Infusion liquid of glossy privet fruit and astragalus root for strengthening body resistance and preparation method thereof
Technical field
What the present invention relates to is a kind of deficient that various diseases causes that be mainly used in; Cooperate operation, lonizing radiation, chemotherapy, promote medicine---infusion liquid of glossy privet fruit and astragalus root for strengthening body resistance and preparation method thereof that normal function recovers.Belong to the Chinese patent medicine preparing technical field.
Background technology
The body resistance-strengthening Zhenqi series of products are a kind of deficient that various diseases causes that are mainly used in; Cooperate operation, lonizing radiation, chemotherapy, promote the medicine that normal function recovers.ZHENQI FUZHENG KELI is recorded kind for the second ten fens volumes (P117 in 1998) of " the Sanitation Ministry medicine standard " Chinese traditional patent formulation preparation.The side is made up of Fructus Ligustri Lucidi, the Radix Astragali.Effect with boosting qi and nourishing yin, strengthening the body resistance, modern pharmacology experimental results show that this product can be used for improving immune function of human body, protection bone marrow and adrenal cortex function.Be mainly used in deficient, prolonged illness (liver cirrhosis, chronic atrophic gastritis, diabetes, tuberculosis etc.) that various diseases causes clinically; Cooperate postoperative, puerperal patient's recovery; The putting of cancer patient, chemotherapeutic period there are the auxiliary treatment effect, can obviously improve patient's late result, promote the recovery of normal function.Also can be used as weakness or elderly patients' health care medication.
At present, the body resistance-strengthening Zhenqi series of products on the market have ZHENQI FUZHENG KELI (taking after mixing it with water), capsule, are a kind of classical Chinese patent medicines.This product prescription uses origin for a long time, and prescription is formed rationally, compatibility is appropriate, has the good and clinical curative effect support.Its route of administration is oral, and oral formulations needs to enter body circulation and then performance curative effect through gastrointestinal absorption, has the characteristics such as incomplete, that onset is slow, bioavailability is low that absorb; Simultaneously, to the patient of oral inconvenience, the application of oral formulations has its scope limitation.
Summary of the invention
Purpose of the present invention is exactly the defective at above-mentioned existence, provides a kind of good stability, absorption is abundant, rapid-action, curative effect is high for infusion liquid of glossy privet fruit and astragalus root for strengthening body resistance of drug administration by injection and preparation method thereof.It is characterized in that adopting the active component in the water extraction extraction Fructus Ligustri Lucidi and the Radix Astragali, the water extract is with 60% ~ 80% ethanol precipitation, filter, must precipitate and supernatant: get an amount of dissolved in distilled water of precipitation, reuse 60% ~ 90% ethanol repeatedly precipitates or purifies with hollow fiber column ultrafilter, preparation polysaccharide effective site; Supernatant behind the water extract precipitate with ethanol, reclaim ethanol to there not being the alcohol flavor, (organic solvent can be any organic solvent that is used to extract saponin component in the natural product chemistry with suitable organic solvent, comprise ethyl acetate, n-butyl alcohol and isoamyl alcohol etc.) extraction, with the washing of 1% sodium hydroxide solution, obtain Fructus Ligustri Lucidi, Radix Astragali saponin effective kind part again.Get the relevant effective site of Radix Astragali total saponins class with Fructus Ligustri Lucidi, polysaccharide effective site, isoosmotic adjusting agent and antiseptic etc. are through the infusion liquid of glossy privet fruit and astragalus root for strengthening body resistance of a kind of drug administration by injection of suitable prepared.
The present invention is achieved through the following technical solutions:
The medicament composing prescription proportioning: Fructus Ligustri Lucidi accounts for 10-90%, and the Radix Astragali accounts for 90-10%, and its optimum weight proportioning is a Fructus Ligustri Lucidi 50%, the Radix Astragali 50%; By weight above-mentioned.Preparation method comprises following processing step: processing step one, medical material pre-treatment: granule or coarse powder are chosen, clean, dry, are ground into to medical material Fructus Ligustri Lucidi, the Radix Astragali respectively;
Processing step two, extraction process
Get Fructus Ligustri Lucidi, Milkvetch Root granule, the deionized water of doubly measuring with 6-15 extracts 3 times or extracts with percolation with 8-50 times of water gaging by decocting method, infusion process, merge extractive liquid,, filter, concentrating under reduced pressure becomes every 1ml to be equivalent to the medicinal liquid of 1.5g crude drug, adds ethanol and reaches 60%-80% to containing the alcohol amount, leaves standstill 24 hours, filter, must precipitate and filtered solution;
1), polysaccharide effective site preparation
Get precipitation, the decompression cold drying adds an amount of dissolved in distilled water, add ethanol and reach 60-90%, left standstill 24 hours, filter to containing the alcohol amount, the precipitation adding distil water is dissolved into 1% solution, crosses hollow fiber column ultrafilter (molecular cut off is greater than 6000), and ultrafiltrate is evaporated to dried; Get perhaps that the gained precipitation adds an amount of dissolved in distilled water again behind the secondary precipitate with ethanol, add ethanol and reach 60-90%, left standstill 24 hours, filter, get precipitation, promptly get polysaccharide effective site with an amount of absolute ethanol washing 1-2 time to containing the alcohol amount;
2), Fructus Ligustri Lucidi, Radix Astragali total saponins effective site
Supernatant behind the water extract-alcohol precipitation, decompression recycling ethanol is to there not being the alcohol flavor, adding distil water makes resolution of precipitate, filters, and three times (organic solvent can be any organic solvent that is used to extract saponin component in the natural product chemistry with organic solvent extraction, comprise ethyl acetate, n-butyl alcohol and isoamyl alcohol etc.), combining extraction liquid is washed secondary with 1% aqueous sodium hydroxide washes, discards alkaline solution, reclaim under reduced pressure organic solvent extraction liquid and be concentrated into dried, the relevant effective site of Radix Astragali total saponins class with Fructus Ligustri Lucidi;
Processing step three, transfusion preparation technology
1), claim sample:
Get the relevant effective site of Radix Astragali total saponins class with Fructus Ligustri Lucidi, polysaccharide effective site, isoosmotic adjusting agent by and antiseptic.Described isoosmotic adjusting agent is one or more the compositions in glucose, sodium chloride, xylitol, sorbitol, calcium chloride, magnesium chloride, potassium chloride, lactose, the sodium lactate.Described antiseptic is wherein one or more the compositions that benzyl alcohol, chlorocresol, methyl hydroxybenzoate, ethyl hydroxybenzoate, ethyl hydroxybenzoate etc. can be used for doing in the injection antiseptic.
2), dosing:
A, dense joining: with load weighted isoosmotic adjusting agent and antiseptic, join in 50% ~ 70% the water for injection of total dosing amount, stir and make dissolving fully.Add an amount of water for injection and make dissolving, add the relevant effective site of Radix Astragali total saponins class with Fructus Ligustri Lucidi, after polysaccharide effective site stirs and makes dissolving fully, add 0.3% ~ 0.5% (g/v) needle-use activated carbon of dosing amount, stirred 15-20 minute, put cold, filter, add injection and be diluted with water to the prescription prescribed volume, regulate PH to 7-7.5, filter;
B, rare joining: add to the full amount of water for injection, add dosing amount 0.02% ~ 0.1% (g/v) needle-use activated carbon, stirred 15-20 minute, put coldly, filter, regulate PH to 7-7.5, filtration;
3), packing:
Fill is in 50ml, 100ml, 200ml, 250ml, 500ml infusion bottle, and the gland of jumping a queue, sterilization are labelled, and packing gets product.
Finished product detection
The detection index is as follows:
1, differentiate: carry out the thin layer discriminating of oleanolic acid, astragaloside, should be up to specification.
2, check: comprise projects such as clarity, pH value, content uniformity, resin, tannin, heavy metal, aseptic, pyrogen, the result should be up to specification.
3, assay: adopt high performance liquid chromatography, the content of astragaloside in the test sample.
4, finger printing inspection: get finished product, make need testing solution after being dissolved in water, adopt high performance liquid chromatography, carry out gradient elution, write down one hour finger printing of Radix Astragali saponin class and polysaccharide respectively, and compare with reference fingerprint, the result should be up to specification.
Advantage of the present invention:
Body resistance-strengthening Zhenqi injection series of products and same veriety (ZHENQI FUZHENG KELI, capsule) relatively have following characteristics:
1, this product is based on ZHENQI FUZHENG KELI, traditional Chinese medicine culture and advanced preparation process are combined, the utilization modern scientific method, Chinese medicine new product newly developed on the basis of summing up in conjunction with the experimentation of Chemistry for Chinese Traditional Medicine, analytical chemistry, pharmacology of Chinese materia medica and clinical efficacy thereof and amount of literature data.About this product prepared, we use high-efficient liquid phase chromatogram technology, it is carried out the finger printing research of expecting preparation from former, with finger printing as one of quality control index, new by being somebody's turn to do of dosage form comprehensively, improve the quality standard of original product, actively develop the research of its effective site and the mechanism of action simultaneously, formulated the infusion liquid of glossy privet fruit and astragalus root for strengthening body resistance for drug administration by injection of new generation.
2, this product is an injecting and administering preparations, and its process route is more consummate rationally, the Fructus Ligustri Lucidi of enrichment and the effective ingredient of the Radix Astragali, and purity is higher.Show through experimentation: this technology has stronger science, feasibility, and the prepared sample quality of this technology is stable, meets the prescription of treatment.ZHENQI FUZHENG KELI, capsule route of administration are oral; This product route of administration is a drug administration by injection, need not digest and assimilate through gastrointestinal, has determined curative effect, rapid-action characteristics.The development of this dosage form has simultaneously brought Gospel for the patient of oral inconvenience.
3, infusion solution can be directly used in intravenously administrable among the present invention, does not need with glucose or normal saline redilution again, and is easy to use; Contact with air in the time of can avoiding uncork and redilution due to secondary pollution, increased the clinical practice safety.
The present invention will be further described by embodiment:
The specific embodiment
Embodiment 1
1, prescription: Fructus Ligustri Lucidi 50% Radix Astragali 50%
2, technology:
1), extract: get Fructus Ligustri Lucidi, the Milkvetch Root granule of recipe quantity, with the deionization water boiling and extraction of 8 times of amounts 3 times, merge extractive liquid,, filter, filtrate decompression is condensed into the medicinal liquid that every 1ml is equivalent to the 1.5g crude drug, adds ethanol and reaches 70% to containing the alcohol amount, left standstill 24 hours, and filtered, must precipitate and filtered solution; Get precipitation, the decompression cold drying adds an amount of dissolved in distilled water, adds ethanol and reaches 80% to containing the alcohol amount, left standstill 24 hours, and filtered, the precipitation adding distil water is dissolved into 1% solution, cross hollow fiber column ultrafilter (molecular cut off is greater than 6000), ultrafiltrate is evaporated to dried, promptly gets polysaccharide effective site; Supernatant behind the water extract-alcohol precipitation, decompression recycling ethanol is to there not being the alcohol flavor, adding distil water makes resolution of precipitate, filter, use n-butanol extraction three times, merge butanol extraction liquid, aqueous sodium hydroxide washes with 1% is washed secondary, discard alkaline solution, reclaim under reduced pressure organic solvent extraction liquid and be concentrated into dried, the relevant effective site of Radix Astragali total saponins class with Fructus Ligustri Lucidi.
2), preparation:
(1), claim sample:
Get Radix Astragali total saponins class relevant effective site with Fructus Ligustri Lucidi, polysaccharide effective site, glucose isoosmotic adjusting agent and chlorocresol antiseptic.
(2), dosing (dense joining): with load weighted isoosmotic adjusting agent and antiseptic, join in 50%% the water for injection of total dosing amount, stir and make dissolving fully.Add an amount of water for injection and make dissolving, add the relevant effective site of Radix Astragali total saponins class with Fructus Ligustri Lucidi, after polysaccharide effective site stirs and makes dissolving fully, add 0.3% (g/v) needle-use activated carbon of dosing amount, stirred 20 minutes, put cold, filter, add injection and be diluted with water to the prescription prescribed volume, regulate PH to 7, filter;
(3), packing:
Fill is in the 250ml infusion bottle, and the gland of jumping a queue, sterilization are labelled, and packing gets product.
Embodiment 2
1, prescription: Fructus Ligustri Lucidi 50% Radix Astragali 50%
2, technology:
1), extracts: Fructus Ligustri Lucidi, the Milkvetch Root granule of getting recipe quantity, deionized water dipping with 12 times of amounts extracts 3 times, merge extractive liquid,, filter, filtrate decompression is condensed into the medicinal liquid that every 1ml is equivalent to the 1.5g crude drug, adds ethanol and reaches 70% to containing the alcohol amount, leaves standstill 24 hours, filter, must precipitate and filtered solution; Get precipitation, the decompression cold drying adds an amount of dissolved in distilled water, adds ethanol again and reaches 80% to containing the alcohol amount, left standstill 24 hours, and filtered, the precipitation adding distil water is dissolved into 1% solution, cross hollow fiber column ultrafilter (molecular cut off is greater than 6000), ultrafiltrate is evaporated to dried, gets polysaccharide effective site.Supernatant behind the water extract-alcohol precipitation, decompression recycling ethanol is to there not being the alcohol flavor, adding distil water makes resolution of precipitate, filter, use ethyl acetate extraction three times, the combined ethyl acetate extract, aqueous sodium hydroxide washes with 1% is washed secondary, discard alkaline solution, reclaim under reduced pressure organic solvent extraction liquid and be concentrated into dried, the relevant effective site of Radix Astragali total saponins class with Fructus Ligustri Lucidi.
2), preparation:
(1), claims sample: get Radix Astragali total saponins class relevant effective site with Fructus Ligustri Lucidi, polysaccharide effective site, sodium chloride isoosmotic adjusting agent and benzyl alcohol antiseptic.
(2), dosing (rare joining): add to the full amount of water for injection, add dosing amount 0.05% (g/v) needle-use activated carbon, stirred 18 minutes, put coldly, filter, regulate PH to 7.2, filtration;
(3), packing: fill is in the 100ml infusion bottle, and the gland of jumping a queue, sterilization are labelled, and packing gets product.
Embodiment 3
1, prescription: Fructus Ligustri Lucidi 50% Radix Astragali 50%
2, technology:
1), extracts: Fructus Ligustri Lucidi, the Milkvetch Root of getting recipe quantity, be ground into coarse powder, it is moistening to add low amounts of water, the percolator of packing into, the deionized water soaked overnight that adds 10 times of amounts, with 40 times of water gaging percolation, collect percolate, concentrating under reduced pressure becomes every 1ml to be equivalent to the medicinal liquid of 1.5g crude drug, add ethanol and reach 70% to containing the alcohol amount, left standstill 24 hours, and filtered, must precipitate and filtered solution; Get precipitation, the decompression cold drying adds an amount of dissolved in distilled water, add ethanol again and reach 80%, left standstill 24 hours, filter to containing the alcohol amount, precipitation adds an amount of dissolved in distilled water again, add ethanol and reach 85%, left standstill 24 hours, filter to containing the alcohol amount, get precipitation with an amount of absolute ethanol washing 2 times,, drying under reduced pressure promptly gets polysaccharide effective site.Supernatant behind the water extract-alcohol precipitation, decompression recycling ethanol is to there not being the alcohol flavor, adding distil water makes resolution of precipitate, filter,, merge the isoamyl alcohol extract with isoamyl alcohol extraction three times, aqueous sodium hydroxide washes with 1% is washed secondary, discard alkaline solution, reclaim under reduced pressure organic solvent extraction liquid and be concentrated into dried, the relevant effective site of Radix Astragali total saponins class with Fructus Ligustri Lucidi.
2), preparation:
(1), claims sample: get the relevant effective site of Radix Astragali total saponins class, polysaccharide effective site, xylitol isoosmotic adjusting agent and methyl hydroxybenzoate, propylparaben antiseptic with Fructus Ligustri Lucidi.
(2), dosing (rare joining): add to the full amount of water for injection, add dosing amount 0.05% (g/v) needle-use activated carbon, stirred 20 minutes, put coldly, filter, regulate PH to 7.5, filtration;
(3), packing: fill is in the 500ml infusion bottle, and the gland of jumping a queue, sterilization are labelled, and packing gets product.
Embodiment 4
1, prescription: Fructus Ligustri Lucidi 50% Radix Astragali 50%
2, technology:
1), extract: get Fructus Ligustri Lucidi, the Milkvetch Root granule of recipe quantity, with the deionization water boiling and extraction of 8 times of amounts 3 times, merge extractive liquid,, filter, filtrate decompression is condensed into the medicinal liquid that every 1ml is equivalent to the 1.5g crude drug, adds ethanol and reaches 70% to containing the alcohol amount, left standstill 24 hours, and filtered, must precipitate and filtered solution; Get precipitation, the decompression cold drying adds an amount of dissolved in distilled water, adds ethanol and reaches 80% to containing the alcohol amount, leaves standstill 24 hours, filters, and must precipitate and filtered solution; Get precipitation and add an amount of dissolved in distilled water again, add ethanol and reach 90%, left standstill 24 hours, filter, get precipitation with an amount of absolute ethanol washing 2 times to containing alcohol amount,, drying under reduced pressure promptly gets polysaccharide effective site.Supernatant behind the water extract-alcohol precipitation, decompression recycling ethanol is to there not being the alcohol flavor, adding distil water makes resolution of precipitate, filter, use n-butanol extraction three times, merge butanol extraction liquid, aqueous sodium hydroxide washes with 1% is washed secondary, discard alkaline solution, reclaim under reduced pressure organic solvent extraction liquid and be concentrated into dried, the relevant effective site of Radix Astragali total saponins class with Fructus Ligustri Lucidi.
2), preparation:
(1), claims sample: get Radix Astragali total saponins class relevant effective site with Fructus Ligustri Lucidi, polysaccharide effective site, glucose isoosmotic adjusting agent and chlorocresol antiseptic.
(2), dosing (rare joining): add to the full amount of water for injection, add dosing amount 0.05% (g/v) needle-use activated carbon, stirred 15 minutes, put coldly, filter, regulate PH to 7, filtration;
(3), packing: fill is in the 250ml infusion bottle, and the gland of jumping a queue, sterilization are labelled, and packing gets product.