CN1541669A - Prepared traditional Chinese drug Liangfu drop pills for treating epigastric pain - Google Patents
Prepared traditional Chinese drug Liangfu drop pills for treating epigastric pain Download PDFInfo
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- CN1541669A CN1541669A CNA031242456A CN03124245A CN1541669A CN 1541669 A CN1541669 A CN 1541669A CN A031242456 A CNA031242456 A CN A031242456A CN 03124245 A CN03124245 A CN 03124245A CN 1541669 A CN1541669 A CN 1541669A
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Abstract
The Chinese medicine Liangfu dripping pill for treating gastric cavity pain is prepared with polyglycol-6000 as medium and galagal rhizome and nutagrass flatsedge rhizome extractive as active components. The present invention has the advantages of small dosage, fast dissolving speed, high bioavailability, stable quality and simple preparation process.
Description
Technical field
The present invention relates to a kind of Chinese patent medicine liangfuwan and preparation technology thereof who treats gastric abscess, belong to field of traditional Chinese, more precisely improvement dosage form and the preparation technology thereof on the basis of former dosage form Liang Fu Wan.
Background technology
Liang Fu Wan is the ancient dosage form watered pill, is used for the treatment of gastric abscess, has significant curative effect through the proof of clinical practice for many years, but owing to be subjected to the limitation of dosage form and dose, and can not satisfy vast gastric abscess patient demand far away.
At first, the molten diffusing time of Liang Fu Wan is grown (30 minutes), causes oral absorption slower, has reduced bioavailability, is unfavorable for the drug effect performance; Secondly, taking dose is bigger, and each about 47～94 balls of dose (being equivalent to crude drug amount 3～6 grams) cause the inconvenience of taking medicine to patient especially old people; Moreover Liang Fu Wan medicine instability is placed the change that active substance content promptly took place in a year, is unfavorable for storage; And the preparation technology of Liang Fu Wan is ground into direct general ball molding behind the powder with the prescription medical material, because at present no quality standard is controlled, manufactured goods all have much room for improvement at aspects such as dissolubility, dissolution rate, bioavailability and stability; And have the dust pollution phenomenon in the production process, be unfavorable for labor protection.
Therefore, be badly in need of a kind of novel form that can overcome the Liang Fu Wan of above shortcoming of exploitation.
Summary of the invention
The purpose of this invention is to provide that a kind of taking dose is little, dissolution velocity is fast, bioavailability is high, the Chinese patent medicine liangfuwan of stay-in-grade treatment gastric abscess.
Another object of the present invention provides a kind of preparation technology of this liangfuwan of easy and simple to handle, quality controllable, no dust pollution.
A kind of Chinese patent medicine liangfuwan for the treatment of gastric abscess, it is by making as the polyethylene glycol 6000 of substrate with as the Rhizoma Alpiniae Officinarum of active component and the extract of Rhizoma Cyperi (processing).Described " processing " means the processed with vinegar of one of Chinese medicine processing, sees under the pharmacopeia appendix IID item.With ratio of weight and number is that 1: 1 Rhizoma Alpiniae Officinarum and Rhizoma Cyperi (processing) extracted with the second alcohol and water, is condensed into extractum respectively, and reuse ethyl acetate extraction, extract are concentrated into the dried dried cream of extract that becomes, and are active component.
The ratio of weight and number of described active component and substrate is 1: 2.5～1: 3.5.
Described active component is to be made through extracting according to 1: 1 ratio of weight and number by Rhizoma Alpiniae Officinarum and Rhizoma Cyperi (processing).
Describedly be extracted as alcohol extraction or water is carried or water alcohol mixes and carries.
A kind of preparation technology who treats the Chinese patent medicine liangfuwan of gastric abscess comprises the steps:
1) medical material is handled: 500 gram Rhizoma Alpiniae Officinarum and 500 gram Rhizoma Cyperis (processing) are extracted with the second alcohol and water, be condensed into extractum respectively, reuse ethyl acetate extraction, extract are concentrated into the dried dried cream of extract that becomes;
2) medicinal liquid preparation: taking polyethylene glycol 6000 is put in the container, is heated to 70～80 ℃ in water-bath, treat whole fusions after, be that 1: 2.5～3.5 ratio adds the dried cream of extract according to the dried cream of extract and Polyethylene Glycol ratio of weight and number, be stirred to dissolving, even;
3) drip system: the medicinal liquid for preparing is transferred in the reservoir, and airtight and insulation is at 70 ℃, and regulator solution titer valve splashes in 5～10 ℃ the liquid paraffin;
4) drying: with the drop pill drop that forms to the greatest extent and the erasing liquor paraffin body, drying, promptly.
Extract with the second alcohol and water in the described medical material treatment step and be meant respectively and respectively extract 2 times with the second alcohol and water.
Be meant usefulness ethyl acetate extraction 4 times with ethyl acetate extraction in the described medical material treatment step, each consumption is 1000ml.
The described extraction with ethanol is meant each usefulness 6000～8000ml ethanol extraction 1 hour.
Described water extracts and is meant each usefulness 8000～10000ml water extraction half an hour.
Advantage of the present invention is: liangfuwan extracts through refining, and the solid dispersion technology of application of advanced is prepared from, and it has not only overcome the deficiency of original dosage form, brings following significant advantage simultaneously:
1) taking dose is little: every clothes dosage is 10～20 balls only, take 1/4 of dose for former dosage form, are equivalent to crude drug 3～6 gram equally, be convenient to the patient especially the gerontal patient accept and take.
2) dissolution velocity is fast: dissolve scattered time limit has been accelerated medicine dissolution velocity in vivo for being 6 minutes only, is beneficial to absorption of human body and has shifted to an earlier date the drug effect time.
3) bioavailability height: medical material is made with extra care, and effective ingredient has obtained concentrating; After medicine and the substrate congruent melting medicine is dispersed in the substrate, when eutectic solution was formed in condensation, medicine and substrate generated two kinds of superfine crystallizations simultaneously, helped absorbing, and brought into play curative effect rapidly, improved bioavailability.
4) steady quality: formulated quality control standard, single dose is accurate; Drug microparticles is embedded in the substrate entity, the imporosity, and air can not spread into, thereby has increased stability of drug.
5) easy and simple to handle, the no dust pollution of preparation process is beneficial to labor protection.
In sum, the present invention has good prospects for application at the aspects such as dissolubility, dissolution rate and bioavailability that improve medicine, is treatment gastric abscess disease, realizes the forward position pharmaceutical dosage form that the modernization of Chinese medicine develops.
The specific embodiment
The preparation of embodiment 1, liangfuwan
1, prescription: Rhizoma Alpiniae Officinarum 500g, Rhizoma Cyperi (processing) 500g
2, method for making:
1) medical material is handled: with Rhizoma Alpiniae Officinarum and Rhizoma Cyperi (processing) according to recipe quantity with each reflux, extract, of 95% (V/V) second alcohol and water 2 times, each 6000ml extracted 1 hour during with 95% (V/V) ethanol extraction, each 8000ml extracts half an hour during with water extraction, be condensed into extractum respectively, relative density is for being respectively 1.25 and 1.10; Add 1000ml water, make extractum become suspension, reuse ethyl acetate extraction 4 times, each 1000ml, extract are concentrated into the dried dried cream of extract that becomes after filtering and merging, and paste-forming rate is 3.4%.
2) medicinal liquid preparation: get 85 gram polyethylene glycol 6000s and put in the container, in water-bath, be heated to 70 ℃, treat whole fusions after, add extract 34 grams (by 1: 2.5), be stirred to dissolving, even;
3) drip system: the medicinal liquid for preparing is transferred in the reservoir, and airtight and insulation is at 70 ℃, and regulator solution titer valve splashes in 5 ℃ the liquid paraffin;
4) drying: with the drop pill drop that forms to the greatest extent and the erasing liquor paraffin body, drying, promptly.
This drop pill specification is every ball 45mg.On inspection, the drop pill outward appearance rounding of making, big or small homogeneous, color and luster unanimity; Weight differential complies with relevant regulations.Instructions of taking: oral, usual amounts is one time 10～20 ball, 3 times on the one.
This technology shows through pilot scale research, and prescription is formed rationally, process stabilizing, controlled, easy row.
The preparation of embodiment 2, liangfuwan
1, prescription: Rhizoma Alpiniae Officinarum 500g, Rhizoma Cyperi (processing) 500g
2, method for making:
1) medical material is handled: with Rhizoma Alpiniae Officinarum and Rhizoma Cyperi (processing) according to recipe quantity with each reflux, extract, of 85% (V/V) second alcohol and water 2 times, each 8000ml extracted 1 hour during with 85% (V/V) ethanol extraction, each 10000ml extracts half an hour during with water extraction, be condensed into extractum respectively, relative density is for being respectively 1.35 and 1.15; Add 1000ml water, make extractum become suspension, reuse ethyl acetate extraction 4 times, each 1000ml, extract are concentrated into the dried dried cream of extract that becomes after filtering and merging, and paste-forming rate is 3.8%.
2) medicinal liquid preparation: get 133 gram polyethylene glycol 6000s and put in the container, in water-bath, be heated to 80 ℃, treat whole fusions after, add dried cream 38 grams of extract (by 1: 3.5), be stirred to dissolving, even;
3) drip system: the medicinal liquid for preparing is transferred in the reservoir, and airtight and insulation is at 70 ℃, and regulator solution titer valve splashes in 10 ℃ the liquid paraffin;
4) drying: with the drop pill drop that forms to the greatest extent and the erasing liquor paraffin body, drying, promptly.
This drop pill specification is every ball 45mg.On inspection, the drop pill outward appearance rounding of making, big or small homogeneous, color and luster unanimity; Weight differential complies with relevant regulations.Instructions of taking: oral, usual amounts is one time 10～20 ball, 3 times on the one.
This technology shows through pilot scale research, and prescription is formed rationally, process stabilizing, controlled, easy row.
The preparation of embodiment 3, liangfuwan
1, prescription: Rhizoma Alpiniae Officinarum 500g, Rhizoma Cyperi (processing) 500g
2, method for making:
1) medical material is handled: with Rhizoma Alpiniae Officinarum and Rhizoma Cyperi (processing) according to recipe quantity with each reflux, extract, of 90% (V/V) second alcohol and water 2 times, each 7000ml extracted 1 hour during with 90% (V/V) ethanol extraction, each 9000ml extracts half an hour during with water extraction, be condensed into extractum respectively, relative density is for being respectively 1.30 and 1.12; Add 1000ml water, make extractum become suspension, reuse ethyl acetate extraction 4 times, each 1000ml, extract are concentrated into the dried dried cream of extract that becomes after filtering and merging, and paste-forming rate is 3.5%.
2) medicinal liquid preparation: get 105 gram polyethylene glycol 6000s and put in the container, in water-bath, be heated to 75 ℃, treat whole fusions after, add extract 35 grams (by 1: 3), be stirred to dissolving, even;
3) drip system: the medicinal liquid for preparing is transferred in the reservoir, and airtight and insulation is at 70 ℃, and regulator solution titer valve splashes in 8 ℃ the liquid paraffin;
4) drying: with the drop pill drop that forms to the greatest extent and the erasing liquor paraffin body, drying, promptly.
This drop pill specification is every ball 45mg.On inspection, the drop pill outward appearance rounding of making, big or small homogeneous, color and luster unanimity; Weight differential complies with relevant regulations.Instructions of taking: oral, usual amounts is one time 10～20 ball, 3 times on the one.
This technology shows through pilot scale research, and prescription is formed rationally, process stabilizing, controlled, easy row.
Embodiment 4, experiment disintegration
1, material: liangfuwan lot number 20020918 (preparation of liangfuwan seminar)
Liang Fu Wan lot number 20000214 (Zhenjiang pharmaceutical factory of traditional Chinese medicine product)
2, method: according to Chinese Pharmacopoeia version appendix in 2000 XII A item following disintegration of inspection method, check its disintegration, use instrument to be disintegration instrument CHP-II type (Tianjin electronic machine two factories)
3, result: former Liang Fu Wan disintegration is 30 minutes, and liangfuwan is 6 minutes.
4, conclusion: liangfuwan disintegration only is 6 minutes, is 1/5 of former Liang Fu Wan disintegration, shows that liangfuwan is molten rapidly in vivo to loose, and onset time is short, can bring into play curative effect rapidly.
Embodiment 5, stability experiment
1, material: instrument is high performance liquid chromatograph HP-110, disintegration instrument CHP-II type (Tianjin civil power
Sub-instrument two factories)
Chromatographic column is YWG-C18 4.6mm * 250mm (the three-dimensional chromatographic apparatus in a Tianjin factory)
Reagent is methanol, phosphoric acid, and water etc. are analytical pure (Tianjin reagent two factories) all
Reference substance is kaempferide (purchasing in Nat'l Pharmaceutical ﹠ Biological Products Control Institute)
2, method: according to the contained effective ingredient of liangfuwan is flavone compound, and kaempferide is one of effective ingredient wherein,, formulates with kaempferide as component target control technology stable in order to make process stabilizing.Its method is to adopt high performance liquid chromatography, is reference substance with the kaempferide, and methanol: phosphoric acid: water is mobile phase, is the 368nm place detecting wavelength, measures kaempferide content in the liangfuwan.And adopt disintegration tester to measure dissolve scattered time limit.
3, result:
Liang Fu Wan and liangfuwan stability experiment result
4, conclusion: above-mentioned experiment shows: at the aspects such as content of outward appearance, dissolve scattered time limit and effective ingredient kaempferide, liangfuwan is all stable than Liang Fu Wan.
Embodiment 6, effect experiment
1, material
1) be subjected to the reagent thing:
Liangfuwan: brown drop pill, every gram contain crude drug 7.99 grams (liangfuwan seminar provides)
Liang Fu Wan: positive control drug, lot number 20000214 (Zhenjiang pharmaceutical factory of traditional Chinese medicine product)
Acecoline: white powder, lot number 20000420 (Shanghai reagent three factories product)
2) animal:
Kunming mouse, male and female half and half, body weight 18-22 gram; Wistar rat male and female half and half, body weight restrains at 250-300.Above animal breeds by the court animal housing, the Laboratory Animal Facility quality certification " accurate No. 013 of the real moving facility in Tianjin ", and committee issues by the Tianjin management of laboratory animal, meets primary standard. normally raise after 3 days for usefulness.
3) instrument: pressure transducer (YP100) .056 monitor (HIT's product)
2, method:
1) to the analgesic activity of mice:
Kunming mouse, male and female half and half, body weight 18～22 gram. the acetum 0.2ml/g body weight of the equal lumbar injection 0.6% of each mice the previous day, that writes down each mice in 15 minutes turns round the body number of times.Got in second day and turn round 92 of the mice of body number of times within 20～45 times in 15 minutes, knob body number of times is divided into 6 groups at random, 10 every group.The administration group is irritated stomach liangfuwan and positive drug Liang Fu Wan, the carboxymethylcellulose sodium solution of blank oral administration gavage 0.5% acecoline, one day twice, accumulated dose is 12.0g crude drug/Kg, give the acetic acid 0.2ml/20g body weight of wanting pneumoretroperitoneum injection 0.6% in a hour for the second time, write down respectively organize mice in 15 minutes turn round the body number of times, experimental result is carried out statistical procedures with the t check.
2) diastole to rat stomach influences:
48 of Wistar rats, male and female half and half, body weight 250～300 grams, fasting is 24 hours before the experiment, freely drinks water, be divided into 6 groups at random by body weight, every group 8, the administration group is respectively to liangfuwan and positive control drug Liang Fu Wan, and dosage is 6g crude drug/Kg, the blank group gives 0.5%CMC, urethane anesthesia (1.2g/Kg, ip), the abdominal part median incision, expose the abdominal cavity, insert a thin plastic pipe to gastral cavity through the duodenum otch, ligation is fixed, and cleans gastral cavity repeatedly with normal saline (37 ℃) and ends to flowing out clear liquid. inject 2ml37 ℃ normal saline again to gastral cavity from plastic tube, intubate is connected in pressure transducer, stablized duodenal administration, 1 hour lumbar injection behind the medicine 30 minutes, acecoline (3mg/Kg) is pressed variation with autographic apparatus record gastric. and experimental result is carried out statistical procedures with the t check.
3, result:
1) to the analgesic activity of mice: see Table 1
Table 1 liangfuwan is to the analgesic activity of mice
| Group | Dosage (the g crude drug/Kg) | Animal (only) | Turn round body number of times ± sd (inferior/15 minute) |
| Blank group | ????- | ????10 | 30.6±8.8 |
| Liang Fu Wan | ????12 | ????10 | 13.1±9.9** |
| Liangfuwan | ????12 | ????10 | 13.6±16.0** |
Annotate: * * compares P＜0.01 with the blank group
The result shows, after blank group causes pain model with acetic acid, in 15 minutes of record, the animal that is caused by pain is turned round the number of times average out to 30.6 of body, and the statistical standard difference is 8.8 times, after animal gives the former dosage form treatment of Liang Fu Wan, the animal that is caused by pain is turned round the number of times on average remaining 13.1 times of body, and after animal gave the treatment of novel form liangfuwan, the animal that is caused by pain was turned round the number of times on average remaining 13.6 times of body, it is about 60% to illustrate that medicine reduces pain reaction, novel form and former dosage form basically identical.
2) diastole to rat stomach influences: see Table 2
Table 2: the influence that liangfuwan is pressed the anesthetized rat gastric
| Behind the medicine | Dosage (the g crude drug/Kg) | Animal (only) | Before the medicine | After the gastric pressing | Behind the Ach | ?ΔP |
| Blank | ??8 | 8 | ??5.59±2.78 | ?6.03±3.09 | ?12.68±3.51 | ?6.65±2.95 |
| Liang Fu Wan | ??6 | 8 | ??5.86±1.61 | ?4.81±1.41 | ?8.20±3.54* | ??3.39±3.19 |
| Liangfuwan | ??6 | 8 | ??5.46±2.31 | ?5.71±2.52 | ?7.69±2.72** | ??1.98±1.63 |
Annotate: * compares P＜0.05 with blank, * * compares P＜0.014 with the blank group
The result shows, after blank group causes experimental stomach spasm with acetylcholine (ACH), high nearly one times of gastric voltage rise, after animal gives the former dosage form treatment of Liang Fu Wan, it is high about 50% to have alleviated gastric voltage rise that stomach spasm causes, after animal gives the treatment of novel form liangfuwan, has alleviated the gastric voltage rise high about 70% that stomach spasm causes, illustrate that medicine has spasmolysis, novel form be better than former dosage form.
4, conclusion: pharmacodynamic experiment shows that liangfuwan has spasmolytic, analgesic activity, and the convection potential gastric abscess has significant curative effect.
Claims (10)
1, a kind of Chinese patent medicine liangfuwan for the treatment of gastric abscess, it is by making as the polyethylene glycol 6000 of substrate with as the Rhizoma Alpiniae Officinarum of active component and the extract of Rhizoma Cyperi (processing).
2, liangfuwan according to claim 1 is characterized in that: the ratio of weight and number of described active component and substrate is 1: 2.5～1: 3.5.
3, liangfuwan according to claim 1 is characterized in that: described active component is to be made through extracting according to 1: 1 ratio of weight and number by Rhizoma Alpiniae Officinarum and Rhizoma Cyperi (processing).
4, liangfuwan according to claim 3 is characterized in that: describedly be extracted as alcohol extraction or water is carried or water alcohol mixes and carries.
5, a kind of preparation technology who treats the Chinese patent medicine liangfuwan of gastric abscess comprises the steps:
1) medical material is handled: 500 gram Rhizoma Alpiniae Officinarum and 500 gram Rhizoma Cyperis (processing) are extracted with the second alcohol and water, be condensed into extractum respectively, reuse ethyl acetate extraction, extract are concentrated into the dried dried cream of extract that becomes;
2) medicinal liquid preparation: taking polyethylene glycol 6000 is put in the container, is heated to 70～80 ℃ in water-bath, treat whole fusions after, be that 1: 2.5～3.5 ratio adds the dried cream of extract according to the dried cream of extract and Polyethylene Glycol ratio of weight and number, be stirred to dissolving, even;
3) drip system: the medicinal liquid for preparing is transferred in the reservoir, and airtight and insulation is at 70 ℃, and regulator solution titer valve splashes in 5～10 ℃ the liquid paraffin;
4) drying: with the drop pill drop that forms to the greatest extent and the erasing liquor paraffin body, drying, promptly.
6, preparation technology according to claim 5 is characterized in that: the concentration of alcohol in the described medical material treatment step is 85～95% (V/V).
7, preparation technology according to claim 5 is characterized in that: extract with the second alcohol and water in the described medical material treatment step and be meant with respectively extracting 2 times with the second alcohol and water respectively.
8, preparation technology according to claim 5 is characterized in that: be meant usefulness ethyl acetate extraction 4 times with ethyl acetate extraction in the described medical material treatment step, each consumption is 1000ml.
9, preparation technology according to claim 7 is characterized in that: the described extraction with ethanol is meant each usefulness 6000～8000ml ethanol extraction 1 hour.
10, preparation technology according to claim 7 is characterized in that: described water extracts and is meant each usefulness 8000～10000ml water extraction half an hour.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03124245 CN1259099C (en) | 2003-04-30 | 2003-04-30 | Prepared traditional Chinese drug Liangfu drop pills for treating epigastric pain |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03124245 CN1259099C (en) | 2003-04-30 | 2003-04-30 | Prepared traditional Chinese drug Liangfu drop pills for treating epigastric pain |
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| Publication Number | Publication Date |
|---|---|
| CN1541669A true CN1541669A (en) | 2004-11-03 |
| CN1259099C CN1259099C (en) | 2006-06-14 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 03124245 Expired - Fee Related CN1259099C (en) | 2003-04-30 | 2003-04-30 | Prepared traditional Chinese drug Liangfu drop pills for treating epigastric pain |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1310029C (en) * | 2005-01-14 | 2007-04-11 | 贵州黄果树立爽药业有限公司 | Method for preparing liangfuwan and method for controlling quality |
| CN101926949B (en) * | 2009-06-25 | 2012-04-18 | 天津太平洋制药有限公司 | Preparation process of galangal and rhizoma cyperi liquid capsule |
| CN102552781A (en) * | 2010-12-27 | 2012-07-11 | 天津药物研究院 | Chinese medicinal preparation galanga-nutgrass galingale rhizome tablet for treating epigastric pain and preparation method thereof |
| CN105056058A (en) * | 2015-07-16 | 2015-11-18 | 王乾林 | Traditional Chinese medicine pharmaceutical for treating stomachache with cold and qi stagnation |
-
2003
- 2003-04-30 CN CN 03124245 patent/CN1259099C/en not_active Expired - Fee Related
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1310029C (en) * | 2005-01-14 | 2007-04-11 | 贵州黄果树立爽药业有限公司 | Method for preparing liangfuwan and method for controlling quality |
| CN101926949B (en) * | 2009-06-25 | 2012-04-18 | 天津太平洋制药有限公司 | Preparation process of galangal and rhizoma cyperi liquid capsule |
| CN102552781A (en) * | 2010-12-27 | 2012-07-11 | 天津药物研究院 | Chinese medicinal preparation galanga-nutgrass galingale rhizome tablet for treating epigastric pain and preparation method thereof |
| CN105056058A (en) * | 2015-07-16 | 2015-11-18 | 王乾林 | Traditional Chinese medicine pharmaceutical for treating stomachache with cold and qi stagnation |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1259099C (en) | 2006-06-14 |
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