CN101081255A - kazukiyo oral liquid agent and its preparing process - Google Patents

Abstract

The present invention relates to orally taken preparations and their preparation process. Three kinds of Chinese medicinal materials, including Chinese goldthread, rhubarb and skullcap root in certain weight proportion are water extracted, and the extract is prepared into oral liquid, oral mixture or syrup. Compared with corresponding solid preparation, the orally taken preparations of the present invention have the advantages of convenient taking, fast absorption and high bioavailability.

Description

One kazukiyo oral liquid agent and preparation method thereof

Technical field:

The present invention relates to a kind of is the oral liquid that effective ingredient is made with Rhizoma Coptidis, Radix Et Rhizoma Rhei, three kinds of Chinese medicines of Radix Scutellariae, is specially: a clear oral liquid, a clear mixture, a clear syrup.

Background technology:

The present invention writes out a prescription and mainly is made up of Chinese medicines such as Rhizoma Coptidis, Radix Scutellariae, Radix Et Rhizoma Rhei, and the fire of Rhizoma Coptidis, the clear eliminating the pathogens from the lung stomach of Radix Scutellariae in the side, Radix Et Rhizoma Rhei making the adverse-rising QI downwards, its discharge function are more brought into play and drawn effect hot descending, the purging FU-organs detoxifcation.Full side share and integrates pathogenic fire purging, toxin expelling, the skin ulcer that disappears, plays the effect of eliminating fire and detoxication, eliminating stasis and resolving masses, removing dampness heat clearing away altogether.

Can not only to rush down three warmers damp and hot for Radix Et Rhizoma Rhei among the we, and its hardship falls interaction energy the fire of inflammation is let out down, removing burning wood away under the boiler, it is descending to draw heat, sending down the abnormal ascending QI is flat to be dashed, straight folding upward, middle burnt calorific potential, have powerful pathogenic fire purging, anastalsis; Rhizoma Coptidis is kind especially to clear away heart-fire through excess-fire; Radix Scutellariae more is longer than lung heat clearing fire and part of the body cavity above the diaphragm housing the heart and lungs excess-heat.All medicines are played the effect of heat clearing and damp drying, eliminating fire and detoxication, removing stasis to stop bleeding altogether.

Modern pharmacological research shows: the main effective ingredient example hydrochloric acid berberine of we, baicalin, Radix Et Rhizoma Rhei are feared quinones and derivant thereof etc. have highly significant to propionibacterium acnes antiinflammatory, antibacterial action.

Clinical pharmacology and Chinese medicine research show, thereby Radix Et Rhizoma Rhei and Radix Scutellariae all can improve phagocytic function raising immune function of human body by excited reticuloendothelial system, baicalin in the Radix Scutellariae, wogonoside then improve the lymphoblastic transformation rate in addition, the excited uterine smooth muscle of energy, increase frequency of uterine contraction. improve its tension force, thereby play the immunologic function of hemostasis and raising human body.So, be mainly used in antiinflammatory clinically, bring down a fever, analgesia, antibacterial, antiviral, promote platelet aggregation, increase local platelet count, shorten, clotting time, thus the anastalsis of playing, cholesterol reducing, function of gallbladder promoting and blood pressure lowering etc.; Can treat the hypertension due to acute and chronic upper respiratory tract infection, allergic rhinitis, constipation and enteritis, carbuncle sore tumefacting virus, oral ulcer, gingival swelling and pain, burn due to hot liquid or fire, acute icterohepatitisshock, bleeding hemorrhoids, the hyperlipemia.

The acute respiratory infection disease is the commonly encountered diseases that is caused by virus or bacterial infection, frequently-occurring disease, and wherein viral infection does not have special effect medicine therapeutic at present.Though bacterial infection has alternative effective antibiotic, the drug resistance phenomenon is on the rise, and influences clinical efficacy greatly.The pure Chinese medicinal preparation that product of the present invention is made up of Radix Et Rhizoma Rhei, Radix Scutellariae etc.Have effects such as heat clearing and damp drying, eliminating fire and detoxication, removing stasis to stop bleeding.Not only have antiviral and broad-spectrum antiseptic dual function, and the effect of significant refrigeration function and raising, adjusting immunologic function is arranged.The hyperpyrexia that causes for virus or bacterial infection has good antipyretic effect, and side effect is little.Low price is worth clinical expansion.

The production and sales at home of YIQING KELI and capsule, and be widely used in clinical.Chinese Pharmacopoeia has recorded the YIQING KELI agent, and a clear soft capsule in addition of listing is all oral solid formulation, and its function cures mainly and obtained certainly.According to the demand of clinical application, we have developed a clear oral liquid, change its dosage form and have obtained a clear solution, have taking convenience, homogeneity is good, mouthfeel is good, absorption is fast, the bioavailability advantages of higher, enriches clinical application.But, the present report that does not also have a clear solution.

Technology contents:

In order to improve the curative effect of medicine, the convenient use the invention provides: a kind of more convenient, curative effect more obvious one tasty and refreshing clothes solution novel form and preparation method thereof of taking.

Concrete scheme is:

1. a kazukiyo oral liquid agent: refer to a clear oral liquid, a clear mixture, a clear syrup.It is characterized in that: by Rhizoma Coptidis, Radix Et Rhizoma Rhei, three kinds of medical materials of Radix Scutellariae by weight component be prepared from.Its components by weight percent is: 33～138 parts of Rhizoma Coptidis, 100～400 parts of Radix Et Rhizoma Rhei, 50～200 parts of Radix Scutellariaes, make 500～5000 parts of oral administration solution dosage forms.Best composition is: 66 parts of Rhizoma Coptidis, 200 parts of Radix Et Rhizoma Rhei, 100 parts of Radix Scutellariaes, make 1000 parts of oral administration solution dosage forms.

2. preparation method is:

A. with three kinds of Chinese medicines respectively or add the water of 4～15 times of medical material weight after mixing, decoct and extract 1～3 time, collecting decoction filters, and is evaporated to relative density and is about 1.05～1.20 (70 ℃).

B. above-mentioned three kinds of concentrated solutions are merged, regulating pH value with sodium hydroxide solution is 8.5～10.5, adds cosolvent, flavoring agent, antiseptic and an amount of water, and cold preservation is (the best is 12 hours) more than 6 hours, and filtration, embedding, sterilization get product.

C. in a, b item, relate to:

Water: the water that refers to the Chinese Pharmacopoeia regulation.

Cosolvent: refer to pharmaceutically receptible cosolvent, comprising: glycerol, propylene glycol, ethanol, sorbitol, molecular weight are 300～800 Polyethylene Glycol, mannitol, lactic acid and citric acid and salt thereof.

Flavoring agent: refer to pharmaceutically receptible flavoring agent, comprising: steviol glycosides, sucrose, steviosin, saccharin sodium, Mel, Abbas are smooth.

Antiseptic: refer to pharmaceutically receptible antiseptic, comprising: benzoic acid and salt thereof, sorbic acid and salt thereof, phenol and salt thereof.

The present invention has selected the preparation technology of product by the research to product preparation process and process conditions, has carried out the pilot scale pilot production by the determined technology of result of study, and every technological parameter, testing result show that all this process stabilizing is feasible.Also, carried out the quality research and the stability test of product of the present invention according to the requirement of one one of Chinese Pharmacopoeia version in 2005:

1 character

This product is brown or brown liquid, and it is little sweet, bitter to distinguish the flavor of.

2 differentiate

The TLC method is adopted in the discriminating of Radix Et Rhizoma Rhei, with Radix Et Rhizoma Rhei control medicinal material and the contrast of emodin reference substance, in the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color; Put in the ammonia steam smoked after, inspect under the daylight, speckle becomes redness.

The TLC method is adopted in the discriminating of Radix Scutellariae, with Radix Scutellariae control medicinal material and the contrast of baicalin reference substance, in the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show the speckle of same color.

The TLC method is adopted in the discriminating of Rhizoma Coptidis, with Rhizoma Coptidis control medicinal material and the contrast of berberine hydrochloride reference substance, in the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show identical yellow fluorescence speckle.

3 check

Relative density, pH value, clarity, loading amount, microbial limit all meet the regulation of one one of Chinese Pharmacopoeia version in 2005.

Heavy metal: the heavy metal check result is less than 10pmm.

Arsenic salt: arsenic salt check result is less than 2pmm.

4 assays

Adopt content of baicalin in the high effective liquid chromatography for measuring Radix Scutellariae, according to extracting choice of Solvent, methodological study results such as the investigation of extraction time test, the stability of having carried out sample introduction precision, sample solution, linearity, the response rate, replica test, formulated the content assaying method of this product, this product content limit is every and contains Radix Scutellariae with baicalin (C ₂₁H ₁₈O ₁₁) meter, must not be less than 21mg.

Stability test

1 accelerated test

Sample was placed three months under the condition of 40 ℃ ± 2 ℃ of temperature, relative humidity 75% ± 5%, respectively at checking the 0th, 1,2,3 the end of month, with comparison in 0 month.The result shows that significant change does not all take place every investigation indexs such as its character, discriminating, inspection, assay, limit test of microbe.

2 long term tests

Sample is placed test in 24 months under 25 ℃ ± 2 ℃ of temperature, relative humidity 60% ± 10% condition, respectively at checking the 0th, 3,6,9,12,18,24 the end of month, with comparison in 0 month.The result shows, long term test 24 months, and every quality system mark is all up to specification.

Stability test explanation controllable product quality of the present invention has good stability.

Further specify the present invention below by embodiment.It should be understood that embodiments of the invention are to be used to illustrate the present invention rather than limitation of the present invention.Essence according to the present invention all belongs to the scope of protection of present invention to the simple modifications that the present invention carries out.Unless otherwise indicated, percent of the present invention is percetage by weight.

Embodiment:

Embodiment one

Get Rhizoma Coptidis 165 gram, Radix Et Rhizoma Rhei 500 grams, Radix Scutellariae 250 grams, more than three flavors, add 8 times of water gagings respectively and decoct twice, 1.5 hours for the first time, 1 hour for the second time, merge first and second time decocting liquid, filter, filtrate decompression is concentrated into relative density and is about 1.10 (70 ℃).Above-mentioned three kinds of concentrated solutions are merged, regulate pH value to 8.5-9.5, filter, add glycerol 150ml, steviol glycosides 5g, sodium benzoate 6g, add purified water and make 2500ml with the 8%-10% sodium hydroxide solution.Cold preservation is more than 12 hours, fine straining, and embedding, sterilization,, promptly.

Embodiment two

Get Rhizoma Coptidis 165 gram, Radix Et Rhizoma Rhei 500 grams, Radix Scutellariae 250 grams, more than three flavors, add 8 times of water gagings respectively and decoct twice, 1.5 hours for the first time, 1 hour for the second time, merge first and second time decocting liquid, filter, filtrate decompression is concentrated into relative density and is about 1.10 (70 ℃).Above-mentioned three kinds of concentrated solutions are merged, regulate pH value to 8.5-9.5, filter, add glycerol 150ml, sucrose 1000g, sodium benzoate 6g, add purified water and make 2500ml with the 8%-10% sodium hydroxide solution.Cold preservation is more than 12 hours, fine straining, and embedding, sterilization,, promptly.

Embodiment three

Get Rhizoma Coptidis 165 gram, Radix Et Rhizoma Rhei 500 grams, Radix Scutellariae 250 grams, more than three flavors, add 8 times of water gagings respectively and decoct twice, 1.5 hours for the first time, 1 hour for the second time, merge first and second time decocting liquid, filter, filtrate decompression is concentrated into relative density and is about 1.10 (70 ℃).Above-mentioned three kinds of concentrated solutions are merged, regulate pH value to 8.5-9.5, filter, add glycerol 250ml, steviol glycosides 8g, sodium benzoate 10g, add purified water and make 5000ml with the 8%-10% sodium hydroxide solution.Cold preservation is more than 12 hours, fine straining, and embedding, sterilization,, promptly.

Embodiment four

Get Rhizoma Coptidis 165 gram, Radix Et Rhizoma Rhei 500 grams, Radix Scutellariae 250 grams, more than three flavors, add 8 times of water gagings respectively and decoct twice, 1.5 hours for the first time, 1 hour for the second time, merge first and second time decocting liquid, filter, filtrate decompression is concentrated into relative density and is about 1.10 (70 ℃).Above-mentioned three kinds of concentrated solutions are merged, regulate pH value to 8.5-9.5, filter, add glycerol 250ml, sucrose 2000g, sodium benzoate 10g, add purified water and make 5000ml with the 8%-10% sodium hydroxide solution.Cold preservation is more than 12 hours, fine straining, and embedding, sterilization,, promptly.

Claims (2)

1. a kazukiyo oral liquid agent: refer to a clear oral liquid, a clear mixture, a clear syrup.It is characterized in that: by Rhizoma Coptidis, Radix Et Rhizoma Rhei, three kinds of medical materials of Radix Scutellariae by weight component be prepared from.Its components by weight percent is: 33～138 parts of Rhizoma Coptidis, 100～400 parts of Radix Et Rhizoma Rhei, 50～200 parts of Radix Scutellariaes, make 500～5000 parts of oral administration solution dosage forms.Best composition is: 66 parts of Rhizoma Coptidis, 200 parts of Radix Et Rhizoma Rhei, 100 parts of Radix Scutellariaes, make 1000 parts of oral administration solution dosage forms.

2. require the preparation method of the kazukiyo oral liquid agent under in the of 1 according to patent, it is characterized in that:

A. with three kinds of Chinese medicines respectively or add the water of 4～15 times of medical material weight after mixing, decoct and extract 1～3 time, collecting decoction filters, and is evaporated to relative density and is about 1.05～1.20 (70 ℃).

B. above-mentioned three kinds of concentrated solutions are merged, regulating pH value with sodium hydroxide solution is 8.5～10.5, adds cosolvent, flavoring agent, antiseptic and an amount of water, and cold preservation is (the best is 12 hours) more than 6 hours, and filtration, embedding, sterilization get product.

C. under requiring 2, patent relates in a, the b item:

Water: the water that refers to the Chinese Pharmacopoeia regulation.

Cosolvent: refer to pharmaceutically receptible cosolvent, comprising: glycerol, propylene glycol, ethanol, sorbitol, molecular weight are 300～800 Polyethylene Glycol, mannitol, lactic acid and citric acid and salt thereof.

Flavoring agent: refer to pharmaceutically receptible flavoring agent, comprising: steviol glycosides, sucrose, steviosin, saccharin sodium, Mel, Abbas are smooth.

Antiseptic: refer to pharmaceutically receptible antiseptic, comprising: benzoic acid and salt thereof, sorbic acid and salt thereof, phenol and salt thereof.