CN108186968B - Wenweishu capsule - Google Patents
Wenweishu capsule Download PDFInfo
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- CN108186968B CN108186968B CN201810016062.XA CN201810016062A CN108186968B CN 108186968 B CN108186968 B CN 108186968B CN 201810016062 A CN201810016062 A CN 201810016062A CN 108186968 B CN108186968 B CN 108186968B
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- 239000002775 capsule Substances 0.000 title claims abstract description 71
- 239000000463 material Substances 0.000 claims abstract description 43
- 230000002496 gastric effect Effects 0.000 claims abstract description 42
- 210000002784 stomach Anatomy 0.000 claims abstract description 34
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 32
- 239000003814 drug Substances 0.000 claims abstract description 32
- 238000010792 warming Methods 0.000 claims abstract description 29
- 229920002472 Starch Polymers 0.000 claims abstract description 27
- 239000008107 starch Substances 0.000 claims abstract description 27
- 235000019698 starch Nutrition 0.000 claims abstract description 27
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims abstract description 16
- 235000012239 silicon dioxide Nutrition 0.000 claims abstract description 16
- 239000000377 silicon dioxide Substances 0.000 claims abstract description 16
- 229940079593 drug Drugs 0.000 claims abstract description 15
- 239000007902 hard capsule Substances 0.000 claims abstract description 10
- FGXWKSZFVQUSTL-UHFFFAOYSA-N domperidone Chemical group C12=CC=CC=C2NC(=O)N1CCCN(CC1)CCC1N1C2=CC=C(Cl)C=C2NC1=O FGXWKSZFVQUSTL-UHFFFAOYSA-N 0.000 claims abstract description 9
- 229960001253 domperidone Drugs 0.000 claims abstract description 9
- 239000009636 Huang Qi Substances 0.000 claims abstract description 7
- 244000223760 Cinnamomum zeylanicum Species 0.000 claims abstract description 5
- 235000002722 Dioscorea batatas Nutrition 0.000 claims abstract description 5
- 235000006536 Dioscorea esculenta Nutrition 0.000 claims abstract description 5
- 240000001811 Dioscorea oppositifolia Species 0.000 claims abstract description 5
- 235000003416 Dioscorea oppositifolia Nutrition 0.000 claims abstract description 5
- 235000017803 cinnamon Nutrition 0.000 claims abstract description 5
- 241000005787 Cistanche Species 0.000 claims abstract description 4
- 241000756943 Codonopsis Species 0.000 claims abstract description 4
- 239000000843 powder Substances 0.000 claims description 38
- 239000008187 granular material Substances 0.000 claims description 32
- 238000001035 drying Methods 0.000 claims description 27
- 238000002156 mixing Methods 0.000 claims description 24
- 239000011248 coating agent Substances 0.000 claims description 22
- 238000000576 coating method Methods 0.000 claims description 22
- 238000003756 stirring Methods 0.000 claims description 22
- 239000007788 liquid Substances 0.000 claims description 18
- 239000000284 extract Substances 0.000 claims description 16
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 15
- 238000002360 preparation method Methods 0.000 claims description 11
- 238000007873 sieving Methods 0.000 claims description 11
- 239000007779 soft material Substances 0.000 claims description 8
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 6
- 238000001704 evaporation Methods 0.000 claims description 6
- 230000008020 evaporation Effects 0.000 claims description 6
- 238000005303 weighing Methods 0.000 claims description 6
- 238000005507 spraying Methods 0.000 claims description 5
- 241000007126 Codonopsis pilosula Species 0.000 claims description 4
- 235000013399 edible fruits Nutrition 0.000 claims description 4
- 239000000203 mixture Substances 0.000 claims description 4
- 239000006228 supernatant Substances 0.000 claims description 4
- 241000132012 Atractylodes Species 0.000 claims description 3
- 239000000706 filtrate Substances 0.000 claims description 3
- 230000005176 gastrointestinal motility Effects 0.000 claims description 3
- 238000000227 grinding Methods 0.000 claims description 3
- 238000011068 loading method Methods 0.000 claims description 3
- 230000001737 promoting effect Effects 0.000 claims description 3
- 230000002040 relaxant effect Effects 0.000 claims description 3
- 238000005070 sampling Methods 0.000 claims description 3
- 235000009917 Crataegus X brevipes Nutrition 0.000 claims description 2
- 235000013204 Crataegus X haemacarpa Nutrition 0.000 claims description 2
- 235000009685 Crataegus X maligna Nutrition 0.000 claims description 2
- 235000009444 Crataegus X rubrocarnea Nutrition 0.000 claims description 2
- 235000009486 Crataegus bullatus Nutrition 0.000 claims description 2
- 235000017181 Crataegus chrysocarpa Nutrition 0.000 claims description 2
- 235000009682 Crataegus limnophila Nutrition 0.000 claims description 2
- 235000004423 Crataegus monogyna Nutrition 0.000 claims description 2
- 240000000171 Crataegus monogyna Species 0.000 claims description 2
- 235000002313 Crataegus paludosa Nutrition 0.000 claims description 2
- 235000009840 Crataegus x incaedua Nutrition 0.000 claims description 2
- 238000001514 detection method Methods 0.000 claims description 2
- 239000012530 fluid Substances 0.000 claims description 2
- 229940107666 astragalus root Drugs 0.000 claims 1
- 239000007901 soft capsule Substances 0.000 abstract description 18
- 230000000694 effects Effects 0.000 abstract description 11
- 241000092665 Atractylodes macrocephala Species 0.000 abstract description 3
- 238000000034 method Methods 0.000 description 8
- 238000011049 filling Methods 0.000 description 7
- 238000010561 standard procedure Methods 0.000 description 7
- 239000011247 coating layer Substances 0.000 description 4
- 210000000936 intestine Anatomy 0.000 description 4
- 239000010410 layer Substances 0.000 description 4
- 230000008855 peristalsis Effects 0.000 description 4
- 230000003213 activating effect Effects 0.000 description 3
- 238000001914 filtration Methods 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 206010000087 Abdominal pain upper Diseases 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 238000000605 extraction Methods 0.000 description 2
- 239000006187 pill Substances 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 208000018556 stomach disease Diseases 0.000 description 2
- 238000009495 sugar coating Methods 0.000 description 2
- 239000010154 weishu Substances 0.000 description 2
- 241000173529 Aconitum napellus Species 0.000 description 1
- 206010063659 Aversion Diseases 0.000 description 1
- 241000336315 Cistanche salsa Species 0.000 description 1
- 208000012895 Gastric disease Diseases 0.000 description 1
- 208000007882 Gastritis Diseases 0.000 description 1
- 208000019790 abdominal distention Diseases 0.000 description 1
- 229940023019 aconite Drugs 0.000 description 1
- 208000022531 anorexia Diseases 0.000 description 1
- 206010003549 asthenia Diseases 0.000 description 1
- 238000010923 batch production Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000000740 bleeding effect Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 208000016644 chronic atrophic gastritis Diseases 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 206010061428 decreased appetite Diseases 0.000 description 1
- 230000000249 desinfective effect Effects 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 238000005538 encapsulation Methods 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 210000004051 gastric juice Anatomy 0.000 description 1
- 230000007661 gastrointestinal function Effects 0.000 description 1
- 241000411851 herbal medicine Species 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 239000008188 pellet Substances 0.000 description 1
- 238000010298 pulverizing process Methods 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
Classifications
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- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
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- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
- A61K31/454—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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Abstract
The invention relates to the field of medicines, in particular to a capsule for warming stomach, which aims to solve the problem of common curative effect of the existing capsule for warming stomach, and provides a capsule for warming stomach, which comprises a capsule, a capsule shell and a capsule: comprises main materials of 183g of radix astragali Preparata, 183g of radix Codonopsis, 150g of radix Aconiti lateralis (black slice), 183g of Chinese yam, 183g of Atractylodes macrocephala (stir-fried), 90g of cinnamon, 225g of fructus crataegi (stir-fried), 150g of dried orange peel, 60g of fructus Amomi, 183g of herba cistanches (steamed with wine), 225g of smoked plum, 183g of fructus Psoraleae, and auxiliary materials of starch, talcum powder and silicon dioxide; the capsule shell is a hard capsule shell, the capsule is filled in the capsule shell, 210g of starch, 2g of talcum powder and 1g of silicon dioxide are used as auxiliary materials, the powdered gastrointestinal motivating medicine is attached to the outside of the capsule shell, the main material of the gastrointestinal motivating medicine is domperidone, the starch is used as the auxiliary material, and a soft capsule layer is wrapped outside the gastrointestinal motivating medicine.
Description
Technical Field
The invention relates to the field of medicines, in particular to a stomach warming and relaxing capsule.
Background
According to the legal standards: chinese pharmacopoeia 2015 edition part one P1626 page:
[ CHEM ] 183g of Codonopsis pilosula, 183g of radix astragali Preparata, 183g of rhizoma Dioscoreae, 183g of Atractylodes macrocephala (parched), 225g of mume fructus, 150g of pericarpium Citri Tangerinae, 150g of radix Aconiti lateralis (processed with black powder), 90g of cortex Cinnamomi, 183g of Cistanchis herba (steamed with wine), 225g of fructus crataegi (parched), 60g of fructus Amomi, and 183g of fructus Psoraleae.
[ PREPARATION METHOD ] pulverizing fructus Amomi into fine powder; decocting the rest materials in water twice (1.5 hr for the first time and 1 hr for the second time), mixing decoctions, filtering, standing, collecting supernatant, and concentrating to relative density
Adding fructus Amomi fine powder into the fluid extract at 70 deg.C, mixing with appropriate amount of pulvis Talci, starch and silicon dioxide, granulating, drying, and making into capsule 1000 granules.
[ PROPERTIES ] the product is a hard capsule, and the content is fine powder and granules from brown to brown; slightly sour and bitter.
[ FUNCTIONS AND INDICATIONS ] can warm the middle-jiao and nourish the stomach, promote the circulation of qi and alleviate pain. Can be used for treating gastralgia due to deficiency-cold of middle warmer, with the symptoms of gastralgia, abdominal distention, belch, anorexia, aversion to cold, and asthenia; chronic atrophic gastritis and superficial gastritis with the above syndromes.
[ DOSAGE AND ADMINISTRATION ] administered orally. 3 granules at a time, 2 times a day.
[ caution ] it is not used when the stomach is bleeding; uncooked, cold, greasy and indigestible foods are prohibited.
[ Specification ] 0.4g per granule
[ STORAGE ] sealing.
Most of the existing stomach warming and soothing capsules sold in the market are prepared according to the prescription, and the curative effect is general.
Disclosure of Invention
The technical problem to be solved by the invention is as follows: in order to solve the problem of common curative effect of the existing stomach warming and soothing capsules on the market, the stomach warming and soothing capsules are provided.
The technical scheme adopted by the invention for solving the technical problems is as follows: a stomach warming and soothing capsule comprises a capsule, a capsule shell and a capsule: comprises main materials of 183g of radix astragali Preparata, 183g of radix Codonopsis, 150g of radix Aconiti lateralis (black slice), 183g of Chinese yam, 183g of Atractylodes macrocephala (stir-fried), 90g of cinnamon, 225g of fructus crataegi (stir-fried), 150g of dried orange peel, 60g of fructus Amomi, 183g of herba cistanches (steamed with wine), 225g of smoked plum, 183g of fructus Psoraleae, and auxiliary materials of starch, talcum powder and silicon dioxide; the capsule shell is a hard capsule shell, the capsule is filled in the capsule shell, 210g of starch, 2g of talcum powder and 1g of silicon dioxide are used as auxiliary materials, a powdery gastrointestinal stimulant is attached outside the capsule shell, the gastrointestinal stimulant is mainly domperidone, the starch is used as an auxiliary material, and a soft capsule layer is wrapped outside the gastrointestinal stimulant.
In order to achieve the best curative effect, the gastrointestinal motility promoting medicine comprises 10g of domperidone as a main material and 90g of starch as an auxiliary material.
In another embodiment of the present invention, the gastrointestinal stimulant is coated with a sugar coating.
The preparation method of the stomach warming and soothing capsule comprises the following steps:
A. decocting eleven kinds of decoction pieces of radix astragali preparata, codonopsis pilosula, radix aconiti lateralis preparata, Chinese yam, bighead atractylodes rhizome (fried), cinnamon, fructus crataegi nanensis (fried), dried orange peel, cistanche salsa (steamed with wine), dark plum and fructus psoraleae twice with water under the steam pressure of 0.10-0.25 MPa, the mass of the first added water is 7 times of the total mass of eleven kinds of decoction pieces, decocting for 1.5 hours, the mass of the second added water is 5 times of the total mass of eleven kinds of decoction pieces, decocting for 1 hour, filtering with 120-mesh gauze, standing the filtrate, absorbing supernatant, transferring into an external circulation evaporation concentrator, controlling the vacuum degree of the external circulation evaporation concentrator to be-0.06-0.08 MPa, the steam pressure to be 0.05-0.15 MPa, the temperature to be 65-72 ℃, concentrating until the relative density is 1.10-1.12 at 70 ℃, transferring the feed liquid into a reduced pressure concentration tank for relay concentration until the relative density is 1.28-1.30 at 70 ℃, obtaining extract with weight of 200g +/-5 g;
B. crushing fructus amomi in the stomach-warming and soothing main material into fine powder, transferring the fine powder into a two-dimensional motion mixer for mixing, sampling after mixing for 8 minutes, sieving the fine powder of fructus amomi, starch, talcum powder and silicon dioxide after the detection is qualified, and sieving all the materials by a 60-mesh sieve;
C. b, uniformly dividing the crushed and sieved fine fructus amomi powder, starch, talcum powder and silicon dioxide and the extract obtained in the step A into 6 parts on average, 10g of fine fructus amomi powder, 35g of starch, 0.333g of talcum powder and 0.167g of silicon dioxide, putting the materials into a wet mixing granulator for operation, adjusting the stirring speed to be 150rpm, adjusting the side cutter speed to be 1500rpm, and stirring for 15 minutes; when the extract is added, the stirring speed is firstly reduced to 80rpm, the stirring speed is adjusted to 150rpm again after the addition of the extract is finished, the side cutter stirring speed is 1500rpm, the timing stirring is started from the addition of the extract for 5 minutes, a soft material is obtained, then the soft material is transferred to a swing type granulator, wet granules are prepared by using a 12-mesh sieve, the wet granules are transferred to a drying tray for drying, the drying temperature is 80-85 ℃, the wet granules are taken out after being dried for 1 hour, the quick granulating machine is placed for operation, the soft material is granulated by using a 16-mesh sieve and then transferred to a flow-through oven for continuous drying, the drying time of the wet granules is 3 hours, after the drying of the wet granules is finished, the wet granules are transferred to a square cone mixer for mixing for 8 minutes, the dry granules after the total mixing are weighed, the loading amount is;
D. gastrointestinal motivators: stirring and mixing 10g of domperidone powder and 90g of starch serving as an auxiliary material, fully grinding, and sieving by a 60-mesh sieve for later use;
E. and D, adding the inner capsule prepared in the step C into the hollow soft capsule by using a soft capsule filling machine, filling 0.1 g/grain of gastrointestinal stimulant into a space between the inner capsule and the soft capsule layer, and finally completing packaging.
When the sugar-coated stomach-warming and comfort capsule is prepared: the gastrointestinal motivating agent comprises 10g of main material domperidone powder and 90g of auxiliary material starch, and is fully ground after being stirred and mixed, and the mixture is sieved by a 60-mesh sieve; weighing 0.1 g/granule of gastrointestinal stimulant, spraying the coating liquid on the gastrointestinal stimulant, uniformly coating the gastrointestinal stimulant on an inner capsule, and drying to obtain the stomach warming and soothing capsule.
The preparation method of the sugar coating comprises the following steps: 20g of coating powder is weighed, 270ml of 95% ethanol and 55ml of pure water are added, and the mixture is stirred for two hours by a stirrer, so that the coating powder is completely dissolved and dispersed to prepare coating liquid.
The invention has the beneficial effects that the capsule for warming stomach and soothing improves the existing capsule for warming stomach and soothing, firstly, the gastrointestinal motivating medicine starts to dissolve within 5-10 minutes after the patient takes the medicine, the peristalsis of the stomach is accelerated or the normal peristalsis speed is recovered, the capsule for warming stomach and soothing prepared according to the record in Chinese pharmacopoeia starts to dissolve after the patient takes the medicine 30-45 minutes, at the moment, the peristalsis of the stomach and the stomach of the patient is powerful, the medicine in the capsule for warming stomach and soothing is absorbed twice with half the effort, the gastrointestinal activity of the patient is simply activated firstly, then the medicine for warming stomach is absorbed, the effect is more remarkable, the curative effect is better, and the patient can take less medicine.
Detailed Description
The invention relates to a stomach warming and relaxing capsule, which is prepared by firstly preparing 183g of codonopsis pilosula, 183g of radix astragali preparata, 183g of Chinese yam, 183g of bighead atractylodes rhizome (fried) 183g, 225g of dark plum fruit, 150g of dried orange peel, 150g of aconite (black tablets), 90g of cinnamon, 183g of cistanche (steamed with wine), 225g of hawthorn fruit (fried), 60g of fructus amomi and 183g of fructus psoraleae according to a formula of P1626 page of Chinese pharmacopoeia 2015, adding 210g of starch, 2g of talcum powder and 1g of silicon dioxide as auxiliary materials, uniformly mixing, granulating, drying, encapsulating to prepare 1000 granules, wrapping a layer of stomach and intestine activating medicinal powder outside an inner capsule, wrapping the stomach and intestine activating medicinal powder with a soft capsule, or uniformly wrapping the inner capsule after spraying a coating liquid on the stomach and intestine activating medicinal powder, and drying.
The specific production comprises the following steps:
preparing an inner capsule medicament:
firstly) material receiving and distributing
A. And (5) obtaining decoction pieces according to the batch production instruction list.
B. Calibration of the platform scale:
a. the platform scale is placed on a flat and stable plane for leveling.
b. Calibration was performed with standard weights.
c. Weighing the rest 11 kinds of decoction pieces except fructus Amomi.
II) extraction
A. Decocting the decoction pieces of radix astragali Preparata, radix Codonopsis, radix Aconiti lateralis (black shun tablet), rhizoma Dioscoreae, Atractylodis rhizoma (parched), cortex Cinnamomi, fructus crataegi (parched), pericarpium Citri Tangerinae, Cistanchis herba (steamed with wine), mume fructus, and fructus Psoraleae in water twice under steam pressure of 0.10-0.25 MPa according to "standard operating procedure of multifunctional extraction tank" (SOP-P-2025); adding 7 times of water for the first time, decocting for 1.5 hours, adding 5 times of water for the second time, decocting for 1 hour, and mixing decoctions; filtering with 120 mesh gauze, standing the filtrate, and transferring the supernatant into an external circulation evaporation concentrator; the water adding amount is 7 times and 5 times of the total mass of the eleven decoction pieces respectively.
B. Concentrating according to standard operating procedure of external circulation evaporation concentrator (SOP-P-2026), controlling vacuum degree to be-0.06-0.08 MPa, steam pressure to be 0.05-0.15 MPa, temperature to be 65-72 ℃, concentrating until the relative density is 1.10-1.12 at 70 ℃, transferring the feed liquid into a reduced pressure concentration tank for continuous concentration, continuing concentrating according to standard operating procedure of the reduced pressure concentration tank (SOP-P-2031), concentrating until the relative density is 1.28-1.30 at 70 ℃, and obtaining extract with weight of 200g +/-5 g.
Thirdly) crushing and mixing
A. Crushing fructus amomi in the prescription into fine powder according to the standard operation procedure of an FWS-350 winnowing type Chinese herbal medicine micro crusher (SOP-P-2036), transferring the fine powder into a two-dimensional motion mixer, then operating according to the standard operation procedure of an EYH-300 two-dimensional motion mixer (SOP-P-2008), mixing for 8 minutes, sampling, and detecting for later use after the sample is qualified.
B. Calculating the material balance rate and the crushing process yield of the fructus amomi crushing process; the material balance limit range is 97-100%, and the yield limit range is 96-100%.
Four) sieving
A. Sieving fructus Amomi fine powder, starch, pulvis Talci, and silicon dioxide according to ZS-600 vibrating sieve Standard operating Specification (SOP-P-2074), and sieving all materials with 60 mesh sieve.
B. Calculating the material balance rate of the sieving procedure and the yield of the sieving procedure; the material balance limit range is 97-100%, and the yield limit range is 96-100%.
Fifthly) weighing and distributing materials
A. The crushed and sieved fine powder, starch and extract of fructus amomi are averagely divided into 6 parts, each part of fine powder of fructus amomi is 10g, each part of starch is 35g, each part of talcum powder is 0.333g, and each part of silicon dioxide is 0.167 g.
Sixthly) granulating, drying, finishing and totally mixing
A. Putting 10g of fructus amomi fine powder, 35g of starch, 0.333g of talcum powder and 0.167g of silicon dioxide into a wet mixing granulator, and adjusting the stirring speed to be 150rpm and the side cutter speed to be 1500rpm according to the standard operation procedure of a GHL-250 type wet mixing granulator (SOP-P-2076) for stirring for 15 minutes; and when the extract is added, the stirring speed is firstly reduced to 80rpm, the stirring speed is adjusted back to 150rpm after the addition of the extract is finished, the stirring speed of a side cutter is 1500rpm, and the stirring is performed for 5 minutes from the addition of the extract to prepare a proper soft material.
B. The soft material was transferred to a rocking granulator and wet granulated with a 12 mesh sieve according to YK-160 Standard operating rules for rocking granulator (SOP-P-2005).
C. And transferring the wet granules into a baking pan, and drying according to CTG-Z-II flow-through oven standard operating protocol (SOP-P-2079) at the drying temperature of 80-85 ℃.
D. After the granules are dried for 1 hour, the granules are taken out, put into a KZL-200 quick granulator and operated according to standard operation protocol of the KZL-200 quick granulator (SOP-P-2180), granulated by a 16-mesh sieve and transferred into a flow-through oven for continuous drying, and the drying time of wet granules is 3 hours.
E. After the pellets were dried, they were transferred to a square cone mixer and mixed for 8 minutes according to standard procedures for JFH1.5M3 square cone mixers (SOP-P-2081).
F. The dry granules after total mixing were weighed.
G. Calculating the process material balance rate and the process yield; the material balance limit range is 95-100%, and the yield limit range is 94-100%.
Seven) capsule filling
A. And taking the components such as the metering disc, the filling rod and the like, cleaning, disinfecting, drying and installing after drying.
B. Adjusting the loading amount to 0.4 g/capsule according to standard operation protocol of NJP-2500C Capsule filling machine (SOP-P-2042), and filling the dry granules into hollow capsules to obtain inner capsules.
C. And (5) putting into a tank for later use.
Gastrointestinal stimulant preparation:
the procedures of material taking, material distribution and weighing are the same as those of the preparation of the inner capsule medicament, and the detailed description is omitted below; firstly, taking the domperidone powder and the starch as an auxiliary material, grinding, sieving by a 60-mesh sieve to obtain 10g of domperidone powder and 90g of starch, mixing the powder and the starch, pouring the mixture into a stirrer, stirring at a low speed for 2 minutes and at a high speed for 1 minute, circulating for 10 times, and taking out for later use.
The preparation method of the soft capsule for warming stomach of the invention comprises the following steps:
the soft capsule shell meeting the medical standard is purchased in the market and filled by a soft capsule filling machine, firstly the prepared inner capsule is filled, 0.1g of gastrointestinal stimulant is added between the inner capsule and the soft capsule layer, and finally the soft capsule warming and stomach soothing capsule is prepared by encapsulation.
The prepared soft capsule for warming and soothing the stomach has good effect on old stomach disease patients, the soft capsule is dissolved after the patients take the soft capsule for about 10 minutes, the gastrointestinal motivating drug in the soft capsule is fine powder, the gastrointestinal motivating drug is not dried after being prepared, the water content is higher than that of the gastrointestinal motivating drug subjected to a drying process, the soft capsule is quickly dissolved and absorbed after entering gastric juice, the gastrointestinal motility is enhanced by acting on the stomach and intestine, the internal drug begins to be dissolved after the hard capsule shell is disintegrated about 45 minutes after the medicine is taken, the gastrointestinal activity is quite high after the hard capsule shell is disintegrated for about 30 minutes until the gastrointestinal motivating drug takes effect, the components in the inner capsule are absorbed at the moment, and the effect is better with half the effort.
The preparation method of the sugar-coated stomach warming and soothing capsule of the invention comprises the following steps:
weighing 20g of coating powder which meets the medical standard in the market, adding 270ml of 95% ethanol and 55ml of pure water, stirring for two hours by using a stirrer to completely dissolve and disperse the coating powder to prepare a coating liquid for later use, wherein the coating liquid may have differences according to different blending of manufacturers; taking a prepared inner capsule, wrapping 0.1g of gastrointestinal stimulant outside a hard capsule shell of the inner capsule, uniformly spraying coating liquid on the gastrointestinal stimulant, and drying the sprayed pills to obtain the sugar-coated warming and stomach-soothing capsule; the specific drying time of the pill is different according to different coating powders and different spraying amounts; the method for wrapping the gastrointestinal stimulant outside the hard capsule shell of the inner capsule can be changed according to the actual conditions of enterprises, for example, a special powder planting device can be selected for execution, and a small amount of coating liquid can be sprayed outside the hard capsule shell to help wrap the gastrointestinal stimulant.
The prepared sugar-coated Weishu capsule is suitable for patients with poor gastrointestinal function or new gastropathy, 0.1 g/granule of gastrointestinal motivating drug is mostly mixed in the coating liquid after being sprayed with the coating liquid, and is also mixed with the coating layer after being dried, the capsule is taken by patients, the coating layer is dissolved after about 5 minutes, the gastrointestinal motivating drug coated in the coating layer is released along with the dissolution when the gastrointestinal motivating drug is dissolved, the gastrointestinal motivating drug is released more slowly than the gastrointestinal motivating drug in the soft capsule Weishu, the gastrointestinal motivating drug is dried after being sprayed on the coating layer, the absorption is slower than the soft capsule stomach warming and soothing, and the gastrointestinal burden of the patients is smaller; the hard capsule shell is disintegrated and the internal medicine begins to dissolve about 30 minutes after the medicine is taken, the gastrointestinal promoting medicine takes effect about 25 minutes, the gastrointestinal activity is improved relatively to the former, and the components in the inner capsule are absorbed at the moment, so that the effect is obvious.
Generally speaking, the Wenweishu tablet of the invention firstly helps patients to recover or improve gastrointestinal peristalsis and improve the subsequent absorption of the Chinese medicinal preparation in the inner capsule; the above values are for preparing 1000 granules of the formula for warming stomach of the present invention, and the preparation of 1000 granules is an ideal state, i.e. no breakage and no undesirable product appear in the production process, and the formula can be proportionally expanded or reduced in production scale.
In light of the foregoing description of the preferred embodiment of the present invention, many modifications and variations will be apparent to those skilled in the art without departing from the spirit and scope of the invention. The technical scope of the present invention is not limited to the content of the specification, and must be determined according to the scope of the claims.
Claims (1)
1. A stomach warming and relaxing capsule is characterized in that: comprises a sachet and a capsule shell, wherein the sachet comprises: comprises main materials of 183g of roasted astragalus root, 183g of codonopsis pilosula, 150g of black shun tablet, 183g of Chinese yam, 183g of stir-fried bighead atractylodes rhizome, 90g of cinnamon, 225g of fried south hawthorn fruit, 150g of dried orange peel, 60g of fructus amomi, 183g of wine-steamed cistanche, 225g of dark plum fruit, 183g of fructus psoraleae, 210g of auxiliary material starch, 2g of talcum powder and 1g of silicon dioxide; the capsule shell is a hard capsule shell, the capsule is filled in the capsule shell to prepare an inner capsule, the capsule shell is externally coated with powdered gastrointestinal motivating drug, and the gastrointestinal motivating drug is uniformly coated on the inner capsule after being sprayed with a coating liquid; the gastrointestinal motility promoting medicine comprises 10g of domperidone as a main material and 90g of starch as an auxiliary material;
the stomach warming and soothing capsule is prepared by the following preparation method:
A. decocting eleven kinds of decoction pieces of radix astragali Preparata, radix Codonopsis, HEISHUANG tablet, rhizoma Dioscoreae, clear parched Atractylodis rhizoma, cortex Cinnamomi, parched fructus crataegi, pericarpium Citri Tangerinae, wine steamed Cistanchis herba, mume fructus and fructus Psoraleae in WENWEISHU main materials with water twice under the steam pressure of 0.10-0.25 MPa, the weight of the first added water is 7 times of the total weight of eleven kinds of decoction pieces, decocting for 1.5 hours, the mass of the water added for the second time is 5 times of the total mass of the eleven decoction pieces, the decoction is carried out for 1 hour, the decoction is filtered by 120-mesh spun silk, the filtrate is stood and then the supernatant fluid is absorbed and transferred into an external circulation evaporation concentrator, controlling the vacuum degree of an external circulation evaporation concentrator to be-0.06 to-0.08 MPa, the steam pressure to be 0.05 to 0.15MPa and the temperature to be 65 to 72 ℃, concentrating the material liquid until the relative density is 1.10 to 1.12 at 70 ℃, transferring the material liquid into a reduced pressure concentration tank for continuous concentration, and concentrating the material liquid until the relative density is 1.28 to 1.30 at 70 ℃ to obtain the extract with the weight of 200g +/-5 g;
B. crushing fructus amomi in the stomach-warming and soothing main material into fine powder, transferring the fine powder into a two-dimensional motion mixer for mixing, sampling after mixing for 8 minutes, sieving the fine powder of fructus amomi, starch, talcum powder and silicon dioxide after the detection is qualified, and sieving all the materials by a 60-mesh sieve;
C. b, uniformly dividing the crushed and sieved fine fructus amomi powder, starch, talcum powder and silicon dioxide and the extract obtained in the step A into 6 parts on average, 10g of fine fructus amomi powder, 35g of starch, 0.333g of talcum powder and 0.167g of silicon dioxide, putting the materials into a wet mixing granulator for operation, adjusting the stirring speed to be 150rpm, adjusting the side cutter speed to be 1500rpm, and stirring for 15 minutes; when the extract is added, the stirring speed is firstly reduced to 80rpm, the stirring speed is adjusted to 150rpm again after the addition of the extract is finished, the side cutter stirring speed is 1500rpm, the timing stirring is started from the addition of the extract for 5 minutes, a soft material is obtained, then the soft material is transferred to a swing type granulator, wet granules are prepared by using a 12-mesh sieve, the wet granules are transferred to a drying tray for drying, the drying temperature is 80-85 ℃, the wet granules are taken out after being dried for 1 hour, the quick granulating machine is placed for operation, the soft material is granulated by using a 16-mesh sieve and then transferred to a flow-through oven for continuous drying, the drying time of the wet granules is 3 hours, after the drying of the wet granules is finished, the wet granules are transferred to a square cone mixer for mixing for 8 minutes, the dry granules after the total mixing are weighed, the loading amount is adjusted to be 0.4 g/granule, and the granules are filled into a hollow capsule shell to prepare an inner capsule for standby;
D. gastrointestinal motivators: stirring and mixing 10g of domperidone powder and 90g of starch serving as an auxiliary material, fully grinding, and sieving by a 60-mesh sieve; weighing 0.1 g/granule of gastrointestinal stimulant, spraying coating liquid on the gastrointestinal stimulant, uniformly coating the gastrointestinal stimulant on an inner capsule, and drying to obtain a stomach warming and soothing capsule;
the preparation method of the coating liquid comprises the following steps: 20g of coating powder is weighed, 270ml of 95% ethanol and 55ml of pure water are added, and the mixture is stirred for two hours by a stirrer, so that the coating powder is completely dissolved and dispersed to prepare coating liquid.
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1285741A (en) * | 1997-12-17 | 2001-02-28 | 阿克斯肯制药公司 | Double capsule for the administration of active principles in multiple therepies |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1285741A (en) * | 1997-12-17 | 2001-02-28 | 阿克斯肯制药公司 | Double capsule for the administration of active principles in multiple therepies |
Non-Patent Citations (1)
| Title |
|---|
| "慢性胃炎中西医结合诊疗共识意见（2011.天津）";中国中西医结合学会消化系统疾病专业委员会;《现代消化及介入诊疗》;20121231;第17卷(第3期);172-177 * |
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