CN101112415A - Compound milettia reticulata tablets and method for preparing the same - Google Patents
Compound milettia reticulata tablets and method for preparing the same Download PDFInfo
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- CN101112415A CN101112415A CNA2007100434532A CN200710043453A CN101112415A CN 101112415 A CN101112415 A CN 101112415A CN A2007100434532 A CNA2007100434532 A CN A2007100434532A CN 200710043453 A CN200710043453 A CN 200710043453A CN 101112415 A CN101112415 A CN 101112415A
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Abstract
The present invention pertains to the pharmaceutical field of traditional Chinese medicine, which relates to a compound suberect spatholobus stem tablet and the preparation method. The present invention aims at reducing the dosage, facilitating the administration and improving the quality of controllability, reforms the traditional process of the compound suberect spatholobus stem pastes, establishes the HPLC content determination method of the main ingredients of the traditional Chinese medicine and the TLC identification method of the main ingredients in the compound traditional Chinese medicine, and prepares the compound suberect spatholobus stem tablet of the invention. The present invention is used for the treatment of blood deficiency, numbness of hands and feet, joint pains and irregular menstruation. Compared with the traditional compound suberect spatholobus stem pastes, the present invention has easy drug administration and small administration dosage; the main ingredients can be identified qualitatively and has strong speciality; the contents of the main active ingredients can be determined, thus improving the quality controllability.
Description
Technical field
The invention belongs to field of traditional Chinese medicine pharmacy, relate to a kind of compound milettia reticulata tablets and preparation method thereof.
Background technology
Compound suberect spatholobus stem pastes is a Chinese medicine, record in " Chinese pharmacopoeia (version was an one in 2005), processed by medicines such as Yunnan Caulis Spatholobi cream powder, Radix Cyathulae, Radix Dipsaci, Flos Carthami and Semen sojae atricolors, function is enriched blood, is invigorated blood circulation, regulating menstruation, is used for blood deficiency, numb hand and foot, joint aches and menoxenia.Said preparation determined curative effect, applicating history are long, but the finished product quality is hard, reuse wine, water half and half stewedization are taken after mixing it with water after needing when taking earlier monoblock cream to be broken into pieces, the user is very inconvenient, (6～10g) also are difficult to accurate grasp to each taking dose, and the consumption of adjuvant Oryza glutinosa, maltose surpasses 70% of total amount, strengthened dosage.Do not see quality controling research report at present in the document as yet to compound suberect spatholobus stem pastes, " Chinese pharmacopoeia compound suberect spatholobus stem pastes item lacks content assaying method down to version in 2005, and qualitative identification only stipulated the chromogenic reaction of preparation character and Coumarins, phenolic compound, and specificity is poor.
Summary of the invention
The objective of the invention is to overcome the defective of prior art, a kind of taking convenience is provided, dosage is little, and the compound milettia reticulata tablets of definite curative effect is arranged.
The present invention with reduce consumption, the controllability of conveniently taking, improve the quality is purpose, the compound suberect spatholobus stem pastes traditional handicraft is reformed, wherein set up thin layer chromatography (TLC) discrimination method of three flavor principal agents in high performance liquid chromatography (RP-HPLC) content assaying method of monarch drug main component and the compound recipe, made compound milettia reticulata tablets of the present invention.
Quality control of the present invention adopts the RP-HPLC method that index components is carried out quantitatively; Adopt the TLC method that principal agent Yunnan Caulis Spatholobi, Radix Cyathulae and Radix Dipsaci in this tablet are carried out qualitative identification.
'Compound spatholobus stem preparation of the present invention is to be that raw material adds the tablet that adjuvant is made with Chinese medicine Yunnan Caulis Spatholobi cream powder, Radix Cyathulae, Radix Dipsaci, Flos Carthami and Semen sojae atricolor, wherein the weight portion proportioning of each crude drug is: 218.75 parts in Yunnan Caulis Spatholobi cream powder (water of Yunnan Caulis Spatholobi is promoted extract powder), 59.5 parts of Radix Cyathulaes, 53 parts of Radix Dipsacis, 5 parts on Flos Carthami, 12.5 parts in Semen sojae atricolor.
Compound milettia reticulata tablets of the present invention can be treated blood deficiency, numb hand and foot, joint aches and menoxenia.
Further purpose of the present invention provides the preparation method of above-mentioned compound milettia reticulata tablets.
Compound milettia reticulata tablets of the present invention prepares by following method and step:
(1) get Yunnan Caulis Spatholobi, add 4-6 times of water gaging decoction 3 times, each 2-4 hour, collecting decoction filtered, and filtrate is condensed into thick paste, and is dry below 80 ℃, pulverizes, and sieves, and gets Yunnan Caulis Spatholobi cream powder;
(2) Radix Cyathulae, Radix Dipsaci, Flos Carthami, Semen sojae atricolor add 4-6 times of water gaging decoction 2-3 time, and each 1-2 hour, collecting decoction, filtration, filtrate concentrates, and adds Yunnan Caulis Spatholobi cream powder, fully mixes thoroughly, and drying below 80 ℃ is pulverized, and sieves, and gets the intermediate dry extract;
(3) get 8 parts of above-mentioned dry extracts, add adjuvant 1-2 part, mixing is granulated, drying, and granulate adds disintegrating agent, tabletting;
(4) by the special-shaped Fructus Schisandrae Sphenantherae fourth element in the RP-HPLC mensuration Yunnan Caulis Spatholobi cream powder and the content of kadsurin;
(5) by TLC qualitative identification Yunnan Caulis Spatholobi, Radix Cyathulae and Radix Dipsaci.
The described adjuvant of above-mentioned tablet is the adjuvant commonly used that pharmaceutical field prepares tablet, comprises diluent: lactose, amylum pregelatinisatum, sodium carboxymethyl cellulose, dextrin, microcrystalline Cellulose etc.; Wetting agent: ethanol, syrup etc.; Disintegrating agent: carboxymethyl starch sodium, polyplasdone XL etc. and lubricant: magnesium stearate, Pulvis Talci etc., select for use in the above-mentioned adjuvant any one to use separately or severally be used in combination by different proportion.
Take 10g by the compound suberect spatholobus stem pastes single, be equivalent to take intermediate 2.7g at every turn, calculate according to this, compound milettia reticulata tablets provided by the present invention is each only need be taken about 3g, under the prerequisite of determined curative effect, obviously reduced dosage, for the user provides convenience.
Description of drawings
Fig. 1 is the HPLC chromatogram that mixes reference substance, compound milettia reticulata tablets and negative control sample thereof,
Wherein, A: mix reference substance; B: 'Compound spatholobus stem sheet; C: lack the Yunnan Caulis Spatholobi negative sample.
Fig. 2 is the discriminating of Yunnan Caulis Spatholobi in the compound milettia reticulata tablets,
Wherein ,+: compound milettia reticulata tablets;-: lack the Yunnan Caulis Spatholobi negative control; S1: special-shaped Fructus Schisandrae Sphenantherae fourth element; S2: kadsurin; Polarity: petroleum ether-ethyl acetate (1: 1).
Fig. 3 is the discriminating of Radix Cyathulae in the compound milettia reticulata tablets,
Wherein ,+: compound milettia reticulata tablets;-: lack the Radix Cyathulae negative control; S: Radix Cyathulae control medicinal material; Polarity: petroleum ether-chloroform-acetone (8: 1: 1).
Fig. 4 is the discriminating of Radix Dipsaci in the compound milettia reticulata tablets,
Wherein ,+: compound milettia reticulata tablets;-: lack the Radix Dipsaci negative control; S: Radix Dipsaci control medicinal material; Polarity: chloroform-methanol (5: 1).
The specific embodiment
Get Yunnan Caulis Spatholobi, decoct with water three times, 6 times of water gaging 4h for the first time, 4 times of water gaging 3h for the second time, 4 times of water gaging 2h filter for the third time, and filtrate is concentrated into 1.30g/ml, and 60 ℃ of vacuum dryings are pulverized, and cross sieve No. six, and are standby; Radix Cyathulae, Radix Dipsaci, Flos Carthami, Semen sojae atricolor decoct with water three times, each 4 times of water gaging 2h, and collecting decoction filters, and filtrate is concentrated into 0.73g/ml, adds Yunnan Caulis Spatholobi cream powder, fully mixes thoroughly, and 60 ℃ of vacuum dryings are pulverized, and cross sieve No. five.With the dried cream powder that obtains and sodium carboxymethyl cellulose, starch, microcrystalline Cellulose and polyplasdone XL in 8: 0.5: 0.5: 0.3: 0.4 ratio uniform mixing, spray 50% ethanol (consumption 30%) system soft material, pushed 22 eye mesh screens, 60 ℃ of oven dry, by 22 orders and 30 mesh sieve granulate, get the granule of 22 orders ~ 30 order sizes, add 3% disintegrating agent polyplasdone XL, mix homogeneously, tabletting.
Get Yunnan Caulis Spatholobi, decoct with water three times, 6 times of water gaging 4h for the first time, 4 times of water gaging 3h for the second time, 4 times of water gaging 2h filter for the third time, and filtrate is concentrated into 1.27g/ml, and 60 ℃ of vacuum dryings are pulverized, and cross sieve No. six, and are standby; Radix Cyathulae, Radix Dipsaci, Flos Carthami, Semen sojae atricolor decoct with water three times, each 4 times of water gaging 2h, and collecting decoction filters, and filtrate is concentrated into 0.70g/ml, adds Yunnan Caulis Spatholobi cream powder, fully mixes thoroughly, and 60 ℃ of vacuum dryings are pulverized, and cross sieve No. five.With the dried cream powder that obtains and sodium carboxymethyl cellulose, starch, microcrystalline Cellulose in 8: 0.5: 0.5: 1 ratio uniform mixing, spray 50% ethanol (consumption 30%) system soft material, pushing 22 eye mesh screens granulates, 60 ℃ of oven dry, by 22 orders and 30 mesh sieve granulate, get the granule of 22 ~ 30 order sizes, tabletting.
Get Yunnan Caulis Spatholobi, decoct with water three times, 6 times of water gaging 4h for the first time, 4 times of water gaging 3h for the second time, 4 times of water gaging 2h filter for the third time, and filtrate is concentrated into 1.28g/ml, and 60 ℃ of vacuum dryings are pulverized, and cross sieve No. six, and are standby; Radix Cyathulae, Radix Dipsaci, Flos Carthami, Semen sojae atricolor decoct with water three times, each 4 times of water gagings 2 hours, and collecting decoction filters, and filtrate is concentrated into 0.73g/ml, adds Yunnan Caulis Spatholobi cream powder, fully mixes thoroughly, and 60 ℃ of vacuum dryings are pulverized, and cross sieve No. five.With the dried cream powder that obtains and lactose, starch and microcrystalline Cellulose in 8: 0.5: 0.5: 1 ratio uniform mixing, spray 50% ethanol (consumption 30%) system soft material, pushed 22 eye mesh screens and granulated, 60 ℃ of dryings, by 22 orders and 30 mesh sieve granulate, get the granule of 22 ~ 30 order sizes, tabletting.
By the Pharmacopoeia of the People's Republic of China (version was an one in 2005) regulation the made tablet of the foregoing description is carried out tablet formulation and learn inspection, total amount difference, disintegration and moisture inspection all meet the requirements.
The present invention finds that Lignanoids compounds is the main active of compound milettia reticulata tablets monarch drug Yunnan Caulis Spatholobi cream powder provided by the present invention, wherein again with special-shaped Fructus Schisandrae Sphenantherae fourth element (HD) with kadsurin (KA) content is higher, activity is stronger.The present invention is by three batches of compound milettia reticulata tablets of previous embodiment 1 method preparation, and adopts the RP-HPLC method to measure the wherein content of HD and KA respectively.Chromatographic condition and measurement result are as follows:
Chromatographic condition
Chromatographic column: Phenomenex Luna C18 (250 * 4.6mm, 5 μ m); Pre-column: Security GuardCartridges C18 (3.0 * 4.0mm); Column temperature: 35 ℃; Mobile phase: methanol-acetonitrile-water continuous gradient eluting, 10: 40: 50 (0min) → 10: 47: 43 (23min) → 10: 50: 40 (35min) → 10: 80: 10 (59min), 65min altogether; Flow velocity 1ml/min; Detect wavelength 230nm.
The tablet negative control sample chromatogram figure that mixes reference substance, compound milettia reticulata tablets and scarce Yunnan Caulis Spatholobi shows (Fig. 1), and wherein the HD retention time is about 37.5min, and the KA retention time is about 43.5min.
Table 1 be HD in three batches of compound milettia reticulata tablets, KA assay result (μ g/g) (n=3).
Table 1
| |
1 | 2 | 3 |
| HD KA | 19.2063±0.6149 20.0957±0.5867 | 21.6969±0.0362 23.3239±0.0687 | 23.5261±0.0879 24.8031±0.2497 |
The present invention has carried out the TLC evaluation, method and result such as following to Yunnan Caulis Spatholobi, Radix Cyathulae, three key components of Radix Dipsaci in the compound milettia reticulata tablets prepared in the previous embodiment 1:
1, the TLC of Yunnan Caulis Spatholobi differentiates
Get 1 of compound milettia reticulata tablets (being ground into fine powder), add cyclohexane extraction 20ml, supersound extraction 30min filters, and filtrate is concentrated into 0.2ml, as need testing solution.The tablet negative control solution that lacks Yunnan Caulis Spatholobi with the method preparation.Other gets the plain and kadsurin reference substance of special-shaped Fructus Schisandrae Sphenantherae fourth, adds cyclohexane extraction respectively and makes the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2005) test, draw each 5 μ l of reference substance solution, negative control solution and need testing solution, put in same silica gel G F respectively
254On the lamellae, be developing solvent, launch, take out, dry, put under the ultra-violet lamp (254nm) and observe with petroleum ether (60～90 ℃)-chloroform-acetone (8: 1: 1).In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical skin dark stain; In the negative control chromatograph, there is not obvious speckle (Figure 12).Be that developing solvent is verified with cyclohexane extraction-ethyl acetate (8: 2) or toluene-ethyl acetate (6: 1) in addition, obtain similar result.
2, the TLC of Radix Cyathulae differentiates
Get 1 of compound milettia reticulata tablets (being ground into fine powder), add methanol 20ml, supersound extraction 30min filters, and filtrate decompression reclaims solvent, and residue adds chloroform 0.5ml dissolving, as need testing solution.Make the tablet negative control solution that lacks Radix Cyathulae with method.Other gets Radix Cyathulae control medicinal material 0.1g, shines medical material solution in pairs with legal system.According to thin layer chromatography (" an appendix VI of Chinese pharmacopoeia version in 2005 B) test, draw each 5 μ l of control medicinal material solution, negative control solution and need testing solution, put in same silica gel G F respectively
254On the lamellae, be developing solvent, launch, take out, dry, put ultra-violet lamp (365nm) under and observe with petroleum ether (60～90 ℃)-ethyl acetate (1: 1), in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, apparent identical sapphirine speckle; In the negative control chromatograph, with the corresponding position of control medicinal material chromatograph on immaculate (Fig. 3).Be that developing solvent is verified with cyclohexane extraction-ethyl acetate (8: 2) or petroleum ether-chloroform-methanol (10: 9: 1) in addition, obtain similar result.
3, the TLC of Radix Dipsaci differentiates
Get 1 of compound milettia reticulata tablets (being ground into fine powder), add water 10ml suspendible, use n-butanol extraction three times, each 10ml merges n-butanol layer, and filtrate decompression reclaims solvent, and residue adds chloroform 0.5ml dissolving, as need testing solution.Make the tablet negative control solution that lacks Radix Dipsaci with method.Other gets Radix Dipsaci control medicinal material 0.1g, adds n-butyl alcohol 10ml supersound extraction 30min, filters, and filtrate decompression reclaims solvent, and residue adds chloroform 0.5ml dissolving, medical material solution in contrast.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2005) test, draw each 5 μ l of control medicinal material solution, negative control solution and need testing solution, put in same silica gel G F respectively
254On the lamellae, upper strata with n-butyl alcohol-methanol-water (6: 1: 5) is developing solvent, launch, take out, dry, spray vanillin-concentrated sulphuric acid colour developing liquid, 105 ℃ of bakings are clear to developing the color, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical bluish violet speckle, spot colors graduates into black; In the negative control chromatograph, with the corresponding position of control medicinal material chromatograph on immaculate (Fig. 4).Be that developing solvent is verified with chloroform-methanol (5: 1) in addition, obtain similar result.
Claims (6)
1. compound milettia reticulata tablets, it is characterized in that with Chinese medicine Yunnan Caulis Spatholobi cream powder, Radix Cyathulae, Radix Dipsaci, Flos Carthami and Semen sojae atricolor being that raw material adds adjuvant and makes tablet, wherein the weight portion proportioning of each crude drug is: 218.75 parts in Yunnan Caulis Spatholobi cream powder, 59.5 parts of Radix Cyathulaes, 53 parts of Radix Dipsacis, 5 parts on Flos Carthami, 12.5 parts in Semen sojae atricolor prepares by following method:
(1) get Yunnan Caulis Spatholobi, add 4-6 times of water gaging decoction 3 times, each 2-4 hour, collecting decoction filtered, and filtrate is condensed into thick paste, and is dry below 80 ℃, pulverizes, and sieves, and gets Yunnan Caulis Spatholobi cream powder;
(2) Radix Cyathulae, Radix Dipsaci, Flos Carthami, Semen sojae atricolor add 4-6 times of water gaging decoction 2-3 time, and each 1-2 hour, collecting decoction, filtration, filtrate concentrates, and adds Yunnan Caulis Spatholobi cream powder, mixes thoroughly, and drying below 80 ℃ is pulverized, and sieves, and gets the intermediate dry extract;
(3) get 8 parts of above-mentioned dry extracts, add adjuvant 1-2 part, mixing is granulated, drying, and granulate adds disintegrating agent, tabletting;
(4) the special-shaped Fructus Schisandrae Sphenantherae fourth element in the employing high effective liquid chromatography for measuring Yunnan Caulis Spatholobi cream powder and the content of kadsurin;
(5) adopt thin layer chromatography qualitative identification Yunnan Caulis Spatholobi, Radix Cyathulae and Radix Dipsaci.
2. by the described compound milettia reticulata tablets of claim 1, it is characterized in that described adjuvant is selected from one or more combination of following adjuvant:
Diluent, wetting agent, disintegrating agent and/or lubricant;
Wherein, diluent is selected from lactose, amylum pregelatinisatum, sodium carboxymethyl cellulose, dextrin or microcrystalline Cellulose; Wetting agent is selected from ethanol or syrup; Disintegrating agent is selected from carboxymethyl starch sodium or polyplasdone XL; Lubricant is selected from magnesium stearate or Pulvis Talci.
3. by the described compound milettia reticulata tablets of claim 1, the mensuration chromatographic condition that it is characterized in that described high performance liquid chromatography is: with octadecyl bonding phase silica gel is filler, adding acetonitrile-methanol-water is mobile phase, gradient elution: 10: 40: 50 0min, 10: 47: 43 23min, 10: 50: 40 35min, 10: 80: 10 (59min), 65min altogether; Flow velocity 1ml/min; Detect wavelength 230nm.
4. by the described compound milettia reticulata tablets of claim 1, it is characterized in that the qualitative Yunnan Caulis Spatholobi condition of identifying of described thin layer chromatography is: with special-shaped Fructus Schisandrae Sphenantherae fourth element or kadsurin is reference substance, is at 6: 1 developing solvent with 60～90 ℃-chloroform-acetone of petroleum ether 8: 1: 1, cyclohexane extraction-ethyl acetate 8: 2 or toluene-ethyl acetate.
5. by the described compound milettia reticulata tablets of claim 1, it is characterized in that the qualitative Radix Cyathulae condition of identifying of described thin layer chromatography is: with the Radix Cyathulae control medicinal material is contrast, is at 10: 9: 1 developing solvent with 60～90 ℃-ethyl acetate of petroleum ether 1: 1, cyclohexane extraction-ethyl acetate 8: 2 or petroleum ether-chloroform-methanol.
6. by the described compound milettia reticulata tablets of claim 1, it is characterized in that the qualitative Radix Dipsaci condition of identifying of described thin layer chromatography is: with the Radix Dipsaci control medicinal material is contrast, is at 5: 1 developing solvent with 6: 1: 5 upper solution of n-butyl alcohol-methanol-water or chloroform-methanol.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104991032A (en) * | 2015-07-23 | 2015-10-21 | 北京市药品检验所 | Thin layer chromatography for identifying doped kadsura longepedunculata in Chinese magnoliavine |
| CN109846923A (en) * | 2019-01-23 | 2019-06-07 | 云南广福药业有限公司 | A kind of extracting method of Caulis Kadsurae |
-
2007
- 2007-07-05 CN CNA2007100434532A patent/CN101112415A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104991032A (en) * | 2015-07-23 | 2015-10-21 | 北京市药品检验所 | Thin layer chromatography for identifying doped kadsura longepedunculata in Chinese magnoliavine |
| CN109846923A (en) * | 2019-01-23 | 2019-06-07 | 云南广福药业有限公司 | A kind of extracting method of Caulis Kadsurae |
| CN109846923B (en) * | 2019-01-23 | 2021-09-17 | 云南广福药业有限公司 | Extraction method of Yunnan caulis spatholobi |
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Open date: 20080130 |