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CN-116785994-B - Preparation method of progesterone vaginal gel

CN116785994BCN 116785994 BCN116785994 BCN 116785994BCN-116785994-B

Abstract

The invention discloses a preparation method of progesterone vaginal gel, which relates to the technical field of gynecological medicine preparation, the preparation method of the progesterone vaginal gel is realized by using a preparation device of the progesterone vaginal gel, the preparation device of the progesterone vaginal gel comprises a mixing kettle, the top of the mixing kettle is fixedly provided with a top plate, the inside of mixing kettle is provided with the drive mechanism of striking off jointly with the roof inboard, the drive is striking off the mechanism outside and is provided with oil phase preparation mechanism, oil phase preparation mechanism outside bottom is provided with water phase preparation mechanism and oil phase preparation mechanism outside top is provided with premix preparation mechanism, roof and water phase preparation mechanism outside are provided with the drive supporting mechanism jointly. The invention can effectively shorten the transfer time of the premix and the oil phase, further improve the preparation efficiency of the finished gel product, and simultaneously can recover the residual oil phase, thereby ensuring the quality of the finished gel product while avoiding the waste of the oil phase.

Inventors

  • XiaHou Qunshan
  • XU QIONG

Assignees

  • 吉安长江生物药业有限公司

Dates

Publication Date
20260512
Application Date
20230627

Claims (8)

  1. 1. The preparation method of the progesterone vaginal gel is characterized by comprising a preparation device of the progesterone vaginal gel, wherein the preparation device of the progesterone vaginal gel comprises a mixing kettle (1), a top plate (2) is fixedly arranged at the top of the mixing kettle (1), a driving scraping mechanism (3) is jointly arranged inside the mixing kettle (1) and inside the top plate (2), an oil phase preparation mechanism (4) is arranged outside the driving scraping mechanism (3), an aqueous phase preparation mechanism (5) is arranged at the bottom outside the oil phase preparation mechanism (4), a premix preparation mechanism (7) is arranged at the top outside the oil phase preparation mechanism (4), a driving supporting mechanism (6) is jointly arranged outside the top plate (2) and the aqueous phase preparation mechanism (5), the inside of the mixing kettle (1) is divided into an upper cavity, a middle cavity and a lower cavity by the premix preparation mechanism (7) and the driving supporting mechanism (6), and an inner cavity is formed inside the oil phase preparation mechanism (4); The driving scraping mechanism (3) comprises a driving shaft (31), a driving motor (32), a lifting plate (33), a connecting pipe (34), a rotating plate (35) and an oleophobic scraping plate (36); The driving shaft (31) penetrates through the top of the inner cavity of the mixing kettle (1) and the top plate (2), and is rotationally connected with the mixing kettle (1) and the top plate (2) through bearings, the driving motor (32) is fixedly arranged at the bottom of the inner cavity of the mixing kettle (1) and is in transmission connection with the driving shaft (31), the lifting plate (33), the connecting pipe (34), the rotating plate (35) and the oleophobic scraping plate (36) are sequentially sleeved on the outer side of the driving shaft (31) from top to bottom, the lifting plate (33) is in transmission connection with the driving shaft (31) through reciprocating threads, one end of the connecting pipe (34) is rotationally nested at the bottom of the lifting plate (33) through bearings, the other end of the connecting pipe is rotationally nested at the top of the rotating plate (35) through bearings, the rotating plate (35) is slidably nested at the outer side of the driving shaft (31) along the vertical direction, and the oleophobic scraping plate (36) is fixedly connected with the driving shaft (31). The oil phase preparation mechanism (4) comprises an outer sleeve (41), an inner sleeve (42), a driving groove (43), a discharging groove (44), an avoiding groove (45), a first magnet (46) and a first stirring rod (47); The utility model discloses a mixing kettle, including outer sleeve (41), inner sleeve (42), driving groove (43), lower silo (44), avoidance groove (45) are provided with in outer sleeve (41) outside bottom, first magnet (46) are provided with two, two first magnet (46) are fixed respectively to be set up in inner sleeve (42) both sides, first puddler (47) are provided with a plurality of, a plurality of first puddler (47) are evenly fixed the cup joint and are set up in drive shaft (31) outside bottom, outer sleeve (41) outside top is evenly offered in driving groove (43), lower silo (44) are offered in outer sleeve (41) outside middle part, avoidance groove (45) are provided with two first magnet (46) are fixed respectively in inner sleeve (42) both sides.
  2. 2. The method for preparing the progesterone vaginal gel according to claim 1, wherein the aqueous phase preparation mechanism (5) comprises a rotary ring (51), a second magnet (52), a first fixed ring (53), a rotary rod (54), a driving gear (55) and a second stirring rod (56).
  3. 3. The method for preparing the progesterone vaginal gel according to claim 2, wherein the rotating ring (51) is slidably sleeved on the outer side of the inner sleeve (42), two second magnets (52) are arranged, the two second magnets (52) are fixedly nested on two sides inside the rotating ring (51), the first fixing ring (53) is rotatably sleeved on the outer side of the rotating ring (51) through a bearing and is fixedly connected with the inner wall of the mixing kettle (1), the rotating rod (54) is fixedly arranged at the bottom of the rotating ring (51), the driving gear (55) is fixedly arranged at the bottom end of the rotating rod (54), a plurality of second stirring rods (56) are arranged, and the plurality of second stirring rods (56) are uniformly and fixedly arranged on the outer side of the rotating rod (54).
  4. 4. The method for preparing the progesterone vaginal gel of claim 3, wherein the driving and supporting mechanism (6) comprises an inner plate (61), an intermediate ring (62), an outer ring (63) and an annular rack (64).
  5. 5. The method for preparing the progesterone vaginal gel according to claim 4, wherein the inner plate (61) is rotatably sleeved on the bottom of the outer side of the driving shaft (31) through a bearing, the middle ring (62) is rotatably arranged on the outer side of the inner plate (61) through the bearing, the rotating rod (54) penetrates through the middle ring (62) and is rotatably connected with the middle ring (62) through the bearing, the outer ring (63) is rotatably sleeved on the outer side of the middle ring (62) through the bearing and is fixedly connected with the inner wall of the mixing kettle (1), and the annular rack (64) is fixedly arranged on the bottom of the outer ring (63) and is meshed with the driving gear (55).
  6. 6. The method for preparing a progesterone vaginal gel according to claim 5, wherein the premix preparation mechanism (7) comprises an annular baffle (71), a rotating sleeve (72), a driving slide (73), a stirring plate (74), a discharging channel (75) and a second fixing ring (76).
  7. 7. The method for preparing the progesterone vaginal gel according to claim 6, wherein the annular baffle plate (71) is sleeved on the outer side of the outer sleeve (41) in a sliding manner and fixedly connected with the inner wall of the mixing kettle (1), the rotary sleeve (72) is rotatably arranged at the top of the annular baffle plate (71) and is jointed with the outer wall of the outer sleeve (41), the driving sliding blocks (73) are arranged at two sides of the inner part of the rotary sleeve (72), the stirring plates (74) and the blanking channels (75) are respectively fixedly arranged at a plurality of positions, the stirring plates (74) are uniformly and fixedly arranged at the bottom of the outer side of the rotary sleeve (72) and are fixedly jointed with the top of the annular baffle plate (71), the blanking channels (75) are uniformly arranged at the bottom of the outer side of the rotary sleeve (72), the stirring plates (74) and the blanking channels (75) are alternately arranged, and the second fixing rings (76) are rotatably sleeved on the top of the rotary sleeve (72) through bearings and are fixedly connected with the inner wall of the mixing kettle (1).
  8. 8. The preparation method of the progesterone vaginal gel as claimed in claim 7, wherein the preparation method of the progesterone vaginal gel specifically comprises the following steps: S1, adding progesterone, carbomer and polycarbophil into an upper chamber, adding glycerin, sorbic acid and purified water into a middle chamber, adding liquid paraffin and hydrogenated palm oil into an inner chamber through an opening at the top of an outer sleeve (41), and then starting a driving motor (32); S2, after the driving motor (32) is started, the driving shaft (31) is driven to continuously rotate, the lifting plate (33) is driven to ascend when the driving shaft (31) rotates, meanwhile, the rotating plate (35) is driven to rotate, the outer sleeve (41) and the inner sleeve (42) are driven to rotate when the rotating plate (35) rotates, and the lifting plate (33) drives the outer sleeve (41) to ascend outside the inner sleeve (42) through the connecting pipe (34) and the rotating plate (35); S3, driving a first stirring rod (47) to uniformly mix materials in an inner cavity when a driving shaft (31) rotates, driving a rotating sleeve (72) to rotate through a driving groove (43) and a driving sliding block (73) when an outer sleeve (41) rotates, driving a plurality of stirring plates (74) to uniformly mix materials in an upper cavity when the rotating sleeve (72) rotates, driving a rotating ring (51) to rotate through a first magnet (46) and a second magnet (52) when the inner sleeve (42) rotates, and driving a second stirring rod (56) to uniformly mix materials in a centering cavity through a rotating rod (54) when the rotating ring (51) rotates; s4, when the rotary rod (54) rotates by taking the driving shaft (31) as the axis, the intermediate ring (62) and the driving gear (55) are driven to synchronously rotate, at the moment, under the action of the annular rack (64), the driving gear (55) drives the rotary rod (54) to rotate, so that the second stirring rod (56) revolves by taking the driving shaft (31) as the axis and synchronously rotates by taking the rotary rod (54) as the axis; S5, when the rising distance of the lifting plate (33) reaches a first threshold value, the driving sliding block (73) slides to the inner side of the blanking groove (44) from the driving groove (43), at the moment, the rotating sleeve (72) is not rotated any more, then the uniformly mixed material in the annular baffle (71) enters the inner side of the blanking groove (44) through a plurality of blanking channels (75), and then slides outwards along the inner wall of the blanking groove (44), so that the material is uniformly thrown into the material in the middle chamber; S6, when the rising distance of the lifting plate (33) reaches a second threshold value, the bottom of the inner cavity of the outer sleeve (41) is attached to the top of the outer side of the inner sleeve (42), and then the outer sleeve (41) drives the inner sleeve (42) to synchronously rise along with the continuous rising of the lifting plate (33), in the rising process of the inner sleeve (42), materials in the inner cavity enter the middle cavity from the opening at the bottom of the inner sleeve (42) and are mixed with the materials in the middle cavity, and at the moment, the first stirring rod (47) also starts to uniformly mix the materials in the middle cavity; S7, when the rising distance of the lifting plate (33) reaches a third threshold value, the oleophobic scraping plate (36) enters the inner side of the inner sleeve (42), and then the oleophobic scraping plate (36) scrapes the material remained on the inner wall of the inner sleeve (42) and falls into the middle cavity when the lifting plate (33) continues to rise, and meanwhile the rotating ring (51) also scrapes the material remained on the outer wall of the inner sleeve (42); S8, when the rising distance of the lifting plate (33) reaches a fourth threshold value, the inner sleeve (42) is moved out of the inner side of the rotary ring (51), at the moment, the rotary ring (51) is not rotated any more, when the rising distance of the lifting plate (33) reaches a fifth threshold value, the oleophobic scraping plate (36) reaches the bottom opening of the inner sleeve (42), and then the materials in the middle chamber are uniformly mixed along with the continuous mixing of the first stirring rod (47) to prepare a progesterone vaginal gel finished product; s9, outputting the progesterone vaginal gel finished product, and then lifting the lifting plate (33) by a distance When the sixth threshold is reached, the lifting plate (33) moves to the topmost end of the reciprocating thread outside the driving shaft (31), The lifting plate (33) moves downwards to reset along with the continuous rotation of the driving shaft (31).

Description

Preparation method of progesterone vaginal gel Technical Field The invention relates to the technical field of gynecological medicine preparation, in particular to a preparation method of progesterone vaginal gel. Background Progesterone is an important component for regulating female reproductive system, and mainly acts on female uterus, ovary, breast and central nervous system, and when female is in menstrual cycle and luteal phase during pregnancy, blood concentration of progesterone in body is high, and endogenous progesterone can transform endometrium from hyperplasia phase to secretion phase, and maintain normal physiological change. The patent of the invention of the issued publication No. CN 113288865B discloses a preparation method of progesterone vaginal gel, which comprises the steps of preparing a premix of raw material medicine progesterone and polymer, then adding the premix into a water phase to obtain a hydrogel phase, adding a proper amount of sodium hydroxide solution, and adjusting the pH value to 2.5-3.5 to obtain the progesterone vaginal gel. However, the above preparation method has some drawbacks found by those skilled in the art after practical application, and it is obvious that the transfer operation between different containers is required after the preparation of the premix and the oil phase to achieve the mixing of the premix and the water phase and the mixing of the oil phase and the hydrogel phase, and the transfer between different containers inevitably results in an increase in the preparation time and a decrease in the preparation efficiency when applied to the industrial production operation. The oil phase still has part attached to the inside of the original container after the transfer is finished due to the self characteristics of the oil phase, and the transfer is not only completely caused to waste the oil phase, but also the actual proportion of the oil phase to the hydrogel phase is affected, so that the quality of the finished progesterone vaginal gel is affected. Therefore, it is necessary to invent a method for preparing a progesterone vaginal gel to solve the above problems. Disclosure of Invention The invention aims to provide a preparation method of progesterone vaginal gel, which aims to solve the problems in the background technology. The preparation method of the progesterone vaginal gel is realized by using a preparation device of the progesterone vaginal gel, the preparation device of the progesterone vaginal gel comprises a mixing kettle, a top plate is fixedly arranged at the top of the mixing kettle, a driving scraping mechanism is jointly arranged inside the mixing kettle and inside the top plate, an oil phase preparation mechanism is arranged outside the driving scraping mechanism, an aqueous phase preparation mechanism is arranged at the bottom outside the oil phase preparation mechanism, a premix preparation mechanism is arranged at the top outside the oil phase preparation mechanism, a driving bearing mechanism is jointly arranged outside the top plate and the aqueous phase preparation mechanism, the premix preparation mechanism and the driving bearing mechanism divide the inside of the mixing kettle into an upper chamber, a middle chamber and a lower chamber, and an inner chamber is formed inside the oil phase preparation mechanism; the driving scraping mechanism comprises a driving shaft, a driving motor, a lifting plate, a connecting pipe, a rotating plate and an oleophobic scraping plate; The driving shaft penetrates through the top of the inner cavity of the mixing kettle and the top plate and is rotationally connected with the mixing kettle and the top plate through bearings, the driving motor is fixedly arranged at the bottom of the inner cavity of the mixing kettle and is in transmission connection with the driving shaft, the lifting plate, the connecting pipe, the rotating plate and the oleophobic scraping plate are sequentially sleeved on the outer side of the driving shaft from top to bottom and are in transmission connection with the driving shaft through reciprocating threads, one end of the connecting pipe is rotationally nested on the bottom of the lifting plate through bearings and the other end of the connecting pipe is rotationally nested on the top of the rotating plate through bearings, the rotating plate is slidingly nested on the outer side of the driving shaft along the vertical direction, and the oleophobic scraping plate is fixedly connected with the driving shaft; The oil phase preparation mechanism comprises an outer sleeve, an inner sleeve, a driving groove, a discharging groove, an avoiding groove, a first magnet and a first stirring rod; The utility model discloses a mixing kettle, including outer sleeve, inner sleeve, driving groove, first puddler, outer sleeve slip run through setting up in the mixing kettle top, the inner sleeve slides the nestification along vertical direction and sets up in the outer sleeve inboa