CN1679616A - Compound tablet for treating gastritis and preparation thereof - Google Patents
Compound tablet for treating gastritis and preparation thereof Download PDFInfo
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- CN1679616A CN1679616A CN 200510049008 CN200510049008A CN1679616A CN 1679616 A CN1679616 A CN 1679616A CN 200510049008 CN200510049008 CN 200510049008 CN 200510049008 A CN200510049008 A CN 200510049008A CN 1679616 A CN1679616 A CN 1679616A
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- compound tablet
- treating gastritis
- hyprolose
- tablet
- vitamin
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Abstract
A compound medicine in the form of tablet for treating gastritis contains proportionally gentamycin sulfate, procaine hydrochloride, VB12 and medicinal additives.
Description
Technical field
The invention belongs to pharmaceutical preparation, relate to medical technical field, exactly is a kind of gentamycin procaine dimension B that is used for treating gastritis
12Sheet and preparation method.
Background technology
Gentamycin sulfate is an aminoglycoside antibiotics, and Hp is had stronger inhibitory action, can cut off source of disease effectively.Procaine hydrochloride can play sealing process to the teleneuron of damage mucomembranous surface, thereby can block the stimulation rapid alleviating pain of focus to the central nervous system; Have vasorelaxation action simultaneously, gastric mucosa vasodilation, microcirculation are improved, the mucosa blood volume increases, and repair function strengthens, and promotes that inflammation disappears; Other there are some researches prove that procaine hydrochloride still has certain short digestive tract power effect, but the symptom that the gastric emptying that the relieve chronic gastritis sufferer occurs is postponed, is short of power.Vitamin B
12Be to form the essential material of digestive tract normal epithelium cell.The three share and can play the effect that antibiotic, pain relieving and promotion gastric mucosa are repaired.
Patent of invention ZL98110391.X discloses a kind of tablet for the treatment of gastritis, comprises label and coatings, and the Main Ingredients and Appearance of label is a gentamycin sulfate 2-4 million international units, procaine hydrochloride 0.1-0.2 gram and vitamin 50-100 microgram; The Main Ingredients and Appearance of coatings is a 5%IV gastric solubleness acrylic resin 0.005-0.01 gram, 2% hydroxypropyl emthylcellulose 0.005-0.01 gram.This tablet adopts art for coating, and dosage is bigger.
Similar listing product mainly contains capsule and granule at present, but capsule shells can contain the moisture up to 15%, and very easily moisture absorption of gentamycin, can influence the quality of medicine, and capsule shells can influence the rate of release of medicine to a certain extent, influences the effect of anti-inflammatory analgetic; Contained sugar part is more in the granule, is unfavorable for the reparation of gastric mucosa and taking of some patient.
Summary of the invention
The invention provides the quick stripping of a kind of energy, be used for gentamycin sulfate, procaine hydrochloride and the vitamin B of anti-inflammatory analgetic and reparation gastric mucosa
12Compound tablet and preparation method.
A kind of compound tablet that is used for treating gastritis provided by the invention mainly comprises gentamycin sulfate, procaine hydrochloride, vitamin B
12And pharmaceutic adjuvant, every sulfur acid gentamycin 1 million international units, procaine hydrochloride 50mg, vitamin B
1210 μ g, pharmaceutic adjuvant 0.13-0.25g.
The pharmaceutic adjuvant that the present invention selects for use comprises disintegrating agent, filler, fluidizer and lubricant.The disintegrating agent of selecting for use is a hyprolose, and filler is lactose and microcrystalline Cellulose, and fluidizer is micropowder silica gel, and lubricant is a Pulvis Talci.The consumption of hyprolose is the 5%-30% that accounts for the tablet total weight amount.
The preparation method of compound tablet of the present invention comprises that the ratio of taking by weighing is gentamycin sulfate, the 50mg procaine hydrochloride of 1 million international units, and an amount of lactose, microcrystalline Cellulose and 50% hyprolose are crossed 60 mesh sieves with the abundant mixing of equivalent incremental method; With ethanol system soft material, cross 40 mesh sieves, oven dry below 80 ℃, 30 mesh sieve granulate; In addition with 10 μ g vitamin Bs
12, remaining hyprolose is with the abundant mixing of equivalent incremental method, again with the aforementioned particles mixing, adds an amount of micropowder silica gel and Pulvis Talci, abundant mixing; Carry out intermediate and measure, it is heavy to calculate sheet, packing warehouse-in behind the tabletting.
The gentamycin sulfate that the present invention selects for use has stronger killing action to HP, thereby eliminates pathogenic bacterium; Procaine hydrochloride plays sealing process to the teleneuron of damage mucomembranous surface, and the blocking-up vagus reflex reduces pepsic zest secretion, and make the mucus of gastric mucosa layer exempt from decomposition, and can remove the stomach smooth muscle spasm, thus rapid alleviating pain; Vitamin B
12Participate in carbon one unit metabolism in the body, the reparation of gastric epithelial cell is played a driving role; Pharmaceutic adjuvant is selected for use well behaved disintegrating agents such as hyprolose to be aided with other pharmaceutic adjuvants and is made compound tablet, and not only release is quick but also physical property is good to make it.The outstanding advantage of the tablet of preparation is the energy rapid release, and disperses fully, and the patient who especially is fit to child and dysphagia takes.
The specific embodiment
Embodiment 1:
(1) prescription
Gentamycin sulfate 1,000 ten thousand units
Procaine hydrochloride 50g
Vitamin B
120.01g
Lactose 55g
Microcrystalline Cellulose 65g
Hyprolose 12g
Micropowder silica gel 2.5g
Pulvis Talci 1.5g
1000
(2) technology
The principal agent porphyrize is crossed 100 mesh sieves, and adjuvant is crossed 80 mesh sieves.Take by weighing the gentamycin sulfate, procaine hydrochloride, lactose, microcrystalline Cellulose of recipe quantity and 50% hyprolose with the abundant mixing of equivalent incremental method, cross 60 mesh sieves.With ethanol system soft material, cross 40 mesh sieves, oven dry below 80 ℃, 30 mesh sieve granulate.Other is with the vitamin B of recipe quantity
12, remaining hyprolose is with the abundant mixing of equivalent incremental method, again with dried granule mixing, adds micropowder silica gel and Pulvis Talci, fully mixing.Carry out intermediate and measure, calculate the heavy back of sheet tabletting, the packing warehouse-in.
Embodiment 2:
(1) prescription
Gentamycin sulfate 1,000 ten thousand units
Procaine hydrochloride 50g
Vitamin B
120.01g
Lactose 58g
Microcrystalline Cellulose 70g
Hyprolose 20g
Micropowder silica gel 2.5g
Pulvis Talci 1.5g
1000
(2) technology
The principal agent porphyrize is crossed 100 mesh sieves, and adjuvant is crossed 80 mesh sieves.Take by weighing the gentamycin sulfate, procaine hydrochloride, lactose, microcrystalline Cellulose of recipe quantity and 50% hyprolose with the abundant mixing of equivalent incremental method, cross 60 mesh sieves.With ethanol system soft material, cross 40 mesh sieves, oven dry below 80 ℃, 30 mesh sieve granulate.Other is with the vitamin B of recipe quantity
12, remaining hyprolose is with the abundant mixing of equivalent incremental method, again with dried granule mixing, adds micropowder silica gel and Pulvis Talci, fully mixing.Intermediate is measured, and it is heavy to calculate sheet, tabletting, packing, warehouse-in.
Embodiment 3:
(1) prescription
Gentamycin sulfate 1,000 ten thousand units
Procaine hydrochloride 50g
Vitamin B
120.01g
Lactose 75g
Microcrystalline Cellulose 90g
Hyprolose 60g
Micropowder silica gel 2.5g
Pulvis Talci 1.5g
1000
(2) technology
The principal agent porphyrize is crossed 100 mesh sieves, and adjuvant is crossed 80 mesh sieves.Take by weighing the gentamycin sulfate, procaine hydrochloride, lactose, microcrystalline Cellulose of recipe quantity and 50% hyprolose with the abundant mixing of equivalent incremental method, cross 60 mesh sieves.With ethanol system soft material, cross 40 mesh sieves, oven dry below 80 ℃, 30 mesh sieve granulate.Other is with the vitamin B of recipe quantity
12, remaining hyprolose is with the abundant mixing of equivalent incremental method, again with dried granule mixing, adds micropowder silica gel and Pulvis Talci, fully mixing.Intermediate is measured, and it is heavy to calculate sheet, tabletting, packing, warehouse-in.
Embodiment 4:
(1) prescription
Gentamycin sulfate 1,000 ten thousand units
Procaine hydrochloride 50g
Vitamin B
120.01g
Lactose 65g
Microcrystalline Cellulose 80g
Hyprolose 90g
Micropowder silica gel 2.5g
Pulvis Talci 1.5g
1000
(2) technology
The principal agent porphyrize is crossed 100 mesh sieves, and adjuvant is crossed 80 mesh sieves.Take by weighing the gentamycin sulfate, procaine hydrochloride, lactose, microcrystalline Cellulose of recipe quantity and 50% hyprolose with the abundant mixing of equivalent incremental method, cross 60 mesh sieves.With ethanol system soft material, cross 40 mesh sieves, oven dry below 80 ℃, 30 mesh sieve granulate.Other is with the vitamin B of recipe quantity
12, remaining hyprolose is with the abundant mixing of equivalent incremental method, again with dried granule mixing, adds micropowder silica gel and Pulvis Talci, fully mixing.Intermediate is measured, and it is heavy to calculate sheet, tabletting, packing, warehouse-in.
Test data of experiment of the present invention:
1. influence factor:
Get the tablet by the preparation of embodiment 1 prescription, put in the culture dish, (25 ℃, RH92.5%) and under 60 ℃ of hot conditionss, outward appearance is observed in sampling after 5,10 days, measures dissolution, content and related substance to place the high light, high humidity of 4500lx.The result is as shown in table 1.
Table 1 influence factor result of the test
| The placement condition | Time (my god) | The investigation project | ||||
| Character | Related substance (%) | Dissolution (%) | Gentamycin content (%) | Procaine hydrochloride content (%) | ||
| Illumination (4500Lx) | ????0 | The off-white color sheet | ????0.1 | Up to specification | ????99.3 | ????96.5 |
| ????5 | The off-white color sheet | ????0.1 | Up to specification | ????99.6 | ????96.5 | |
| ????10 | The off-white color sheet | ????0.2 | Up to specification | ????99.1 | ????96.7 | |
| High temperature (60 ℃) | ????5 | The off-white color sheet | ????0.2 | Up to specification | ????98.6 | ????96.6 |
| ????10 | The off-white color sheet | ????0.3 | Up to specification | ????98.1 | ????95.9 | |
| High humidity (RH92.5%) | ????5 | Erotic film slightly | ????0.2 | Up to specification | ????98.4 | ????96.5 |
| ????10 | Erotic film slightly | ????0.9 | Up to specification | ????97.8 | ????96.5 | |
From influence factor's result of the test as seen, tablet of the present invention removes slightly flavescence of color and luster under high humidity (92.5%) condition, related substance slightly increases, and other every indexs are constant substantially, illustrate that this tablet is basicly stable.
2. quality index
Tablet of the present invention has been worked out discriminating, inspection, assay and limit requirement by relevant requirements under two tablet items of version Chinese Pharmacopoeia in 2000, and every after measured index all meets the requirements.
3. the test of pesticide effectiveness
(1) to the observation of curative effect of rat chronic gastritis
60 of the SD rats of healthy weight 200-240g, ♀ ♂ half and half divides two groups at random.30 of the embodiment of the invention 1 aqueous solution groups (test group), 30 of normal saline groups (matched group).Press Pan Shi (1990) method, make rat chronic gastritis model with deoxycholic acid and ethanol, test group gavages the aqueous solution 0.5ml (17.5mg) of embodiment 1 preparation every day simultaneously, matched group gavages normal saline 0.5ml every day, behind the 3mo rat is put to death, take out the Mus stomach and conduct a survey, the result shows:
Perusal, rats in test groups gastric mucosa surface pinkiness is with more mucus.And the control rats gastric mucosa is pale, the mucus rareness, and gastric mucosa is dispersed in hemorrhage in addition and has gallbladder color transudate to adhere to.Microscopically sees that test group gastric mucosa surface mucus is abundanter, and superficial epithelium is more complete, and idol has the downright bad exfoliative cyte that are dispersed in, and the arteries and veins body structure is arranged closely, and the vasodilation and the connective tissue proliferation of a matter are lighter.And matched group Mus gastric mucosa surface mucus is less, top layer epithelial cell necrosis, come off and damaged, and atrophy of part body of gland or cryptomere expansion, and see that the obviously connective tissue proliferation of expansion and volume of a matter blood vessel is arranged, and stretch into and wrap the pocket body of gland between body of gland.
The sxemiquantitative of two groups of inflammation degree shows that relatively test group gastric antrum inflammation obviously alleviates than matched group, and matched group gastric mucosa layer is than the test group attenuation and muscular layer of mucosa obviously thickens (table 2-3)
Table 2: two groups of gastric mucosa of rat inflammation degree sxemiquantitative relatively
| Gastric antrum portion | Body of stomach | |
| Test group | ????2.17±0.06 * | ????1.43±0.19 |
| Matched group | ????2.24±0.09 * | ????1.61±0.15 |
*P＜0.05
Table 3: two groups of gastric mucosa of rat layers and muscular layer of mucosa thickness is (ц m) relatively
| The mucosa bed thickness | The mucomembranous skin bed thickness | |||
| Hole portion | Body | Hole portion | Body | |
| Test group n=150 | ?373±118.97 | ?565±163.19 | ??42.55±14.16 * | 48.34±11.58 * |
| Matched group n=150 | ?356±115.72 | ?572±147.25 | ??87.67±11.6 * | 99.82±12.45 * |
*P＜0.01
Test group gastric mucosa mucus amount increases (P＜0.01) than matched group, and acid mucus in the gastric juice, neutral mucus and pepsin content but are starkly lower than matched group (P＜0.05, table 4).
Table 4: the acid of two groups of Mus gastric juice, neutral mucus and pepsin content analysis contrast (mg/ml)
| Acid mucus | Neutral mucus | Pepsin | |
| Test group | ??0.36±0.05 * | ??0.56±0.13 * | ????0.63±0.08 ** |
| Matched group | ??0.62±0.02 * | ??1.15±0.07 * | ????1.36±0.17 ** |
*P＜0.01??
**P＜0.05
Animal experiment shows that after using the present invention, rat chronic gastritis forms number and obviously reduces, and has inflammation also slighter.The protection of gastric mucosa surface mucus gel layer is good, and pepsin content is lower in the gastric juice, and the micromolecule mucus that is decomposed is also less.These and matched group compare obvious difference.Proof the present invention prevents and protective effect being formed with of chronic gastritis.
(2) to the observation of curative effect of rat chronic ulcer
Select the Vistar rat of body weight 200 ± SD20g, hungry 4h cuts open the belly, 0.5cm place stomach serous coat injects 10% acetic acid 0.05ml above pylorus, sew up at random, art finishes ad libitum access drinking-water, and began medication the same day, shared 8d, the morning of 9d is with sacrifice of animal, observe the gastropathy situation, result of the test shows: the present invention has the effect of the chronic ulcer that obvious suppression acetic acid brings out, and gastric ulcer area and volume are dwindled, with matched group comparing difference highly significant (P＜0.01), the present invention is respectively 78% to the gastric ulcer suppression ratio.
Table 5 tablet of the present invention is to the influence of rat chronic gastric ulcer
| Group | Number of animals (only) | Ulcer area (mm 2) | Ulcer volume (%) | ??P |
| The test group matched group | ????6 ????6 | ????0.15±0.13 ????0.72±0.29 | ??9.02±6.27 ??41.7±18.9 | ??＜0.01 |
Claims (8)
1. compound tablet that is used for treating gastritis is characterized in that: it is formed and mainly comprises gentamycin sulfate, procaine hydrochloride, vitamin B
12And pharmaceutic adjuvant; Every sulfur acid gentamycin 1 million international units, procaine hydrochloride 50mg, vitamin B
1210 μ g, pharmaceutic adjuvant 0.13-0.25g.
2. the compound tablet that is used for treating gastritis as claimed in claim 1 is characterized in that: pharmaceutic adjuvant comprises disintegrating agent, filler, fluidizer and lubricant.
3. the compound tablet that is used for treating gastritis as claimed in claim 1 is characterized in that: disintegrating agent is a hyprolose.
4. the compound tablet that is used for treating gastritis as claimed in claim 1 is characterized in that: filler is lactose and microcrystalline Cellulose.
5. the compound tablet that is used for treating gastritis as claimed in claim 1 is characterized in that: fluidizer is micropowder silica gel.
6. the compound tablet that is used for treating gastritis as claimed in claim 1 is characterized in that: lubricant is a Pulvis Talci.
7. the compound tablet that is used for treating gastritis as claimed in claim 1 is characterized in that: the consumption of hyprolose is to account for 5%～30% of tablet total weight amount.
8. preparation method that is used to prepare the described compound tablet of claim 1, comprise that the ratio of taking by weighing is gentamycin sulfate, the 50mg procaine hydrochloride of 1 million international units, an amount of lactose, microcrystalline Cellulose and 50% hyprolose are crossed 60 mesh sieves with the abundant mixing of equivalent incremental method; With ethanol system soft material, cross 40 mesh sieves, oven dry below 80 ℃, 30 mesh sieve granulate; In addition with 10 μ g vitamin Bs
12, remaining hyprolose is with the abundant mixing of equivalent incremental method, again with the aforementioned particles mixing, adds an amount of micropowder silica gel and Pulvis Talci, abundant mixing; Carry out intermediate and measure, it is heavy to calculate sheet, packing warehouse-in behind the tabletting.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510049008 CN1679616A (en) | 2005-02-01 | 2005-02-01 | Compound tablet for treating gastritis and preparation thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510049008 CN1679616A (en) | 2005-02-01 | 2005-02-01 | Compound tablet for treating gastritis and preparation thereof |
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| Publication Number | Publication Date |
|---|---|
| CN1679616A true CN1679616A (en) | 2005-10-12 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510049008 Pending CN1679616A (en) | 2005-02-01 | 2005-02-01 | Compound tablet for treating gastritis and preparation thereof |
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| Country | Link |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103006682A (en) * | 2012-12-27 | 2013-04-03 | 上海海虹实业(集团)巢湖今辰药业有限公司 | Preparation method of granules for diminishing inflammation, relieving pain and promoting gastric mucosa repair |
| CN105147638A (en) * | 2015-10-30 | 2015-12-16 | 成都通德药业有限公司 | Method for producing compound procaine hydrochloride capsules |
-
2005
- 2005-02-01 CN CN 200510049008 patent/CN1679616A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103006682A (en) * | 2012-12-27 | 2013-04-03 | 上海海虹实业(集团)巢湖今辰药业有限公司 | Preparation method of granules for diminishing inflammation, relieving pain and promoting gastric mucosa repair |
| CN105147638A (en) * | 2015-10-30 | 2015-12-16 | 成都通德药业有限公司 | Method for producing compound procaine hydrochloride capsules |
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