CN101433588B - Method for producing five-ester dropping pills - Google Patents

Method for producing five-ester dropping pills Download PDF

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Publication number
CN101433588B
CN101433588B CN2008101885350A CN200810188535A CN101433588B CN 101433588 B CN101433588 B CN 101433588B CN 2008101885350 A CN2008101885350 A CN 2008101885350A CN 200810188535 A CN200810188535 A CN 200810188535A CN 101433588 B CN101433588 B CN 101433588B
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drop pill
water dropper
thermotank
ball
bucket
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CN101433588A (en
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颜锋
穆正义
熊水根
刘春阳
廖新华
钱进
陶琳
林亚伦
刘孝乐
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Nanchang Hongyi Technology Co Ltd
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Nanchang Hongyi Technology Co Ltd
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Abstract

The invention relates to a method for producing a five-ester drop pill. A kadsura japonica alcohol extract is produced from a dry and ripe fruit of Schisandra sphenanthera Rehd.et Wils of a magnoliaceae plant, namely kadsura japonica through a water decoction and alcohol extraction method; and the kadsura japonica alcohol extract as a raw material, polyethylene glycol as a substrate and dimethyl silicon oil as a condensate are used to produce the five-ester drop pill through a diameter-limited cylindrical concave surface type nozzle dropper comprising a screw thread column, a prism column, a dropper column, a medicine liquid hopper, a cylindrical dropper pipe and a concave surface type nozzle and a drop producing method of a drop pill forming device comprising a forming system, a heating and warm preservation system, a cooling and warm preservation system, a drop pill and condensate separation and collection system and a condensate circulation system. Compared with the five-ester droppill produced by the prior equipment, the produced five-ester drop pill remarkably improves the roundness degree, the difference of the weight of pills, the time limit of dissolution and disintegration and the breakage degree and obviously increases the rate of qualified products.

Description

Method for producing five-ester dropping pills
Technical field
The present invention relates to Fructus Schisandrae Sphenantherae ethanol extractum's production method and be raw material with the Fructus Schisandrae Sphenantherae ethanol extractum, be substrate with the Polyethylene Glycol, be condensed fluid with the dimethicone, adopt limited diameter cylindric concave mouth of pipe water dropper and drop pill pill finisher dropping preparation method production WUZHI DIWAN.
Background technology
The main component of WUZHI DIWAN is a Fructus Schisandrae Sphenantherae ethanol extractum, can reduce the serum aminotransferase, and the clinical demonstration of application result for many years is used for chronic, chronic persistent hepatitis Glutamate pyruvate transaminase rises person safety, effective.
Fructus Schisandrae Sphenantherae is the dry mature fruit of Magnoliacea plant schisandra chinensis Schisandra sphenanthera Rehd.et Wils., contain lignanoid, volatile oil, fatty oil, acylate, inorganic acid salt, pectin, polysaccharide, protein, glycoside, esters, heterocyclic etc., wide clinical application is to be the five-ester capsule that raw material is made with the Fructus Schisandrae Sphenantherae ethanol extractum at present, but because long, poor stability of molten diffusing time of its disintegrate, bed, dysphagia, the gerontal patient defectives such as inconvenience of taking medicine influence giving full play to of its curative effect.
Compare with the five-ester capsule, the WUZHI DIWAN disintegrate is molten looses and medicine stability obviously improves, bed, dysphagia, gerontal patient take medicine conveniently, compliance improves, especially at the easy characteristics of knock-on of glutamate pyruvate transaminase after chronic, the chronic persistent hepatitis patient drug withdrawal, WUZHI DIWAN can make the patient accomplish to reduce gradually dose to keep maintenance dose to reach that the treatment glutamate pyruvate transaminase continues not fall or the purpose of rising repeatedly easily, component uses more convenient, and the therapeutical effect of medicine is more given full play to.
But, in the WUZHI DIWAN production process, cylindric plane mouth of pipe water dropper and drop pill formation system that existing drop pill production equipment uses make the ball method of double differences different and roundness pill is wayward, the ball method of double differences different big, the pill formability is poor, accepted product percentage and production efficiency are low.
Summary of the invention
The present invention is under the condition of stablizing Fructus Schisandrae Sphenantherae ethanol extractum's production technology and quality, be raw material with the Fructus Schisandrae Sphenantherae ethanol extractum, be substrate, be condensed fluid with the dimethicone with the Polyethylene Glycol, adopt limited diameter cylindric concave mouth of pipe water dropper and drop pill pill finisher dropping preparation method production WUZHI DIWAN, the solution existing equipment production WUZHI DIWAN ball method of double differences is different greatly, the problem of pill formability difference, improves accepted product percentage and production efficiency.The technical solution used in the present invention is as follows:
(1) the pure extractum production method of of southern taste and flavour or food of southern taste and flavour
Get the dry mature fruit Fructus Schisandrae Sphenantherae of Magnoliacea plant schisandra chinensis Schisandra sphenanthera Rehd.et Wils. and soaked 0.5 hour, decoct each 2 hours 2 times, filter, discard filtrate, the medicinal residues drying is pulverized, with 5 times of amount alcohol reflux of 70% 2 times, 2 hours for the first time, 1.5 hours for the second time, merging filtrate, concentrating under reduced pressure, relative density is 1.01~1.05 Fructus Schisandrae Sphenantherae ethanol extractum when making 60 ℃.
(2) method for producing five-ester dropping pills
Getting 1 weight portion Fructus Schisandrae Sphenantherae ethanol extractum is added in fused 1~20 weight portion Polyethylene Glycol, stir evenly, make uniform medicinal liquid, under 80 ℃~100 ℃ heat-retaining conditions, drip system with limited diameter cylindric concave mouth of pipe water dropper and drop pill pill finisher dropping preparation method, with the cooling of 50 ℃~0 ℃ dimethicone gradient, oily ball separates, and is forced air drying 1~8 hour in 30 ℃~40 ℃ the rotating cage in temperature, the sieve ball selects ball, makes WUZHI DIWAN.
(3) the cylindric concave mouth of pipe of limited diameter water dropper
The cylindric concave mouth of pipe of limited diameter of the present invention water dropper, as shown in drawings, comprise screw thread silk post 1, the prism 2 that is connected with screw thread silk post, the water dropper post 3 that is connected with prism, be embedded in the medicinal liquid hopper 4 that is upright cup-shaped in the screw thread silk post, be embedded in screw thread silk post, prism and water dropper post, on connect and connect cylindric water dropper pipe 5 of running through of the water dropper concave mouth of pipe under the medicinal liquid hopper, be embedded in and be the water dropper concave mouth of pipe 6 that handstand cup-shaped and rim of a cup are connected with the water dropper pipe in the water dropper post.
Using method: consult accompanying drawing, substitute straight hole thin wall type water dropper on the existing drop pill machine, be connected with the drop pill machine by screw thread silk post 1 and get final product with limited diameter of the present invention cylindric concave mouth of pipe water dropper.
(4) drop pill pill finisher
Drop pill pill finisher of the present invention, as shown in drawings, comprise seal cup 1, observe bucket 2, thermotank 5, cooling tank 6, become ball bucket 27, drop pill discharging opening 11, condensed fluid and drop pill separator and condensate outlet 24, seal cup 1 is located at into the topmost of ball bucket 27, be fixed on the observation bucket 2 with screw 12, collect by seal cup 1 from observing bucket 2 condensed fluid that overflow, observing bucket 2 links to each other in the bottom of seal cup 1 and with seal cup 1 and communicates, thermotank 5 usefulness screws 13 are installed in the top that the below of observing bucket 2 tightly is enclosed within into ball bucket 27, sealing gasket 10 usefulness bolts 19, nut 20 and spring washer 21 are installed in thermotank 5 bottoms, bottom one side of thermotank 5 is installed valve 14, protective cover 8 usefulness screws 17 are installed in the top of thermotank 5, sealing ring 15 is installed on the top of thermotank 5,16,18, thermotank seal cover 9 is installed in a upper lateral part of thermotank 5, under the protective cover 8, the below that cooling tank 6 is installed in thermotank 5 tightly is enclosed within into the bottom of ball bucket 27, refrigerant inlet 25 and outlet 26 are installed in the top and the bottom of cooling tank 6 respectively, become ball bucket 27 bottoms tapered by hydraulic quick coupler dead ring 22, hydraulic quick coupler sealing gasket 23 is connected with drop pill separator and condensate outlet 24 with condensed fluid with drop pill discharging opening 11 and communicates, condensate outlet 24 and drop pill discharging opening 11 are installed in two rightabouts of same horizontal level, and condensate outlet 24 links to each other with one-tenth ball bucket 27 tops by the carrier pipe on the carriage 7 and communicates.
Using method: consult accompanying drawing, open thermotank seal cover 9, add hand-hole 3 by heat medium and in thermotank 5, fill with heat medium, in cooling tank 6, fill with cold-producing medium by refrigerant inlet 25, make cold-producing medium at cooling tank 6 internal recycle by refrigerant outlet 26, be closed into ball bucket 27 bottom hydraulic quick couplers 22,23, in becoming ball bucket 27, fill with condensed fluid, start power supply, make thermotank 5 heat mediums to temperature required and keep constant, make cooling tank 6 be cooled to temperature required and keep constant, condensate outlet 24 is communicated with by pipeline with becoming ball bucket 27, and carry with liquid pump and to make condensed fluid in becoming ball bucket 27, form circulation, the condensed fluid that overflows is collected with seal cup 1 and is recycled, and is from top to bottom as the temperature of condensed fluid in the ball bucket 27 that gradient is successively decreased and when keeping constant temperature rank, be opened into ball bucket 27 bottom hydraulic quick couplers 22,23, open water dropper, make the sedimentation and become ball in the one-tenth ball bucket 27 that is full of gradient temperature rank condensed fluid of the fused medicinal liquid that oozes, collect drop pill at drop pill discharging opening 11, promptly.
(5) method of detection beneficial effect of the present invention
1. roundness: the drop pill of making should be sphere or class sphere, and the major diameter of ball and the difference of minor axis should be less than 1mm.
2. the ball method of double differences is different: an appendix IK checks that the ball method of double differences is different should mistake ± 10% according to Chinese Pharmacopoeia version in 2005.
3. molten diffusing disintegration: check that according to an appendix XII of Chinese Pharmacopoeia version in 2005 A it's 30 minutes should be past molten diffusing disintegration time.
4. friability: get 20 of drop pill, two appendix XG check according to Chinese Pharmacopoeia version in 2005, subtract weight loss and must not cross 1%.
5. accepted product percentage: what roundness, the ball method of double differences different, molten diffusing disintegration, friability were all up to specification is certified products, and the percentage ratio of certified products amount and total output is accepted product percentage.
Description of drawings
Fig. 1 is the vertical view of the cylindric concave mouth of pipe of limited diameter water dropper.
Fig. 2 is the upward view of the cylindric concave mouth of pipe of limited diameter water dropper.
Fig. 3 is the elevation cross-sectional view of the cylindric concave mouth of pipe of limited diameter, indicating 1 among the figure is the cylindric concave mouth of pipe of limited diameter water dropper screw thread silk post, indicating 2 among the figure is the cylindric concave mouth of pipe of limited diameter prisms, indicating 3 among the figure is the cylindric concave mouth of pipe of limited diameter water dropper posts, indicating 4 among the figure is the cylindric concave mouth of pipe of limited diameter medicinal liquid hoppers, indicating 5 among the figure is the cylindric concave mouth of pipe of limited diameter water dropper pipes, and indicating 6 among the figure is the cylindric water dropper concave of limited diameter mouths of pipe.
Fig. 4 is a drop pill pill finisher elevation cross-sectional view, and wherein 1 is seal cup, the 2nd, observe bucket, the 3rd, heat medium adds hand-hole, and the 4th, heat medium adds pipe, the 5th, thermotank, the 6th, cooling tank, the 7th, carriage, the 8th, protective cover, the 9th, thermotank seal cover, the 10th, sealing gasket, the 11st, drop pill discharging opening, 12,13, the 17th, screw, the 14th, valve, 15,16, the 18th, sealing ring, the 19th, bolt, the 20th, nut, the 21st, spring washer, the 22nd, hydraulic quick coupler dead ring, the 23rd, hydraulic quick coupler sealing gasket, the 24th, condensed fluid and drop pill separator and condensate outlet, the 25th, refrigerant inlet, the 26th, refrigerant outlet, the 27th, become the ball bucket.
The specific embodiment
Embodiment 1
Get Fructus Schisandrae Sphenantherae ethanol extractum's 1 weight portion, be added in the fused 1 weight portion Polyethylene Glycol, stir evenly, make uniform medicinal liquid, under 85 ℃ of heat-retaining conditions, drip system, with 45 ℃~0 ℃ dimethicone gradient cooling with limited diameter cylindric concave mouth of pipe water dropper and drop pill pill finisher dropping preparation method, the oil ball separates, in temperature is forced air drying 3 hours in 35 ℃ the rotating cage, and the sieve ball selects ball, makes WUZHI DIWAN.
Embodiment 2
Get Fructus Schisandrae Sphenantherae ethanol extractum's 1 weight portion, be added in the fused 3 weight portion Polyethylene Glycol, stir evenly, make uniform medicinal liquid, under 95 ℃ of heat-retaining conditions, drip system, with 40 ℃~0 ℃ dimethicone gradient cooling with limited diameter cylindric concave mouth of pipe water dropper and drop pill pill finisher dropping preparation method, the oil ball separates, in temperature is forced air drying 5 hours in 30 ℃ the rotating cage, and the sieve ball selects ball, makes WUZHI DIWAN.
Embodiment 3
Get Fructus Schisandrae Sphenantherae ethanol extractum's 1 weight portion, be added in the fused 5 weight portion Polyethylene Glycol, stir evenly, make uniform medicinal liquid, under 80 ℃ of heat-retaining conditions, drip system, with 35 ℃ dimethicone gradient cooling with limited diameter cylindric concave mouth of pipe water dropper and drop pill pill finisher dropping preparation method, the oil ball separates, in temperature is forced air drying 6 hours in 35 ℃ the rotating cage, and the sieve ball selects ball, makes WUZHI DIWAN.
Embodiment 4
Get Fructus Schisandrae Sphenantherae ethanol extractum's 1 weight portion, be added in the fused 10 weight portion Polyethylene Glycol, stir evenly, make uniform medicinal liquid, under 95 ℃ of heat-retaining conditions, drip system, with 45 ℃~0 ℃ dimethicone gradient cooling with limited diameter cylindric concave mouth of pipe water dropper and drop pill pill finisher dropping preparation method, the oil ball separates, in temperature is forced air drying 8 hours in 40 ℃ the rotating cage, and the sieve ball selects ball, makes WUZHI DIWAN.
Embodiment 5
Get Fructus Schisandrae Sphenantherae ethanol extractum's 1 weight portion, be added in the fused 15 weight portion Polyethylene Glycol, stir evenly, make uniform medicinal liquid, under 90 ℃ of heat-retaining conditions, drip system, with 50 ℃~0 ℃ dimethicone gradient cooling with limited diameter cylindric concave mouth of pipe water dropper and drop pill pill finisher dropping preparation method, the oil ball separates, in temperature is forced air drying 8 hours in 30 ℃ the rotating cage, and the sieve ball selects ball, makes WUZHI DIWAN.
Embodiment 6
Get Fructus Schisandrae Sphenantherae ethanol extractum's 1 weight portion, be added in the fused 20 weight portion Polyethylene Glycol, stir evenly, make uniform medicinal liquid, under 85 ℃ of heat-retaining conditions, drip system, with 40 ℃~0 ℃ dimethicone gradient cooling with limited diameter cylindric concave mouth of pipe water dropper and drop pill pill finisher dropping preparation method, the oil ball separates, in temperature is forced air drying 8 hours in 30 ℃ the rotating cage, and the sieve ball selects ball, makes WUZHI DIWAN.
The five-ester droplet of producing with existing equipment relatively, five-ester droplet roundness, the ball method of double differences of ball production of the present invention be different, leach disintegration time limited, friability significantly improves, accepted product percentage obviously improves. The beneficial effect that the present invention obtains sees the following form.
Table: the beneficial effect that the present invention obtains

Claims (1)

1. method for producing five-ester dropping pills is characterized in that it is that the dry mature fruit Fructus Schisandrae Sphenantherae of getting Magnoliacea plant schisandra chinensis Schisandra sphenanthera Rehd.et Wils. was soaked 0.5 hour, decocts 2 times, each 2 hours, filter, discard filtrate, the medicinal residues drying, pulverize, with the alcohol reflux of 5 times of amounts 70% 2 times, 2 hours first time, 1.5 hours for the second time, merging filtrate, concentrating under reduced pressure, relative density is 1.01~1.05 Fructus Schisandrae Sphenantherae ethanol extractum when making 60 ℃; Getting 1 weight portion Fructus Schisandrae Sphenantherae ethanol extractum is added in fused 1~20 weight portion Polyethylene Glycol, stir evenly, make uniform medicinal liquid, under 80 ℃~100 ℃ heat-retaining conditions, drip system with limited diameter cylindric concave mouth of pipe water dropper and drop pill pill finisher dropping preparation method, with the cooling of 50 ℃~0 ℃ dimethicone gradient, oily ball separates, and is forced air drying 1~8 hour in 30 ℃~40 ℃ the rotating cage in temperature, the sieve ball selects ball, makes WUZHI DIWAN; The cylindric concave mouth of pipe of described limited diameter water dropper comprises screw thread silk post (1), the prism (2) that is connected with screw thread silk post, the water dropper post (3) that is connected with prism, be embedded in the medicinal liquid hopper (4) that is upright cup-shaped in the screw thread silk post, be embedded in screw thread silk post, prism and water dropper post, on connect and connect cylindric water dropper pipe of running through of the water dropper concave mouth of pipe (5) under the medicinal liquid hopper, be embedded in and be the water dropper concave mouth of pipe (6) that handstand cup-shaped and rim of a cup are connected with the water dropper pipe in the water dropper post; Described drop pill pill finisher comprises seal cup (1), observe bucket (2), thermotank (5), cooling tank (6), become ball bucket (27), drop pill discharging opening (11) and condensed fluid and drop pill separator and condensate outlet (24), seal cup (1) is at the topmost that becomes ball bucket (27), be fixed on the observation bucket (2) with screw (12), seal cup (1) links to each other with observation bucket (2) and communicates, thermotank (5) is installed in the top that the below of observing bucket (2) tightly is enclosed within into ball bucket (27) with screw (13), the below that cooling tank (6) is installed in thermotank (5) tightly is enclosed within into the bottom of ball bucket (27), become ball bucket (27) bottom tapered by hydraulic quick coupler dead ring (22), hydraulic quick coupler sealing gasket (23) is connected with drop pill separator and condensate outlet (24) with condensed fluid with drop pill discharging opening (11) and communicates, condensate outlet (24) and drop pill discharging opening (11) are installed in two rightabouts of same horizontal level, and condensate outlet (24) links to each other with the top of one-tenth ball bucket (27) and communicates by being installed in carrier pipe on the carriage (7); The condensed fluid that overflows from observe bucket (2) is collected by seal cup (1), sealing gasket (10) bolt (19), nut (20) and spring washer (21) are installed in the bottom of thermotank (5), thermotank (5) bottom one side is installed valve (14), protective cover (8) is installed in the top of thermotank (5) with screw (17), sealing ring (15) is installed on the top of thermotank (5), (16), (18), thermotank seal cover (9) is installed in a upper lateral part of thermotank (5), under the protective cover (8), refrigerant inlet (25) and outlet (26) are installed in the top and the bottom of cooling tank (6) respectively, and condensed fluid carrier pipe carriage (7) is installed around the cooling tank (6).
CN2008101885350A 2008-12-19 2008-12-19 Method for producing five-ester dropping pills Active CN101433588B (en)

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Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101647754B (en) * 2009-09-17 2011-11-09 河北工业大学 Traditional Chinese medicine pill preprocessing deoiling device
CN103285084A (en) * 2012-03-05 2013-09-11 上海中药制药技术有限公司 Production method for fructus schizandrae extract dripping pills
EP3020387B1 (en) * 2013-07-11 2020-07-01 Tasly Pharmaceutical Group Co., Ltd. Air-cooling drop pill production line
CN103860729B (en) * 2014-03-18 2017-01-25 成都润华堂制药有限公司 Five-ester dropping pill and preparation method thereof
CN104721182A (en) * 2015-02-10 2015-06-24 广东中西达一新药开发有限公司 Application of five-ester pill as liver transporter inhibitor

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Application publication date: 20090520

Assignee: NANCHANG HELIOEAST PHARMACEUTICAL Co.,Ltd.

Assignor: HELIOEAST SCIENCE & TECH Co.,Ltd.

Contract record no.: X2022980013422

Denomination of invention: Production method of five ester dropping pills

Granted publication date: 20101222

License type: Exclusive License

Record date: 20220830