CN1733266A - Chinese traditional medicine preparation for relieving food retention, resolving stagnation and harmonizing stomach, process for preparing the same and quality controlling method thereof - Google Patents
Chinese traditional medicine preparation for relieving food retention, resolving stagnation and harmonizing stomach, process for preparing the same and quality controlling method thereof Download PDFInfo
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Abstract
The invention discloses a Chinese traditional medicinal preparation for relieving food retention, resolving stagnation and harmonizing stomach, process for preparation and quality control method, whose main constituents include haw, medicated leaven, pinellia tuber, poria cocos, dried orange peel, capsule of weeping forsythia, radish seeds, and malt. The preparing process comprises, distilling dried orange peel and capsule of weeping forsythia to obtain volatile oil, charging other herbs, watering and grilling, filtrating, merging the filter liquor, concentrating the filtrate, stewing, concentrating the supernatant fluid into thick grease, drying, charging dried orange peel volatile oil, mixing homogenously, charging right amount of adjuvant, the preparation can be made into the forms of dripping pills, or microcapsules or soft capsules.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation and preparation method thereof and method of quality control, relate in particular to a kind of Chinese medicine preparation and preparation method thereof and method of quality control of dyspepsia and intestinal stasis relieving stomach function regulating.
Background technology:
Drop pill in the Chinese medicine preparation or micropill or pellet capsule or soft capsule, change dosage form and manage as new drug research according to the relevant laws and regulations of China's drug control as a kind of pharmaceutical dosage form.The existing dosage form of this product is granule, tablet, pill etc., has all listed the national drug standards in.
The technology features of existing guarantor and granule is to get Pericarpium Citri Reticulatae and Fructus Forsythiae volatile matter distillation oil, and Six-elements such as medicinal residues and all the other Fructus Crataegis decoct with water secondary with the medicinal liquid after distilling, and filter, merging filtrate, filtrate are concentrated into about 2000ml, leave standstill, get supernatant and continue to be condensed into the clear paste that relative density is 1.30～1.32 (50～55 ℃), 1 part of qinghuo reagent adds 3 parts of cane sugar powders, 1 part in dextrin and ethanol are an amount of, mixing is made granule, drying, add volatile oil such as Pericarpium Citri Reticulatae, mixing promptly.
Inconvenience is carried, stores, is taken in existing guarantor and granule existence, needs boiled water to take after mixing it with water, and contains shortcomings such as sugar.
The technology features of existing guarantor and sheet is that Massa Medicata Fermentata is ground into fine powder, sieves; Fructus Crataegi warm macerating 24 hours, leachate are concentrated to every gram and are equivalent to 2 Keshan short, bristly hair or beards, add 4 times of amounts of 80% ethanol, leave standstill, and get supernatant, reclaim ethanol, and are concentrated into the thick paste shape; Other gets Pericarpium Citri Reticulatae and extracts volatile oil, and the aqueous solution behind distillation device is in addition collected, and the five tastes such as the Pericarpium Citri Reticulatae medicinal residues and the Rhizoma Pinelliae decoct with water secondary, and 1.5 hours for the first time, 1 hour for the second time, collecting decoction left standstill, and filtered, and filtrate adds the aqueous solution behind the above-mentioned distillation, is condensed into thick paste; With Massa Medicata Fermentata powder and above-mentioned two kinds of thick paste mixings, drying is pulverized, and makes granule, drying, and spray adds Oleum Citri Reticulatae, and mixing is airtight, and compacting is in blocks, promptly.
Existing guarantor and sheet have bioavailability low, child and old people shortcoming such as be difficult for swallowing.
The technology features of present lenitive pill is: Fructus Crataegi (Jiao), Massa Medicata Fermentata (stir-fry), Rhizoma Pinelliae (processed), Poria, Pericarpium Citri Reticulatae, Fructus Forsythiae, Semen Raphani (stir-fry), Fructus Hordei Germinatus (stir-fry) eight flavor medical materials, be ground into fine powder, and sieve, mixing is used water pill, and drying is made the watered pill; Or every 100g powder adds refined honey 125～155g and makes big honeyed pills, promptly.
Existing lenitive pill has bioavailability low, and the drug effect produce effects is slow, shortcoming such as is difficult for taking.
Summary of the invention:
The Chinese medicine preparation and preparation method thereof and the method for quality control that the purpose of this invention is to provide a kind of dyspepsia and intestinal stasis relieving stomach function regulating overcome the above-mentioned drawback of prior art, improve quality, curative effect, the bioavailability of product, satisfy the needs of medical treatment better.
The objective of the invention is to be achieved through the following technical solutions.
A kind of Chinese medicine preparation of dyspepsia and intestinal stasis relieving stomach function regulating, it is that main constituent is guarantor and drop pill or micropill or the pellet capsule or the soft capsule of Fructus Crataegi (Jiao), Massa Medicata Fermentata (stir-fry), Rhizoma Pinelliae (processed), Poria, Pericarpium Citri Reticulatae, Fructus Forsythiae, Semen Raphani (stir-fry), Fructus Hordei Germinatus (stir-fry).
Its preparation method is:
(1) medicine constituent and percentage by weight thereof are as follows:
Fructus Crataegi (Jiao) 30～42%, Massa Medicata Fermentata (stir-fry), Rhizoma Pinelliae (processed), Poria each 8～15%, Pericarpium Citri Reticulatae, Fructus Forsythiae, Semen Raphani (stir-frys), Fructus Hordei Germinatus (stir-fry) respectively 5～12%;
Medicine constituent optimum weight percentage ratio is:
Fructus Crataegi (Jiao) 37.5%, Massa Medicata Fermentata (stir-fry), Rhizoma Pinelliae (processed), Poria each 12.5%, Pericarpium Citri Reticulatae, Fructus Forsythiae, Semen Raphani (stir-frys), Fructus Hordei Germinatus (stir-fry) respectively 6.25%;
(2) get Pericarpium Citri Reticulatae and Fructus Forsythiae distillating extracting oil, standby; Medicinal residues are standby, and the medicinal liquid after the distillation is standby;
(3) medicinal residues of getting Fructus Crataegi, Massa Medicata Fermentata (stir-fry), Rhizoma Pinelliae (processed), Poria, Semen Raphani (stir-fry), Fructus Hordei Germinatus (stir-fry) and (2) gained decoct with water 1～3 time with the medicinal liquid after distilling, filter, merging filtrate, filtrate is concentrated in right amount, leave standstill, get supernatant and continue to be condensed into thick paste, cold drying, be ground into fine drug powder, standby;
(4) get the fine drug powder of (3) gained, add the volatile oil of (2) gained, mix homogeneously gets hybrid medicine, and is standby;
(5) with one or more of stearic acid or glyceryl monostearate or insect wax or Cera Flava or Polyethylene Glycol (PEG4000 or PEG6000) or sodium stearate or glycerin gelatine or polyoxyethylene monostearate (S-40) or Poloxamer188 or other suitable adjuvant, use with by arbitrary proportion, be heated to the hybrid medicine that adds (4) gained after whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 70～100 ℃, under heat-retaining condition, go in the liquid coolant (liquid paraffin or methyl-silicone oil or vegetable oil or water or ethanol) by dropping-pill machine, condensation cured becomes ball, coolant is use up and removed to the drop pill drop of molding, dry, coating or coating not, promptly get drop pill, or enteric coated, promptly get enteric coated drop pill;
(6) get the fine drug powder of (3) gained, add an amount of adjuvant, mix homogeneously is granulated, and adds the volatile oil of (2) gained, and coating or coating are not made the micropill of diameter less than 2.5mm, or enteric coated, make the enteric coated micropill of diameter less than 2.5mm; Maybe, incapsulate, promptly get pellet capsule the micropill that makes;
Micropill or pellet capsule adjuvant are following one or more combinations or other suitable adjuvant, use with by arbitrary proportion: ethyl cellulose (EC), the polypropylene polysiloxanes, the wax class, Polyethylene Glycol (PEG), stearic acid, Lac, acrylic resin, polyvinyl alcohol, polyvinylpyrrolidone (PVP), methylcellulose, hydroxypropyl cellulose, cellulose propionate, the acrylic resin aqueous dispersion, the pseudo-latex of ethyl cellulose, cellulose acetate-phthalate (CAP) latex, polyphenyl dioctyl phthalate vinyl acetate (PVAP) aqueous dispersion, propylene glycol, glycerol, triacetin, acetyl list monoglyceride, phthalic acid ester, polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, lactose, fructose, sucrose.
(7) get the fine drug powder of (3) gained, add suitable adjuvant, mix homogeneously, the volatile oil of adding (2) gained is suppressed or is dripped and makes soft capsule.
A kind of method of quality control of Chinese medicine preparation of dyspepsia and intestinal stasis relieving stomach function regulating, it is the method for quality control of guarantor and drop pill or micropill or pellet capsule or soft capsule:
Assay, according to high effective liquid chromatography for measuring, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Get acetonitrile-acetic acid-water (30～40: 2～5: 55～63) be mobile phase; Detect wavelength 265～290nm; Theoretical cam curve is calculated by the Hesperidin peak should be no less than 3000;
It is an amount of that the preparation of reference substance solution, precision take by weighing the Hesperidin reference substance, adds methanol and make the solution that every 1ml contains 0.05-0.12mg, in contrast product solution;
This medicine 0.3～1.2g is got in the preparation of need testing solution, and accurate the title decides, and the accurate methanol 40～80ml that adds claims to decide weight, supersound process 20-40 minute, put and be chilled to room temperature, claim again to decide weight, supply the weight that subtracts mistake with methanol, shake up, leave standstill, filter, get subsequent filtrate as need testing solution;
Algoscopy, accurate respectively reference substance solution and each 5～10ul of need testing solution of drawing injects chromatograph of liquid, measures.
Specific embodiments:
The present invention further specifies as follows in conjunction with specific embodiments:
A kind of Chinese medicine preparation of dyspepsia and intestinal stasis relieving stomach function regulating, it is that main constituent is guarantor and drop pill or micropill or the pellet capsule or the soft capsule of Fructus Crataegi (Jiao), Massa Medicata Fermentata (stir-fry), Rhizoma Pinelliae (processed), Poria, Pericarpium Citri Reticulatae, Fructus Forsythiae, Semen Raphani (stir-fry), Fructus Hordei Germinatus (stir-fry).
The Chinese medicine preparation of a kind of dyspepsia and intestinal stasis relieving stomach function regulating of the present invention mainly can help digestion, intestinal stasis relieving, stomach function regulating.Be mainly used in food stagnation and stagnate distension and fullness in the abdomen, belching and acid regurgitation, loss of appetite.
The preparation method of Chinese medicine preparation of the present invention is:
(1) medicine constituent and weight consumption are as follows:
Fructus Crataegi (Jiao) 300g, Massa Medicata Fermentata (stir-fry) 100g, Rhizoma Pinelliae (processed) 100g, Poria 100g, Pericarpium Citri Reticulatae 50g, Fructus Forsythiae 50g, Fructus Hordei Germinatus (stir-fry) 50g, Semen Raphani (stir-fry) 50g;
(2) get Pericarpium Citri Reticulatae and Fructus Forsythiae distillating extracting oil, standby; Medicinal residues are standby, and the medicinal liquid after the distillation is standby;
(3) medicinal residues of getting Fructus Crataegi, Massa Medicata Fermentata (stir-fry), Rhizoma Pinelliae (processed), Poria, Semen Raphani (stir-fry), Fructus Hordei Germinatus (stir-fry) and (2) gained add decocting 2 times with the medicinal liquid after distilling, filter, merging filtrate, filtrate is concentrated into 2000ml, leave standstill, get supernatant and continue to be condensed into thick paste, cold drying, be ground into fine drug powder, standby;
(4) get the fine drug powder of (3) gained, add the volatile oil of (2) gained, mix homogeneously gets hybrid medicine, and is standby;
(5) a kind of Chinese medicine preparation drop pill of dyspepsia and intestinal stasis relieving stomach function regulating is to protect and drop pill, its preparation method is a hybrid medicine of getting (4) gained, Polyethylene Glycol PEG6000 80g, stearic acid 26g, Poloxamer188 15g, treat Polyethylene Glycol PEG6000, stearic acid, Poloxamer188 adds above-mentioned hybrid medicine after being heated to whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 80 ℃, at heat-retaining condition by splashing in the liquid paraffin, be condensed into ball, with the drop pill drop of molding to the greatest extent and the erasing liquor paraffin body, cold drying promptly gets drop pill, or enteric coated, promptly get enteric coated drop pill.
(6) a kind of Chinese medicine preparation micropill of dyspepsia and intestinal stasis relieving stomach function regulating or pellet capsule are guarantor and micropill or pellet capsule, its preparation method is a fine drug powder of getting (3) gained, with 80g dextrin mix homogeneously, 5%PVP alcohol liquid is binding agent, at first preparing 60 purpose granules and make parent nucleus, is binding agent with 5%PVP alcohol liquid again, adds the volatile oil of (2) gained, add the mixed powder amplification and make 40 purpose micropills, promptly make micropill; Or the enteric coated enteric coated micropill that promptly gets; Maybe the micropill that makes is incapsulated, promptly get pellet capsule.
(7) a kind of Chinese medicine preparation soft capsule of dyspepsia and intestinal stasis relieving stomach function regulating is to protect and soft capsule, its preparation method is a fine drug powder of getting (3) gained, behind water dissolution, the adding adjuvant is the combination of one or more different proportions in PEG400, vegetable oil, aromatic hydrocarbon esters, glycerol, isopropyl alcohol, the tween, the volatile oil that adds (2) gained is suppressed or is dripped and makes soft capsule.
A kind of method of quality control of Chinese medicine preparation of dyspepsia and intestinal stasis relieving stomach function regulating, it is the method for quality control of guarantor and drop pill or micropill or pellet capsule or soft capsule, it is characterized in that:
Assay, according to high effective liquid chromatography for measuring, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Get acetonitrile-acetic acid-water (36: 4: 60) and be mobile phase; Detect wavelength 283nm; Theoretical cam curve is calculated by the Hesperidin peak should be no less than 3000;
It is an amount of that the preparation of reference substance solution, precision take by weighing the Hesperidin reference substance, adds methanol and make the solution that every 1ml contains 0.05mg, in contrast product solution;
This medicine 0.2g is got in the preparation of need testing solution, and accurate the title decides, and the accurate methanol 50ml that adds claims to decide weight, supersound process 30 minutes is put and is chilled to room temperature, claims to decide weight again, supplies the weight that subtracts mistake with methanol, shake up, leave standstill, filter, get subsequent filtrate as need testing solution;
Algoscopy, accurate respectively reference substance solution and each 5ul of need testing solution of drawing injects chromatograph of liquid, measures.
Advantage of the present invention is:
Take, easy to carry, gastrointestinal irritation is little, constant product quality is conducive to improve drug effect.
Claims (4)
1, a kind of Chinese medicine preparation of dyspepsia and intestinal stasis relieving stomach function regulating is characterized in that it is that main constituent is guarantor and drop pill or micropill or the pellet capsule or the soft capsule of Fructus Crataegi (Jiao), Massa Medicata Fermentata (stir-fry), Rhizoma Pinelliae (processed), Poria, Pericarpium Citri Reticulatae, Fructus Forsythiae, Semen Raphani (stir-fry), Fructus Hordei Germinatus (stir-fry).
2, a kind of preparation method of Chinese medicine preparation of dyspepsia and intestinal stasis relieving stomach function regulating, it is guarantor and drop pill or micropill or pellet capsule or preparation of soft capsule method, it is characterized in that:
(1) medicine constituent and percentage by weight thereof are as follows:
Fructus Crataegi (Jiao) 30～42%, Massa Medicata Fermentata (stir-fry), Rhizoma Pinelliae (processed), Poria each 8～15%, Pericarpium Citri Reticulatae, Fructus Forsythiae, Semen Raphani (stir-frys), Fructus Hordei Germinatus (stir-fry) respectively 5～12%;
(2) Pericarpium Citri Reticulatae and Fructus Forsythiae distillating extracting oil are standby; Medicinal residues are standby, and the medicinal liquid after the distillation is standby;
(3) Fructus Crataegi, Massa Medicata Fermentata (stir-fry), Rhizoma Pinelliae (processed), Poria, Semen Raphani (stir-fry), Fructus Hordei Germinatus (stir-fry) decoct with water 1～3 time with the medicinal liquid after distilling with (2) gained medicinal residues, filter, merging filtrate, filtrate is concentrated in right amount, leave standstill, get supernatant and continue to be condensed into thick paste, cold drying, be ground into fine drug powder, standby;
(4) get the fine drug powder of (3) gained, add the volatile oil of (2) gained, mix homogeneously gets hybrid medicine, and is standby; After adding suitable adjuvant, make drop pill or micropill or pellet capsule or soft capsule;
The preparation method of its drop pill is: with one or more of stearic acid or glyceryl monostearate or insect wax or Cera Flava or Polyethylene Glycol (PEG4000 or PEG6000) or sodium stearate or glycerin gelatine or polyoxyethylene monostearate (S-40) or Poloxamer188 or other suitable adjuvant, use with by arbitrary proportion, be heated to the hybrid medicine that adds (4) gained after whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 70～100 ℃, under heat-retaining condition, go in the liquid coolant (liquid paraffin or methyl-silicone oil or vegetable oil or water or ethanol) by dropping-pill machine, condensation cured becomes ball, coolant is use up and removed to the drop pill drop of molding, dry, coating or coating not, promptly get drop pill, or enteric coated, promptly get enteric coated drop pill;
The preparation method of its micropill or pellet capsule is: get the fine drug powder of (3) gained, add an amount of adjuvant, mix homogeneously is granulated, and adds the volatile oil of (2) gained, and coating or coating are not made the micropill of diameter less than 2.5mm, promptly get micropill; Or enteric coated, promptly get enteric coated micropill; Maybe, incapsulate, promptly get pellet capsule the micropill that makes;
Micropill or pellet capsule adjuvant are following one or more combinations or other suitable adjuvant, use with by arbitrary proportion: ethyl cellulose (EC), the polypropylene polysiloxanes, the wax class, Polyethylene Glycol (PEG), stearic acid, Lac, acrylic resin, polyvinyl alcohol, polyvinylpyrrolidone (PVP), methylcellulose, hydroxypropyl cellulose, cellulose propionate, the acrylic resin aqueous dispersion, the pseudo-latex of ethyl cellulose, cellulose acetate-phthalate (CAP) latex, polyphenyl dioctyl phthalate vinyl acetate (PVAP) aqueous dispersion, propylene glycol, glycerol, triacetin, acetyl list monoglyceride, phthalic acid ester, polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, lactose, fructose, sucrose;
Its preparation of soft capsule method is: gets the fine drug powder of (3) gained, adds suitable adjuvant, and mix homogeneously, the volatile oil of adding (2) gained is suppressed or is dripped and makes soft capsule;
Adjuvant is one or more combinations or other suitable adjuvant of following material, uses with by arbitrary proportion: PEG400, vegetable oil, aromatic hydrocarbon esters, glycerol, isopropyl alcohol, tween.
3, a kind of method of quality control of Chinese medicine preparation of dyspepsia and intestinal stasis relieving stomach function regulating, it is the method for quality control of guarantor and drop pill or micropill or pellet capsule or soft capsule, it is characterized in that:
Assay, according to high effective liquid chromatography for measuring, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Get acetonitrile-acetic acid-water (30～40: 2～5: 55～63) be mobile phase; Detect wavelength 265～290nm; Theoretical cam curve is calculated by the Hesperidin peak should be no less than 3000;
It is an amount of that the preparation of reference substance solution, precision take by weighing the Hesperidin reference substance, adds methanol and make the solution that every 1ml contains 0.04-0.10mg, in contrast product solution;
This medicine 0.1～1.0g is got in the preparation of need testing solution, and accurate the title decides, and the accurate methanol 40～80ml that adds claims to decide weight, supersound process 20-40 minute, put and be chilled to room temperature, claim again to decide weight, supply the weight that subtracts mistake with methanol, shake up, leave standstill, filter, get subsequent filtrate as need testing solution;
Algoscopy, accurate respectively reference substance solution and each 5～10ul of need testing solution of drawing injects chromatograph of liquid, measures.
4, the preparation method of the Chinese medicine preparation of a kind of dyspepsia and intestinal stasis relieving stomach function regulating according to claim 2 is characterized in that the optimum weight percentage ratio of its main constituent is:
Fructus Crataegi (Jiao) 37.5%, Massa Medicata Fermentata (stir-fry), Rhizoma Pinelliae (processed), Poria each 12.5%, Pericarpium Citri Reticulatae, Fructus Forsythiae, Semen Raphani (stir-frys), Fructus Hordei Germinatus (stir-fry) respectively 6.25%.
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102886000A (en) * | 2012-11-05 | 2013-01-23 | 太极集团重庆中药二厂有限公司 | Preparation method of digestant pills |
| CN103893628A (en) * | 2014-03-05 | 2014-07-02 | 青岛农业大学 | Pharmaceutical composition with digesting effect and preparation method thereof |
| CN105250829A (en) * | 2015-11-19 | 2016-01-20 | 哈尔滨圣吉药业股份有限公司 | Dispersible tablets with function of promoting digestion to eliminate stagnation and preparation method thereof |
| CN105341582A (en) * | 2015-11-19 | 2016-02-24 | 黄海娟 | Hawthorn fruit-containing food digesting beverage and preparation technology thereof |
| CN108186837A (en) * | 2018-03-12 | 2018-06-22 | 江西地康药业有限公司 | Guarantor and oral liquid |
| CN108578628A (en) * | 2018-06-26 | 2018-09-28 | 思南县人民医院 | A kind of Chinese medicine preparation and application and preparation method for children's having indigestion appetizing |
| CN114470119A (en) * | 2021-12-24 | 2022-05-13 | 江苏七○七天然制药有限公司 | Digestion-promoting and stomach-harmonizing capsule and preparation method thereof |
-
2005
- 2005-07-29 CN CN 200510031935 patent/CN1733266A/en active Pending
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102886000A (en) * | 2012-11-05 | 2013-01-23 | 太极集团重庆中药二厂有限公司 | Preparation method of digestant pills |
| CN102886000B (en) * | 2012-11-05 | 2015-01-07 | 太极集团重庆中药二厂有限公司 | Preparation method of digestant pills |
| CN103893628A (en) * | 2014-03-05 | 2014-07-02 | 青岛农业大学 | Pharmaceutical composition with digesting effect and preparation method thereof |
| CN103893628B (en) * | 2014-03-05 | 2016-08-31 | 青岛农业大学 | A kind of pharmaceutical composition with food digesting action and preparation method thereof |
| CN105250829A (en) * | 2015-11-19 | 2016-01-20 | 哈尔滨圣吉药业股份有限公司 | Dispersible tablets with function of promoting digestion to eliminate stagnation and preparation method thereof |
| CN105341582A (en) * | 2015-11-19 | 2016-02-24 | 黄海娟 | Hawthorn fruit-containing food digesting beverage and preparation technology thereof |
| CN108186837A (en) * | 2018-03-12 | 2018-06-22 | 江西地康药业有限公司 | Guarantor and oral liquid |
| CN108578628A (en) * | 2018-06-26 | 2018-09-28 | 思南县人民医院 | A kind of Chinese medicine preparation and application and preparation method for children's having indigestion appetizing |
| CN114470119A (en) * | 2021-12-24 | 2022-05-13 | 江苏七○七天然制药有限公司 | Digestion-promoting and stomach-harmonizing capsule and preparation method thereof |
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