CN112274545A

CN112274545A - Production process of red ginseng extract tablet

Info

Publication number: CN112274545A
Application number: CN202011286316.3A
Authority: CN
Inventors: 刘伟德; 孙红梅; 李振; 陈结梅
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-11-17
Filing date: 2020-11-17
Publication date: 2021-01-29

Abstract

The invention relates to the technical field of red ginseng tablets, in particular to a production process of a red ginseng extract tablet, which comprises the following steps: coarsely crushing and sieving; extracting; concentrating; drying and crushing for the first time; granulating; drying for the second time; finishing the grains; totally mixing; tabletting; detecting metal; and (6) bottling. The yield of the three batches of red ginseng medicinal materials to extract is about 15.0%, the fluctuation is small, and the trial production condition is stable; selecting magnesium of magnesium stearate as an indication index for the total mixing uniformity, setting the total mixing time to be 30min, detecting the content of magnesium by taking the front sample, the middle sample and the rear sample respectively, and mixing for 30min because the content deviation is not large according to a detection result; three batches of trial production show that the yield is relatively ideal, and the large-scale production can be carried out.

Description

Production process of red ginseng extract tablet

Technical Field

The invention relates to the technical field of red ginseng tablets, in particular to a production process of a red ginseng extract tablet.

Background

The red ginseng is a cooked product of ginseng, has the effects of tonifying primordial qi, tonifying spleen and lung, promoting the production of body fluid and soothing the nerves, has the characteristics of warmer property, large and powerful fire and strong efficacy, and is better than tonifying primordial qi, restoring yang and rescuing from collapse, and tonifying qi and controlling blood. From the perspective of health care and body building, red ginseng is a good tonic product for people with deficiency of qi and blood and yang deficiency, and can be used for tonifying people with frequent cold feeling, unhealthy hands and feet, dizziness, lassitude, weakness of limbs, easy fatigue, shortness of breath, dyspnea, frequent cold in stomach, long-term diarrhea, insomnia, dreaminess, impotence, frequent micturition and the like. The red ginseng is reasonably developed and utilized to regulate physiological problems of physical overdriving, physical weakness, malnutrition, mental weariness, fatigue, weakness and the like caused by frequent staying up of mental and physical workers, and becomes a necessary development trend in the technical field of red ginseng tablets in the future.

The existing red ginseng extract tablets have low production efficiency, large loss and unsatisfactory yield.

Disclosure of Invention

In order to solve the technical problems, the invention provides a production process of red ginseng extract tablets with high efficiency and ideal yield.

The invention adopts the following technical scheme:

a production process of a red ginseng extract tablet comprises the following steps:

coarse crushing and sieving: pulverizing raw materials of Ginseng radix Rubri and sieving with 5 mesh sieve;

extraction: extracting for three times, wherein the maximum feeding amount of each tank is 500kg, 10 times of water is added for the first time, 8 times of water is added for the second time, 8 times of water is added for the third time, the temperature is 95 +/-5 ℃, and each time lasts for 1.5 hours; the filtering fineness of the precision filter is 15 mu m;

concentration: concentrating under reduced pressure at 78 + -6 deg.C under negative pressure of 0.04-0.08 MPa to obtain concentrated solution with concentration specific gravity of 1.05-1.07(75 + -6 deg.C);

drying and crushing for the first time: adding 1/2 filler when the concentrated solution is further concentrated to specific gravity of 1.08-1.10 to obtain mixed powder; drying the mixed powder until the water content is 4-5%; pulverizing the dried material, and sieving with 100 mesh sieve to obtain Ginseng radix Rubri extract powder;

and (3) granulating: preparing an adhesive; putting the weighed red ginseng extract powder, D-mannitol and microcrystalline cellulose into a wet granulator; covering a granulator cover, stirring and chopping the dry powder for 5 minutes, wherein the stirring frequency is 32Hz, and the chopping frequency is 14Hz, so as to ensure that the materials are uniformly mixed; after the dry powder is uniformly stirred, adjusting the stirring frequency to be 14Hz, cutting the dry powder to be 7HZ, adding an adhesive, adding 20-25% of white granulated sugar syrup into each pot of granulated materials, carefully observing the state of the materials, and judging whether the white granulated sugar syrup needs to be continued according to the particle size and the dryness and wetness degree of the materials; adding the prepared material into a swing granulator, sieving with a 20-mesh sieve, and performing swing granulation;

and (3) secondary drying: opening hot air circulation oven drying equipment, and drying the prepared particles for 100-65 ℃ for 120 minutes at the drying temperature of 60-65 ℃; after drying, sampling and measuring the moisture of the particles; if the moisture content of the dried particles is detected to be qualified, entering the next procedure; if the water content is higher than the standard requirement, reworking and boiling and drying again until the water content meets the requirement;

straightening: grading the second dried granules to 20 meshes;

total mixing: adding magnesium stearate into the granules in the granule finishing step; putting the materials into a total mixer according to a feeding table, setting the rotating speed of a main shaft of the total mixer to be 6 revolutions per minute, sampling when mixing for 20 minutes and 30 minutes, uniformly taking 3 points respectively according to the stages before, during and after mixing to measure the magnesium content, and performing the next process after confirming that the materials are uniformly mixed according to the detection result; marking the mixed materials, conveying the materials to an intermediate station for temporary storage and recording;

tabletting: thoroughly cleaning and disinfecting equipment before tabletting, and checking the running condition of the equipment; ensuring the production environment (the relative humidity is less than or equal to 65 percent and the temperature is 18-26 ℃) of a production workshop; the mixed materials are sterilized in time after the outer package is removed between the outer package removing room, and material marks are pasted on the inner package in time; adding the sterilized mixture into a hopper, testing the pressure at low speed, and adjusting the size of the tablets to be 1.0g +/-5% according to the process requirement; passing the pressed tablets through a rotary vibrating screen to remove powder of the tablets;

and (3) metal detection: passing the tablets through a metal detector; rechecking the tablets removed by the metal detector on other verified metal detectors once again, wherein the tablets passing through the metal detector are qualified, and the tablets not passing through the metal detector are discarded;

bottling: before production, packaging materials, including 150ml bottles, bottle caps, electromagnetic films and moisture-proof beads, are placed in a buffer room, sterilized by ultraviolet rays for 30 minutes and then sent into a filling room; wiping and disinfecting the filling machine table with 75% alcohol before filling; arranging the bottles on a bottle feeder of a counting machine, and enabling the bottle openings to face upwards; putting the filled tablets into a hopper of a tablet counting machine; setting the index of a tablet counting machine as 120 tablets, adjusting the electric eye and speed simultaneously to ensure the accuracy and normal speed of the counting, adjusting the speed of delivering the tablets and ensuring that one tablet passes through the electric eye; detecting a storage bin of the particle counting machine in the filling process to ensure that the particle counting machine does not break; the dust collector of the particle counting machine is kept normally open, and dust near the electric eye is cleaned once every 2 hours in the normal production process; sampling and weighing the bottle filled with the tablets by using an electronic scale (0.01g sensing amount) to ensure the filling accuracy, and counting the filling amount of the tablets in the bottle if the weight is abnormal; production can be recovered if the product is normal; putting the sorted bottles on a conveying line, putting a bag of damp-proof beads into each bottle, if the damp-proof beads are damaged, immediately stopping the machine for checking, cleaning an on-site production line, and tracing forward to ensure that no damaged damp-proof beads exist in the bottles; putting the electromagnetic film into a bottle cap, covering the bottle cap with the electromagnetic film with a bottle, screwing down, and sealing by an electromagnetic film sealing machine; after sealing, each bottle is required to check the sealing quality of the electromagnetic film, and the sealing is required to be tight without wrinkles or broken openings, if the sealing is not qualified, the sealing is required to be re-sealed, and the record is made; and sampling and submitting for inspection.

The technical proposal is further improved in that in the first drying and crushing step, the filler is microcrystalline cellulose.

The technical proposal is further improved in that in the granulating step, the adhesive is a food-grade 60 percent white granulated sugar syrup solution.

The technical scheme is further improved in that in the step of carefully observing the state of the material and judging whether the white granulated sugar syrup needs to be continued or not according to the particle size and the dryness and wetness degree of the material, the judgment is based on the fact that when the particles of the material are uniform and are slightly kneaded into a mass and are crushed by light pressure, 25kg of edible 60% white granulated sugar syrup is used for every 100kg of the material, and the adhesive is preferably added within about 3 minutes.

The technical proposal is further improved in that the moisture content is required to be 3.0-5.5% in the step of sampling and measuring the moisture of the granules after the drying is finished.

The technical scheme is further improved in that in the step of timely sterilizing the mixed materials after the materials are taken off and externally packaged between the external packaging taking-off and the internal packaging pasting the material marks, the sterilization mode is one or more of disinfectant wiping, ozone sterilization or ultraviolet sterilization.

The technical scheme is further improved in that the sterilized mixture is added into a hopper, low-speed pressure testing is firstly carried out, the size of the tablet is adjusted to be 1.0g +/-5% according to the technological requirements, after the requirements are met, the appearance of the tablet is checked to have unqualified conditions such as cracking, edge deletion, section, edge rolling, sticking, obvious spots, pitted surface and the like, the hardness is required to be more than or equal to 6.0kg, the friability is less than or equal to 0.5%, and the moisture content is less than or equal to 7.0g/100 g; note that the feed was continued, and the weight of the tablets was checked every 15 minutes during the production, and 10 tablets were weighed to between 1.0 g. + -. 0.75% using a 0.001g sensory balance.

The technical proposal is further improved in that a hardness detector is adopted for detection in the step of requiring the hardness to be more than or equal to 6.0 kg; in the step of requiring the friability to be less than or equal to 0.5%, the detection method is 0923 which is the general rule of the four parts of the 2015 version in Chinese pharmacopoeia.

The technical proposal is further improved in that in the step that the moisture content is less than or equal to 7.0g/100g, the GB 5009.3 is adopted as the detection method.

The technical scheme is further improved in that in the step of metal detection, the sensitivity of the metal detector is 65mV, and the iron: not less than 0.3 mm; non-ferrous metals: not less than 0.4 mm; stainless steel: not less than 0.5 mm; the detection rate of the standard part sliding through the detector under the gravity of 45 degrees is 100 percent; before starting up and after finishing production, a standard part is needed to be used for checking the metal detector; every 1 hour, the metal detector is inspected with a standard.

The invention has the beneficial effects that:

the invention improves the production process of the red ginseng extract tablet, has good production stability, effectively improves the production efficiency and has ideal yield.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention.

straightening: grading the second dried granules to 20 meshes;

Specifically, in the first drying and crushing step, the filler is microcrystalline cellulose.

Specifically, in the granulating step, the binder is a food-grade 60% white granulated sugar syrup solution.

Specifically, in the step of carefully observing the state of the material and judging whether the white granulated sugar syrup needs to be continued or not according to the particle size and the dryness of the material, the judgment is based on the fact that when the particles of the material are uniform and are slightly kneaded into a mass, and when the material is crushed by light pressure, the white granulated sugar syrup is added with the reference amount of 25kg of edible 60% white granulated sugar syrup for every 100kg of the material, and the adhesive is preferably added within about 3 minutes.

Specifically, in the step of sampling and measuring the moisture content of the granules after the drying is finished, the moisture content is required to be 3.0-5.5%.

Specifically, in the step of sterilizing the mixed material in time after the outer package is taken off between the outer package taking-off and the material mark is attached to the inner package in time, the sterilization mode is one or more of disinfectant wiping, ozone sterilization or ultraviolet sterilization.

Specifically, the sterilized mixture is added into a hopper, pressure is tested at low speed, the size of the tablet is adjusted to be 1.0g +/-5% according to the process requirements, after the requirements are met, the appearance of the tablet is checked to have unqualified conditions such as cracking, edge deletion, section, edge curling, sticking, obvious spots, pitted surface and the like, the hardness is required to be more than or equal to 6.0kg, the friability is less than or equal to 0.5%, and the moisture content is less than or equal to 7.0g/100 g; note that the feed was continued, and the weight of the tablets was checked every 15 minutes during the production, and 10 tablets were weighed to between 1.0 g. + -. 0.75% using a 0.001g sensory balance.

Specifically, in the step of requiring the hardness to be more than or equal to 6.0kg, a hardness detector is adopted for detection; in the step of requiring the friability to be less than or equal to 0.5%, the detection method is 0923 in the general rule of the four parts of the 2015 version of Chinese pharmacopoeia; in the step that the moisture content is less than or equal to 7.0g/100g, GB 5009.3 is adopted as a detection method.

Specifically, in the metal detection step, the sensitivity of the metal detector was 65mV, iron: not less than 0.3 mm; non-ferrous metals: not less than 0.4 mm; stainless steel: not less than 0.5 mm; the detection rate of the standard part sliding through the detector under the gravity of 45 degrees is 100 percent; before starting up and after finishing production, a standard part is needed to be used for checking the metal detector; every 1 hour, the metal detector is inspected with a standard.

The three batches of red ginseng were trial-produced as shown by the following results:

preparing a production device as shown in table one:

list of production facilities

Serial number	Device name/model	Suppliers of goods	Device function	Device status
					1	Two-stage reverse osmosis purified water treatment system	GUANGDONG JINGYUAN PURE WATER EQUIPMENT Co.,Ltd.	Preparation of purified Water	Is normal
2	500L extraction tank	JIANGYIN SHANYUAN ENVIRONMENTAL PROTECTION EQUIPMENT Co.,Ltd.	Extraction of medicinal materials	Is normal
					3	Storage tank	JIANGYIN SHANYUAN ENVIRONMENTAL PROTECTION EQUIPMENT Co.,Ltd.	Stock extract	Is normal
4	Single-effect external circulation vacuum concentrator	JIANGYIN SHANYUAN ENVIRONMENTAL PROTECTION EQUIPMENT Co.,Ltd.	Concentrated extract	Is normal
					5	Wind circulation oven	CHANGZHOU HAIJIANG DRYING EQUIPMENT Co.,Ltd.	Drying	Is normal
6	Electric heating sandwich pot	CHANGZHOU HAIJIANG DRYING EQUIPMENT Co.,Ltd.	Decocted syrup	Is normal
					7	High-efficiency universal pulverizer	CHANGZHOU HAIJIANG DRYING EQUIPMENT Co.,Ltd.	Pulverizing	Is normal
8	Quick granulating machine	CHANGZHOU HAIJIANG DRYING EQUIPMENT Co.,Ltd.	Whole grain	Is normal
					9	Oscillating granulator	CHANGZHOU HAIJIANG DRYING EQUIPMENT Co.,Ltd.	Swing granulation	Is normal
10	Vertical high-speed mixer	CHANGZHOU HAIJIANG DRYING EQUIPMENT Co.,Ltd.	Mixing	Is normal
					11	Three-dimensional motion mixer	CHANGZHOU HAIJIANG DRYING EQUIPMENT Co.,Ltd.	Total mixing	Is normal
12	Full-automatic high-speed tablet press	BEIJING HANLIN HANGYU TECHNOLOGY DEVELOPMENT Co.,Ltd.	Tabletting	Is normal
					13	Automatic electronic tablet counter	Manufactured by Shanghai Laitian energy Ltd	Counting bottle	Is normal
14	SP bottle feeding turntable	Manufactured by Shanghai Laitian energy Ltd	Bottle arranging device	Is normal
					15	X-ray foreign body detector	TECHIK INSTRUMENT (SHANGHAI) Co.,Ltd.	Foreign object detection	Is normal

The results of the measurements are shown in the following table:

list of identified materials

TABLE III confirmation raw materials List

Name of packing material	The result of the detection	Disinfection
			150ml electromagnetic film	Qualified	30min
150ml bottle	Qualified	30min
			150ml bottle cap	Qualified	30min
Damp-proof bead	Qualified	30min

Detection record of Epimedium-radix ginseng rubra medicinal material

Table five concentrated solution test recording table

Table six dry powder test record table

Table seven tablet testing record table

Table eight finished product inspection recording table

Table nine mixing uniformity testing recording table

Table ten pieces weight stability test recording table

Record table for process parameter information of each step of table eleven

TABLE twelve-Charge yield calculation table

TABLE for transfer rate of epitridecanoid saponins

TABLE fourteen extraction concentrate and extract powder yield recording table

As can be seen from the table, the cream yield of the three batches of the red ginseng extract is more than 80%, the yield of the red ginseng extract of the three batches is about 15.0%, the fluctuation is small, and the trial production condition is stable; selecting magnesium of magnesium stearate as an indication index for the total mixing uniformity, setting the total mixing time to be 30min, detecting the content of magnesium by taking the front sample, the middle sample and the rear sample respectively, and mixing for 30min because the content deviation is not large according to a detection result; three batches of trial production show that the yield is relatively ideal, and the large-scale production can be carried out.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the present invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A production process of a red ginseng extract tablet is characterized by comprising the following steps:

straightening: grading the second dried granules to 20 meshes;

2. The process for producing a red ginseng extract tablet according to claim 1, wherein the filler is microcrystalline cellulose in the first drying and pulverizing step.

3. The process for producing a red ginseng extract tablet according to claim 1, wherein in the granulating step, the binder is a food-grade 60% white sugar syrup solution.

4. The production process of the red ginseng extract tablet as claimed in claim 1, wherein in the step of carefully observing the state of the material and determining whether to continue the white granulated sugar syrup according to the particle size and the dryness of the material, the determination is based on that when the particles of the material are uniform and are lightly kneaded into a mass and are lightly pressed and then crushed, the white granulated sugar syrup is added with a reference amount of 25kg of edible 60% white granulated sugar syrup per 100kg of the material, and the binder is preferably added within about 3 minutes.

5. The process for producing a red ginseng extract tablet according to claim 1, wherein the moisture content is required to be 3.0% to 5.5% in the step of drying the granules and sampling the granules to measure moisture.

6. The process for producing a red ginseng extract tablet according to claim 1, wherein the mixed material is sterilized in time after removing the outer package between the outer packages and in time after attaching the material label to the inner package, the sterilizing being performed by one or more of wiping with a disinfectant, ozone sterilization or ultraviolet sterilization.

7. The production process of the red ginseng extract tablet as claimed in claim 1, wherein the sterilized mixture is fed into a hopper, and is subjected to low-speed pressure testing, the size of the tablet is adjusted to 1.0g +/-5% according to process requirements, and after the requirements are met, the appearance of the tablet is checked to see whether the tablet has unqualified conditions such as cracking, edge deletion, fracture, edge curl, sticking, obvious spots, pitted surface and the like, and the required hardness is more than or equal to 6.0kg, the friability is less than or equal to 0.5%, and the moisture content is less than or equal to 7.0g/100 g; note that the feed was continued, and the weight of the tablets was checked every 15 minutes during the production, and 10 tablets were weighed to between 1.0 g. + -. 0.75% using a 0.001g sensory balance.

8. The production process of the red ginseng extract tablet according to claim 7, wherein in the step of requiring hardness of not less than 6.0kg, the hardness is detected using a hardness detector; in the step of requiring the friability to be less than or equal to 0.5%, the detection method is 0923 which is the general rule of the four parts of the 2015 version in Chinese pharmacopoeia.

9. The production process of a red ginseng extract tablet according to claim 7, wherein in the step of moisture content of 7.0g/100g or less, GB 5009.3 is used as a detection method.

10. The process for producing a red ginseng extract tablet according to claim 1, wherein in the metal detection step, the sensitivity of the metal detector is 65mV, iron: not less than 0.3 mm; non-ferrous metals: not less than 0.4 mm; stainless steel: not less than 0.5 mm; the detection rate of the standard part sliding through the detector under the gravity of 45 degrees is 100 percent; before starting up and after finishing production, a standard part is needed to be used for checking the metal detector; every 1 hour, the metal detector is inspected with a standard.