CN1895520A - Gastrin magnesium granules and preparation thereof - Google Patents

Gastrin magnesium granules and preparation thereof Download PDF

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Publication number
CN1895520A
CN1895520A CN 200610086980 CN200610086980A CN1895520A CN 1895520 A CN1895520 A CN 1895520A CN 200610086980 CN200610086980 CN 200610086980 CN 200610086980 A CN200610086980 A CN 200610086980A CN 1895520 A CN1895520 A CN 1895520A
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rhizoma acori
acori graminei
volatile oil
clathrate
granule
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CN1895520B (en
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杨尚华
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Hongmei Pharmaceutical (China) Co., Ltd.
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LOKIS PHARMACEUTICAL (JILIN) GROUP CO Ltd
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Abstract

A medicine 'Gastric bismuth magnesium particle' and its preparing process are also disclosed. It features that the volatile oil of grass-leaved sweetflag rhizome is wrapped by beta-cyclodextrin, and its additive (sweetening agent and tangerine essence) is carefully chosen.

Description

A kind of gastrin magnesium granules and preparation method thereof
Technical field
The invention belongs to the pharmaceutical technology field, be specifically related to a kind of gastrin magnesium granules and preparation method thereof, more particularly relate to a kind of by bismuth aluminate, Heavy Magnesium Carbonate, sodium bicarbonate, Radix Glycyrrhizae extractum powder, FULANGSHULIPI, Fructus Foeniculi, Aloe and Rhizoma Acori Graminei combination novel taste granule and preparation method thereof through being prepared from.
Technical background
Gastropathy is the common frdquently encountered disease of serious harm human health, generally is meant gastritis stomach function regulating and duodenal ulcer disease, its symptom initial or slight outbreak be epigastric discomfort, glutted, heartburn, retch, feel sick etc.Multiple reason can cause gastropathy, can become the cause of disease of gastropathy as diet, environment, heredity, medicine, antibacterial and chemicals damage, smoking etc., consequently causes gastroxia stomach function regulating mucosa injury to increase the weight of.The medicine of therefore treating gastropathy can be divided into two classes, and a class is for neutralizing or weakening the medicine of gastric acid and press down sour medicine H 2Receptor antagonist; One class is for increasing the medicine of gastric mucosa defence capability.
Application number is that the patent documentation of CN03157561.7 and CN200510132701.1 discloses a kind of pharmaceutical composition for the treatment of gastropathy, component is that bismuth aluminate, Heavy Magnesium Carbonate, sodium bicarbonate, Radix Glycyrrhizae extractum powder, FULANGSHULIPI, Fructus Foeniculi powder, Aloe powder are or/and Rhizoma Acori Graminei is called Weibimei medicical composition for treating stomach disease.The bismuth aluminate that wherein contains can form layer protecting film on stomach and duodenal mucosa, thereby promotes mucosa regeneration and the normal healing that quickens ulcer; Sodium bicarbonate and Heavy Magnesium Carbonate be as the antacid part gastric acid that can neutralize, thereby prevent gastric acid and the pepsin erosion damage to gastric mucosa; Radix Glycyrrhizae extractum powder contains active ingredients such as celery sugar liquirtin, has antiulcer action, can alleviate the gastrointestinal smooth muscular spasm; Fructus Foeniculi contains a certain amount of volatile oil, has dispersing cold for relieving pain, regulating qi-flowing for harmonizing stomach effect, has the gastrointestinal of adjusting function, antiulcer, the effect of promotion bile secretion; FULANGSHULIPI has the therapeutical effect that promotes tissue repair; Rhizoma Acori Graminei contains volatile oil such as asarone, has removing dampness appetizing, circulation of qi promoting except that the effect of expanding, and can secrete by facilitating digestion liquid, prevents gastrointestinal abnormal fermentation, and can alleviate the intestinal tube smooth muscle spasm; The Aloe polysaccharide that Aloe contains has good anti-gastric injury effect, anti-gastric-ulcer effect.
Stomach bismuth magnesium is the Chinese medicine and western medicine mixture of treatment gastropathy, and Western medicine takes stopgap measures, and Chinese medicine effects a permanent cure.Granule is the first-selected dosage form of its treatment gastropathy.But find that in clinical practice the Aloe that contains in the prescription has special foul smell, flavor is extremely bitter; The volatile oil that contains in the Rhizoma Acori Graminei has special abnormal flavour, makes the gastrin magnesium granules finally obtain when the patient takes, very bad of mouthfeel, and patient's compliance is very poor, thereby has influenced the curative effect of medicine greatly.
Summary of the invention
At above the deficiencies in the prior art, research worker of the present invention has been carried out further research to above-mentioned gastrin magnesium granules, develops a kind of new gastrin magnesium granules of delicious, good patient compliance.So the present invention is the result to the patent application document follow-up study of CN03157561.7 and CN200510132701.1.
The object of the present invention is to provide a kind of new gastrin magnesium granules and preparation method thereof; This granule is antiacid and compound preparation gastric mucosal protection; have convergence, in and effects such as gastric acid, protection gastric mucosa, catharsis relieving constipation, spasmolytic, appetizing relieving distension, aspect the digestive system disease such as treatment gastric and duodenal ulcers, chronic superficial gastritis, hyperchlorhydria, heartburn, stomach spasm, nervous dyspepsia good effect is being arranged.
Granule of the present invention has comprised principal agent and adjuvant; Each set of dispense ratio of its principal agent is: 210 parts of bismuth aluminate, 410 parts of Heavy Magnesium Carbonate, 250 parts of sodium bicarbonate, 250 parts of Radix Glycyrrhizae extractum powders, 15 parts of FULANGSHULIPI, 15 parts in Fructus Foeniculi, 30 parts of Aloes, 100 parts of Rhizoma Acori Graminei volatile oil clathrates (wherein volatile oil 7.0ml); Each set of dispense ratio of its adjuvant is: 182 parts of cyclamates, 30 parts in essence of Fructus Citri tangerinae flavor, 1530 parts in dextrin.
Above-mentioned cyclamate content is the 14.0-15.0% of principal agent weight.
Above-mentioned flavoring orange essence content is the 2.2-2.5% of principal agent weight.
Above-mentioned weight portion can be the known content units of field of medicaments such as μ g, mg, g, kg.
Granule of the present invention is antiacid and compound preparation gastric mucosal protection, have convergence, in and effects such as gastric acid, protection gastric mucosa, catharsis relieving constipation, spasmolytic, appetizing relieving distension.
The preparation process of granule of the present invention is as follows:
The preparation of Rhizoma Acori Graminei clathrate:, get the volatile oil diluent with an amount of ethanol dilution of Rhizoma Acori Graminei volatile oil; The beta-schardinger dextrin-of 14 times of amounts of volatile oil is joined in isopyknic 70-80 ℃ hot water, in mortar, grind evenly; Grinding ring dextrin solution limit, limit splashes into the volatile oil diluent gradually, and grinds 1 hour, obtains liquid Rhizoma Acori Graminei clathrate; 45-50 ℃ of drying pulverized, and crosses 100 mesh sieves, obtains the Rhizoma Acori Graminei clathrate.
Other principal agent compositions are pulverized in will writing out a prescription, and mix, and cross 120 mesh sieves, and the method and the Rhizoma Acori Graminei clathrate that progressively increase according to equivalent carry out abundant mixing, obtain the principal agent mixture.
Adjuvant cyclamate, orange powder essence, dextrin are pulverized, crossed 100 mesh sieves, the method mixing according to equivalent is progressively increased obtains the adjuvant mixture.
Principal agent and adjuvant mixture are mixed, make binding agent with 75% ethanol and granulate, 45-50 ℃ of oven for drying, granulate, packing promptly gets granule of the present invention.
With beta-schardinger dextrin-Rhizoma Acori Graminei volatile oil is carried out enclose, promptly can remove the specific peculiar smell of volatile oil, can also strengthen the stability of volatile oil.
Granule of the present invention by bismuth aluminate, Heavy Magnesium Carbonate, sodium bicarbonate, Radix Glycyrrhizae extractum powder, FULANGSHULIPI, Fructus Foeniculi, Aloe, Rhizoma Acori Graminei totally eight kinds of medicine components replenish mutually by the different effects that stresses and act synergistically on digestive system, especially Aloe and Rhizoma Acori Graminei play beyond thought effect with the synergism of bismuth aluminate compound recipe.
Granule of the present invention is antiacid and compound preparation gastric mucosal protection, have convergence, in and effects such as gastric acid, protection gastric mucosa, spasmolytic, appetizing relieving distension, and this medicine has that treatment speed is fast, the symptom pain relief soon, the cure rate advantages of higher; Can be used for treating digestive system disease such as gastric and duodenal ulcers, chronic superficial gastritis, hyperchlorhydria, heartburn, stomach spasm, nervous dyspepsia.
Usage is as follows: oral, and a 1-2 bag, 3 times on the one, warm water delivery service, continuously 1-2 month is a course of treatment, but decrement is kept later on, preventing recurrence, or by doctor's advice.
Aloetic special foul smell and bitterness have been covered in the new gastrin magnesium granules agent that preparation method of the present invention obtains, and have removed the specific peculiar smell of the volatile oil that contains in the Rhizoma Acori Graminei, make that the taste of granule is better, and patient's compliance is better.And volatile oil is carried out enclose with beta-schardinger dextrin-, and make that oxidized rotten volatile ingredient is more stable easily, can better keep curative effect.
Sweeting agent at present commonly used has that A Siba is sweet, saccharin sodium, xylitol and stevioside.The present invention has carried out a large amount of experiments the sweeting agent that principal agent was fit to has been carried out preferably.
Principal agent and other adjuvant keep inconvenience, use each above sweeting agent to be prepared into granule, then it are estimated.The result is as follows:
Stevioside: band is bitter in sweet, too high easy increase cost of price and patient burden.
A Siba is sweet: sweet taste is too heavy, increase cost on the high side and patient burden.
Saccharin sodium: band was bitter during it was sweet, add a little and does not hide bitterness and abnormal flavour in the prescription, added the bitterness of self and also come out, and it can be used for the diabetes patient not have bibliographical information, so superseded.
Xylitol: the sweet taste of xylitol own is just little, need the amount that adds can and sucrose addition basically identical, and price sucrose exceeds more than 3 times, and can not cover the bitterness in the prescription, so superseded.
Cyclamate: delicious, cost is low, but also can be used in the diabetes patient.So sweeting agent is selected from cyclamate.
Essence: mainly be various fruity essence, comprise the Fructus Mali pumilae flavor, the Fructus Fragariae Ananssae flavor, the Fructus Musae flavor, the essence of Fructus Citri tangerinae flavor is cheap and tasty, more acceptant.
Above-mentioned sweeting agent cyclamate and flavoring orange essence all are that research worker of the present invention gropes out through a large amount of experiments, are fit to the pharmaceutic adjuvant of principal agent of the present invention.
Beta-Asarone is the main active in the Rhizoma Acori Graminei volatile oil, research worker of the present invention to inclusion essential oil and not the beta-Asarone in the granule of enclose carried out assay.Content assaying method according to document [Ke Xuehong, etc.RP-HPLC measures the content of beta-Asarone, α-asaricin in Rhizoma Acori Graminei, the Rhizoma Acori Calami medical material.CHINA JOURNAL OF CHINESE MATERIA MEDICA, 29 (3): 279] reversed phase high-performance liquid chromatography in is carried out.Medical material is commercially available same a collection of, and recipe quantity is identical, and preparation process is identical.No. 1 granule, volatile oil is enclose not, makes 1000 bags; No. 2 granules, inclusion essential oil is made 1000 bags.Placed at ambient temperature 12 months, and measured once at regular intervals.Measurement result sees Table 1.
For more convenient, 0 month content is designated as 100%.
Table 1 assay result
Time (moon) Beta-Asarone content (%)
No. 1 No. 2
0 3 6 9 12 100 97.5 94.3 91.2 88.7 100 99.2 98.4 97.3 95.6
By above-mentioned assay result as can be seen, the stability of main effective ingredient beta-Asarone in the new granule of the present invention obviously improves in the Rhizoma Acori Graminei.
Good in order to verify the compliance that the new gastrin magnesium granules patient of the present invention uses, research worker of the present invention has been carried out following experiment with former gastrin magnesium granules in contrast.
With 1000 testers, be divided into two groups, 500 every group.At first take former gastrin magnesium granules for one group, take the new gastrin magnesium granules of the present invention again; Another group is at first taken the new gastrin magnesium granules of the present invention, takes former gastrin magnesium granules again.Give a mark for two kinds of granules respectively :-2 are divided into beyond affordabilityly, and-1 is divided into reluctantly and can accepts, and 0 is divided into and accepts, and 1 is the acceptance of energy happiness, and 2 are divided into fully and can accept.The record score, gather as follows:
In 1000 experimenters, there have 872 people to play expression in-2 fens to former gastrin magnesium granules to be beyond affordability, and 128 people play expression in-1 fen and can accept reluctantly, unmanned making a call to 0 minute, 1 minute, 2 minutes.
In 1000 experimenters, there are 645 people to play the acceptance that expression can be happy in 1 minute to new gastrin magnesium granules, 276 people play expression in 2 fens and can accept fully, and having 79 people to play expression in 0 fen can accept.
By above experiment as can be seen, the new gastrin magnesium granules agent of the present invention has improved the poor taste of former gastrin magnesium granules really, has improved patient's compliance.
The specific embodiment
Further describe the present invention with embodiment below, help understanding, but described embodiment only is used to illustrate the present invention rather than restriction the present invention the present invention and advantage thereof, better effects if.
Prescription is: bismuth aluminate 210g, Heavy Magnesium Carbonate 410g, sodium bicarbonate 250g, Radix Glycyrrhizae extractum powder 250g, FULANGSHULIPI 15g, Fructus Foeniculi 15g, Aloe 30g, Rhizoma Acori Graminei volatile oil 7.0ml, 182 parts of cyclamates, 30 parts in essence of Fructus Citri tangerinae flavor, 1530 parts in dextrin.
The preparation of Rhizoma Acori Graminei clathrate: the 7ml Rhizoma Acori Graminei volatile oil gets the volatile oil diluent with the ethanol dilution of 20ml; The 100g beta-schardinger dextrin-adds in 70-80 ℃ of hot water of 100ml, grinds in mortar evenly; Grinding ring dextrin solution limit, limit splashes into the volatile oil diluent gradually, and grinds 1 hour, obtains liquid Rhizoma Acori Graminei clathrate; 45-50 ℃ of drying pulverized, and crosses 100 mesh sieves, obtains the Rhizoma Acori Graminei clathrate.
Other principal agent compositions are pulverized in will writing out a prescription, and mix, and cross 120 mesh sieves, and the method and the Rhizoma Acori Graminei clathrate that progressively increase according to equivalent carry out abundant mixing, obtain the principal agent mixture;
Adjuvant cyclamate, orange powder essence, starch are pulverized, crossed 100 mesh sieves, the method mixing according to equivalent is progressively increased obtains the adjuvant mixture;
Principal agent and adjuvant mixture are mixed, make binding agent with 75% ethanol and granulate 45-50 ℃ of oven for drying, granulate, packing.
Usage: oral, a 1-2 bag, 3 times on the one, warm water delivery service, continuously 1-2 month is a course of treatment, but decrement is kept later on, preventing recurrence, or by doctor's advice.

Claims (4)

1, a kind of gastrin magnesium granules, it is to add the granule that pharmaceutic adjuvant is prepared from by bismuth aluminate, Heavy Magnesium Carbonate, sodium bicarbonate, Radix Glycyrrhizae extractum powder, FULANGSHULIPI, Fructus Foeniculi, Aloe and Rhizoma Acori Graminei volatile oil by special ratios combination back, it is characterized in that, Rhizoma Acori Graminei volatile oil carries out enclose with beta-schardinger dextrin-, comprises cyclamate and flavoring orange essence in the pharmaceutic adjuvant.
2, granule according to claim 1 is characterized in that, described cyclamate content is the 14.0-15.0% of principal agent weight.
3, granule according to claim 1 is characterized in that, described flavoring orange essence content is the 2.2-2.5% of principal agent weight.
4, granule according to claim 1 is characterized in that, its preparation method is:
Preparation prescription consists of: bismuth aluminate 210g, Heavy Magnesium Carbonate 410g, sodium bicarbonate 250g, Radix Glycyrrhizae extractum powder 250g, FULANGSHULIPI 15g, Fructus Foeniculi 15g, Aloe 30g, the clathrate 100g that contains Rhizoma Acori Graminei volatile oil 7.0ml, cyclamate 182g, Fructus Citri tangerinae flavor essence 30g, dextrin 1530g;
The preparation of Rhizoma Acori Graminei clathrate:, get the volatile oil diluent with an amount of ethanol dilution of Rhizoma Acori Graminei volatile oil; The beta-schardinger dextrin-of 14 times of amounts of volatile oil is joined in isopyknic 70-80 ℃ hot water, in mortar, grind evenly; Grinding ring dextrin solution limit, limit splashes into the volatile oil diluent gradually, and grinds 1 hour, obtains liquid Rhizoma Acori Graminei clathrate; 45-50 ℃ of drying pulverized, and crosses 100 mesh sieves, obtains the Rhizoma Acori Graminei clathrate;
Other principal agent compositions are pulverized in will writing out a prescription, and mix, and cross 120 mesh sieves, and the method and the Rhizoma Acori Graminei clathrate that progressively increase according to equivalent carry out abundant mixing, obtain the principal agent mixture;
Adjuvant cyclamate, orange powder essence, dextrin are pulverized, crossed 100 mesh sieves, the method mixing according to equivalent is progressively increased obtains the adjuvant mixture;
Principal agent and adjuvant mixture are mixed, make binding agent with 75% ethanol and granulate, 45-50 ℃ of oven for drying, granulate, packing promptly gets granule of the present invention.
CN2006100869807A 2006-06-22 2006-06-22 Gastrin magnesium granules and preparation thereof Active CN1895520B (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104906326A (en) * 2015-06-10 2015-09-16 弘美制药(中国)有限公司 Stomach bismuth-magnesium granules and preparation method thereof
CN112773811A (en) * 2021-02-02 2021-05-11 暨南大学 Application of pseudo-ginseng extract
CN116350699A (en) * 2023-06-01 2023-06-30 弘美制药(中国)有限公司 Preparation method of rhizoma acori graminei volatile oil and stomach bismuth magnesium granule compound preparation

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105147900A (en) * 2015-07-31 2015-12-16 东北师范大学 Preventive and therapeutic effect of compound bismuth and magnesium granules on gastric cancer

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1201775C (en) * 2002-12-18 2005-05-18 辽宁省中医研究院 Medicine for treating insomnia-sleeping particle and preparation thereof
CN1286501C (en) * 2003-09-24 2006-11-29 太平洋医药(通化)有限公司 Medicine composition for treating stomach disease, its preparation method and use

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104906326A (en) * 2015-06-10 2015-09-16 弘美制药(中国)有限公司 Stomach bismuth-magnesium granules and preparation method thereof
CN104906326B (en) * 2015-06-10 2016-05-11 弘美制药(中国)有限公司 A kind of gastrin magnesium granules and preparation method thereof
CN112773811A (en) * 2021-02-02 2021-05-11 暨南大学 Application of pseudo-ginseng extract
CN116350699A (en) * 2023-06-01 2023-06-30 弘美制药(中国)有限公司 Preparation method of rhizoma acori graminei volatile oil and stomach bismuth magnesium granule compound preparation
CN116350699B (en) * 2023-06-01 2023-08-15 弘美制药(中国)有限公司 Preparation method of rhizoma acori graminei volatile oil and stomach bismuth magnesium granule compound preparation

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