CN101297869A - Gastralgia dispersed tablet and preparation - Google Patents
Gastralgia dispersed tablet and preparation Download PDFInfo
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- CN101297869A CN101297869A CNA2007100089212A CN200710008921A CN101297869A CN 101297869 A CN101297869 A CN 101297869A CN A2007100089212 A CNA2007100089212 A CN A2007100089212A CN 200710008921 A CN200710008921 A CN 200710008921A CN 101297869 A CN101297869 A CN 101297869A
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Abstract
The invention discloses a dispersible gastralgia tablet and a preparation method thereof, the invention carries out the technological reform of the formulation based on the existing ordinary tablets, thus overcoming the shortcomings of heavier fishy smell, difficult administration, slow speed of disintegration and slow onset of action of the original formulation, enriching the types of the drugs, improving the quality standards and further meeting and ensuring the demands on the drugs by the people. The drug has the effects of activating qi-flowing, activating blood circulation, inhibiting acid and stopping pain, which is used for gastralgia, acid regurgitation, belching eructation and epigastric distension caused by qi-stagnancy and blood stasis, as well as gastric and duodenal ulcers and chronic gastritis with the symptoms. The efficacy is significant. The usage and carrying are convenient, which is a clinically popular, safe, stable and effective drug and an ideal product for the modern pharmaceutical enterprises.
Description
Technical field
The present invention relates to the fabricating technology field of Chinese patent medicine dispersible tablet, relate in particular to gastralgia dispersed tablet and preparation method.
Background technology
Dispersible tablet (dispersible tablets) is meant the rapid homodisperse tablet of disintegrate of energy in water, dispersible tablets of Chinese medicine is a raw material with Chinese medicine extract, the former powder of Chinese medicine or refining intermediate exactly, add what proper auxiliary materials was made, can be in water the homodisperse tablet of disintegrate rapidly.Dispersible tablet comes from " British Pharmacopoeia " the earliest, means the tablet novel form of meeting the even suspension of water rapid disintegrate formation.Often because of disintegrate and the slow abundant absorption that influences medicine of medicine stripping, patient's conventional tablet of old man, child and dysphagia has any problem when taking more; Though and the liquid preparation taking convenience, less stable, is stored all inconvenience at packing, transportation.Dispersible tablet has the advantage of tablet and liquid preparation concurrently, and has overcome both deficiencies.Dispersible tablet promptly can add after the aqueous dispersion oral, also can be contained in to suck clothes in the mouth or swallow, and the dispersible tablet kind of abroad having gone on the market has more than 10 at present, 28 kinds of the domestic dispersible tablets of approved so far, but wherein have only a herbal species.The dispersible tablets of Chinese medicine of bibliographical information has Herb Gynostemmae Pentaphylli total glycosides dispersible tablet, gold zone dispersible tablet, Radix Scutellariae lung heat clearing dispersible tablet, Daidzein dispersible tablet at present; Cold drug dispersible tablet and Moschus are protected heart dispersible tablet.According to the relevant drug act of China, change dosage form as a kind of new drug research, original dosage form of gastralgia dispersed tablet is common tablet, has listed in one one of the state-promulgated pharmacopoeia.The technology characteristics of former dosage form is: 3 flavor medicines in the prescription, be ground into fine powder, and sieve, mixing adds Mel and suitable quantity of water, makes granule, drying, tabletting, promptly.This disintegration of tablet speed is slow, and the patient of old man, child and dysphagia has any problem when taking more; Can't satisfy gastralgia acute attack patient's medication demand; And because of containing relatively large Endoconcha Sepiae,, be easy to generate nausea and vomiting so sensation fishy smell is heavier when the patient takes; Simultaneously quality standard still can further improve, and based on this, we use the modern pharmaceutical technology this product technology is done necessary improvement, form new preparation, and the control criterion that improves the quality simultaneously guarantees the quality monitoring of product, benefits the common people.
Summary of the invention
The purpose of this invention is to provide a kind of gastralgia dispersed tablet and preparation method, improve the quality and the curative effect of product, increase the stability of product, enrich medicine variety, to satisfy and to ensure people's medication demand better.
1, the preparation method of gastralgia dispersed tablet comprises the steps:
1.1 the prescription of gastralgia dispersed tablet is formed
Rhizoma Corydalis (vinegar system) 63g; Alumen (forging) 250g; Endoconcha Sepiae (shelling) 187g;
Adjuvant 100～200g makes 1000 altogether
Optimised process is:
Rhizoma Corydalis (vinegar system) 63g; Alumen (forging) 250g; Endoconcha Sepiae (shelling) 187g;
Adjuvant 100g makes 1000 altogether
1.2 the preparation technology of gastralgia dispersed tablet
Take by weighing recipe quantity Rhizoma Corydalis (processed with vinegar) (YHS), the Endoconcha Sepiae of shelling (HPX), calcined Alumen (BF), with crospolyvinylpyrrolidone (PVPP), microcrystalline Cellulose (MCC), sodium lauryl sulphate (SDS), carboxymethyl starch sodium adjuvant mix homogeneously such as (CMS-Na), with polyvinylpyrrolidone (PVP) is that binding agent prepares soft material, No. 2 sieve series grains, 60 ℃ of dryings, No. 2 sieve granulate add micropowder silica gel (SG), mixing, tabletting.Quality inspection, promptly.
In the technology can also there be added adjuvant: any/multiple mixing in low-substituted hydroxypropyl cellulose, magnesium stearate (calcium), sodium lauryl sulphate, Oleum menthae, steviosin, the glycyrrhizin etc. is used.Micropowder silica gel can not add in the technology.
In the technology Rhizoma Corydalis was ground into the powder of 3～No. 7 sieves, the most well No. 7 sieves; Alumen was ground into the powder of 2～No. 5 sieves, the most well No. 3 sieves; Endoconcha Sepiae was ground into the powder of 3～No. 5 sieves, the most well No. 5 sieves; Ingredient powder was broken into the powder of 2～No. 5 sieves, the most well No. 3 sieves.
Added disintegrating agent is crospolyvinylpyrrolidone (PVPP) in the technology, and the ratio of adding is 1: 1～3: 1 in the disintegrating agent, is preferably 2: 1, the also effect of helpful disintegrate of certain added microcrystalline Cellulose, carboxymethyl starch sodium.
The temperature of particle drying is controlled at 50～90 ℃ in the technology, is preferably 60～80 ℃.
In the technology in the added adjuvant each components contents scope as follows: crospolyvinylpyrrolidone (PVPP), microcrystalline Cellulose (MCC), carboxymethyl starch sodium (CMS-Na), with polyvinylpyrrolidone (PVP).
General range preferable range optimum range
PVPP 4％～8％ 3.0％～4.0％ 3.5％
PVP 12％ 0.67％～1.33％ 1.0％
CMS-Na 3％～7％ 3.33％～5.0％ 3.3％
MCC 2％～5％ 5.83％～7.5％ 6.7％
Owing to contain Endoconcha Sepiae in the prescription,, can add suitable correctives sweeting agent so it is heavier to take time sensation fishy smell.Can add an amount of Oleum menthae, menthol, artificial Rhizoma et radix valerianae, the correctives that Cortex Cinnamomi and various fruity etc. are commonly used, general consumption is 0.5%～3%, and is ideal with spray-dired correctives.The sweeting agent that adds can be natural or artificial sweetener, as sugar, saccharin sodium (calcium), agedoite, dihydrochalcone, glycyrrhizin, pure sugar and novel sweetener radix asparagi sweet extract, usually the consumption of natural sweetener is no more than 5%, and the consumption of artificial sweetener is no more than 1%.
Because dispersible tablet need add disintegrating property disintegrating agent, swellability adjuvant and some other filleies preferably, to guarantee tablet disintegrate rapidly, stripping.Therefore shared ratio can not be too high in prescription for the raw material of Chinese medicine medicine, it is generally acknowledged and be advisable below 50%, uses adjuvant to stay enough spaces, and this point is dispersible tablets of Chinese medicine and the remarkable different place of Western medicine dispersible tablet.The ratio that the raw material of Chinese medicine medicine accounts in prescription among the present invention is up to 83%, adjuvant that is added such as PVPP, PVP, MCC are also outside general range, fluidizer wherein, lubricant micropowder silica gel can not add, and have overcome forefathers' understanding defective, have obtained beyond thought effect.
2, the quality control standard of gastralgia dispersed tablet further improves on the basis of original gastralgia tablet among the present invention, former dosage form does not have the limit examine of arsenic salt, heavy metal on checking, now increased heavy metal limit and must not cross 10/1000000ths, arsenic salt must not cross 2/1000000ths; Increased the quantitative assay of tetrahydropalmatine on the assay.
This invention is dosage form technological innovation on the basis of existing conventional tablet, increase new adjuvant, improved disintegration rate, the fishy smell and the quality standard that have improved former tablet have new raising again, to improving the quality of products significant meaning is arranged, enriched medicine variety, the patient of being convenient to old man, child and dysphagia takes, also make people especially gastralgia acute attack patient is more pleased and take, satisfy and ensured people's medication demand.
The specific embodiment
Can further be well understood to the present invention by specific embodiments of the invention given below.But they are not limitation of the invention.
Embodiment 1 orthogonal experiment is optimized the granulating process of gastralgia dispersed tablet
Orthogonal experiment design and result
Four factors of relative percentage composition (being the percentage ratio that used adjuvant accounts for total supplementary product consumption in the prescription) to PVPP, PVP, CMS-Na and MCC in the used adjuvant are investigated, with the dispersed homogeneous degree is to investigate index, determine the consumption of each adjuvant, the results are shown in following table 1～table 3.
Table 1 empirical factor water-glass
Table 2 intuitive analysis result
Table 3 The results of analysis of variance
* represent that this factor has significance.
By The above results as can be known, four factor primary and secondarys that influence tablet granulation technology are: PVPP＞PVP＞MCC＞CMS-Na, best granulating process condition: A
2B
1C
2D
3, i.e. PVPP21%, PVP6%, MCC40%, CMS-Na 20%.
The optimum implementation of embodiment 2 these inventions is: three flavor medicines are up to the standards standby respectively in will writing out a prescription; Rhizoma Corydalis (processed with vinegar) (10.50%), the Endoconcha Sepiae of shelling (41.67%), calcined Alumen (31.17%), add crospolyvinylpyrrolidone (3.50%), microcrystalline Cellulose (6.67%), sodium lauryl sulphate (2.17%), carboxymethyl starch sodium (3.33%) mix homogeneously, with polyvinylpyrrolidone (1%) is that binding agent prepares soft material, No. 2 sieve series grains, 60 ℃ of dryings, No. 2 sieve granulate, tabletting promptly.
Claims (10)
1, a kind of gastralgia dispersed tablet and preparation method is characterized in that:
Passed examination is standby respectively for three flavor medicines in will writing out a prescription; Rhizoma Corydalis (vinegar system), Alumen (forging), Endoconcha Sepiae (shelling) three flavor pulverizing medicinal materials powdereds add the right amount of auxiliary materials mixing, make granule, and drying is with an amount of auxiliary materials and mixing, tabletting, quality inspection, promptly.
2, gastralgia dispersed tablet according to claim 1 and preparation method, it is characterized in that it is made up of the raw material of following weight ratio: 63 parts of Rhizoma Corydalis (vinegar system), 250 parts of Alumens (forging), 187 parts of Endoconcha Sepiaes (shelling), 100～200 parts of adjuvants, preferably 100 parts.
3, gastralgia dispersed tablet according to claim 1 and preparation method is characterized in that added adjuvant contains in the technology: crospolyvinylpyrrolidone, polyvinylpyrrolidone, microcrystalline Cellulose, carboxymethyl starch sodium.
4, according to described gastralgia dispersed tablet of claim 1～3 and preparation method, it is characterized in that added adjuvant also contains in the technology: any/multiple mixing in low-substituted hydroxypropyl cellulose, magnesium stearate (calcium), sodium lauryl sulphate, Oleum menthae, steviosin, the glycyrrhizin etc. is used.
5, according to described gastralgia dispersed tablet of claim 1～4 and preparation method, it is characterized in that: in the technology in the added adjuvant each components contents scope as follows: crospolyvinylpyrrolidone (PVPP), microcrystalline Cellulose (MCC), carboxymethyl starch sodium (CMS-Na), polyvinylpyrrolidone (PVP).
General range preferable range optimum range
PVPP 4％～8％ 3.0％～4.0％ 3.5％
PVP 12％ 0.67％～1.33％ 1.0％
CMS-Na 3％～7％ 3.33％～5.0％ 3.3％
MCC 2％～5％ 5.83％～7.5％ 6.7％
6, according to described gastralgia dispersed tablet of claim 1～5 and preparation method, it is characterized in that: added disintegrating agent is crospolyvinylpyrrolidone (PVPP) in the technology, and the ratio of adding is 1: 1～3: 1 in the disintegrating agent, is preferably 2: 1.
7, according to described gastralgia dispersed tablet of claim 1～6 and preparation method, it is characterized in that: in the technology Rhizoma Corydalis was ground into the powder of 3～No. 7 sieves, the most well No. 7 sieves; With Alumen be ground into 2～No. 5 the sieve powder, the most well No. 3 the sieve; With Endoconcha Sepiae be ground into 3～No. 5 the sieve powder, the most well No. 5 the sieve; With ingredient powder be broken into 2～No. 5 the sieve powder, the most well No. 3 the sieve.
8, according to described gastralgia dispersed tablet of claim 1～7 and preparation method, it is characterized in that: the temperature of particle drying is controlled at 50～90 ℃ in the technology, is preferably 60～80 ℃.
9, according to described gastralgia dispersed tablet of claim 1～8 and preparation method, it is characterized in that: be added with an amount of correctives, sweeting agent in the prescription.
10, according to described gastralgia dispersed tablet of claim 1～9 and preparation method, it is characterized in that: on quality inspection standard, have hardness, the dispersed homogeneous degree of dispersible tablet inspection, have heavy metal limit must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit detection; The quantitative assay of tetrahydropalmatine is arranged.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007100089212A CN101297869A (en) | 2007-04-30 | 2007-04-30 | Gastralgia dispersed tablet and preparation |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007100089212A CN101297869A (en) | 2007-04-30 | 2007-04-30 | Gastralgia dispersed tablet and preparation |
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| CN101297869A true CN101297869A (en) | 2008-11-05 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNA2007100089212A Pending CN101297869A (en) | 2007-04-30 | 2007-04-30 | Gastralgia dispersed tablet and preparation |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102397296A (en) * | 2010-09-17 | 2012-04-04 | 南京星银药业集团有限公司 | Cuttlebone dispersible tablet and its preparation method |
| CN103505517A (en) * | 2013-10-10 | 2014-01-15 | 南京正亮医药科技有限公司 | Preparation method and application of gastralgia tablets |
| CN106236929A (en) * | 2016-08-25 | 2016-12-21 | 陕西必康制药集团控股有限公司 | A kind of medicine treating gastropathy and preparation method thereof |
-
2007
- 2007-04-30 CN CNA2007100089212A patent/CN101297869A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102397296A (en) * | 2010-09-17 | 2012-04-04 | 南京星银药业集团有限公司 | Cuttlebone dispersible tablet and its preparation method |
| CN103505517A (en) * | 2013-10-10 | 2014-01-15 | 南京正亮医药科技有限公司 | Preparation method and application of gastralgia tablets |
| CN103505517B (en) * | 2013-10-10 | 2015-11-25 | 李彦良 | A kind of preparation method of gastralgia tablet and application |
| CN106236929A (en) * | 2016-08-25 | 2016-12-21 | 陕西必康制药集团控股有限公司 | A kind of medicine treating gastropathy and preparation method thereof |
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Open date: 20081105 |