CN105878198A - Pharmaceutical composition containing berberine hydrochloride tablets and preparation process thereof - Google Patents

Pharmaceutical composition containing berberine hydrochloride tablets and preparation process thereof Download PDF

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Publication number
CN105878198A
CN105878198A CN201610360743.9A CN201610360743A CN105878198A CN 105878198 A CN105878198 A CN 105878198A CN 201610360743 A CN201610360743 A CN 201610360743A CN 105878198 A CN105878198 A CN 105878198A
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China
Prior art keywords
parts
radix
pharmaceutical composition
berberine hydrochloride
rhizoma
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CN201610360743.9A
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Chinese (zh)
Inventor
林凡儒
聂昌盛
杨川川
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SHANDONG KERNEL AND HALL PHARMACEUTICAL INDUSTRY Co Ltd
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SHANDONG KERNEL AND HALL PHARMACEUTICAL INDUSTRY Co Ltd
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Priority to CN201610360743.9A priority Critical patent/CN105878198A/en
Publication of CN105878198A publication Critical patent/CN105878198A/en
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4375—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
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Abstract

The invention relates to a pharmaceutical composition containing berberine hydrochloride tablets. The pharmaceutical composition is prepared from the following raw materials: 50kg of berberine hydrochloride tablets, 3kg of carboxymethyl starch sodium and 18kg of purified water to prepare 1 million tablets by a conventional method. The compound berberine hydrochloride tablet medicine composition can be used for treating both symptoms and root cause of enterogastritis, is not toxic or harm to human bodies, does not have side effect, is low in price and simple in preparation, and has a wide application prospect.

Description

Pharmaceutical composition containing Berberine Hydrochloride Tablets and preparation technology thereof
Technical field
The invention belongs to pharmaceutical technology field, be specifically related to treat the Chinese-western medicine preparation of gastroenteritis, particularly with Western medicine salt Acid berberine be main medicinal herb components be the pharmaceutical composition of auxiliary treatment gastroenteritis.
Background technology
Gastroenteritis generally infects because of microorganism and causes, it is possible to because chemical toxicant or medicine cause.Typical clinical manifestations is abdomen Rush down, Nausea and vomiting and stomachache.For health adult, gastroenteritis the most only can cause sense of discomfort and inconvenience in life, can't Cause serious consequence, but in seriously ill, weak, young or old patient, but can cause life-threatening dehydration and electrolysis Matter is disorderly.The type of gastroenteritis symptom and the order of severity depend on microorganism or the type of poisonous substance and the size of amount.Gastroenteritis is Common symptom is diarrhoea, and other symptoms include: stomachache, Nausea and vomiting, heating, loss of appetite, losing weight (is probably de- The sign of water), a large amount of perspire, skin is clammy, myalgia or ankylosis, fecal incontinence etc..Violent vomiting and suffer from diarrhoea permissible Quickly causing dehydration, it is presented with weakness, extreme thirst, oliguria or urine color intensification, xerosis cutis, xerostomia, enophthalmos, baby Few tear when can also behave as crying.Serious vomiting or diarrhoea can cause hyponatremia, hypokalemia, hypotension etc..
Drink the patient that a large amount of saliferous is few or salt-free moisture carrys out liquid make-up and hyponatremia easily occurs.Water and electrolyte Disorder has potential risks, and especially for seriously ill, weak, young or old patient, shock can occur in serious case And renal failure.Gastroenteritis infectiosa can cause because of infection virus, antibacterial, parasite.Poisonous substance and medicine can cause chemical Gastroenteritis.It is the modal cause of disease of gastroenteritis that virus infects, and has multiple virus can cause acute gastroenteritis, is most commonly that colyliform Virus, next to that Norwalk virus, Astrovirus and enteric adenovirus.If acute gastroenteritis not being treated, to disease in time The health of people will result in harmful effect.And the medicine treating this disease in prior art often uses Western medicine to treat, but Western medicine side effect is big, and fundamentally cannot treat acute gastroenteritis, there is therapeutic effect inconspicuous, side effect Big technological deficiency.
Berberine hydrochloride is the Western medicine medicine of conventional treatment gastroenteritis, and it is a kind of isoquinoline alkaloid.It is present in little In many plants that Bo Kedeng 4 section 10 belongs to.Berberine can separate out yellow needle-like crystals from ether.Fusing point 145 DEG C.It is dissolved in water, It is insoluble in benzene, ether and chloroform.Berberine is a kind of quartermary ammonium alkaloids, and its esters dissolubility in water is smaller, such as Hydrochlorate is 1: 500, and sulfate is 1: 30.The crystal that berberine separates out from water or Diluted Alcohol is with 5.5 molecular crystalline water；If Crystallize from chloroform, acetone or benzene, also with corresponding recrystallisation solvent molecule.It is to Hemolytic streptococcus, Staphylococcus aureus Bacterium, gonococcus and Freund, dysentery bacterium all have antibacterial action, and have enhancing leukocyte phagocytosis.The salt of berberine Hydrochlorate (being commonly called as berberine hydrochloride) is widely used in treatment gastroenteritis, bacillary dysentery etc..Berberine can from Radix Berberidis, Rhizoma Coptidis, The plants such as Cortex Phellodendri are extracted.Due to Rhizoma Coptidis poor growth, price is higher, and Cortex Phellodendri source is the most less, and existing China mainly applies three Pin is as extracting raw material.Berberine is a kind of conventional broad spectrum antibiotic, is mainly used in bacillary dysentery, gastroenteritis, carbuncle etc. Bacterial infection.
But, berberine hydrochloride the most occasionally have Nausea and vomiting, erythra and medicine heat etc. side effect, and Berberine Hydrochloride Tablets with contain After the Chinese medicine of tannin and this medicine share, owing to tannin is alkaloid precipitant, the two combines, and generates slightly solubility tannate and sinks Forming sediment, Berberine Hydrochloride Tablets disables for patients with hemolytic anemias and glucose-6-pbosphate dehydrogenase deficiency patient.
Theory of Chinese medical science thinks that gastroenteritis is a kind of common disease, how to cause because feed is improper.It is apt to occur in summer and autumn, suffers from Person's usually sudden onset, has the medical history eating unclean food by mistake, and the initial stage first feels fullness and oppression in the stomach, loss of appetite, Nausea and vomiting, tells Rear symptom can temporarily alleviate, and vomiting content mostly is food even bile.Aggravation subsequently, may occur in which abdominal pain diarrhea, stool Many in water sample, color buff or light green, small number of patients is defecated with mucus pus and blood.The traditional Chinese medical science is divided into dialectical for acute gastroenteritis Following several types, gastrointestinal damp-heat type: disease sees that onset is hurried, to vomit acid regurgitation, feel sick frequently, stomachache battle array is made.Rush down lower urgent (pain in the abdomen Rear heavy), just go not well, just yellow skin is brown and smelly, thirst with desire to drink, vexed, and short urination is red few, yellow and greasy fur, soft and rapid pulse or sliding number；Cold-damp hinders Stagnant type: patient vomits clear water, feels sick frequently, watery stool of suffering from diarrhoea, and stomachache borborygmus are also generated heat with cold syndrome of the stomach, neck or general joint acid Bitterly, white and thin fur or the most greasy, soft pulse；Dyspepsia gastrointestinal type: disease sees that patient feels sick anorexia, obtains appetite very, sends out fast after telling, stomachache, under rushing down Dirty smelly, not the best, rush down rear alleviation of pain, thick and greasy fur, rolling and forceful pulse.
At present, the most constantly there is the medicine of new treatment gastroenteritis to occur, but these all fail to reach really to make us full The effect of meaning.Employing Integrated TCM, treating both the principal and secondary aspects of a disease, the most rationally.The medicine of currently employed therapy of combining Chinese and Western medicine gastroenteritis The rarest, therefore, develop a kind of high-efficiency low-toxicity, the Chinese medicine and western medicine compound drug for the treatment of both the principal and secondary aspects of a disease be still clinic eager needs.
Summary of the invention
It is an object of the invention to provide that a kind for the treatment of both the principal and secondary aspects of a disease, side effect be little, safe ready, cheap containing berberine hydrochloride The pharmaceutical composition of sheet and preparation technology thereof.Its purpose is to solve treatment gastroenteritis, overcome Western medicine toxic and side effects and control The inapparent problem of therapeutic effect, reaches the purpose for the treatment of both the principal and secondary aspects of a disease.
Present inventor is in view of the defect of the medicine existence of existing treatment gastroenteritis, based on being engaged in Chinese medicine for many years Abundant clinical experience and Professional knowledge, from motherland's traditional medicine theory, through constantly clinical research screening for many years In, some medicines chosen prescription, carry out pharmacology, pharmacodynamics and clinical practice etc. are studied, and initiate and develop this The compound preparation with benefiting stomach and stopping pain, warming kidney for dispelling cold of invention.Pharmaceutical composition of the present invention is to treating the stomach that various symptoms cause Enteritis has significant curative effect, taking convenience, non-relapse after healing, safe without toxic side effect, and selected medical material compatibility is suitable, meets Chinese medicine and pharmacy and modern medicine theory, it is possible to reach the purpose for the treatment of both the principal and secondary aspects of a disease, wide popularization and application on clinic.
For achieving the above object, the technical solution used in the present invention is as follows:
Containing the pharmaceutical composition of berberine hydrochloride, it includes following raw material:
Berberine hydrochloride 25kg, medicinal herb components 25kg, carboxymethylstach sodium 3kg, purified water 18kg, conventionally prepare sheet Agent 1,000,000.
Described berberine hydrochloride uses following method to prepare:
1) taking Radix Berberidis coarse powder, concentration 0.5% aqueous sulfuric acid adding 3 times of weight after crossing 20 mesh sieves is allowed to submergence powder, leaching Bubble 5h, filters with absorbent cotton；
2) filtrate of step 1) adds in lime cream and unnecessary sulphuric acid, adjust pH to 7, stand；
3) step 2) filtrate prepared adds the 95%(volume ratio of 3 times of weight) ethanol is heated with stirring to 75 DEG C of backflow 20- 30min, being subsequently adding the ethanol of equivalent and being evaporated to filtrate is brownish red serosity；
4) in brownish red serosity, add 3% acetic acid (volumetric concentration) and be heated to 140 DEG C；
5) add concentration be the hydrochloric acid (volumetric concentration) of 60% to solution muddiness, with frozen water be cooled to berberine hydrochloride separate out, Dry drying obtains fine work berberine hydrochloride.
Described medicinal herb components, is prepared by following raw material:
Radix Glycyrrhizae, Rhizoma Dioscoreae, Herba Euphorbiae Humifusae, Poria, Herba Taraxaci, Cortex Phellodendri, Herba Plantaginis, the Radix Angelicae Dahuricae, Radix Puerariae, Folium Isatidis, Flos Lonicerae maackii, Radix Aconiti Lateralis Preparata, Radix Saposhnikoviae, Rhizoma Corydalis, Rhizoma Zingiberis, Semen Myristicae, Caulis Bambusae In Taenia, Cortex Magnoliae Officinalis, Flos Lonicerae, the Radix Pulsatillae, Fructus Aurantii, Semen Euryales, Pericarpium Citri Reticulatae, Radix Platycodonis, Flos Campsis, the heart of a lotus seed Semen Coicis, the Rhizoma Atractylodis Macrocephalae, Galla Chinensis.
Preferably, described medicinal herb components, the raw material of following weight it is prepared:
33 parts of Radix Glycyrrhizae, Rhizoma Dioscoreae 33 parts, Herba Euphorbiae Humifusae 33 parts, 32 parts of Poria, Herba Taraxaci 32 parts,
Cortex Phellodendri 30 parts, Herba Plantaginis 30 parts, the Radix Angelicae Dahuricae 30 parts, Radix Puerariae 30 parts, Folium Isatidis 30 parts,
Flos Lonicerae maackii 28 parts, Radix Aconiti Lateralis Preparata 28 parts, Radix Saposhnikoviae 28 parts, Rhizoma Corydalis 25 parts, Rhizoma Zingiberis 25 parts,
Semen Myristicae 25 parts, Caulis Bambusae In Taenia 25 parts, Cortex Magnoliae Officinalis 25 parts, Flos Lonicerae 20 parts, the Radix Pulsatillae 20 parts,
Fructus Aurantii 20 parts, Semen Euryales 20 parts, Pericarpium Citri Reticulatae 18 parts, Radix Platycodonis 15 parts, Flos Campsis 15 parts,
Semen Coicis 10 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, Galla Chinensis 10 parts.
The preparation method of described medicinal herb components is as follows:
(1) above-mentioned raw materials is weighed standby
(2) extracting liquorice, Rhizoma Dioscoreae, Semen Euryales slow fire are fried 8 minutes, and air dry of drying in the air after stir-fry to surface is sallow is done, and pulverizes 90 mesh sieves, preparation Composition A;
(3) take Rhizoma Zingiberis, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae pulverized 100 mesh sieves, mix homogeneously, prepared composition B；
(4) Herba Euphorbiae Humifusae, Poria, the Radix Angelicae Dahuricae, Radix Puerariae, Radix Aconiti Lateralis Preparata, Radix Saposhnikoviae, Caulis Bambusae In Taenia, the Radix Pulsatillae, Fructus Aurantii, Radix Platycodonis, Semen Coicis, Galla Chinensis are taken Put into container, add the distilled water of 5 times amount, after soaking 2 hours, boil 3 hours, extract decoction liquor；Again add 3 times amount to steam Distilled water, boils 2 hours, extracts decoction liquor；Finally, add 2 times amount distilled water, heated and boiled 1 hour, extract decoction liquor；Merge Three decoction liquor, are condensed into the extractum that density is 1.1g/ml, and 60 DEG C dried, pulverizes prepared composition C；
(5) take surplus stock add 3 times of weight 85%(volume ratios) ethanol, reflux, extract, 2 times, each 1 hour, extracting solution close And, it is concentrated into the extractum that density is 1.1g/ml, 60 DEG C are dried, pulverize prepared composition D；
(6) it is uniformly mixed into point A, B, C, D and get final product.
Instructions of taking, one time 1,3 times on the one.
Technical solutions according to the invention are on the basis of the clinical experience of Chinese traditional treatment gastroenteritis, become in conjunction with modern pharmacy Fruit develop with the compound preparation of Integrated TCM.Chinese medicine and Western medicine are effectively combined, have the strongest benefiting stomach and stopping pain, The function of warming kidney for dispelling cold.The present invention uses the Chinese crude drug of different properties, has carried out scientific compatibility, can reach preferably to treat effect Really, and safety, toxic and side effects is little, and preparation is simple, and focus of going directly, healing time is short, controls difficulty in relapse after healing.
The component of medicine of the present invention all uses natural raw material of Chinese medicine, and it prepares simplicity, and medicine source is extensive, with low cost, its Following the prescriptions principle of the traditional Chinese medical science, all medicines share, and bring out the best in each other；And the difference for herbal raw material uses different places Reason mode so that drug effect discharges to greatest extent, verifies by clinic application, and it is evident in efficacy reliably, mild in medicine property and, do not go out Existing toxic and side effects, has a extensive future.
The present invention is by medicine components, the reasonable selection of proportioning, by the berberine hydrochloride constituent reduction of every tablet one Half, greatly reduce the side effect of Western medicine berberine hydrochloride, and achieve preferable therapeutic effect, both meet state-promulgated pharmacopoeia to having Close the requirement of drug dose, can guarantee that again good therapeutic effect, non-evident effect.
Detailed description of the invention
Embodiment 1
Containing the pharmaceutical composition of berberine hydrochloride, it includes following raw material:
Berberine hydrochloride 25kg, medicinal herb components 25kg, carboxymethylstach sodium 3kg, purified water 18kg, conventionally prepare sheet Agent 1,000,000.
Described berberine hydrochloride uses commercially available or following method to prepare:
1) taking Radix Berberidis coarse powder, concentration 0.5% aqueous sulfuric acid adding 3 times of weight after crossing 20 mesh sieves is allowed to submergence powder, leaching Bubble 5h, filters with absorbent cotton；
2) filtrate of step 1) adds in lime cream and unnecessary sulphuric acid, adjust pH to 7, stand；
3) step 2) filtrate prepared adds the 95%(volume ratio of 3 times of weight) ethanol is heated with stirring to 75 DEG C of backflow 20- 30min, being subsequently adding the ethanol of equivalent and being evaporated to filtrate is brownish red serosity；
4) in brownish red serosity, add 3% acetic acid (volumetric concentration) and be heated to 140 DEG C；
5) add concentration be the hydrochloric acid (volumetric concentration) of 60% to solution muddiness, with frozen water be cooled to berberine hydrochloride separate out, Dry drying obtains fine work berberine hydrochloride.
Said method a step can directly prepare refined berberine, and the berberine purity prepared is high, and average yield reaches To 10%, reduce raw-material consumption, improve production efficiency.
Described medicinal herb components, is prepared by the raw material of following weight:
33 parts of Radix Glycyrrhizae, Rhizoma Dioscoreae 33 parts, Herba Euphorbiae Humifusae 33 parts, 32 parts of Poria, Herba Taraxaci 32 parts,
Cortex Phellodendri 30 parts, Herba Plantaginis 30 parts, the Radix Angelicae Dahuricae 30 parts, Radix Puerariae 30 parts, Folium Isatidis 30 parts,
Flos Lonicerae maackii 28 parts, Radix Aconiti Lateralis Preparata 28 parts, Radix Saposhnikoviae 28 parts, Rhizoma Corydalis 25 parts, Rhizoma Zingiberis 25 parts,
Semen Myristicae 25 parts, Caulis Bambusae In Taenia 25 parts, Cortex Magnoliae Officinalis 25 parts, Flos Lonicerae 20 parts, the Radix Pulsatillae 20 parts,
Fructus Aurantii 20 parts, Semen Euryales 20 parts, Pericarpium Citri Reticulatae 18 parts, Radix Platycodonis 15 parts, Flos Campsis 15 parts,
Semen Coicis 10 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, Galla Chinensis 10 parts.
The preparation method of described medicinal herb components is as follows:
(1) above-mentioned raw materials is weighed standby
(2) extracting liquorice, Rhizoma Dioscoreae, Semen Euryales slow fire are fried 8 minutes, and air dry of drying in the air after stir-fry to surface is sallow is done, and pulverizes 90 mesh sieves, preparation Composition A;
(3) take Rhizoma Zingiberis, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae pulverized 100 mesh sieves, mix homogeneously, prepared composition B；
(4) Herba Euphorbiae Humifusae, Poria, the Radix Angelicae Dahuricae, Radix Puerariae, Radix Aconiti Lateralis Preparata, Radix Saposhnikoviae, Caulis Bambusae In Taenia, the Radix Pulsatillae, Fructus Aurantii, Radix Platycodonis, Semen Coicis, Galla Chinensis are taken Put into container, add the distilled water of 5 times amount, after soaking 2 hours, boil 3 hours, extract decoction liquor；Again add 3 times amount to steam Distilled water, boils 2 hours, extracts decoction liquor；Finally, add 2 times amount distilled water, heated and boiled 1 hour, extract decoction liquor；Merge Three decoction liquor, are condensed into the extractum that density is 1.1g/ml, and 60 DEG C dried, pulverizes prepared composition C；
(5) take surplus stock add 3 times of weight 85%(volume ratios) ethanol, reflux, extract, 2 times, each 1 hour, extracting solution close And, it is concentrated into the extractum that density is 1.1g/ml, 60 DEG C are dried, pulverize prepared composition D；
(6) it is uniformly mixed into point A, B, C, D and get final product.
Instructions of taking, one time 1,3 times on the one.
Embodiment 2
Studies on acute toxicity
Healthy rat and mice single oral gavage respectively gives the pharmaceutical composition of the present invention, and given low is clinical plan consumption 100 times.After administration, mice occurs that light activity reduces, and within about 1 hour, recovers normal, Continuous Observation 7 days after administration, and none moves Thing is dead, its overall health of patients, diet, takes the photograph water, urine and body weight and increases all normal, obvious acute toxic reaction does not occurs, also Do not cause animal dead.The reactions such as obvious acute toxic reaction does not occurs in mice, and rat occurs having loose bowels just, activity minimizing, anxious Property toxicity target organ is liver and spleen.Point out this medicine acute toxicity low, clinical drug safety.
Embodiment 3
Clinical experiment
Case selection:
Selecting the gastroenteritis patient 103 example clinical observation made a definite diagnosis, patient is randomly divided into treatment group and matched group two groups, treatment group 52 Example, matched group 51 example, treatment group and the course of disease of two groups of cases of matched group, degrees of symptoms are basically identical, without significant difference, tool There is comparability.
Medicament selection:
Treatment group takes pharmaceutical composition of the present invention, oral, three times a day, and each 1；
Matched group takes commercially available Berberine Hydrochloride Tablets, oral, three times a day, and each 1.
Warm water delivery service after meal；Within 3 days, being 1 course for the treatment of, the person of being in a bad way follows the doctor's advice the meal with wine amount of adding.
Efficacy determination:
(1) cure: stomachache, Nausea and vomiting, heating, loss of appetite, lose weight, perspiration in a large number, skin is clammy, myalgia or Ankylosis symptom all disappears, and physical recovery is normal.
(2) effective: stomachache, Nausea and vomiting, heating, loss of appetite, lose weight, perspire in a large number, skin is clammy, muscle Pain or ankylosis symptom substantially alleviate, and health has taken a turn for the better.
(3) effective: stomachache, Nausea and vomiting, heating, loss of appetite, lose weight, perspiration in a large number, skin are clammy, muscle Pain or ankylosis symptom have alleviated, and health is clearly better.
(4) invalid: by above-mentioned symptom after treatment without alleviating or increasing the weight of.
Shown in concrete therapeutic outcome table 1: P ＜ 0.05
Table 1
Group Example time Cure Effective Effectively Invalid Total effective rate (%)
Treatment group 52 29 12 7 4 94
Matched group 51 16 9 17 9 82.5
As seen from the above table: treatment group total effective rate is substantially better than matched group, has significant difference.
Embodiment 4
Exemplary embodiments
Zhang, female, 29 years old, patient's the most usually upper abdomen and upper abdomen lower paroxysmal pain to the right, diet was poor, with feeling sick, detests oil, sometimes goes out Now vomitting, symptom of diarrhea, look into through gastroscope and be diagnosed as gastroenteritis, the pharmaceutical composition giving the embodiment of the present invention 1 preparation is controlled Treating, after taking 1 course for the treatment of, food is received and is become good, detests oil and alleviates, and paroxysmal pain, diarrhoea number of times reduce, after taking 2 courses for the treatment of, and paroxysmal pain, diarrhoea All disappear, cure.
Ma, man, 50 years old, suffer from acute gastroenteritis, with Nausea and vomiting, suffer from abdominal pain, suffer from diarrhoea, the symptom such as heating, take this The pharmaceutical composition of bright embodiment 1 preparation, after 2 days, vomits, stopping of suffer from diarrhoea, after 1 course for the treatment of, and transference cure, fully recover.
Above-mentioned each Chinese medicine and western medicine interaction compatibility that the present invention uses, can play its collaborative effect of curing the disease, and raw material of Chinese medicine used is each There is between composition drug effect be interweaved and mutually promote and coordinate usefulness, according to clinical verification, gastroenteritis is had and well treats effect Really, in the applicant's medical practice for many years, the case Numerous of healing, all obtain good effect, and also with low cost, Alleviate the burden of patient.

Claims (7)

1. containing the pharmaceutical composition of Berberine Hydrochloride Tablets, it includes following raw material:
Berberine hydrochloride 50kg, carboxymethylstach sodium 3kg, purified water 18kg, conventionally prepare 1,000,000, tablet.
2. containing the pharmaceutical composition of Berberine Hydrochloride Tablets, it includes following raw material:
Berberine hydrochloride 25kg, medicinal herb components 25kg, carboxymethylstach sodium 3kg, purified water 18kg, conventionally prepare sheet Agent 1,000,000.
Pharmaceutical composition the most according to claim 2, it is characterised in that described medicinal herb components prepared by following raw material and :
Radix Glycyrrhizae, Rhizoma Dioscoreae, Herba Euphorbiae Humifusae, Poria, Herba Taraxaci, Cortex Phellodendri, Herba Plantaginis, the Radix Angelicae Dahuricae, Radix Puerariae, Folium Isatidis, Flos Lonicerae maackii, Radix Aconiti Lateralis Preparata, Radix Saposhnikoviae, Rhizoma Corydalis, Rhizoma Zingiberis, Semen Myristicae, Caulis Bambusae In Taenia, Cortex Magnoliae Officinalis, Flos Lonicerae, the Radix Pulsatillae, Fructus Aurantii, Semen Euryales, Pericarpium Citri Reticulatae, Radix Platycodonis, Flos Campsis, the heart of a lotus seed Semen Coicis, the Rhizoma Atractylodis Macrocephalae, Galla Chinensis.
4. according to the pharmaceutical composition described in claim 2-3, it is characterised in that former by following weight of described medicinal herb components Material medicine is prepared:
33 parts of Radix Glycyrrhizae, Rhizoma Dioscoreae 33 parts, Herba Euphorbiae Humifusae 33 parts, 32 parts of Poria, Herba Taraxaci 32 parts,
Cortex Phellodendri 30 parts, Herba Plantaginis 30 parts, the Radix Angelicae Dahuricae 30 parts, Radix Puerariae 30 parts, Folium Isatidis 30 parts,
Flos Lonicerae maackii 28 parts, Radix Aconiti Lateralis Preparata 28 parts, Radix Saposhnikoviae 28 parts, Rhizoma Corydalis 25 parts, Rhizoma Zingiberis 25 parts,
Semen Myristicae 25 parts, Caulis Bambusae In Taenia 25 parts, Cortex Magnoliae Officinalis 25 parts, Flos Lonicerae 20 parts, the Radix Pulsatillae 20 parts,
Fructus Aurantii 20 parts, Semen Euryales 20 parts, Pericarpium Citri Reticulatae 18 parts, Radix Platycodonis 15 parts, Flos Campsis 15 parts,
Semen Coicis 10 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, Galla Chinensis 10 parts.
5. according to the pharmaceutical composition described in claim 2-4, it is characterised in that the preparation method of described medicinal herb components is such as Under:
1) above-mentioned raw materials is weighed standby；
2) extracting liquorice, Rhizoma Dioscoreae, Semen Euryales, mixing, fry 8 minutes with slow fire, pulverized 90 mesh sieves, prepared composition A；
3) Rhizoma Zingiberis, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae are taken, mixing, pulverized 100 mesh sieves, mix homogeneously, prepared composition B；
4) Herba Euphorbiae Humifusae, Poria, the Radix Angelicae Dahuricae, Radix Puerariae, Radix Aconiti Lateralis Preparata, Radix Saposhnikoviae, Caulis Bambusae In Taenia, the Radix Pulsatillae, Fructus Aurantii, Radix Platycodonis, Semen Coicis, Galla Chinensis are taken, Mixing, puts into container, adds the distilled water of 5 times of weight, after soaking 2 hours, boils 3 hours, extracts decoction liquor；Again add The distilled water of 3 times of weight, boils 2 hours, extracts decoction liquor；Finally, the distilled water of 2 times of weight of addition, heated and boiled 1 hour, Extract decoction liquor；Merging three decoction liquor, be condensed into the extractum that density is 1.1g/ml, 60 DEG C dried, pulverizes prepared composition C；
5) take surplus stock medicine, mixing, add 3 times of weight 85%(volume ratios) ethanol, reflux, extract, 2 times, each 1 hour, carry Taking liquid to merge, be concentrated into the extractum that density is 1.1g/ml, 60 DEG C dried, pulverizes prepared composition D；
6) it is uniformly mixed into point A, B, C, D and get final product.
6. according to the pharmaceutical composition described in claim 1-4, it is characterised in that described berberine hydrochloride uses following method system Standby:
1) taking Radix Berberidis coarse powder, concentration 0.5% aqueous sulfuric acid adding 3 times of weight after crossing 20 mesh sieves is allowed to submergence powder, leaching Bubble 5h, filters with absorbent cotton；
2) filtrate of step 1) adds in lime cream and unnecessary sulphuric acid, adjust pH to 7, stand；
3) step 2) filtrate prepared adds the 95%(volume ratio of 3 times of weight) ethanol is heated with stirring to 75 DEG C of backflow 20- 30min, being subsequently adding the ethanol of equivalent and being evaporated to filtrate is brownish red serosity；
4) in brownish red serosity, add 3% acetic acid (volumetric concentration) and be heated to 140 DEG C；
5) add concentration be the hydrochloric acid (volumetric concentration) of 60% to solution muddiness, with frozen water be cooled to berberine hydrochloride separate out, It is dried drying.
7. the application of pharmaceutical composition described in claim 1-5.
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陆鹏飞等: "《陆氏中医诊治验方》", 30 April 2014, 中医古籍出版社 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111643466A (en) * 2020-07-27 2020-09-11 江苏长江药业有限公司 Preparation method of berberine hydrochloride tablets

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