CN101642491B - Method for analyzing inflammation-relieving capsule - Google Patents
Method for analyzing inflammation-relieving capsule Download PDFInfo
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- CN101642491B CN101642491B CN200910176878XA CN200910176878A CN101642491B CN 101642491 B CN101642491 B CN 101642491B CN 200910176878X A CN200910176878X A CN 200910176878XA CN 200910176878 A CN200910176878 A CN 200910176878A CN 101642491 B CN101642491 B CN 101642491B
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- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention belongs to the technical field of the traditional Chinese medicine, which in particular discloses a method for analyzing an inflammation-relieving capsule. By the execution of the invention, the quality stability and the detection repeatability of an inflammation-relieving capsule product can be ensured.
Description
[technical field]
The invention belongs to technical field of traditional Chinese medicines, be specifically related to a kind of analytical approach of moisture of inflammation-relieving capsule content.
[background technology]
The composition of inflammation-relieving capsule is that folium isatidis, rheum officinale, plaster stone, menthol, auxiliary material are starch.Function cures mainly as clearing heat-fire, defaecation.For abscess of throat, toothache, have a dizzy spell, and mouth and nose are given birth to sore, and wind fire hot eyes, suffer from constipation.Usage and dosage, oral, one time 4,2 times on the one.
It is the dry leaf of cruciferae isatis Isatis indigotica Fort. that the folium isatidis another name is blue buttocks leaf, this product.Divide in summer, two seasons of autumn and gather for 2～3 times, remove impurity, dry.The many shrinkages of folium isatidis are curling, some fragmentations.After intact leaf flattens, be oblong to oval shape and fall lanceolar, long 5～20 centimetres, wide 2～6 centimetres; The dark slightly point of projection of upper surface dull gray green, some visible color; Tip is blunt, and full edge or wavy, be extended down to petiole under base portion is narrow and be wing; Long 4～10 centimetres of petiole, light brown yellow.Matter is crisp.Gas is micro-, micro-acid of distinguishing the flavor of, hardship, puckery.
The green and brown look of Dyers Woad Leaf.Lower epidermis cell anticline is slightly crooked, slightly becomes beaded to thicken; The pore inequality, 3～4 of accessory cells.Mesophyll section palisade tissue and spongy tissue are without obvious differentiation.
Get Dyers Woad Leaf 0.5g, add 20 milliliters of chloroforms, added hot reflux 1 hour, filter, filtrate is concentrated into 1 milliliter, as need testing solution.Separately get indigo, indigo red reference substance, chlorination is copied into every 1 milliliter of mixed solution that contains 1mg, product solution in contrast.According to thin-layered chromatography (appendix VI B) test, draw above-mentioned two kinds of each 5ul of solution, put respectively on same silica gel g thin-layer plate, take benzene-chloroform-acetone (5: 4: 1) as developping agent, launch, take out, dry.In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, aobvious identical blue spot and light violet magenta spot respectively.
Folium isatidis nature and flavor hardship, cold.The thoughts of returning home, stomach warp, cure mainly and comprise: staphylococcus aureus, alpha streptococcus, diplococcus meningitidis, streptococcus pneumonia, micrococcus catarrhalis, typhoid bacillus, Escherichia coli, Bacillus influenzae, corynebacterium diphtheriae and shigella dysenteriae are all had to certain inhibiting effect, japanese encephalitis virus, mumps virus, influenza virus etc. are also had to inhibiting effect; Kill leptospiral effect; Through In vitroandin vivotrial, find that there is the effect of the enterobacteria 0111B4 of Chinese People's Anti-Japanese Military and Political College endotoxin; Heating has obvious refrigeration function to infectiousness, and cooling is fast, and toxicity is little; Caused inflammatory reaction has obvious inhibiting effect to multiple proinflammatory agent; Antivirus action: relevant different virus strain has inhibition or delays cytopathic effect to the infection of the upper respiratory tract.
Rheum officinale pronunciation as medicinal material the time is large (da ì) yellow (hu á ng), is the dry root and rhizome of polygonum rheum palmatum Rheum palmatum L., the ancient especially big yellow Rheum tanguticum Maxim.ex Balf. of Tang or Rheum officinale Rheum officinale Baill..Rheum officinale nature and flavor hardship, cold.Return spleen, stomach, large intestine, liver, pericardium channel.
Rheum officinale begins to be stated from Shennong's Herbal, classifies low-grades as.Rheum officinale is the dry root and rhizome of the ancient especially big yellow Rheum tanguticum Maxim.ex Balf. of polygonum rheum palmatum Rheum palmatumL., Tang or Rheum officinale Rheum officinale Baill..Before the withered or inferior spring germination of autumn Mo cauline leaf, excavate, remove radicula, scrape off crust, valve cutting or section, rope is worn bunchiness drying or convection drying.Rheum officinale is that class is cylindrical, conical, oval or irregular bulk, and long 3～17 centimetres, 3～10 centimetres of diameters.The surperficial yellowish-brown of the person that eliminates the crust is to rufous, and the visible off-white color reticular texture that has and asterism (special-shaped vascular bundle) are dispersed in, residual crust sepia, many tools rope hole and thick wrinkle.The solid ，You De of matter center is slightly soft, the light red brown or yellowish-brown of section, aobvious graininess; Rhizome marrow broadness, have the asterism circular row or be dispersed in; The prosperity of root woody part, the radial texture of tool, the stratification ring is obvious, without asterism.Gas delicate fragrance, bitter is and micro-puckery, and that chews sticks to one's teeth, and sand feeling is arranged.
The rheum officinale function cures mainly and comprises: the logical intestines that purge heat, removing pattogenic heat from the blood and toxic material from the body, stimulate the menstrual flow by the stasis of blood.For real hot constipation, stagnant stomachache, rush down dysentery not well, jaundice with damp-heat pathogen, and blood-head is told nosebleed, hot eyes, pharynx is swollen, abdominalgia with intestinal abscess, the carbuncle furunculosis that swells, hemostasis is through closing, and traumatic injury, control scald outward; Upper gastrointestinal bleeding.Prepared RADIX ET RHIZOMA RHEI with wine is apt to clear part of the body cavity above the diaphragm housing the heart and lungs noxious heat in the blood system.Swollen for the hot eyes pharynx, gingivitis.Prepared RADIX ET RHIZOMA RHEI rushes down exerts oneself to delay, purging intense heat and detonicating.For pathogenic fire,toxin and furuncles.The hemostasis of charred RADIX ET RHIZOMA RHEI cooling blood and removing stasis.For blood-head, stasis of blood bleeder is arranged.
Rheum officinale is applied to dry feces, stagnant rushes down dysentery, and constipation with heat retention, high fever tongue Huang etc.With compatibilities such as saltcake, the bark of official magnolia, the dried immature fruit of citron oranges; For burning hot high Sheng, urgent blood overflow, and the sudden and violent pain of hot eyes, hot carbuncle furuncle etc.Join the coptis, the root of large-flowered skullcap, the root bark of tree peony, the radix paeoniae rubrathe and be equal to use; For the stagnant stomachache of the stasis of blood in postpartum, hemostasis stagnates, menstruation is obstructed, and traumatic injury, the stasis of blood are stagnant has a pain etc.Must coordinate the medicine of blood circulation promoting competent silt in use, as peach kernel, the radix paeoniae rubrathe, safflower, be equal to use.In addition, but Qinghua is damp and hot and for jaundice again for rheum officinale, clinical manyly apply with medicine compatibilities such as oriental wormwood, cape jasmines; As rheum officinale is ground into powder, also can be used as the medicine for external application of scald and pathopyretic ulcer, have clearing heat and detoxicating effect.
Rheum officinale can alleviate the endotoxin induction low blood pressure, eliminate oxygen radical, reduce the level of the endogenous nitric oxide such as flush phase blood plasma, lung, small intestine again, reduce intestines, liver, vascular permeability and pulmonary, alleviate the intestines parietal vessel permeability increase that endotoxin causes, prevent that bacterial translocation from intestine and endotoxin from entering blood circulation etc.Clinical critical illness prevention and the treatment gastrointestinal functional failure such as severe trauma, infectious shock, MODS of can be used for.Our experience: rhubarb 30 grams are decocted into 100 milliliters, bowel lavage or oral, 100 milliliters, 1-3 times/day, but also bowel lavage and oral and use.Until gurgling sound recovers to start decrement.
The rheum officinale bitter cold, the gas that easily injures one's stomach, weakness of the spleen and the stomach person is cautious use of; Women's pregnancy, menstrual period, lactation should be avoided use.Deficiency-cold in spleen and stomach, deficiency of blood gas are weak, before women's tire, postpartum, menstrual period and lactation equal careful clothes.The subsidiary reactions such as rhubarb is for oral administration may feel sick, vomiting, stomachache, can alleviate after general drug withdrawal.
The rheum officinale square section: root phellem layer and cortex are removed mostly.Bast is obvious; The parenchymal tissue prosperity.Form layer Cheng Huan.Wood ray is closeer, and wide 2～4 row cells, include brown thing; The non-lignify of conduit, normal 1 to several gatherings, sparse arrangement.Parenchyma cell contains calcium oxalate cluster crystal, and contains the majority starch grain.Rhizome marrow broadness, wherein common mucilage cavity, inside have the rufous thing; Special-shaped vascular bundle is dispersed in, and forms layer Cheng Huan, and xylem is positioned at and forms layer foreign side, and bast is positioned at and forms layer side, the star-shaped ejaculation of ray.The powder yellowish-brown.Calcium oxalate cluster crystal diameter 20～160 μ m, have to 190 μ m.The non-lignify of bordered pit, reticulate pattern, screw thread and annular duct.Amylum body is a lot of, the spherical or polygon of simple grain class, and diameter 3～45 μ m, omphalion is starlike; Composite grain is comprised of 2～8 gradation.Get Rhubarb a small amount of, carry out microsublimation, visible water chestnut shape needle or pinniform crystallization.
Rheum officinale is conventional Chinese medicine, has purge heat logical intestines, removing pattogenic heat from the blood and toxic material from the body, pursues the effect that the stasis of blood is stimulated the menstrual flow.For real hot constipation, stagnant stomachache, rush down dysentery not well, jaundice with damp-heat pathogen, and blood-head is told nosebleed, hot eyes, pharynx is swollen, abdominalgia with intestinal abscess, the carbuncle furunculosis that swells, hemostasis is through closing, and injury from falling down, control scald outward; Upper gastrointestinal bleeding.Prepared RADIX ET RHIZOMA RHEI with wine is apt to clear part of the body cavity above the diaphragm housing the heart and lungs noxious heat in the blood system.Swollen for the hot eyes pharynx, gingivitis data source: medical education net.Prepared RADIX ET RHIZOMA RHEI rushes down exerts oneself to delay, and rushes down scorching detoxifcation.For pathogenic fire,toxin and furuncles.The hemostasis of charred RADIX ET RHIZOMA RHEI cooling blood and removing stasis.For blood-head, stasis of blood haemorrhage is arranged.Modern medicine proves, rheum officinale has catharsis, cholagogic, protects the liver, antiulcer, the effect such as antibiotic, antiviral.For the rheum officinale domestic literature, there is not yet obvious toxicity report at present, but the Abroad in Recent Years academic journals renal toxicity and the carcinogenicity of archen and anthraquinone analog compound thereof have more been reported.
Gypsum (plaster stone) is for expelling pathogenic factors from muscles for clearing heat, and relieving restlessness is quenched the thirst, cure mainly to control the pyreticosis high fever and do not move back, and vexed coma, delirious speech is gone mad, thirsty and dry pharynx, lung heat is breathed heavily urgency, the heatstroke spontaneous perspiration, stomach fire headache, toothache, the heat poison is stopped up and is contained, and sends out the spot dermexanthesis, aphthae.Forge deposited regenerating tissue to heal wond.Control ulcer sores outward, burst and do not close up, the burning hot wound of soup.The gypsum acrid-sweet flavor, cold.Deficiency-cold in spleen and stomach and the deficiency of blood, fever due to yin deficiency person avoid clothes." medicine origin ": " " curing mainly secret formula " cloud, the stomach of trembling with fear, make us not eating, and non-abdomen has very hot person, can not gently use." the plaster stone principal ingredient is hydrous calcium sulfate (CaSO42H2O).The plaster of paris refers to that plaster stone heats the material of sloughing water of crystallization, and application is less in traditional Chinese medicine.
Menthol is a kind of saturated cyclic alcohol that obtains in peppermint.Have another name called menthol, Mentholum, this product is colourless needle-like or prism-shaped crystallization or white crystalline powder; The special aroma that peppermint is arranged, flavor is just scorching hot rear refrigerant; Ethanolic solution shows neutral reaction.This product is very easily dissolved in ethanol, chloroform, ether, liquid paraffin or volatile oil, soluble,very slightly in water.Fusing point should be 42～44 ℃.
Menthol and glucuronic acid form bond and discharge in urine and bile, and various isomeride are combined with glucuronic acid with the difference amount.In dog and rat body, produce the molecular degradation reaction.It can the menthones metabolin form exist.
The menthol function cures mainly as aromatic drug, remedium corrigens and carminative.Can be used for skin or mucous membrane and produce refrigerant sense and be not suitable for to alleviate, main pain.During storage, seal, put shady and cool place and preserve.
The peppermint brain-capacity optionally stimulates the frigidoreceptor of human body skin or mucous membrane, produces sense of cold reflection and creeping chill, causes skin and mucosa vessel retraction (in fact skin keeps normal), to the blood vessel of deep tissue, also can cause and shrinks and produce therapeutic action.External application can anti-inflammatory, and pain relieving is antipruritic, stimulates circulation, and alleviates edema etc.; For oral administration in compound preparation, can alleviate local inflammation (sphagitis) and treatment flu, and stomach invigorating is arranged, the wind dispelling effect.(adaptation symptom) external application is for local analgesia, and is antipruritic, and headache is dizzy, bite by mosquitos; Collunarium, for catching cold nasal obstruction, sucks or sprays for sphagitis; Oral can stomach invigorating.
Along with the growth of wage-earners, computer and bend over one's desk working increasing; Also have the electromagnetism of periphery and increasing of chemical contamination, function of human body " getting angry " becomes and day by day takes place frequently.Based on this, the inflammation-relieving capsule of developing on the traditional Chinese medicine basis becomes the standing medicine of a kind of family.For the quality of the product that more effectively guarantees inflammation-relieving capsule, the inventor has also dropped into great effort for the analysis of this medicine.
Determination of moisture in Traditional Chinese medicine historical preparation is very crucial and basic analysis project, and pharmacopeia is for pill, granule, and the formulations such as capsule are all stipulated moisture.Its assay method is also method definite and commonly used.
What the determination of moisture of inflammation-relieving capsule was adopted at present is toluene method and oven drying method, and these 2 kinds of methods have simple, easy and simple to handle characteristics.
[summary of the invention]
The object of the present invention is to provide a kind of analytical approach of moisture of inflammation-relieving capsule content, the method can embody the application principles of formulating prescriptions of inflammation-relieving capsule really, really reacts exactly the water cut of final drug.
Analytical approach of the present invention particularly, adopt the moisture of gas chromatography determination inflammation-relieving capsule content.
Above-mentioned analytical approach, the chromatography room temperature of described vapor-phase chromatography is 130-140 ℃, vaporizer temperature: 160-180 ℃, flow rate of carrier gas are the 30-40 ml/min.
Above-mentioned analytical approach, is characterized in that described carrier gas is nitrogen.
Above-mentioned analytical approach, is characterized in that described carrier gas is argon gas.
Inflammation-relieving capsule of the present invention is produced in strict accordance with the standard technology tissue.Starting material are all through just feeding intake after the assay was approved.
In order to verify moisture in inflammation-relieving capsule, the moisture of inflammation-relieving capsule that the inventor has adopted gas chromatography determination, the another people of result is taken aback is that the measurement result of vapor-phase chromatography and toluene method and oven drying method are far from each other.The inventor has carried out repeatedly revision test to its mensuration and has still drawn this test findings thus, and concrete numerical value is as follows:
Thus, the inventor has produced query to toluene method and the oven drying method that is common at present the inflammation-relieving capsule moisture determination.Through the gypsum in the prescription of inflammation-relieving capsule is contained to water of crystallization, adopt toluene method and oven drying method all the water of crystallization in gypsum can be detected, based on gypsum in we, it is plaster stone, as remove water of crystallization and become the plaster of paris, with the prescription principle of this preparation, run counter to, so the inventor recognizes, adopts Water By Gas Chromatography to divide and is only the detection method that more meets inflammation-relieving capsule medication mechanism.
[embodiment]
Following embodiment further describes the present invention, but described embodiment is only be used to illustrating the present invention rather than restriction the present invention.Following examples are all got the inflammation-relieving capsule agent of 6 lot numbers, and lot number is respectively 090304,090305,090306,090307,090308,090309.
The determination of moisture contrast of embodiment-inflammation-relieving capsule
[inspection] this product is capsule, should meet the relevant regulations under appendix I L capsule item of Chinese Pharmacopoeia version in 2000.According to pharmacopeia regulation, to the moisture of this product 6 batch samples, content uniformity, disintegration time limited, microbial limit check, moisture is no more than 9.0%, and content uniformity, disintegration time limited, microbial limit are all at acceptability limit.Test and result are as follows.
The chromatography room temperature of the vapor-phase chromatography of vapor-phase chromatography is 130-140 ℃, and vaporizer temperature: 160-180 ℃, flow rate of carrier gas are the 30-40 ml/min.Carrier gas is nitrogen or argon gas.
Moisture is got this product content, according to aquametry (appendix IX H of Chinese Pharmacopoeia version in 2000), measures, and knot is in Table 1.
The moisture determination data of table 1 inflammation-relieving capsule
As can be known by result, this product meets appendix I L capsule item ShiShimonoseki regulation of Chinese Pharmacopoeia version in 2000, and moisture is less than 9.0%.And the result that adopts Water By Gas Chromatography to divide meets the principle of the former side's medication of inflammation-relieving capsule more.
Claims (1)
1. the analytical approach of the moisture of an inflammation-relieving capsule content, it is characterized in that adopting the following methods analysis: the moisture that adopts gas chromatography determination inflammation-relieving capsule content, the chromatography room temperature of described vapor-phase chromatography is 130-140 ℃, vaporizer temperature: 160-180 ℃, flow rate of carrier gas is the 30-40 ml/min, and carrier gas is nitrogen or argon gas.
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| 刘传银.气相色谱法测定中药材中的水分含量.《郧阳师范高等专科学校学报》.2004,第24卷(第3期),46. |
| 气相色谱法测定中药材中的水分含量;刘传银;《郧阳师范高等专科学校学报》;20040630;第24卷(第3期);46 * |
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