CN101053569A - Bismuth glycyrrhizate capsule and its preparation - Google Patents
Bismuth glycyrrhizate capsule and its preparation Download PDFInfo
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- CN101053569A CN101053569A CN 200610034901 CN200610034901A CN101053569A CN 101053569 A CN101053569 A CN 101053569A CN 200610034901 CN200610034901 CN 200610034901 CN 200610034901 A CN200610034901 A CN 200610034901A CN 101053569 A CN101053569 A CN 101053569A
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Abstract
The invention provides a new medical preparation bismuth glycyrrhetate capable of treating stomach and duodenum abscess and preparation method thereof. The purpose of the invention is to complement the current techniques and provides a capsule which is characterized in simple oral-taken, capable of concealing medical peculiar smell, easy taking and good for improving stability of the product. The invention also creates in the preparation method of the raw materials, which has the features of simple process, easy control, stable product quality and suitable for the current large-amount of production etc.
Description
Technical field:
The present invention relates to new drug type of a kind of medicament for resisting peptic ulcer and preparation method thereof, specifically the present invention relates to a kind of bismuth glycyrrhizate capsule preparation and preparation method thereof..
Scape back of the body technology:
Modern society human lives rhythm is accelerated, and operating pressure strengthens, and diet does not have joint, makes peptic ulcer (PU) patient's ratio in rising trend.Control and do not heal, repeatedly outbreak.Suffer from ulcer more its early stage and do not cure fully finding after many gastric cancer intestinal cancer survey of patients.Along with chemical medicine H
2The appearance of receptor antagonist and proton pump inhibitor has made ulcer patient's recent healing be out of question, but has the phenomenon that easily recurs after the drug withdrawal.Relapse rate that data shows PU in a year is arranged at 65%-80%, and relapse rate almost reaches 100% in two years, anti-recurrence has become the key of curing ulcer.Pure Chinese medicinal preparation, though can effectively treat ulcer, slow because of onset, the cycle course of treatment is long, seldom uses clinically.Ulcer patient looks forward to and a kind of medicine that can thoroughly cure ulcer and ulcer no longer be recurred occurs.The key of developing new anti-ulcer medicament is to improve ulcer healing quality (QOUH) comprehensively, as improving regeneration mucous membrane tissue and function Maturity etc., ulcer is reached really, healing completely, and the ulcer of Zhi Yuing does not almost recur fully.Domestic long-term clinical practice proves: collaborative treatment of Chinese and western medicines ulcer can effectively improve QOUH, suppresses ulcer recurrence.And the bismuth glycyrrhizate capsule product of Chinese medicine and classical Western medicine perfect adaptation just.The Chinese and Western combination, dual pharmacology, though oral bismuth determined curative effect before being through with, mouthfeel is poor, in conjunction with the history of the no antiulcer pharmacologically active of acid group (pectic acid, aluminic acid, citric acid, nitric acid), the new era of having started the combination therapy of Chinese and western peptic ulcer.This formula for a product uniqueness, novelty, science, market prospect is wide.
Radix Glycyrrhizae is the rarity in motherland's tradition pools of traditional Chinese medicine, apart from modern existing more than 2,000 year medication history.In the successive dynasties classic of TCM, Radix Glycyrrhizae is regarded as top grade, in order to tonification stomach function regulating, removing the necrotic tissue and promoting granulation, heat-clearing and toxic substances removing, eliminating phlegm and stopping cough, coordinating the actions of various ingredients in a prescription etc.The modern pharmacology pharmacodynamic study shows the glycyrrhizic acid that contains in the Radix Glycyrrhizae effectively antiulcer, antibiotic, antiinflammatory, antacid, pain relieving, hemostasis, has multiple medical values such as human body immunity improving power.The utilization rate of Radix Glycyrrhizae has more reached the degree of " ten sides, nine grass, no grass are the side not " in the herbal mixture prescription of treatment gastropathy.As far back as the eighties of last century sixties just the someone prove that the effective percentage of folk prescription glycyrrhizic acid treatment recurrent gastric ulcer is more than 90%.Zinc glycyrrhizate medicine treatment peptic ulcer mainly is exactly an effect of bringing into play glycyrrhizic acid.
And the treatment that oral bismuth is used for PU as Western medicine also has the history in a century, its pharmacological action to be that mainly bismuth ion can directly kill helicobacter pylori (HP), the protection gastrointestinal mucosa.
Bismuth glycyrrhetate is a Chinese medicine and western medicine complexation preparation, can either directly kill HP, and the protection gastrointestinal mucosa again can be multi-level, have an effect many target spots, and Synergistic, thus improve QOUH comprehensively, effectively treat ulcer, suppress recurrence.
Taste is sweet to have the supermolecule glycyrrhizic acid of antiulcer activity and combining of bismuth ion concurrently, filled up the general good effect of bismuth of having gone on the market at present, but mouthfeel is poor, in conjunction with the active blank of acid group nonreactive ulcer, composition science, novelty.Existing clinically only have a kind of powder type, is widely used in the treatment of gastric and duodenal ulcers, and the general reaction effect of doctors and patients is definite.
The bismuth glycyrrhetate main pharmacological: (1) acts on stomach and duodenum mucosa (ulcer spot), makes ulcer surface not be subjected to gastric acid, and pepsin and food corrode; Promote the reparation of ulcer spot edge tissues, granulation forms and epithelial cell regeneration.(2) promote PGs synthetic, spasmolytic, pain relieving.(3) reduce H+ and bleed back, the gastric acid inhibitory secretion reduces pepsin activity.(4) Synergistic is eradicated HP, and is antibiotic, antiinflammatory.(5) promote stomach mucus synthesis secretion, form protecting film, improve gastric mucosa and organize the aminohexose level, suppress the excessive apoptosis of gastric epithelial cells.(6) to stomach, duodenum mucosa blood flow descends and has the improvement effect, promotes gastric mucosa blood capillary new life, improves regeneration mucous membrane tissue and function Maturity.(7) invigorating the spleen and benefiting QI improves cell and humoral immune function comprehensively.(8) hemostasis, absorption gastrointestinal metabolism toxin.
Deeply use along with clinical, above-mentioned powder type has presented many drawbacks: 1. easily the moisture absorption is lumpd, 2. take, carry inconvenience, 3. quite a few patient is difficult to accept to glycyrrhizic acid abnormal smells from the patient, sweet taste, 4. oral after, stimulate and be trapped on oral cavity, throat and the esophageal wall, and, cause repurchase rate to descend with bismuth metal abnormal flavour.
Summary of the invention:
The objective of the invention is to: solve above-mentioned existence deficiency.Bismuth glycyrrhizate capsule and preparation method thereof is provided.
Preparation bismuth glycyrrhetate raw material adds adjuvant according to a certain percentage, and mixing is encapsulated and make bismuth glycyrrhizate capsule.
(1) prescription: bismuth glycyrrhetate water soluble adjuvant
Bismuth glycyrrhetate: can be Radix Glycyrrhizae extractum and basic bismuth nitrate, bismuth nitrate makes behind the arbitrary raw material reaction of bismuth subcarbonate, also can be arbitrary raw material reaction and making in the ammonium salt of glycyrrhizic acid and the above-mentioned bismuth salt.Optimum is that Radix Glycyrrhizae extractum and basic bismuth nitrate reaction make.
Adjuvant: common starch and cellulose family.Can be starch, mannitol, sodium carboxymethyl cellulose, Celluloasun Microcrystallisatum, carboxymethyl starch sodium, crosslinked sodium carboxymethylcellulose pyce, one or more mix in the carboxyl starch propionate.Usual amounts is 2%--10%, is optimized for: starch, optimized amount are 5%.-10%.
(2) preparation method:
Extracting liquorice acid bismuth raw material and adjuvant are in the abundant mixing of (98%-90%)/(2%-10%) ratio, and be encapsulated, promptly.
Bismuth glycyrrhizate capsule can overcome the deficiency of the drug that looses fully, has easily and swallows, and covers the advantage of drug flavor, and good lucifuge airtight performance helps improving the stability of product.Capsule was both neat and artistic, and was easy to carry again.Be particularly suitable for modernization and produce in enormous quantities, thereby reduce production costs, reduce the medicine valency, towards vast rural market.
Do not contain sugar, do not contain aluminum, conveniently suffer from the ulcer patient of diabetes.Crude drug is legal Radix Glycyrrhizae extractum, basic bismuth nitrate, and the source is wide, and production technology is simple, can be quantitative, and repetitive operation.Production process can not pollute environment.Thisly can treat ulcer, the stomach medicine with distinct distinct Chinese characteristics will have the irreplaceable market competitiveness.
The specific embodiment:
Be that the basis describes the present invention in detail below with embodiments of the invention, but the present invention is not limited thereto.
Example 1: Radix Glycyrrhizae 600g, be ground into coarse powder, extracted 4 hours with being equivalent to the acidifying 95% ethanol 40-50 of 6 times of concentrated hydrochloric acid of medical material amount ℃, extracting solution drips strong aqua ammonia (PH7.2-7.5), add bismuth nitrate, macroporous resin adsorption, Diluted Alcohol eluting, at 60 ℃ of drying under reduced pressure, be ground into fine powder, add 5% carboxymethyl starch sodium, mixing, encapsulated, promptly.Calculate bismuth-containing (Bi) by dry product and should be 10.0-15.0%.
Technology is 60 ℃ of drying under reduced pressure with the cream powder mixture from 60 ℃ of constant pressure and dry revisions clearly, can shorten the medicine heated time significantly, has reduced the heat damage risk of effective ingredient, and to improving drug effect, there is positive effect the shortening production cycle.
Example 2: add the Radix Glycyrrhizae extractum 6Kg after pulverizing in the dissolving tank, add water and heated and stirred, leave standstill, filter, squeeze in the retort to molten entirely.Slowly drip bismuth nitrate solution (basic bismuth nitrate: nitric acid (30%)=0.612Kg: 1.5L) at 35 ℃-45 ℃, isothermal reaction 4-8 hour, strong aqua ammonia below 28 ℃ was transferred PH about 4.5, centrifugal (sedimentation-type centrifuge), be washed to neutrality, dry, 60 ℃ of drying under reduced pressure are pulverized, add 5% starch, mixing, encapsulated, promptly.Calculate bismuth-containing (Bi) by dry product and should be 10.0-15.0%.
Example 3: add the Radix Glycyrrhizae extractum 6Kg after pulverizing in the dissolving tank, add water and heated and stirred, leave standstill, filter, squeeze in the retort to molten entirely.Dripping strong aqua ammonia (PH7.2-7.5) below 28 ℃, stir the back 35 ℃-45 ℃ slowly drip bismuth nitrate solutions (basic bismuth nitrate: nitric acid (30%)=0.612Kg: 1.5L), isothermal reaction 4-8 hour, centrifugal (sedimentation-type centrifuge), be washed to neutrality, dry, 60 ℃ of drying under reduced pressure are pulverized, add 5% starch, mixing, encapsulated, promptly.Calculate bismuth-containing (Bi) by dry product and should be 10.0-15.0%.
Example 4: bismuth glycyrrhetate 12kg+ starch 0.6kg, mixing is adorned 25200 capsules (0.50g/ grain), promptly.Calculate bismuth-containing (Bi) by dry product and should be 10.0-15.0%.
Claims (6)
1. a bismuth glycyrrhizate capsule is characterized in that this capsule is by bismuth glycyrrhetate and is selected from starch, mannitol, carboxymethyl starch sodium, sodium carboxymethyl cellulose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, one or more uniform mixing in the carboxyl starch propionate form.Bismuth glycyrrhetate and above-mentioned adjuvant are counted with weight proportion: 90%-98%: 2%-10%.
2. bismuth glycyrrhizate capsule according to claim 1 is characterized in that adjuvant is optimized for starch, and optimized amount is 5%-10%.
3. bismuth glycyrrhizate capsule according to claim 1, it is characterized in that bismuth glycyrrhetate can be Radix Glycyrrhizae extractum and basic bismuth nitrate, bismuth nitrate, arbitrary raw material reaction in the bismuth subcarbonate and getting also can be that arbitrary raw material reaction makes in the ammonium salt of glycyrrhizic acid and the above-mentioned bismuth salt.
4. be used for right 1 described bismuth glycyrrhizate capsule preparation method, it is characterized in that constituting by following key technology step:
(1) dissolving: Radix Glycyrrhizae extractum is pulverized, added water, heating, molten entirely.
(2) reaction: constant temperature drips bismuth nitrate solution.
(3) leave standstill: after constant temperature is placed, transfer PH.
(4) centrifugal:
(5) drying:
(6) pulverize:
(7) add adjuvant, mixing, encapsulated, promptly.
5. according to the described bismuth glycyrrhizate capsule preparation method of claim 4, it is characterized in that step (2) reaction temperature should be optimized for 35 ℃-45 ℃ at 30 ℃-55 ℃; Step (3) response time should be in 4-8 hour; The centrifugal employing sedimentation-type centrifuge of step (4); Step (5) optimization is adopted 60 ℃ of drying under reduced pressure; (6) adjuvant is optimized for starch, and weight ratio is optimized for: 5%-10%.
6. according to the described bismuth glycyrrhizate capsule preparation method of claim 4, it is characterized in that step (1), (2), (3), (4), (5), (6) gained bismuth glycyrrhetate raw material also can be used for being prepared into the dispersible tablet of bismuth glycyrrhetate, chewable tablet, oral cavity disintegration tablet, effervescent tablet, granule drug, soft capsule, stomach suspension sheet etc.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200610034901 CN101053569A (en) | 2006-04-11 | 2006-04-11 | Bismuth glycyrrhizate capsule and its preparation |
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| CN 200610034901 CN101053569A (en) | 2006-04-11 | 2006-04-11 | Bismuth glycyrrhizate capsule and its preparation |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102470141A (en) * | 2009-07-09 | 2012-05-23 | 日本米诺发源制药株式会社 | Glycyrrhizin as restorative agent for antimicrobial peptide production ability |
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2006
- 2006-04-11 CN CN 200610034901 patent/CN101053569A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102470141A (en) * | 2009-07-09 | 2012-05-23 | 日本米诺发源制药株式会社 | Glycyrrhizin as restorative agent for antimicrobial peptide production ability |
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