CN1857360A - Capsule for treating enteritis and dysentery and its preparing process - Google Patents
Capsule for treating enteritis and dysentery and its preparing process Download PDFInfo
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- CN1857360A CN1857360A CNA2006100185982A CN200610018598A CN1857360A CN 1857360 A CN1857360 A CN 1857360A CN A2006100185982 A CNA2006100185982 A CN A2006100185982A CN 200610018598 A CN200610018598 A CN 200610018598A CN 1857360 A CN1857360 A CN 1857360A
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- capsule
- dysentery
- extract
- taraxacum
- berberine hydrochloride
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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Abstract
The capsule for treating enteritis and dysentery contains main medicine components berberine hydrochloride and taraxacum extract and supplementary material starch. The medicine of the present invention has masked bitter, high bioavailability, high medicine stability, and carrying and use convenience. The preparation process includes mixing berberine hydrochloride, taraxacum extract and starch, adding 75 % concentration ethanol solution, pelletizing, drying, and encapsulating.
Description
Technical field
The present invention relates to a kind of capsule and preparation technology thereof who treats enteritis and dysentery.
Background technology
With berberine hydrochloride and extract of taraxacum be the clear sheet of Lian Pushuan made of primary raw material to the treatment enteritis and dysentery, the inflammation of furuncle and phyma wound, mastitis, cholecystitis have reasonable curative effect.Developing Chinese patent medicine once more, to connect the Pu Shuan clearing capsule important by it, because make capsule into, has many good qualities: the bitterness that can cover medicine, but can have also lettering of shades of colour, and attractive in appearance, be beneficial to and take, carry with easy to use, the bioavailability of medicament height improves medicine stability.
Present domestic targeted treatment enteritis and dysentery, the inflammation of furuncle and phyma wound, mastitis, disease Chinese patent medicines such as cholecystitis are relatively many.And treat enteritis and dysentery at home and abroad, and the inflammation of furuncle and phyma wound, mastitis, the Western medicine of diseases such as cholecystitis is quite big to the side effect of human body, even threat to life, can not use more.Heat-clearing and toxic substances removing of the present invention, dampness-eliminating and dysentery-stopping Chinese patent medicine tablet are to use modern preparation technique to make with extra care under instructing with Traditional Chinese medical theory to form.
Summary of the invention
The purpose of this invention is to provide a kind of capsule for the treatment of enteritis and dysentery.
Another object of the present invention provides a kind of capsule preparation method thereof for the treatment of enteritis and dysentery.
The present invention is achieved like this, and it comprises principal agent and adjuvant, and wherein principal agent is formulated by the following raw materials in part by weight medicine: berberine hydrochloride 7-13 extract of taraxacum 127.5-247.5
Wherein adjuvant is formulated by following substances in parts by weight: filler 10-100, disintegrating agent 0-100, lubricant 0-4, wetting agent 2-10.
Described filler is that in starch, dextrin, the microcrystalline Cellulose one or more are used, disintegrating agent is a polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, in the microcrystalline Cellulose etc. one or more are used or need not, lubricant be in magnesium stearate, Pulvis Talci, the micropowder silica gel one or more be used or need not, wetting agent is a 60-80% ethanol
Preparation method of the present invention: get berberine hydrochloride, extract of taraxacum two medicines add the abundant mixing of starch 52.5g, make granule with 75% ethanol, drying, fill becomes 1000 capsules, promptly.
The extract of taraxacum method for making: get the Herba Taraxaci medical material and break into fine powder, cross 100 mesh sieves, standby; Other gets the Herba Taraxaci medical material and adds 12 times of water gagings decoctions 2 times, 1.5 hours for the first time, 1 hour for the second time, merges decoction liquor, filter, filtrate is concentrated into relative density 1.20 clear paste and surveys in temperature 70～75 ℃ of heat, 1.2 parts of qinghuo reagents, 1 part of Herba Taraxaci fine powder, mixing, drying is made dried cream, promptly.
Advantage of the present invention is: the biological utilisation height of medicine, medicine stability is good, is beneficial to and takes, and is easy to carry, can cover the bitterness of medicine.
The specific embodiment
Embodiment one,
Berberine hydrochloride 10g extract of taraxacum 187.5g
Preparation method of the present invention: get berberine hydrochloride, extract of taraxacum two medicines add the abundant mixing of starch 52.5g, make granule with 75% ethanol, drying, fill becomes 1000 capsules, promptly.
The extract of taraxacum method for making: get the Herba Taraxaci medical material and break into fine powder, cross 100 mesh sieves, standby; Other gets the Herba Taraxaci medical material and adds 12 times of water gagings decoctions 2 times, and 1.5 hours for the first time, 1 hour for the second time, merge decoction liquor, filter, filtrate is concentrated into the clear paste of relative density 1.20, in 70～75 ℃ of surveys of temperature, 1.2 parts of qinghuo reagents, 1 part of Herba Taraxaci fine powder, mixing, drying is made dried cream, promptly.
Embodiment two,
Berberine hydrochloride 7g extract of taraxacum 127.5g
Preparation method of the present invention: get berberine hydrochloride, extract of taraxacum two medicines add the abundant mixing of starch 52.5g, make granule with 65% ethanol, drying, fill becomes 1000 capsules, promptly.
Embodiment three,
Berberine hydrochloride 13g extract of taraxacum 247.5g
Preparation method of the present invention: get berberine hydrochloride, extract of taraxacum two medicines add the abundant mixing of starch 52.5g, make granule with 85% ethanol, drying, fill becomes 1000 capsules, promptly.
Result of study:
One, Study on Preparation data
1 drug effect relevant and the argumentation of composition with process choice
We are made up of berberine hydrochloride, extract of taraxacum.
1.1, berberine hydrochloride is crude drug, and stronger antimicrobial and protozoacide effect are arranged; Berberine hydrochloride has effects such as blood pressure lowering, lax vascular smooth muscle, function of gallbladder promoting, diuresis, local anesthesia, calmness, analgesia.Therefore, in order to keep its effective ingredient to greatest extent, it is more reasonable that the berberine hydrochloride employing directly adds technology.
1.2, the Herba Taraxaci herb contains fat-soluble and water soluble ingredients such as taraxasterol, choline, inulin and pectin.Herba Taraxaci is the conventional medicament of heat-clearing and toxic substances removing, by further research, proves that it has good anti-infectious function in recent years, is widely used in the multiple infective inflammation of clinical each section.Therefore, this prescription employing part medical material is beaten powder, part medical material decocting process not only keeps its effective ingredient to greatest extent but also reduces dose.
2 extraction process conditions are investigated
This prescription is made up of berberine hydrochloride and extract of taraxacum, and therefore, technology is mainly investigated the extract of taraxacum preparation condition.Extract of taraxacum adopts boiling water extraction method, and the factor that influences extraction process by water mainly contains and decocts number of times, decocting time and amount of water.Test serves as to investigate index to carry out determining of extraction process by water with caffeic acid content in dry extract yield and the extract of taraxacum.
Test material: the Herba Taraxaci crude drug originates in Ji'an, Jiangxi available from Zhangshu City pharmaceuticals.Through my company by " Chinese pharmacopoeia Herba Taraxaci medical material standard in 2000 identifies and detect that the medical material that feeds intake is the dry herb of feverfew Herba Taraxaci Taraxacum mongolicum Hand.-Mazz., measures that caffeic acid content is 0.029% in the Herba Taraxaci.
Caffeic acid content assaying method: by " Chinese pharmacopoeia Herba Taraxaci medical material standard content in 2000 is measured item caffeic acid content assaying method down.
2.1 determining of Herba Taraxaci water boiling and extraction number of times: with reference to former technology, be 2 hours, when amount of water is 12 times (according to Herba Taraxaci is the herb medical material, and shared volume is determined greatly), tests the investigation decocting and boil number of times result (seeing Table 1) at decocting time
Table 1 Herba Taraxaci water boiling and extraction number of times is investigated
| Level | Extraction time (inferior) | Dry extract yield (%) | Caffeic acid content (mg/g) |
| 1 2 3 | 1 2 3 | 20.06 26.82 26.90 | 0.47 0.59 0.58 |
By last table result as can be seen: Herba Taraxaci can fully extract its effective ingredient caffeic acid adding 12 times of water gagings decoctions twice, determines that therefore it is 2 times that this technology decocts extraction time.
2.2 determining of Herba Taraxaci water boiling and extraction decocting time:, be that 2 times, amount of water are that test is investigated decocting and boiled time result (seeing Table 2) under 12 times the condition at extraction time with reference to former technology
Table 2 Herba Taraxaci water boiling and extraction decocting time is investigated
| Level | Decocting time (h) for the first time | Decocting time (h) for the second time | Dry extract yield (%) | Caffeic acid content (mg/g) |
| 1 2 3 | 1 1.5 1.5 | 1 1 1.5 | 23.62 26.88 26.95 | 0.53 0.60 0.59 |
By last table result as can be seen: Herba Taraxaci is adding 12 times of amount decoctions of water, and 1.5 hours first time, 1 hour second time can make caffeic acid fully extract, and determines that therefore this technology decocting time is 1.5 hours first time, and be best decocting process 1 hour second time.
2.3 determining of Herba Taraxaci water boiling and extraction amount of water: with reference to former technology, be 2 times, 1.5 hours for the first time at extraction time, under 1 hour the condition, test is investigated decocting and is boiled amount of water result (seeing Table 3) for the second time
Table 3 Herba Taraxaci water boiling and extraction amount of water is investigated
| Level | Amount of water (doubly) | Decocting time (h) for the first time | Decocting time (h) for the second time | Dry extract yield (%) | Caffeic acid content (mg/g) |
| 1 2 3 | 8 10 12 | 1.5 1.5 1.5 | 1 1 1 | 22.10 25.59 26.88 | 0.51 0.58 0.60 |
By last table result as can be seen: Herba Taraxaci is adding 12 times of amount decoctions of water, and 1.5 hours first time, 1 hour second time can make caffeic acid fully extract, and determines that therefore it is best decocting process that this technology decoction amount of water is 12 times.
Determining of 3 supplementary product consumptions
According to the prescription total amount that feeds intake is 197.5g, making 1000 capsules calculates, test is investigated with every capsules content dress 0.20g/ grain, 0.25g/ grain, 0.30g/ grain, the capsule of resultant content thing dress 0.25g/ grain and 0.30g/ grain, its assay stability better, in order to reduce dose and to reduce production costs, determine the capsule of content dress 0.25g/ grain, so per 1000 capsules need add starch 52.5g.
4 different concentration ethanol influence grain forming
Different concentrations of alcohol is the key factor of granulating, experiment with 65%, 75%, the investigation of granulating of 85% 3 kind of concentration of alcohol, the result is as follows:
Table 4 different concentration ethanol is to the investigation of preparation of granules
| Numbering | Concentration of alcohol (%) | The preparation of granules situation |
| 1 2 3 | 65 75 85 | Granule is wet, and difficult granulation granule is attractive in appearance, and the granule of easily granulating is done, not easy-formation |
By last watch test result, my company determines with 75% alcohol granulation to be best granulating process.
4.5 determining of capsule model
Test is with No. 0 capsule trial assembly, and every of content is adorned 0.25g, and content uniformity is all up to specification, so determine that the capsule model is No. 0.
4.6 preparation technology determines
By above optimal process test, determine that the preparation technology who connects the Pu Shuan clearing capsule is:
Get berberine hydrochloride 10g, extract of taraxacum 187.5g two medicines add starch 52.5g mixing, use 75% alcohol granulation, drying, fill becomes 1000 capsules, promptly.
Annotate the extract of taraxacum method for making: get the Herba Taraxaci medical material and break into fine powder, cross 100 mesh sieves, standby; Other gets the Herba Taraxaci medical material and adds 12 times of water gagings decoctions 2 times, 1.5 hours for the first time, 1 hour for the second time, merges decoction liquor, filter, filtrate is concentrated into the clear paste of relative density 1.20 (70～75 ℃ of heat are surveyed), 1.2 parts of qinghuo reagents, 1 part of Herba Taraxaci fine powder, mixing, drying is made dried cream, promptly.
Two, quality stability test
Get this product and be positioned over 40 ℃ by commercially available back, relative humidity is in 75% the climatic chamber 6 months, and through 0,1,2,3, the sampling in June, carrying out the investigation project is character, discriminating, disintegration, assay, limit test of microbe.Every index has no significant change, and is more stable, and effect duration can reach 3 years.The results are shown in Table 5.
Table 5 capsule stability accelerated test (lot number: 20040418) of the present invention
Three, the clinical application effect that connects the Pu Shuan clearing capsule:
1, does observation group's (100 example) with connecting the Pu Shuan clearing capsule, to connect the clear sheet of Pu Shuan is matched group (50 example), carry out clinical comparison in the treatment enteritis and dysentery, observe times of defecation, stool character, course of disease diarrhoea degree, stomachache, intestinal mucosal injury degree, its curative effect is compared as follows:
Table 6 connects Pu Shuan clearing capsule treatment enteritis and dysentery clinical efficacy relatively
| Case load | The recovery from illness number | The produce effects number | Significant figure | Invalid number | Effective percentage | |
| Observation group | 100 | 51 | 30 | 13 | 6 | 94％ |
| Matched group | 50 | 23 | 21 | 2 | 4 | 92％ |
2, doing observation group's (80 example) with connecting the Pu Shuan clearing capsule, is matched group (40 example) to connect the clear sheet of Pu Shuan, carries out clinical comparison at the treatment mastitis, observation analysis mammary gland course of disease situation, and its curative effect is compared as follows:
Table 7 connects Pu Shuan clearing capsule treatment mastitis clinical efficacy relatively
| Case load | The recovery from illness number | The produce effects number | Significant figure | Invalid number | Effective percentage | |
| Observation group | 80 | 41 | 32 | 4 | 3 | 96.25％ |
| Matched group | 40 | 18 | 15 | 5 | 2 | 95％ |
Claims (3)
1, a kind of capsule for the treatment of enteritis and dysentery is characterized in that it comprises principal agent and adjuvant, and wherein principal agent is formulated by the following raw materials in part by weight medicine:
Berberine hydrochloride 7-13 extract of taraxacum 127.5-247.5
Adjuvant is formulated by following substances in parts by weight: filler 10-100, disintegrating agent 0-100, lubricant 0-4, wetting agent 2-10.
2, according to the capsule of claims 1 described treatment enteritis and dysentery, it is characterized in that described filler is that in starch, dextrin, the microcrystalline Cellulose one or more are used, disintegrating agent is a polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, in the microcrystalline Cellulose etc. one or more are used or need not, lubricant be in magnesium stearate, Pulvis Talci, the micropowder silica gel one or more be used or need not, wetting agent is 65 ∽, 85% ethanol.
3, a kind of capsule preparation method thereof of claims 1 described treatment enteritis and dysentery is characterized in that: get berberine hydrochloride, extract of taraxacum two medicines add the abundant mixing of starch 52.5g, make granule with 75% ethanol, and drying, fill becomes 1000 capsules, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100185982A CN100484536C (en) | 2006-03-16 | 2006-03-16 | Capsule for treating enteritis and dysentery and its preparing process |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100185982A CN100484536C (en) | 2006-03-16 | 2006-03-16 | Capsule for treating enteritis and dysentery and its preparing process |
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| Publication Number | Publication Date |
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| CN1857360A true CN1857360A (en) | 2006-11-08 |
| CN100484536C CN100484536C (en) | 2009-05-06 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102973629A (en) * | 2012-10-31 | 2013-03-20 | 河南牧翔动物药业有限公司 | Oral liquid for preventing and treating intestinal diseases of livestock and poultry and preparation method thereof |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101912594A (en) * | 2010-08-11 | 2010-12-15 | 江西德瑞制药有限公司 | Traditional Chinese medicine preparation for treating gastrointestinal diseases |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102973629A (en) * | 2012-10-31 | 2013-03-20 | 河南牧翔动物药业有限公司 | Oral liquid for preventing and treating intestinal diseases of livestock and poultry and preparation method thereof |
| CN102973629B (en) * | 2012-10-31 | 2014-10-22 | 河南牧翔动物药业有限公司 | Oral liquid for preventing and treating intestinal diseases of livestock and poultry and preparation method thereof |
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| CN100484536C (en) | 2009-05-06 |
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