CN101468060A - Pharmaceutical composition - Google Patents
Pharmaceutical composition Download PDFInfo
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- CN101468060A CN101468060A CNA2007103038570A CN200710303857A CN101468060A CN 101468060 A CN101468060 A CN 101468060A CN A2007103038570 A CNA2007103038570 A CN A2007103038570A CN 200710303857 A CN200710303857 A CN 200710303857A CN 101468060 A CN101468060 A CN 101468060A
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- ligustri lucidi
- fructus ligustri
- radix astragali
- extract
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Abstract
The invention provides a traditional Chinese medicine combination, characterized in that the traditional Chinese medicine combination is composed of glossy privet fruit 1-10 weight parts, astragalus root 1-10 weight parts; preferably glossy privet fruit 1-3 weight parts, astragalus root 1-7 weight parts; wherein the glossy privet fruit is used as monarch medicine and the astragalus root is used as adjuvant medicine. The pharmacological experiments indicate that the traditional Chinese medicine combination has good anti-tumor and immunity-increasing effect.
Description
Technical field
The invention belongs to field of traditional Chinese medicine pharmacy, be specifically related to a kind of pharmaceutical composition that contains the Fructus Ligustri Lucidi and the Radix Astragali.
Background technology
Chemotherapy is one of comprehensive treatment of malignant tumor, and the may command tumor development prevents tumor recurrence and transfer, prolongs life cycle, plays an important role in the treatment of malignant tumor.But because the cytotoxicity of antitumor drug, all influential to normal tissue cell such as hemopoietic system, gastrointestinal epithelial, hair follicle, sexual cell etc. in killing tumor cell, in treatment time, is with in various degree toxic reaction, therefore, after conventional chemotherapy finishes, should adhere to the Chinese medicine conditioning, strengthening body resistance and dispelling evil, to set upright, promptly the anticancer detoxifcation Chinese medicine of compatibility on the basis of the body resistance strengthening and constitution consolidating helps healthy energy to recover, and improves immunologic function, improve anticancer ability of preapring for an unfavorable turn of events, prevent the recurrence and the transfer of tumor.
Chemotherapy is one of important measures for the treatment of at present tumor, but the caused toxicity of this therapy is big, Chinese medicine is then paid attention to organic conception, be particular about determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, on the market by Fructus Ligustri Lucidi, the ZHENQI FUZHENG KELI that Radix Astragali prescription forms, capsule is under the differentiation of tcm therapy, improvement to patients ' life quality, assist the raising aspect of chemotherapy effect all to have good effect, but its dosage form has only granule and two kinds of dosage forms of capsule at present, production technology is comparatively backward, just the two water decoction-alcohol sedimentation post-treatment is made preparation, this peroral dosage form is oral after the liver first-pass effect post-absorption enters blood, and bioavailability is low; Injection has rapid-action, and therefore the characteristics that bioavailability is high, change system into ejection preparation with loyal stilbene granule or capsule that Fructus Ligustri Lucidi, Radix Astragali prescription form, and cooperation is put, chemotherapy, and transfusion is used, and will have good market prospect.
Fructus Ligustri Lucidi has another name called Fructus Ilicis Purpureae, is the dry mature fruit of Oleaceae aiphyllium Fructus Ligustri Lucidi, and liver, kidney channel are returned in sweet, the little hardship of nature and flavor, cold, have nourishing the liver and kidney, the function of the black hair that makes eye bright.Mainly contain organic acid, glycoside, terpene and steroid in the Fructus Ligustri Lucidi, its main effective ingredient is an organic acid, comprises oleanolic acid, Fructus Ligustri Lucidi acid, ursolic acid, oleic acid, linolenic acid, tormentic acid etc.In addition, also contain para hydroxybenzene ethyl-alpha-D-glucose glycoside, nuzhenide, apigenin-7-O-beta-D-A glycoside, α-maloic acid methyl ester, feather bean alcohol, cupreol, betulin etc.Be mainly used in multiple diseases such as treatment vertigo and tinnitus, soreness of the waist and knees, early whitening of beard and hair, poor vision, insomnia and dreamful sleep and acute bacillary dysentery, chronic bronchitis clinically.In the square medicine prescription of diseases such as treatment coronary heart disease, hyperlipemia, hyperglycemia, hepatitis, use a lot of.Modern age, pharmacological research showed that Fructus Ligustri Lucidi had defying age, anticancer and improve pharmacological action such as immunologic function.Fructus Ligustri Lucidi is brought into play antitumor action by the reversing tumor cell to the function inhibition of macrophage.Stomach, the gastral 9 kinds of cancerous cell of large intestine there are the obvious suppression effect, and normal fibrocyte is had the propagation facilitation, play inhibition and metastasis effect tumor cell by the secretion that reduces matrilysin.The Fructus Ligustri Lucidi water extract can suppress the crosslinked DNA of Aspergillus flavus B (AFB), reduces the formation of AFB-DNA, thereby thinks that Fructus Ligustri Lucidi can improve immunological function of cancer patients, with the same usefulness of chemotherapeutics, certain efficacy enhancing and toxicity reducing effect is arranged.
The Radix Astragali then has good invigorating the spleen and replenishing QI effect. and the Radix Astragali is a leguminous plant, as Chinese medicine, have benefit and defend the effect of consolidating superficial resistance, inducing diuresis to remove edema, promoting pus discharge and tissue regeneration strengthening and invigorating the spleen and replenishing QI, the Radix Astragali mainly contains saponin, polysaccharide and flavones ingredient, and the Radix Astragali has tangible immunoloregulation function, comprise nonspecific immunity, cellular immunization, humoral immune function, and energy inducement interferon, to immunologic hypofunction, the clinical disease of immunologic function disorder is a kind of up-and-coming medicine.
By retrieval, yet there are no the relevant report of relevant loyal stilbene ejection preparation.
Summary of the invention
For these reasons, we adopt the modern Chinese medicine theory, in conjunction with modern science and technology, with the Fructus Ligustri Lucidi is monarch drug, and the Radix Astragali is a ministerial drug, is combined into pharmaceutical composition, be prepared into pharmaceutical preparation, on the basis of improving your ability of human immunity, reach the effect of treatment tumor, pharmacological evaluation shows that pharmaceutical composition of the present invention has favorable anti-tumor effect.
The present invention adopts ultrafiltration and macroporous adsorbent resin method to obtain the extract of the Radix Astragali, adopt ultrafiltration to obtain the extract of Fructus Ligustri Lucidi, be mixed with into tablet, capsule, granule, oral liquid, soft capsule, drop pill, aqueous injection, injectable powder, infusion solution with pharmaceutic adjuvant.
The present invention is achieved through the following technical solutions.
A kind of pharmaceutical composition is characterized in that it is made up of Chinese medicine Fructus Ligustri Lucidi 1-10 weight portions and the Radix Astragali 1-10 weight portions.
Wherein preferred Fructus Ligustri Lucidi 1-3 weight portions, the Radix Astragali 1-7 weight portions.
The extraction purification of the Fructus Ligustri Lucidi and the Radix Astragali can adopt that process is prepared in the prior art in the pharmaceutical composition of the present invention, also can prepare by following method:
Get Milkvetch Root, be ground into coarse powder, with 5-8 times of water boiling and extraction 3 times,, each 2-5 hours, filter, extracting solution merges, and the ratio that is evaporated to medicinal liquid and crude drug amount is 1:1, and filtrate adds on the macroporous adsorptive resins of having handled well, earlier with 6-8 times of column volume washings, water lotion is collected, 4-8 times of column volumes of reuse, concentration is the 50%-90% ethanol elution, collects ethanol elution, decompression recycling ethanol, concentrated solution is standby, and standby water lotion molecular cut off is 8000 hollow fiber column ultrafilter 3-5 times, keeps circulation fluid, each ultrafiltration to 1/2-1/3 o'clock, add water to original volume, last ultrafiltration to pol is 2%-5%, merges above-mentioned concentrated solution, vacuum drying gets Radix Astragali extract; Getting the Fructus Ligustri Lucidi medical material, be ground into coarse powder, is that the 50%-95% alcohol heating reflux extracts 3 times with 4-8 times, concentration, alcohol extract merges, decompression recycling ethanol to 50 ℃ relative density is the extractum of 1.10-1.20, slowly adds ethanol and makes the alcohol amount of containing reach 70-80%, cold preservation standing over night, filter, decompression filtrate recycling ethanol is to the greatest extent, and the ratio that adds water to medicine liquid volume and crude drug amount is 1:1, stirs and makes dissolving, cross molecular weight and be 3000 ultrafilter membrane ultrafiltration and concentration to doing, Fructus Ligustri Lucidi extract.
Wherein macroporous adsorbent resin is nonpolar or the low pole macroporous adsorbent resin, comprises D
101, AB-8 and ADS-7 type macroporous adsorbent resin.
Obtaining Radix Astragali extract and Fructus Ligustri Lucidi extract is raw material, is prepared into tablet, capsule, granule, oral liquid, soft capsule, drop pill, aqueous injection, injectable powder, infusion solution.
Pharmacology embodiment
Embodiment 1
Experiment material and instrument: 50 of Male Kunming strain mice are provided body weight 20～25g by No.1 Military Medical Univ.'s Experimental Animal Center; Pharmaceutical composition of the present invention; SHENQI FUZHENG ZHUSHEYE, Livzon Group Limin Pharmaceutical Factory production.
Experimental technique and result: 50 random packet of mice: normal saline matched group (blank group), SHENQI FUZHENG ZHUSHEYE group (positive controls), pharmaceutical composition group of the present invention adds the water for injection dissolving fully; Every day 1 time, 0.2ml/ time, continuous ip administration 7d, behind the last administration 1d, mouse peritoneal is injected 5% chicken red blood cell 1ml, puts to death mice after 50 minutes, and get peritoneal fluid and smear sheet, Wright's staining, 100 positive phagocyte of microscopy counting are calculated phagocytic index.The eyeball blood sampling, the preparation blood smear, natural drying carries out α-acetic acid naphthols esterase dyeing (ANAE) according to a conventional method, and 200 lymphocytes of microscopy counting calculate the ANAE+T lymphocyte percentage.Experimental result sees Table 1.
The influence that table 1 pair Turnover of Mouse Peritoneal Macrophages is engulfed (x ± s, n=12)
Annotate: compare with the blank group
*P＜0.01, compare with positive controls [
*] P＜0.05
Experiment conclusion: pharmaceutical composition of the present invention is compared with SHENQI FUZHENG ZHUSHEYE, phagocytic percentage and phagocytic index to the immunologic hypofunction mice are all higher, illustrate that ZHENQI FUZHENG ZHUSHEYE has obvious facilitation to the peritoneal macrophage phagocytic function of immunologic hypofunction mice.
Embodiment 2
To mice S
180The tumor growth inhibitory action
Laboratory animal: healthy mice, body weight 16-20g, male and female are respectively done.Tumor strain: mice S
180(Beijing University of Chinese Medicine provides)
Experiment medicine: normal saline
SHENQI FUZHENG ZHUSHEYE (Livzon Group Limin Pharmaceutical Factory production)
Pharmaceutical composition of the present invention
Experimental technique: get and inoculate the mice S that goes down to posterity
180, in homogenizer, add normal saline, make mice S
180The tumor homogenate, again with normal saline 1:3 dilution, getting 0.2ml then, to inject oxter, a mice left side subcutaneous, weighed in 24 hours, mice tail every day intravenously administrable once, administration volume identical (0.5ml/ is only), totally 7 days.Next day is put to death mice in drug withdrawal, and the subcutaneous tumors piece is peeled off in the also carefulness of weighing, and takes by weighing tumor in the EM50 electronic balance and weighs, and calculate tumour inhibiting rate, sees Table 2:
Two kinds of preparations of table 2 are to mice S
180The tumor growth inhibitory action
Annotate: compare with the blank group
*P＜0.01, compare with positive controls [
*] P＜0.05
Conclusion: show that by above-mentioned pharmacological evaluation the preparation of respectively organizing of the present invention has better pharmacological action.
Preparation embodiment
Embodiment 1
Crude drug is: Fructus Ligustri Lucidi 10000 grams, the Radix Astragali 1000 grams;
Get Milkvetch Root, be ground into coarse powder, with 5 times of water boiling and extraction 3 times, each 2 hours, filter, extracting solution merges, the ratio that is evaporated to medicinal liquid and crude drug amount is 1:1, filtrate adds on the D101 macroporous adsorptive resins of having handled well, and with 6 times of column volume washings, water lotion is standby earlier, 4 times of column volumes of reuse, concentration is 50% ethanol elution, collect ethanol elution, decompression recycling ethanol, concentrated solution is standby, with above-mentioned standby water lotion molecular cut off is 8000 hollow fiber column ultrafilter 3 times, keep circulation fluid, during each ultrafiltration to 1/2, add water to original volume, last ultrafiltration to pol is 2%, merge above-mentioned concentrated solution, vacuum drying gets Radix Astragali effective part extract; Get the Fructus Ligustri Lucidi medical material, be ground into coarse powder, extract 3 times with 4 times, 50% alcohol heating reflux, alcohol extract merges, decompression recycling ethanol to relative density is the extractum of 1.10 (50 ℃), slowly adds ethanol and makes and contain alcohol amount and reach 70%, the cold preservation standing over night, filter, decompression filtrate recycling ethanol is to the greatest extent, and the ratio that adds water to medicine liquid volume and crude drug amount is 1:1, stirs and makes dissolving, cross molecular weight and be 3000 ultrafilter membrane ultrafiltration and concentration to doing, Fructus Ligustri Lucidi extract.
Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, add the injection water, regulate pH to 8.5 to ormal weight, with 0.1% active carbon heat treated 15 minutes, filter, filtrate is with the microporous filter membrane filtration of 0.22 μ m, embedding, sterilization promptly gets 1000 of body resistance-strengthening Zhenqi hydro-acupuncture preparations of the present invention;
Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract and pharmaceutic adjuvant sodium chloride, add the injection water to ormal weight, regulate pH to 8.5-9.0, with 0.1% active carbon heat treated 15-20 minute, filter, filtrate filters embedding with the microporous filter membrane of 0.22 μ m, sterilization promptly gets 1000 bottles of body resistance-strengthening Zhenqi infusion preparations of the present invention;
Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, add the injection water to ormal weight, add an amount of freeze-dried excipient mannitol, stir evenly, regulate pH value to 8.5, boiled 15 minutes with 0.1% active carbon, filter while hot, filtrate filters with the microporous filter membrane of 0.22 μ m, fill, lid is rolled in lyophilization, promptly gets 1000 bottles of body resistance-strengthening Zhenqi lyophilized injectable powders of the present invention.
Embodiment 2
Crude drug is: Fructus Ligustri Lucidi 3000 grams, the Radix Astragali 7000 grams;
Get Milkvetch Root, be ground into coarse powder, with 8 times of water boiling and extraction 3 times, each 5 hours, filter, extracting solution merges, the ratio that is evaporated to medicinal liquid and crude drug amount is 1:1, filtrate adds on the AB-8 macroporous adsorptive resins of having handled well, and with 7 times of column volume washings, water lotion is standby earlier, 5 times of column volumes of reuse, concentration is 55% ethanol elution, collect ethanol elution, decompression recycling ethanol, concentrated solution is standby, with above-mentioned standby water lotion molecular cut off is 8000 hollow fiber column ultrafilter 4 times, keep circulation fluid, during each ultrafiltration to 1/2, add water to original volume, last ultrafiltration to pol is 3%, merge above-mentioned concentrated solution, vacuum drying gets Radix Astragali effective part extract; Get the Fructus Ligustri Lucidi medical material, be ground into coarse powder, extract 3 times with 5 times, 60% alcohol heating reflux, alcohol extract merges, and decompression recycling ethanol to relative density is the extractum of 1.12 (50 ℃), slowly adds ethanol and makes and contain the alcohol amount and reach 75%, the cold preservation standing over night, filter, decompression filtrate recycling ethanol is to the greatest extent, and the ratio that adds water to medicine liquid volume and crude drug amount is 1:1, stirring makes dissolving, cross molecular weight and be 3000 ultrafilter membrane ultrafiltration and concentration, drying, Fructus Ligustri Lucidi extract.
Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, add the injection water, regulate pH to 8.6 to ormal weight, with 0.1% active carbon heat treated 18 minutes, filter, filtrate is with the microporous filter membrane filtration of 0.22 μ m, embedding, sterilization promptly gets 1000 of body resistance-strengthening Zhenqi hydro-acupuncture preparations of the present invention; Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract and pharmaceutic adjuvant glucose, add the injection water to ormal weight, regulate pH to 8.6, with 0.1% active carbon heat treated 18 minutes, filter, filtrate filters embedding with the microporous filter membrane of 0.22 μ m, sterilization promptly gets 1000 bottles of body resistance-strengthening Zhenqi infusion preparations of the present invention; Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, add the injection water to ormal weight, add an amount of freeze-dried excipient sucrose, stir evenly, regulate pH value to 8.6, boiled 15 minutes with 0.1% active carbon, filter while hot, filtrate filters with the microporous filter membrane of 0.22 μ m, fill, lid is rolled in lyophilization, promptly gets 1000 bottles of body resistance-strengthening Zhenqi lyophilized injectable powders of the present invention.
Embodiment 3
The crude drug prescription is: Fructus Ligustri Lucidi 3000 grams, the Radix Astragali 7000 grams;
Get Milkvetch Root, be ground into coarse powder, with 8 times of water boiling and extraction 3 times,, each 5 hours, filter, extracting solution merges, and the ratio that is evaporated to medicinal liquid and crude drug amount is 1:1, and filtrate adds on the ADS-7 type macroporous adsorptive resins of having handled well, earlier with 8 times of column volume washings, water lotion is standby, 8 times of column volumes of reuse, concentration is 90% ethanol elution, collects ethanol elution, decompression recycling ethanol, concentrated solution is standby, is 8000 hollow fiber column ultrafilter 5 times with above-mentioned standby water lotion molecular cut off, keeps circulation fluid, during each ultrafiltration to 1/2, add water to original volume, last ultrafiltration to pol is 5%, merges above-mentioned concentrated solution, vacuum drying gets Radix Astragali effective part extract; Get the Fructus Ligustri Lucidi medical material, be ground into coarse powder, extract 3 times with 8 times, 95% alcohol heating reflux, alcohol extract merges, decompression recycling ethanol to relative density is the extractum of 1.20 (50 ℃), slowly adds ethanol and makes and contain alcohol amount and reach 80%, the cold preservation standing over night, filter, decompression filtrate recycling ethanol is to the greatest extent, and the ratio that adds water to medicine liquid volume and crude drug amount is 1:1, stirs and makes dissolving, cross molecular weight and be 3000 ultrafilter membrane ultrafiltration and concentration to doing, Fructus Ligustri Lucidi extract.
Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, add the injection water, regulate pH to 9.0 to ormal weight, with 0.1% active carbon heat treated 20 minutes, filter, filtrate is with the microporous filter membrane filtration of 0.22 μ m, embedding, sterilization promptly gets 1000 of body resistance-strengthening Zhenqi hydro-acupuncture preparations of the present invention; Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract and pharmaceutic adjuvant sodium chloride, add the injection water to ormal weight, regulate pH to 9.0, with 0.1% active carbon heat treated 20 minutes, filter, filtrate filters embedding with the microporous filter membrane of 0.22 μ m, sterilization promptly gets 1000 bottles of body resistance-strengthening Zhenqi infusion preparations of the present invention; Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, add the injection water to ormal weight, add an amount of freeze-dried excipient, stir evenly, regulate pH value to 9.0, boiled 15 minutes with 0.1% active carbon, filter while hot, filtrate filters with the microporous filter membrane of 0.22 μ m, fill, lid is rolled in lyophilization, promptly gets 1000 bottles of body resistance-strengthening Zhenqi lyophilized injectable powders of the present invention.
Embodiment 4
Crude drug is: Fructus Ligustri Lucidi 2000 grams, the Radix Astragali 6000 grams;
Get Milkvetch Root, be ground into coarse powder, with 6 times of water boiling and extraction 3 times,, each 3 hours, filter, extracting solution merges, and the ratio that is evaporated to medicinal liquid and crude drug amount is 1:1, and filtrate adds on the ADS-7 type macroporous adsorptive resins of having handled well, earlier with 7 times of column volume washings, water lotion is standby, 6 times of column volumes of reuse, concentration is 65% ethanol elution, collects ethanol elution, decompression recycling ethanol, concentrated solution is standby, is 8000 hollow fiber column ultrafilter 4 times with above-mentioned standby water lotion molecular cut off, keeps circulation fluid, during each ultrafiltration to 1/2, add water to original volume, last ultrafiltration to pol is 4%, merges above-mentioned concentrated solution, vacuum drying gets Radix Astragali effective part extract; Get the Fructus Ligustri Lucidi medical material, be ground into coarse powder, extract 3 times with 6 times, 60% alcohol heating reflux, alcohol extract merges, and decompression recycling ethanol to relative density is the extractum of 1.15 (50 ℃), slowly adds ethanol and makes and contain the alcohol amount and reach 75%, the cold preservation standing over night, filter, decompression filtrate recycling ethanol is to the greatest extent, and the ratio that adds water to medicine liquid volume and crude drug amount is 1:1, stirring makes dissolving, cross molecular weight and be 3000 ultrafilter membrane ultrafiltration and concentration, drying, Fructus Ligustri Lucidi extract.
Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, add the injection water, regulate pH to 8.8 to ormal weight, with 0.1% active carbon heat treated 19 minutes, filter, filtrate is with the microporous filter membrane filtration of 0.22 μ m, embedding, sterilization promptly gets 1000 of body resistance-strengthening Zhenqi hydro-acupuncture preparations of the present invention; Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract and pharmaceutic adjuvant glucose, add the injection water to ormal weight, regulate pH to 8.8, with 0.1% active carbon heat treated 19 minutes, filter, filtrate filters embedding with the microporous filter membrane of 0.22 μ m, sterilization promptly gets 1000 bottles of body resistance-strengthening Zhenqi infusion preparations of the present invention; Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, add the injection water to ormal weight, add an amount of freeze-dried excipient lactose, stir evenly, regulate pH value to 8.8, boiled 15 minutes with 0.1% active carbon, filter while hot, filtrate filters with the microporous filter membrane of 0.22 μ m, fill, lid is rolled in lyophilization, promptly gets 1000 bottles of body resistance-strengthening Zhenqi lyophilized injectable powders of the present invention.
Embodiment 5
The crude drug prescription is: Fructus Ligustri Lucidi 2500 grams, the Radix Astragali 3500 grams.
Get Milkvetch Root, be ground into coarse powder, with 7 times of water boiling and extraction 3 times,, each 4 hours, filter, extracting solution merges, and the ratio that is evaporated to medicinal liquid and crude drug amount is 1:1, and filtrate adds on the D101 type macroporous adsorptive resins of having handled well, earlier with 7 times of column volume washings, water lotion is standby, 4 times of column volumes of reuse, concentration is 75% ethanol elution, collects ethanol elution, decompression recycling ethanol, concentrated solution is standby, is 8000 hollow fiber column ultrafilter 5 times with above-mentioned standby water lotion molecular cut off, keeps circulation fluid, during each ultrafiltration to 1/2, add water to original volume, last ultrafiltration to pol is 4%, merges above-mentioned concentrated solution, vacuum drying gets Radix Astragali effective part extract; Get the Fructus Ligustri Lucidi medical material, be ground into coarse powder, extract 3 times with 7 times, 90% alcohol heating reflux, alcohol extract merges, decompression recycling ethanol to relative density is the extractum of 1.18 (50 ℃), slowly adds ethanol and makes and contain alcohol amount and reach 70%, the cold preservation standing over night, filter, decompression filtrate recycling ethanol is to the greatest extent, and the ratio that adds water to medicine liquid volume and crude drug amount is 1:1, stirs and makes dissolving, cross molecular weight and be 3000 ultrafilter membrane ultrafiltration and concentration to doing, Fructus Ligustri Lucidi extract.
Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, add the injection water, regulate pH to 9.0 to ormal weight, with 0.1% active carbon heat treated 15 minutes, filter, filtrate is with the microporous filter membrane filtration of 0.22 μ m, embedding, sterilization promptly gets 1000 of body resistance-strengthening Zhenqi hydro-acupuncture preparations of the present invention; Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract and pharmaceutic adjuvant sodium chloride, add the injection water to ormal weight, regulate pH to 9.0, with 0.1% active carbon heat treated 15 minutes, filter, filtrate filters embedding with the microporous filter membrane of 0.22 μ m, sterilization promptly gets 1000 bottles of body resistance-strengthening Zhenqi infusion preparations of the present invention; Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, add the injection water to ormal weight, add an amount of freeze-dried excipient mannitol, stir evenly, regulate pH value to 8.5, boiled 15 minutes with 0.1% active carbon, filter while hot, filtrate filters with the microporous filter membrane of 0.22 μ m, fill, lid is rolled in lyophilization, promptly gets 1000 bottles of body resistance-strengthening Zhenqi lyophilized injectable powders of the present invention.
Embodiment 6
Crude drug is: Fructus Ligustri Lucidi 2500 grams, the Radix Astragali 5500 grams.
Get Milkvetch Root, be ground into coarse powder, with 5 times of water boiling and extraction 3 times,, each 5 hours, filter, extracting solution merges, and the ratio that is evaporated to medicinal liquid and crude drug amount is 1:1, and filtrate adds on the AB-8 type macroporous adsorptive resins of having handled well, earlier with 6 times of column volume washings, water lotion is standby, 8 times of column volumes of reuse, concentration is 50% ethanol elution, collects ethanol elution, decompression recycling ethanol, concentrated solution is standby, is 8000 hollow fiber column ultrafilter 5 times with above-mentioned standby water lotion molecular cut off, keeps circulation fluid, during each ultrafiltration to 1/2, add water to original volume, last ultrafiltration to pol is 2%, merges above-mentioned concentrated solution, vacuum drying gets Radix Astragali effective part extract; Get the Fructus Ligustri Lucidi medical material, be ground into coarse powder, extract 3 times with 4 times, 95% alcohol heating reflux, alcohol extract merges, decompression recycling ethanol to relative density is the extractum of 1.10 (50 ℃), slowly adds ethanol and makes and contain alcohol amount and reach 80%, the cold preservation standing over night, filter, decompression filtrate recycling ethanol is to the greatest extent, and the ratio that adds water to medicine liquid volume and crude drug amount is 1:1, stirs and makes dissolving, cross molecular weight and be 3000 ultrafilter membrane ultrafiltration and concentration to doing, Fructus Ligustri Lucidi extract.
Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, add the injection water, regulate pH to 8.6 to ormal weight, with 0.1% active carbon heat treated 16 minutes, filter, filtrate is with the microporous filter membrane filtration of 0.22 μ m, embedding, sterilization promptly gets 1000 of body resistance-strengthening Zhenqi hydro-acupuncture preparations of the present invention; Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract and pharmaceutic adjuvant glucose, add the injection water to ormal weight, regulate pH to 8.6, with 0.1% active carbon heat treated 16 minutes, filter, filtrate filters embedding with the microporous filter membrane of 0.22 μ m, sterilization promptly gets 1000 bottles of body resistance-strengthening Zhenqi infusion preparations of the present invention; Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, add the injection water to ormal weight, add an amount of freeze-dried excipient sucrose, stir evenly, regulate pH value to 8.8, boiled 15 minutes with 0.1% active carbon, filter while hot, filtrate filters with the microporous filter membrane of 0.22 μ m, fill, lid is rolled in lyophilization, promptly gets 1000 bottles of body resistance-strengthening Zhenqi lyophilized injectable powders of the present invention.
Embodiment 7
Crude drug is: Fructus Ligustri Lucidi 2000 grams, the Radix Astragali 2000 grams.
Get Milkvetch Root, be ground into coarse powder, with 8 times of water boiling and extraction 3 times,, each 2 hours, filter, extracting solution merges, and the ratio that is evaporated to medicinal liquid and crude drug amount is 1:1, and filtrate adds on the D101 type macroporous adsorptive resins of having handled well, earlier with 6 times of column volume washings, water lotion is standby, 4 times of column volumes of reuse, concentration is 85% ethanol elution, collects ethanol elution, decompression recycling ethanol, concentrated solution is standby, is 8000 hollow fiber column ultrafilter 4 times with above-mentioned standby water lotion molecular cut off, keeps circulation fluid, during each ultrafiltration to 1/3, add water to original volume, last ultrafiltration to pol is 3%, merges above-mentioned concentrated solution, vacuum drying gets Radix Astragali effective part extract; Get the Fructus Ligustri Lucidi medical material, be ground into coarse powder, extract 3 times with 8 times, 75% alcohol heating reflux, alcohol extract merges, decompression recycling ethanol to relative density is the extractum of 1.17 (50 ℃), slowly adds ethanol and makes the alcohol amount of containing reach 70-80%, cold preservation standing over night, filter, decompression filtrate recycling ethanol is to the greatest extent, and the ratio that adds water to medicine liquid volume and crude drug amount is 1:1, stirs and makes dissolving, cross molecular weight and be 3000 ultrafilter membrane ultrafiltration and concentration to doing, Fructus Ligustri Lucidi extract.
Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, add the injection water, regulate pH to 8.7 to ormal weight, with 0.1% active carbon heat treated 17 minutes, filter, filtrate is with the microporous filter membrane filtration of 0.22 μ m, embedding, sterilization promptly gets 1000 of body resistance-strengthening Zhenqi hydro-acupuncture preparations of the present invention; Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract and pharmaceutic adjuvant glucose, add the injection water to ormal weight, regulate pH to 8.7, with 0.1% active carbon heat treated 17 minutes, filter, filtrate filters embedding with the microporous filter membrane of 0.22 μ m, sterilization promptly gets 1000 bottles of body resistance-strengthening Zhenqi infusion preparations of the present invention; Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, add the injection water to ormal weight, add an amount of freeze-dried excipient lactose, stir evenly, regulate pH value to 8.7, boiled 15 minutes with 0.1% active carbon, filter while hot, filtrate filters with the microporous filter membrane of 0.22 μ m, fill, lid is rolled in lyophilization, promptly gets 1000 bottles of body resistance-strengthening Zhenqi lyophilized injectable powders of the present invention.
Embodiment 8
Crude drug is: Fructus Ligustri Lucidi 10000 grams, the Radix Astragali 10000 grams;
Get Milkvetch Root, be ground into coarse powder, with 5 times of water boiling and extraction 3 times, each 2 hours, filter, extracting solution merges, the ratio that is evaporated to medicinal liquid and crude drug amount is 1:1, filtrate adds on the D101 macroporous adsorptive resins of having handled well, and with 6 times of column volume washings, water lotion is standby earlier, 4 times of column volumes of reuse, concentration is 50% ethanol elution, collect ethanol elution, decompression recycling ethanol, concentrated solution is standby, with above-mentioned standby water lotion molecular cut off is 8000 hollow fiber column ultrafilter 3 times, keep circulation fluid, during each ultrafiltration to 1/2, add water to original volume, last ultrafiltration to pol is 2%, merge above-mentioned concentrated solution, vacuum drying gets Radix Astragali effective part extract; Get the Fructus Ligustri Lucidi medical material, be ground into coarse powder, extract 3 times with 4 times, 50% alcohol heating reflux, alcohol extract merges, decompression recycling ethanol to relative density is the extractum of 1.10 (50 ℃), slowly adds ethanol and makes and contain alcohol amount and reach 70%, the cold preservation standing over night, filter, decompression filtrate recycling ethanol is to the greatest extent, and the ratio that adds water to medicine liquid volume and crude drug amount is 1:1, stirs and makes dissolving, cross molecular weight and be 3000 ultrafilter membrane ultrafiltration and concentration to doing, Fructus Ligustri Lucidi extract.
Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, be prepared into 1000 of 1000 bottles of 10000 of 1000 bags of 1000 of 1000 in tablet or capsules or granules or drop pills or oral liquids or soft capsules.
Embodiment 9
Crude drug is: Fructus Ligustri Lucidi 1000 grams, the Radix Astragali 10000 grams;
Get Milkvetch Root, be ground into coarse powder, with 8 times of water boiling and extraction 3 times, each 5 hours, filter, extracting solution merges, the ratio that is evaporated to medicinal liquid and crude drug amount is 1:1, filtrate adds on the AB-8 macroporous adsorptive resins of having handled well, and with 7 times of column volume washings, water lotion is standby earlier, 5 times of column volumes of reuse, concentration is 55% ethanol elution, collect ethanol elution, decompression recycling ethanol, concentrated solution is standby, with above-mentioned standby water lotion molecular cut off is 8000 hollow fiber column ultrafilter 4 times, keep circulation fluid, during each ultrafiltration to 1/2, add water to original volume, last ultrafiltration to pol is 3%, merge above-mentioned concentrated solution, vacuum drying gets Radix Astragali effective part extract; Get the Fructus Ligustri Lucidi medical material, be ground into coarse powder, extract 3 times with 5 times, 60% alcohol heating reflux, alcohol extract merges, and decompression recycling ethanol to relative density is the extractum of 1.12 (50 ℃), slowly adds ethanol and makes and contain the alcohol amount and reach 75%, the cold preservation standing over night, filter, decompression filtrate recycling ethanol is to the greatest extent, and the ratio that adds water to medicine liquid volume and crude drug amount is 1:1, stirring makes dissolving, cross molecular weight and be 3000 ultrafilter membrane ultrafiltration and concentration, drying, Fructus Ligustri Lucidi extract.
Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, be prepared into 1000 of 1000 bottles of 10000 of 1000 bags of 1000 of 1000 in tablet or capsules or granules or drop pills or oral liquids or soft capsules.Embodiment 3
Embodiment 10
The crude drug prescription is: Fructus Ligustri Lucidi 9000 grams, the Radix Astragali 1000 grams;
Get Milkvetch Root, be ground into coarse powder, with 8 times of water boiling and extraction 3 times,, each 5 hours, filter, extracting solution merges, and the ratio that is evaporated to medicinal liquid and crude drug amount is 1:1, and filtrate adds on the ADS-7 type macroporous adsorptive resins of having handled well, earlier with 8 times of column volume washings, water lotion is standby, 8 times of column volumes of reuse, concentration is 90% ethanol elution, collects ethanol elution, decompression recycling ethanol, concentrated solution is standby, is 8000 hollow fiber column ultrafilter 5 times with above-mentioned standby water lotion molecular cut off, keeps circulation fluid, during each ultrafiltration to 1/2, add water to original volume, last ultrafiltration to pol is 5%, merges above-mentioned concentrated solution, vacuum drying gets Radix Astragali effective part extract; Get the Fructus Ligustri Lucidi medical material, be ground into coarse powder, extract 3 times with 8 times, 95% alcohol heating reflux, alcohol extract merges, decompression recycling ethanol to relative density is the extractum of 1.20 (50 ℃), slowly adds ethanol and makes and contain alcohol amount and reach 80%, the cold preservation standing over night, filter, decompression filtrate recycling ethanol is to the greatest extent, and the ratio that adds water to medicine liquid volume and crude drug amount is 1:1, stirs and makes dissolving, cross molecular weight and be 3000 ultrafilter membrane ultrafiltration and concentration to doing, Fructus Ligustri Lucidi extract.
Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, be prepared into 1000 of 1000 bottles of 10000 of 1000 bags of 1000 of 1000 in tablet or capsules or granules or drop pills or oral liquids or soft capsules.
Embodiment 11
Crude drug is: Fructus Ligustri Lucidi 2000 grams, the Radix Astragali 9500 grams;
Get Milkvetch Root, be ground into coarse powder, with 6 times of water boiling and extraction 3 times,, each 3 hours, filter, extracting solution merges, and the ratio that is evaporated to medicinal liquid and crude drug amount is 1:1, and filtrate adds on the ADS-7 type macroporous adsorptive resins of having handled well, earlier with 7 times of column volume washings, water lotion is standby, 6 times of column volumes of reuse, concentration is 65% ethanol elution, collects ethanol elution, decompression recycling ethanol, concentrated solution is standby, is 8000 hollow fiber column ultrafilter 4 times with above-mentioned standby water lotion molecular cut off, keeps circulation fluid, during each ultrafiltration to 1/2, add water to original volume, last ultrafiltration to pol is 4%, merges above-mentioned concentrated solution, vacuum drying gets Radix Astragali effective part extract; Get the Fructus Ligustri Lucidi medical material, be ground into coarse powder, extract 3 times with 6 times, 60% alcohol heating reflux, alcohol extract merges, and decompression recycling ethanol to relative density is the extractum of 1.15 (50 ℃), slowly adds ethanol and makes and contain the alcohol amount and reach 75%, the cold preservation standing over night, filter, decompression filtrate recycling ethanol is to the greatest extent, and the ratio that adds water to medicine liquid volume and crude drug amount is 1:1, stirring makes dissolving, cross molecular weight and be 3000 ultrafilter membrane ultrafiltration and concentration, drying, Fructus Ligustri Lucidi extract.
Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, be prepared into 1000 of 1000 bottles of 10000 of 1000 bags of 1000 of 1000 in tablet or capsules or granules or drop pills or oral liquids or soft capsules.
Embodiment 12
The crude drug prescription is: Fructus Ligustri Lucidi 1500 grams, the Radix Astragali 7500 grams.
Get Milkvetch Root, be ground into coarse powder, with 7 times of water boiling and extraction 3 times,, each 4 hours, filter, extracting solution merges, and the ratio that is evaporated to medicinal liquid and crude drug amount is 1:1, and filtrate adds on the D101 type macroporous adsorptive resins of having handled well, earlier with 7 times of column volume washings, water lotion is standby, 4 times of column volumes of reuse, concentration is 75% ethanol elution, collects ethanol elution, decompression recycling ethanol, concentrated solution is standby, is 8000 hollow fiber column ultrafilter 5 times with above-mentioned standby water lotion molecular cut off, keeps circulation fluid, during each ultrafiltration to 1/2, add water to original volume, last ultrafiltration to pol is 4%, merges above-mentioned concentrated solution, vacuum drying gets Radix Astragali effective part extract; Get the Fructus Ligustri Lucidi medical material, be ground into coarse powder, extract 3 times with 7 times, 90% alcohol heating reflux, alcohol extract merges, decompression recycling ethanol to relative density is the extractum of 1.18 (50 ℃), slowly adds ethanol and makes and contain alcohol amount and reach 70%, the cold preservation standing over night, filter, decompression filtrate recycling ethanol is to the greatest extent, and the ratio that adds water to medicine liquid volume and crude drug amount is 1:1, stirs and makes dissolving, cross molecular weight and be 3000 ultrafilter membrane ultrafiltration and concentration to doing, Fructus Ligustri Lucidi extract.
Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, be prepared into 1000 of 1000 bottles of 10000 of 1000 bags of 1000 of 1000 in tablet or capsules or granules or drop pills or oral liquids or soft capsules.
Embodiment 13
Crude drug is: Fructus Ligustri Lucidi 3000 grams, the Radix Astragali 9500 grams.
Get Milkvetch Root, be ground into coarse powder, with 5 times of water boiling and extraction 3 times,, each 5 hours, filter, extracting solution merges, and the ratio that is evaporated to medicinal liquid and crude drug amount is 1:1, and filtrate adds on the AB-8 type macroporous adsorptive resins of having handled well, earlier with 6 times of column volume washings, water lotion is standby, 8 times of column volumes of reuse, concentration is 50% ethanol elution, collects ethanol elution, decompression recycling ethanol, concentrated solution is standby, is 8000 hollow fiber column ultrafilter 5 times with above-mentioned standby water lotion molecular cut off, keeps circulation fluid, during each ultrafiltration to 1/2, add water to original volume, last ultrafiltration to pol is 2%, merges above-mentioned concentrated solution, vacuum drying gets Radix Astragali effective part extract; Get the Fructus Ligustri Lucidi medical material, be ground into coarse powder, extract 3 times with 4 times, 95% alcohol heating reflux, alcohol extract merges, decompression recycling ethanol to relative density is the extractum of 1.10 (50 ℃), slowly adds ethanol and makes and contain alcohol amount and reach 80%, the cold preservation standing over night, filter, decompression filtrate recycling ethanol is to the greatest extent, and the ratio that adds water to medicine liquid volume and crude drug amount is 1:1, stirs and makes dissolving, cross molecular weight and be 3000 ultrafilter membrane ultrafiltration and concentration to doing, Fructus Ligustri Lucidi extract.
Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, be prepared into 1000 of 1000 bottles of 10000 of 1000 bags of 1000 of 1000 in tablet or capsules or granules or drop pills or oral liquids or soft capsules.
Embodiment 14
Crude drug is: Fructus Ligustri Lucidi 9000 grams, the Radix Astragali 1500 grams.
Get Milkvetch Root, be ground into coarse powder, with 8 times of water boiling and extraction 3 times,, each 2 hours, filter, extracting solution merges, and the ratio that is evaporated to medicinal liquid and crude drug amount is 1:1, and filtrate adds on the D101 type macroporous adsorptive resins of having handled well, earlier with 6 times of column volume washings, water lotion is standby, 4 times of column volumes of reuse, concentration is 85% ethanol elution, collects ethanol elution, decompression recycling ethanol, concentrated solution is standby, is 8000 hollow fiber column ultrafilter 4 times with above-mentioned standby water lotion molecular cut off, keeps circulation fluid, during each ultrafiltration to 1/3, add water to original volume, last ultrafiltration to pol is 3%, merges above-mentioned concentrated solution, vacuum drying gets Radix Astragali effective part extract; Get the Fructus Ligustri Lucidi medical material, be ground into coarse powder, extract 3 times with 8 times, 75% alcohol heating reflux, alcohol extract merges, decompression recycling ethanol to relative density is the extractum of 1.17 (50 ℃), slowly adds ethanol and makes the alcohol amount of containing reach 70-80%, cold preservation standing over night, filter, decompression filtrate recycling ethanol is to the greatest extent, and the ratio that adds water to medicine liquid volume and crude drug amount is 1:1, stirs and makes dissolving, cross molecular weight and be 3000 ultrafilter membrane ultrafiltration and concentration to doing, Fructus Ligustri Lucidi extract.
Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, add the injection water, regulate pH to 8.7 to ormal weight, with 0.1% active carbon heat treated 17 minutes, filter, filtrate is with the microporous filter membrane filtration of 0.22 μ m, embedding, sterilization promptly gets 2000 of body resistance-strengthening Zhenqi hydro-acupuncture preparations of the present invention;
Get the Radix Astragali, Fructus Ligustri Lucidi effective part extract, be prepared into 1000 of 1000 bottles of 10000 of 1000 bags of 1000 of 1000 in tablet or capsules or granules or drop pills or oral liquids or soft capsules.
Claims (5)
1, a kind of pharmaceutical composition is characterized in that it is made up of Chinese medicine Fructus Ligustri Lucidi 1-10 weight portions and the Radix Astragali 1-10 weight portions.
2, a kind of pharmaceutical composition according to claim 1, Fructus Ligustri Lucidi 1-3 weight portions wherein, the Radix Astragali 1-7 weight portions.
3, a kind of preparation of drug combination method according to claim 1 and 2 is characterized in that:
Get Milkvetch Root, be ground into coarse powder, with 5-8 times of water boiling and extraction 3 times,, each 2-5 hours, filter, extracting solution merges, and the ratio that is evaporated to medicinal liquid and crude drug amount is 1:1, and filtrate adds on the macroporous adsorptive resins of having handled well, earlier with 6-8 times of column volume washings, water lotion is collected, 4-8 times of column volumes of reuse, concentration is the 50%-90% ethanol elution, collects ethanol elution, decompression recycling ethanol, concentrated solution is standby, and standby water lotion molecular cut off is 8000 hollow fiber column ultrafilter 3-5 times, keeps circulation fluid, each ultrafiltration to 1/2-1/3 o'clock, add water to original volume, last ultrafiltration to pol is 2%-5%, merges above-mentioned concentrated solution, vacuum drying gets Radix Astragali extract; Getting the Fructus Ligustri Lucidi medical material, be ground into coarse powder, is that the 50%-95% alcohol heating reflux extracts 3 times with 4-8 times, concentration, alcohol extract merges, decompression recycling ethanol to 50 ℃ relative density is the extractum of 1.10-1.20, slowly adds ethanol and makes the alcohol amount of containing reach 70-80%, cold preservation standing over night, filter, decompression filtrate recycling ethanol is to the greatest extent, and the ratio that adds water to medicine liquid volume and crude drug amount is 1:1, stirs and makes dissolving, cross molecular weight and be 3000 ultrafilter membrane ultrafiltration and concentration to doing, Fructus Ligustri Lucidi extract.
4, according to the preparation method of the described a kind of drug regimen of claim 3, wherein macroporous adsorbent resin is nonpolar or the low pole macroporous adsorbent resin, comprises D
101, AB-8 and ADS-7 type macroporous adsorbent resin.
5, pharmaceutical composition according to claim 1 and 2 is prepared into tablet, capsule, granule, oral liquid, soft capsule, drop pill, aqueous injection, injectable powder, infusion solution.
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| Application Number | Priority Date | Filing Date | Title |
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| CNA2007103038570A CN101468060A (en) | 2007-12-26 | 2007-12-26 | Pharmaceutical composition |
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| CNA2007103038570A CN101468060A (en) | 2007-12-26 | 2007-12-26 | Pharmaceutical composition |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103169773A (en) * | 2011-12-20 | 2013-06-26 | 洛阳惠中兽药有限公司 | Traditional Chinese medicine compound preparation for enhancing livestock immunity and preparation method |
| CN104208163A (en) * | 2014-09-16 | 2014-12-17 | 成都乾坤动物药业有限公司 | Chinese veterinary drug composition for improving animal immunity as well as application and preparation method of Chinese veterinary drug composition |
-
2007
- 2007-12-26 CN CNA2007103038570A patent/CN101468060A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103169773A (en) * | 2011-12-20 | 2013-06-26 | 洛阳惠中兽药有限公司 | Traditional Chinese medicine compound preparation for enhancing livestock immunity and preparation method |
| CN103169773B (en) * | 2011-12-20 | 2015-07-15 | 洛阳惠中兽药有限公司 | Traditional Chinese medicine compound preparation for enhancing livestock immunity and preparation method |
| CN104208163A (en) * | 2014-09-16 | 2014-12-17 | 成都乾坤动物药业有限公司 | Chinese veterinary drug composition for improving animal immunity as well as application and preparation method of Chinese veterinary drug composition |
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