CN105770567A - Traditional Chinese medicine composition for treating hoove and preparation thereof - Google Patents

Abstract

The invention relates to a preparing method of a traditional Chinese medicine composition for treating hoove and a preparation thereof. The preparing method includes the steps of firstly, crushing melanterite, wheat, fructus ziziphi jujubae, radix aucklandiae and euphorbia kansui into powder above 10 mesh and extremely fine powder; secondly, using the powder as the medicine active component, and preparing the pharmaceutic preparation composition according to a conventional pharmaceutical engineering method.

Description

A kind of Chinese medicine composition treating hoove and preparation thereof

Technical field:

The present invention relates to a kind of Chinese medicine composition, particularly to a kind of Chinese medicine composition treating hoove and preparation thereof.

Background technology:

Distension disease, is the traditional Chinese medical science general designation to diseases such as various ascites pleural fluid, edema, edema, names such as drum with thorax abdomen tympanites, swells with abdominal part, the colour of skin is greenish yellow, abdominal part venation exposes as feature.Distension disease is divided into " flatulence, tympanitis due to blood stasis, dropsy " according to the difference of etiology and pathogenesis, the distension disease of traditional medicine refers to all diseases being main clinical manifestation with edema, these syndromes are by disease by liver, lung, the heart, kidney, in gas, blood, water alluvial abdomen, can not be discharged by health excretory function, so that thorax abdomen swells day by day, ultimately form tympanites.

The drug main of existing treatment distension disease to have its prescription of ascites pill to be Melanteritum (vinegar system), Radix Kansui, Fructus Jujubae (enucleation stir-fry), the Radix Aucklandiae etc..Existing ascites pill is the sugar-coat watered pill, aobvious brown after removing sugar-coat；Sour in the mouth, puckery.Its discrimination method is as follows: take this product 1g, removes sugar-coat, and finely ground, add water 10ml, boils 10 minutes, filter, take filtrate 1ml, add iron potassuim cyanide test liquid 2～3, namely generate blue precipitate, separating, be deposited in dilute hydrochloric acid insoluble, hydro-oxidation sodium test solution, in brown precipitate.

Its function cures mainly as follows: inducing diuresis to remove edema, and dehumidify spleen invigorating.For distension disease, distension and fullness of the chest and abdomen, extremity edema, constipation, oliguria with reddish urine.

Chinese medicine ingredients effect in ascites pill is as follows:

Fructus Jujubae: another name Fructus Jujubae, dry Fructus Jujubae, Chinese date, for the dry mature fruit of Rhamnaceae thing Fructus Jujubae ZiziphusjujubaMill..

Melanteritum: another name Melanteritum, ferrosisuifas crudus.This product is the Ore of Sulfates fossil water Melanteritum.Main containing water containing ferrous sulfate (FeSO₄·7H₂O), after excavating, assorted stone is removed.

Radix Kansui: call main field, Chong Ze, sweet ligusticumic, mound ligusticumic, Gan Ze, bitter pool, Bai Ze, ugly, the Ling Ze of ghost.This product is the dried root of euphorbia plant Radix Kansui EuphorbiakansuiT.N.LiouexT.P.Wang.

The Radix Aucklandiae: another name honey perfume, Radix Aristolochiae, spices, five Radix Aucklandiae.This product is the dry root of feverfew Radix Aucklandiae AucklandialappaDecne..

Semen Tritici aestivi: another name bran wheat, swimmer, Fructus Tritici Levis, absolutely empty wheat, Semen Tritici aestivi soft grit, wheat.Dry mature fruit for grass Semen Tritici aestivi TriticumaestivumL..

Prior art discloses the following relevant information of ascites pill

Ascites pill is second medicine recorded of " Drug Standard of Ministry of Public Health of the Peoples Republic of China " Traditional Chinese medicine historical preparation, is clinical conventional Chinese patent medicine, is made up of five kinds of Chinese medicine such as Melanteritum (vinegar system), Radix Kansui, Fructus Jujubaes.There is effect of inducing diuresis to remove edema, dehumidifying spleen invigorating, be mainly used in the symptoms such as distension disease, distension and fullness of the chest and abdomen, extremity edema, constipation, oliguria with reddish urine.Ascites pill quality standard records in " Drug Standard of Ministry of Public Health of the Peoples Republic of China " Traditional Chinese medicine historical preparation second.Content is as follows:

[prescription] Melanteritum (vinegar system) 200g Radix Kansui 20g Fructus Jujubae (enucleation stir-fry) 200g Radix Aucklandiae 20g Semen Tritici aestivi (stir-fry) 100g

[method for making] above five tastes, are ground into fine powder, sieve, mixing；With water pill, less than 60 DEG C dry, and sugar coating to obtain final product.[character] this product is the sugar-coat watered pill, aobvious brown after removing sugar-coat；Sour in the mouth, puckery.[function with cure mainly] inducing diuresis to remove edema, dehumidify spleen invigorating.For distension disease, distension and fullness of the chest and abdomen, extremity edema, constipation, oliguria with reddish urine.[usage and consumption] taking medicine before meal, one time 10,3 times on the one, child is cut down according to the circumstance.[attention] with Radix Glycyrrhizae with clothes, can not avoid Sal and mustard wheat flour.[specification] every 10 weight 1.3g[storages] seal, moistureproof.

Following Chinese patent describes method of quality control

200810056503.5	The quality standard of ascites pill and preparation thereof and detection method
		201110222362.1	The quality standard of ascites pill and preparation thereof and detection method

The present inventor finds in clinic and production practices, prior art is in curative effect, stability, the aspects such as the saving of raw material need to improve, and to improve the effect of medicine, extend shelf life, that reduces medicine makes consumption, improving the adaptability of medicine, for this present inventor, prior art having been improved, thus completing the present invention.

Summary of the invention:

For improving the defect of prior art, the present invention provides the new preparation method of a kind of ascites pill, ascites pill of the present invention, and its formula is as follows:

Ascites pill described in preferred invention, its formula is as follows:

Composition described above is by weight as proportioning, can increase according to corresponding proportion when producing or reduce, as large-scale production can by kilogram in units of, or in units of ton, small-scale production can also in units of milligram, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.

The ratio of above weight proportion obtains through science screening, for special circumstances, such as serious symptom or mild, fat or modest, it is possible to the proportioning of the corresponding amount adjusting composition, increases or reduces less than 100%, and drug effect is constant.

Single medicinal material in composition described above, especially ministerial drug and adjuvant drug, it is also possible to replaced by the suitable Chinese medicine with the identical property of medicine, its medicine effect of the Chinese medicine preparation after replacement is constant.

The ascites pill Chinese medicine preparation compositions of the present invention, is through work by the raw material of Chinese medicine formed by above-mentioned formula, makes pharmaceutically active substance, subsequently, with this material for raw material, it is necessary to time add pharmaceutically acceptable carrier, make according to the routine techniques of galenic pharmacy.

The pharmaceutically active substance of the present invention, its in the formulation shared percentage by weight can be 0.1-99.9%, all the other are pharmaceutically acceptable carrier.The pharmaceutical preparations composition of the present invention, exists in a unit, and described unit dosage form refers to the unit of preparation, such as every of tablet, and every capsules of capsule, every bottle of oral liquid, granule every bag etc..

The Chinese medicine preparation compositions of the present invention can be any pharmaceutically useful dosage form, and these dosage forms include: tablet, capsule, granule, pill, powder, unguentum, sublimed preparation, powder, solution, injection, suppository, spray, drop, patch.The preparation of the present invention, it is preferred that peroral dosage form, as: capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum etc..

The Chinese medicine preparation compositions of the present invention, the preparation of its oral administration can contain conventional excipient, such as binding agent, filler, diluent, tablet agent, lubricant, disintegrating agent, coloring agent, flavoring agent and wetting agent.

The filler being suitable for includes the filler that cellulose, mannitol, lactose are similar with other.Suitable disintegrating agent includes starch, polyvinylpyrrolidone and starch derivatives, for instance sodium starch glycollate.Suitable lubricant includes, for instance magnesium stearate.Suitable pharmaceutically acceptable wetting agent includes sodium lauryl sulphate.

Can passing through to mix, fill, the method that tabletting etc. is commonly used prepares solid oral composition.Carry out mixing repeatedly can make in those compositionss that active substance is distributed in a large amount of filler of whole use.The form of oral liquid can be such as aqueous or oily suspensions, solution, Emulsion, syrup or elixir, or can be a kind of available water before use or the composite dry products of other suitable carrier.This liquid preparation can contain conventional additive, such as suspending agent, such as sorbitol, syrup, methylcellulose, gelatin, hydroxyethyl cellulose, carboxymethyl cellulose, aluminium stearate gel or hydrogenated edible fats, emulsifying agent, for instance lecithin, anhydro sorbitol monooleate or arabic gum；Non-aqueous carrier (they can include edible oil), for instance almond oil, the oily ester of ester of fractionated coconut oil, such as glycerol, propylene glycol or ethanol；Preservative, for instance para hydroxybenzene methyl ester or propyl p-hydroxybenzoate or sorbic acid, and if it is required, conventional flavouring agent or coloring agent can be contained.

nullThe Chinese medicine preparation compositions of the present invention，Applicable pharmaceutically acceptable carrier is optionally added when preparing into medicament，Adjunct ingredient as conventional: mannitol、Sorbitol、Sodium pyrosulfite、Sodium sulfite、Sodium thiosulfate、Cysteine hydrochloride、TGA、Methionine、Vitamin C、EDETATE SODIUM、Ethylenediaminetetraacetic Acid Calcium Salt，The alkali-metal carbonate of monovalence、Acetate、Phosphate or its aqueous solution、Hydrochloric acid、Acetic acid、Sulphuric acid、Phosphoric acid、Aminoacid、Sodium chloride、Potassium chloride、Sodium lactate、Xylitol、Maltose、Glucose、Fructose、Dextran、Glycine、Starch、Sucrose、Lactose、Mannitol、Silicon derivative、Cellulose and its derivates、Alginate、Gelatin、Polyvinylpyrrolidone、Glycerol、POLYSORBATE 80、Agar、Calcium carbonate、Calcium bicarbonate、Surfactant、Polyethylene Glycol、Cyclodextrin、Beta-schardinger dextrin-、Phospholipid material、Kaolin、Pulvis Talci、Calcium stearate、Magnesium stearate etc..

The preparation compositions of the present invention determines usage and dosage according to condition in use, can often taken three times per day, each 1-20 agent, such as: 1-20 bag or grain or sheet.

The preparation method that the present invention further provides preparation compositions of the present invention, described method step is as follows:

1), Melanteritum, Semen Tritici aestivi, Fructus Jujubae, the Radix Aucklandiae, Radix Kansui are ground into the 10 above powder of order to impalpable powder；

2) powder is as active constituents of medicine, and root galenic pharmacy conventional method makes pharmaceutical preparations composition.Compared to the prior art, main active substantially increases the method for the present invention, and drug effect significantly improves, and preparation stability significantly improves,

Below by way of experimental data, beneficial effects of the present invention is described:

Experiment content:

The present invention and prior art carry out contrast experiment

1, drug effect contrast experiment:

This research is intended to rat hepatocirrhosis Ascites Model, medicine of the present invention is evaluated

CCl₄Preparation Hepatocirrhosis Model, is administered according to the weight of animals with 50% miscella solution, and 2 times weekly, 12-15 week can form liver cirrhosis, prepares rat hepatocirrhosis Ascites Model, drug administration and normal saline after modeling success, and body weight, abdominal circumference are measured.

Rat model is randomly divided into three groups: measure the body weight of rat, abdominal circumference before administration, being then divided into following group: model blank control rats gives normal diet, of the present invention group of dosage is 2.0g/kg, and prior art group dosage is 2.0g/kg, every day is administered twice, totally 7 days.Measuring the body weight of rat, abdominal circumference after administration after 7 days, carry out statistical analysis, comparison therapy effect, wherein dosage 2.0g/kg is according to raw medicine calculation.(n=10,)

It is shown that of the present invention group and prior art group parameters index variable quantity compare with negative control group, having obvious significant difference, of the present invention group and prior art group compare, and of the present invention group is substantially better than prior art group in effect.

2, clinical laboratory data

Selecting 50 hepatitis, the patient of cirrhotic ascites, as treatment target, is divided into 2 groups at random, uses the Chinese medicine composition of the present invention to treat the patient of experimental group, and the patient of matched group uses prior art ascites pill to treat.Clinical treatment observation to the Chinese medicine composition of the present invention, adopts the medicine of the present invention and the therapeutic effect table of prior art ascites pill:

Group	n	Effective	Effectively	Invalid	Effective percentage
						The present invention	25	11	11	3	88%
Existing medicine	25	10	11	4	84%

Criterion of therapeutical effect:

Effective: ascites and General Symptoms are alleviated or disappear, and liver function recovers normal substantially.

Effective: ascites and other symptoms are clearly better, and lab testing has improvement.

Invalid: ascites has no and alleviates, other symptoms and liver function are without improving or worsening.

Clinical test results shows: 2 groups of total effective rates compare, and difference has significant, and of the present invention group is better than ascites pill group (P < 0.05).

3, medicine stability experiment:

Sample is placed on 40 DEG C ± 2 DEG C, relative humidity 75% ± 5% when be positioned in climatic chamber, to set time sampling, relevant composition is carried out assay, the primary stability result of the test after test is as follows:

Primary stability result of the test after inventive samples test

Primary stability result of the test after prior art sampling test

Result shows that stability of the present invention is higher.

4, main component Dissolution experiments

Assay method: by Chinese Pharmacopoeia dissolution method (slurry processes), with the degassed purified water of 900ml for dissolution medium, temperature 37+0.5 DEG C, regulate rotating speed 100r/min, take 6 parts of sample, accurately weighed be placed in stripping rotor, respectively at 10min, 20min, 30min, 40min, sample 2ml when 50min, 60min, add equality of temperature medium 2ml simultaneously, centrifugal, measure the dissolution of ferrous sulfate.

Taking the embodiment of the present invention 1 pill and each 6 balls of commercially available pill individually below, survey the dissolution of its effective ingredient ferrous sulfate at different time, result is shown in following table.

The pill different time dissolution determination data that the embodiment of the present invention 1 method prepares

Commercially available pill different time dissolution determination data

From above experimental data it can be seen that the pill prepared by the embodiment of the present invention 1 method, medicine is readily soluble in water, and the dissolution of medicament effective component is greatly improved, thus improving the bioavailability of medicine.

Detailed description of the invention:

Further illustrate the present invention by the following examples, but not as limitation of the present invention.

Embodiment 1

[prescription]

Melanteritum (vinegar system) 200g

Radix Kansui 20g

Fructus Jujubae (enucleation stir-fry) 200g

Radix Aucklandiae 20g

Semen Tritici aestivi (stir-fry) 100g

[method for making]

1), Melanteritum, Semen Tritici aestivi, Fructus Jujubae, the Radix Aucklandiae, Radix Kansui are ground into the 200 above impalpable powders of order；

2-1), powder adds Mel, honeyed pill made by mulse or water-honeyed pill.

2-2), powder adds the correctives such as Mel, mulse and is in harmonious proportion to pasty state, paste, liquid, solid, shaped.

2-3), powder adds appropriate amount of auxiliary materials and makes granule, tablet, capsule, powder.

Embodiment 2

[prescription]

[method for making]

1), Melanteritum, Semen Tritici aestivi, Fructus Jujubae, the Radix Aucklandiae, Radix Kansui are ground into the 80 above powder of order；

2-1), powder adds Mel, honeyed pill made by mulse or water-honeyed pill.

2-2), powder adds the correctives such as Mel, mulse and is in harmonious proportion to pasty state, paste, liquid, solid, shaped.

2-3), powder adds appropriate amount of auxiliary materials and makes granule, tablet, capsule, powder.

Embodiment 3

[prescription]

[method for making]

1), Melanteritum, Semen Tritici aestivi, Fructus Jujubae, the Radix Aucklandiae, Radix Kansui are ground into the 10 above powder of order to impalpable powder；

2-1), powder adds Mel, honeyed pill made by mulse or water-honeyed pill.

2-2), powder adds the correctives such as Mel, mulse and is in harmonious proportion to pasty state, paste, liquid, solid, shaped.

2-3), powder adds appropriate amount of auxiliary materials and makes granule, tablet, capsule, powder.

Claims (3)

1. a preparation method for ascites pill, described ascites pill, its formula is as follows:

Described preparation method, step is as follows:

1), Melanteritum, Semen Tritici aestivi, Fructus Jujubae, the Radix Aucklandiae, Radix Kansui are ground into the 10 above powder of order to impalpable powder；

2) powder is as active constituents of medicine, and root galenic pharmacy conventional method makes pharmaceutical preparations composition.

2. preparation method according to claim 1, wherein said ascites pill, its formula is as follows:

Described preparation method, step is as follows:

1), Melanteritum, Semen Tritici aestivi, Fructus Jujubae, the Radix Aucklandiae, Radix Kansui are ground into the 10 above powder of order to impalpable powder；

2) powder is as active constituents of medicine, and root galenic pharmacy conventional method makes pharmaceutical preparations composition.

3. preparation method according to claim 1, wherein said ascites pill, its formula is as follows:

Described preparation method, step is as follows:

1), Melanteritum, Semen Tritici aestivi, Fructus Jujubae, the Radix Aucklandiae, Radix Kansui are ground into the 10 above powder of order to impalpable powder；

2-1), powder adds Mel, honeyed pill made by mulse or water-honeyed pill.

2-2), powder adds the correctives such as Mel, mulse and is in harmonious proportion to pasty state, paste, liquid, solid, shaped.

2-3), powder adds appropriate amount of auxiliary materials and makes granule, tablet, capsule, powder.