, a third spline shaft is connected in the medicine charging box in a rotating mode and is used for being in spline connection with the second spline shaft, a second cam is fixedly connected to the third spline shaft, a piston cylinder is fixedly connected to the inside of the medicine charging box, a piston is connected in the piston cylinder in a sliding mode, a piston rod is fixedly connected to the piston and abuts against the second cam, a second spring is connected between the piston and the bottom of the piston cylinder, a hopper is fixedly connected to the inside of the medicine charging box, a material conveying pipe is communicated with the hopper, a material discharging pipe is communicated with the bottom of the hopper, a sliding valve is installed on the material discharging pipe, a third spring is connected between, the electromagnet is positioned at the right side of the magnet, a crushing box is fixedly connected in the medicine containing box, a crushing hammer is rotationally connected in the crushing box, the crushing box is communicated with the discharge pipe, a communicating pipe is communicated between the crushing box and the piston cylinder, a first check valve for introducing air into the piston cylinder is installed on the communicating pipe, the bottom of the piston cylinder is communicated with an air outlet pipe, a second check valve for discharging air from the piston cylinder is installed on the air outlet pipe, the outlet of the air outlet pipe faces towards the motor, the bottom of the crushing box is communicated with a nitrogen pipe, a medicine storing box is fixedly connected in the medicine containing box, the crushing box is communicated with the medicine storing box to form a discharge pipe, a discharge valve is installed on the discharge pipe, a medicine storing;
putting refined raw medicine into a conveying pipe, conveying the refined raw medicine into a hopper through a vibration conveying pipe, introducing nitrogen into a crushing box, sucking out the nitrogen in the crushing box, replacing gas in the crushing box, unloading the refined raw medicine into the crushing box from the hopper, introducing nitrogen into the crushing box, crushing for 40min, then discharging the crushed refined raw medicine into a medicine storage box, and storing the refined raw medicine by the medicine storage box.
2. The aseptic refining process of pharmaceutical raw materials according to claim 1, characterized in that: in the step B, the nitrogen gas replacement is performed on the crystallization tank for 5 times.
3. The aseptic refining process of pharmaceutical raw materials according to claim 2, characterized in that: in the step B, the crystallization temperature was set to 10 ℃ and 2200L of acetone as the 2 nd solvent was aseptically filtered and fed at a flow rate of 900L/h while stirring at a rotation speed of 10rpm of the stirring blade.
4. The aseptic refining process of pharmaceutical raw materials according to claim 3, characterized in that: and in the step C, drying is carried out at the temperature of 25 ℃ for 16-24 h.
5. The aseptic refining process of pharmaceutical raw materials according to claim 4, characterized in that: in the step C, the pressure filtration is carried out at a pressure of 0.1 to 0.18 MPa.
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| CN201811637985.3A CN109718100B (en) | 2018-12-29 | 2018-12-29 | Aseptic refining process for medicinal materials |
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| CN201811637985.3A CN109718100B (en) | 2018-12-29 | 2018-12-29 | Aseptic refining process for medicinal materials |
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| CN109718100B true CN109718100B (en) | 2021-06-25 |
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| CN115569722A (en) * | 2022-12-07 | 2023-01-06 | 徐州盛斗士生物科技有限公司 | Traditional Chinese medicine crushing and milling equipment for nephrosis in traditional Chinese medicine internal medicine |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH06143067A (en) * | 1992-10-29 | 1994-05-24 | Sando Yakuhin Kk | Manufacturing plant for high quality product |
| CN103635175A (en) * | 2011-07-06 | 2014-03-12 | 亚碧株式会社 | Sterile refining apparatus for active pharmaceutical ingredients |
| CN104161729A (en) * | 2014-05-22 | 2014-11-26 | 杭州长典医药科技有限公司 | Special ultrafine potassium sodium dehydroandroandrographolide succinate powder preparation and preparation method thereof |
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2018
- 2018-12-29 CN CN201811637985.3A patent/CN109718100B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH06143067A (en) * | 1992-10-29 | 1994-05-24 | Sando Yakuhin Kk | Manufacturing plant for high quality product |
| CN103635175A (en) * | 2011-07-06 | 2014-03-12 | 亚碧株式会社 | Sterile refining apparatus for active pharmaceutical ingredients |
| CN104161729A (en) * | 2014-05-22 | 2014-11-26 | 杭州长典医药科技有限公司 | Special ultrafine potassium sodium dehydroandroandrographolide succinate powder preparation and preparation method thereof |
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