CN108478614A - A kind of preparation method of XIAOAIPING PIAN - Google Patents

A kind of preparation method of XIAOAIPING PIAN Download PDF

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Publication number
CN108478614A
CN108478614A CN201810487852.6A CN201810487852A CN108478614A CN 108478614 A CN108478614 A CN 108478614A CN 201810487852 A CN201810487852 A CN 201810487852A CN 108478614 A CN108478614 A CN 108478614A
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China
Prior art keywords
water
caulis marsdeniae
marsdeniae tenacissimae
preparation
xiaoaiping pian
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Pending
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CN201810487852.6A
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Chinese (zh)
Inventor
张仁刘
刘少敏
谢华
郭传功
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HUBEI CHUANGLI PHARMACEUTICAL CO Ltd
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HUBEI CHUANGLI PHARMACEUTICAL CO Ltd
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Priority to CN201810487852.6A priority Critical patent/CN108478614A/en
Publication of CN108478614A publication Critical patent/CN108478614A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/27Asclepiadaceae (Milkweed family), e.g. hoya
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/282Organic compounds, e.g. fats
    • A61K9/2826Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Mycology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)
  • Medicinal Preparation (AREA)

Abstract

The present invention relates to pharmaceutical technology fields, concretely relate to a kind of preparation method of XIAOAIPING PIAN.This method uses ethyl alcohol to impregnate CAULIS MARSDENIAE TENACISSIMAE first, then decocts three times to extract effective ingredient this CAULIS MARSDENIAE TENACISSIMAE by water, active ingredient and auxiliary material are finally prepared by mixing into XIAOAIPING PIAN according to a certain percentage.This method uses alcohol solution dipping before water extraction, the efficiency of next step water boiling and extraction can not only be improved, more to greatest extent the effective effective ingredient of indication will can be extracted out in CAULIS MARSDENIAE TENACISSIMAE, reduce the leaching of invalid components simultaneously, medication effect is enhanced, production cost is reduced.The CAULIS MARSDENIAE TENACISSIMAE that the method for the present invention extracts further enhances medication effect and safety to the effective effective ingredient purity higher of indication.

Description

A kind of preparation method of XIAOAIPING PIAN
Technical field
The present invention relates to pharmaceutical technology fields, concretely relate to a kind of preparation method of XIAOAIPING PIAN.
Background technology
Cancer is one of the underlying cause of death of most countries in the world today.Although up to the present having tens of kinds of chemotherapy Or anticancer adjuvant drug can be used for clinical treatment, but most drugs can only make disease amelioration, can not cross the purpose to healing. Although the cancer or adult skin tumour of some children have a possibility of healing or long-term remission, most of death rates it is very high and Very common cancer such as gastric cancer, cancer of the esophagus, lung cancer, colorectal cancer, Cervical cancer, leukaemia etc. still lack effective anticancer drug.Slowly Property tracheitis and bronchial asthma be a kind of common disease, frequently-occurring disease, human health is threatened very big, specific aim is very strong at present controls It treats drug also to lack very much, XIAOAIPING PIAN exactly develops in the case.
XIAOAIPING PIAN is medicinal extract piece made of single glaucescent fissistigma root is processed, and CAULIS MARSDENIAE TENACISSIMAE is Asclepiadaceae plant glaucescent fissistigma root (clearance Rattan) Marsdenia tenacissima (Roxb.) Wight et Arn. drying rattan.Product function with cure mainly:Anticancer disappears Inflammation is relievingd asthma.For cancer of the esophagus, gastric cancer, lung cancer, to Several Kinds of Malignancy such as colorectal cancer, cervical carcinoma, leukaemia, also there is a constant current modulation Effect, also can Combined with Radiotherapy, chemotherapy and post-operative treatment.Anticancer, anti-inflammatory, the effect of relievining asthma.For cancer of the esophagus, gastric cancer, lung cancer, big The Several Kinds of Malignancy such as intestinal cancer, Cervical cancer, leukaemia, also can Combined with Radiotherapy, chemotherapy and post-operative treatment.And it is chronic for treating Tracheitis and bronchial asthma.
In the prior art, by State Food and Drug Administration's national drug standards, the preparation method of XIAOAIPING PIAN is:It takes CAULIS MARSDENIAE TENACISSIMAE is soaked 12 hours, is added water to cook three times, 2 hours for the first time, second 1.5 hours, and third time 1 hour merges Decoction liquor, filtration, filtrate are concentrated into the clear cream that relative density is about 1.23 (70-80 DEG C), and it is suitable that the auxiliary materials such as dextrin and starch are added Amount, mixing, granulation or are dried under reduced pressure 60 DEG C of drying, addition magnesium stearate, mixing, and tabletting is made 1000, film coating or packet Sugar-coat, or be pressed into 500, film coating to get.Usage and dosage:It is oral, one time 8~10;Or a 4-5 piece, one day 3 It is secondary.Specification:(1) every weight 0.31g, (2) sugar coated tablet plate core weight 0.3g, every weight 0.63g of (3) Film coated tablets of Film coated tablets.It lacks Point is this product leads to hardness, the friability of tablet using medicinal extract unstable quality, the poor compressibility after granulation made from conventional method Degree lays particular stress on the indexs such as difference and is not easy up to standard, and tablet surface made of suppressing is uneven, influences product quality.This product bitter taste Denseer, taking dose is big, and medication time-histories is long, and tablet volume is larger, dysphagia, and patient's compliance is poor, and drug effect is also difficult to Ensure.
Invention content
The present invention provides a kind of preparation method of Marsdenia tenacissima extract, is somebody's turn to do to overcome the above-mentioned deficiency of the prior art Method can not only improve the efficiency of next step water boiling and extraction, more can to greatest extent will be effective to indication in CAULIS MARSDENIAE TENACISSIMAE Effective ingredient is extracted out, while reducing the leaching of invalid components, enhances medication effect, reduces production Cost.To achieve the goals above, the present invention is realized by the following method:
The present invention proposes a kind of preparation method of XIAOAIPING PIAN, the described method comprises the following steps:
Step 1: taking appropriate CAULIS MARSDENIAE TENACISSIMAE, the alcohol solution dipping of 2-3 times of volume is added 4-8 hours;
Step 2: the CAULIS MARSDENIAE TENACISSIMAE taken out in ethanol solution drains, it is separately added into distilled water and decocts 3 times, each 1.5h, filter It crosses, merging filtrate;
Step 3: the filtrate decompression in step 2 is concentrated into the 1/4 to 1/3 of volume, ethyl alcohol is added while hot, stood Night;
Step 4: the material in step 3 is filtered, filter residue heats water dissolution and carries out alcohol precipitation, in triplicate;
Step 5: gained filter residue adds water to dissolve by heating in step 4, stand, add 3-4g activated carbons, be heated to boiling, keeps the temperature 30min is filtered and is collected filtrate;
Step 6: filtrate is concentrated into paste in step 5,70-75 DEG C is dried under reduced pressure, finely ground to obtain Marsdenia tenacissima extract powder Foam;
Step 7: Marsdenia tenacissima extract powder is uniform with dispersant, the water for being added 12.5% continues to mix, compression Granulation;Tabletting, sugar coating obtain XIAOAIPING PIAN.
Further, the mass fraction of ethanol solution is 60%-80% in the step 1.
Further, the specific method for CAULIS MARSDENIAE TENACISSIMAE being added water to cook in the step 2 is:The amount of water of decoction is for the first time 10 times of crude drug weight decoct 2 hours after impregnating 5 hours, and second amount of water decocted is 7 times of crude drug weight, when decoction Between be 0.5 hour, the amount of water that third time decocts is 4 times of crude drug weight, and decocting time is 1 hour.
Further, the weight proportion of CAULIS MARSDENIAE TENACISSIMAE and dispersant is in the step 7:16-20 parts of CAULIS MARSDENIAE TENACISSIMAE, dispersant 2-5 parts.
Further, the dispersant is any one of dextrin, starch.
Compared with prior art, the beneficial effects of the present invention are:
1, XIAOAIPING PIAN prepared by the present invention has anticancer, anti-inflammatory, the effect of relievining asthma.For cancer of the esophagus, gastric cancer, lung cancer, The Several Kinds of Malignancy such as colorectal cancer, Cervical cancer, leukaemia have special effect, have Synergy and attenuation effect to chemotherapeutics, chronic to treating Tracheitis and bronchial asthma are curative for effect, and without obvious adverse reaction.
2, CAULIS MARSDENIAE TENACISSIMAE uses alcohol solution dipping before water extraction in the present invention, can not only improve the decoction of next step water and carry The efficiency taken more will can be extracted out, simultaneously in CAULIS MARSDENIAE TENACISSIMAE to the effective effective ingredient of indication to greatest extent The leaching for reducing invalid components, enhances medication effect, reduces production cost.
3, the CAULIS MARSDENIAE TENACISSIMAE that method of the invention extracts is to the effective effective ingredient purity higher of indication, into one Step enhances medication effect and safety.
Specific implementation mode
It shows that example illustrates certain embodiments of the present invention, and should not be construed as the model of the limitation present invention It encloses.Present disclosure can be improved from material, method and reaction condition simultaneously, all these improvement should all It falls within the spirit and scope of the present invention.
Embodiment 1:
1, glaucescent fissistigma root 1500g is taken, is placed in 60% ethanol solution of 3L and impregnates 4 hours.
2, after impregnating, glaucescent fissistigma root is taken out and is drained from ethanol solution, is then added water to cook.Decocting method is specific For:The amount of water decocted for the first time is 15L, is decocted 2 hours after impregnating 5 hours, and second amount of water that decocts is 7L, when decoction Between be 0.5 hour, third time decoct amount of water be 4L, decocting time be 1 hour.
3, collecting decoction, filtering, filtrate decompression are concentrated into 5.5L, and ethyl alcohol 10L is added while hot, stood after mixing Night.
4, the material in step 3 is filtered, filter residue heats water dissolution and carries out alcohol precipitation, in triplicate.
5, add water 3L to dissolve by heating the filter residue in step 4, stand, add 3-4g activated carbons, be heated to boiling, keep the temperature 30min, It filters and collects filtrate.
6, filtrate is concentrated into paste in step 5, and 70 DEG C are dried under reduced pressure, finely ground to obtain Marsdenia tenacissima extract powder 75.2g.
7, Marsdenia tenacissima extract powder 64g, the dextrin 8g in step 6 are taken, is uniformly mixed, the water for being added 12.5% continues to mix It closes, compression granulation;Tabletting, sugar coating obtain XIAOAIPING PIAN.
Embodiment 2:
1, glaucescent fissistigma root 1500g is taken, is placed in 70% ethanol solution of 2.5L and impregnates 6 hours.
2, after impregnating, glaucescent fissistigma root is taken out and is drained from ethanol solution, is then added water to cook.Decocting method is specific For:The amount of water decocted for the first time is 15L, is decocted 2 hours after impregnating 5 hours, and second amount of water that decocts is 7L, when decoction Between be 0.5 hour, third time decoct amount of water be 4L, decocting time be 1 hour.
3, collecting decoction, filtering, filtrate decompression are concentrated into 6.5L, and ethyl alcohol 12L is added while hot, stood after mixing Night.
4, the material in step 3 is filtered, filter residue heats water dissolution and carries out alcohol precipitation, in triplicate.
5, add water 4.5L to dissolve by heating the filter residue in step 4, stand, add 3-4g activated carbons, be heated to boiling, keep the temperature 30min is filtered and is collected filtrate.
6, filtrate is concentrated into paste in step 5, and 75 DEG C are dried under reduced pressure, finely ground to obtain Marsdenia tenacissima extract powder 79.6g.
7, Marsdenia tenacissima extract powder 60g, the dextrin 15g in step 6 are taken, is uniformly mixed, the water for being added 12.5% continues Mixing, compression granulation;Tabletting, sugar coating obtain XIAOAIPING PIAN.
Embodiment 3:
1, glaucescent fissistigma root 1500g is taken, is placed in 80% ethanol solution of 3.5L and impregnates 6 hours.
2, after impregnating, glaucescent fissistigma root is taken out and is drained from ethanol solution, is then added water to cook.Decocting method is specific For:The amount of water decocted for the first time is 15L, is decocted 2 hours after impregnating 5 hours, and second amount of water that decocts is 7L, when decoction Between be 0.5 hour, third time decoct amount of water be 4L, decocting time be 1 hour.
3, collecting decoction, filtering, filtrate decompression are concentrated into 5.5L, and ethyl alcohol 10L is added while hot, stood after mixing Night.
4, the material in step 3 is filtered, filter residue heats water dissolution and carries out alcohol precipitation, in triplicate.
5, add water 3.5L to dissolve by heating the filter residue in step 4, stand, add 3-4g activated carbons, be heated to boiling, keep the temperature 30min is filtered and is collected filtrate.
6, filtrate is concentrated into paste in step 5, and 75 DEG C are dried under reduced pressure, finely ground to obtain Marsdenia tenacissima extract powder 77.3g.
7, Marsdenia tenacissima extract powder 70g, the dextrin 16g in step 6 are taken, is uniformly mixed, the water for being added 12.5% continues Mixing, compression granulation;Tabletting, sugar coating obtain XIAOAIPING PIAN.
The foregoing is only a preferred embodiment of the present invention, but scope of protection of the present invention is not limited thereto, Any one skilled in the art in the technical scope disclosed by the present invention, according to the technique and scheme of the present invention and its Inventive concept is subject to equivalent substitution or change, should be covered by the protection scope of the present invention.

Claims (5)

1. a kind of preparation method of XIAOAIPING PIAN, it is characterised in that:It the described method comprises the following steps:
Step 1: taking appropriate CAULIS MARSDENIAE TENACISSIMAE, the alcohol solution dipping of 2-3 times of volume is added 4-8 hours;
Step 2: the CAULIS MARSDENIAE TENACISSIMAE taken out in ethanol solution drains, it is separately added into distilled water and decocts 3 times, each 1.5h, filter, close And filtrate;
Step 3: the filtrate decompression in step 2 is concentrated into the 1/4 to 1/3 of volume, ethyl alcohol is added while hot, stands overnight;
Step 4: the material in step 3 is filtered, filter residue heats water dissolution and carries out alcohol precipitation, in triplicate;
Step 5: gained filter residue adds water to dissolve by heating in step 4, stand, add 3-4g activated carbons, be heated to boiling, keeps the temperature 30min, It filters and collects filtrate;
Step 6: filtrate is concentrated into paste in step 5,70-75 DEG C is dried under reduced pressure, finely ground to obtain Marsdenia tenacissima extract powder;
Step 7: Marsdenia tenacissima extract powder is uniform with dispersant, the water for being added 12.5% continues to mix, compression system Grain;Tabletting, sugar coating obtain XIAOAIPING PIAN.
2. a kind of preparation method of XIAOAIPING PIAN according to claim 1, it is characterised in that:Ethyl alcohol is molten in the step 1 The mass fraction of liquid is 60%-80%.
3. a kind of preparation method of XIAOAIPING PIAN according to claim 1, it is characterised in that:Add decocting in the step 2 The specific method for boiling CAULIS MARSDENIAE TENACISSIMAE is:The amount of water decocted for the first time is 10 times of crude drug weight, is decocted 2 hours after impregnating 5 hours, Second of amount of water decocted is 7 times of crude drug weight, and decocting time is 0.5 hour, and the amount of water that third time decocts is crude drug 4 times of weight, decocting time are 1 hour.
4. a kind of preparation method of XIAOAIPING PIAN according to claim 1, it is characterised in that:CAULIS MARSDENIAE TENACISSIMAE in the step 7 Weight proportion with dispersant is:16-20 parts of CAULIS MARSDENIAE TENACISSIMAE, 2-5 parts of dispersant.
5. a kind of preparation method of XIAOAIPING PIAN according to claim 4, it is characterised in that:The dispersant be dextrin, Any one of starch.
CN201810487852.6A 2018-05-21 2018-05-21 A kind of preparation method of XIAOAIPING PIAN Pending CN108478614A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115737695A (en) * 2022-11-17 2023-03-07 乐泰药业有限公司 Pharmaceutical preparation for treating various malignant tumors, leukemia and chronic bronchitis, and its preparation method and quality control method

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102000131A (en) * 2010-11-29 2011-04-06 杨凌无为制药集团有限公司 Preparation method of cancer-removing tablets
CN105878319A (en) * 2016-05-08 2016-08-24 通化振霖药业有限责任公司 Xiaoaiping tablet and preparation method thereof

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102000131A (en) * 2010-11-29 2011-04-06 杨凌无为制药集团有限公司 Preparation method of cancer-removing tablets
CN105878319A (en) * 2016-05-08 2016-08-24 通化振霖药业有限责任公司 Xiaoaiping tablet and preparation method thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
中华人民共和国卫生部药典委员会,编: "《中华人民共和国卫生部 药品标准 中药成方制剂 第20册》", 31 December 1998 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115737695A (en) * 2022-11-17 2023-03-07 乐泰药业有限公司 Pharmaceutical preparation for treating various malignant tumors, leukemia and chronic bronchitis, and its preparation method and quality control method

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Application publication date: 20180904