CN117257863A - Trollium drop pill and preparation process thereof - Google Patents

Trollium drop pill and preparation process thereof Download PDF

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Publication number
CN117257863A
CN117257863A CN202311508095.3A CN202311508095A CN117257863A CN 117257863 A CN117257863 A CN 117257863A CN 202311508095 A CN202311508095 A CN 202311508095A CN 117257863 A CN117257863 A CN 117257863A
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parts
polyethylene glycol
menthol
stevioside
chinese patent
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CN202311508095.3A
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Chinese (zh)
Inventor
李宏
韩晓倩
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Hainan Jiuxu Pharmaceutical Technology Co ltd
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Hainan Jiuxu Pharmaceutical Technology Co ltd
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Priority to CN202311508095.3A priority Critical patent/CN117257863A/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)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61P11/02Nasal agents, e.g. decongestants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/04Drugs for disorders of the respiratory system for throat disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • A61P31/16Antivirals for RNA viruses for influenza or rhinoviruses
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
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  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Virology (AREA)
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  • General Chemical & Material Sciences (AREA)
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  • Pulmonology (AREA)
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  • Natural Medicines & Medicinal Plants (AREA)
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  • Communicable Diseases (AREA)
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Abstract

The invention discloses a Chinese patent medicine for clearing heat and detoxicating. The Chinese patent medicine is prepared from the following raw materials in parts by mass: 500 parts of trollius chinensis bunge, 205.5 parts of polyethylene glycol 4000, 3 parts of stevioside and 1.5 parts of menthol, and 1000 parts of the trollius chinensis bunge is prepared. The traditional Chinese medicine provided by the invention is used for treating symptoms of upper respiratory tract infection, pharyngitis and tonsillitis caused by pathogenic wind-heat evil attacking the lung and excessive heat evil.

Description

Trollium drop pill and preparation process thereof
Technical Field
The application relates to the technical field of medicines, in particular to a trollflower dripping pill and a preparation process thereof.
Background
Viral upper respiratory tract infection refers to upper respiratory tract inflammation caused by viruses, and has local symptoms such as systemic symptoms, rhinitis, pharyngitis, tonsillitis and the like with different degrees. Including common cold, influenza, adenovirus diseases, syncytial virus diseases, etc., are among the most common diseases of human beings, and the symptoms thereof can be light or heavy. At present, western medicine does not have specific medicines, and the treatment only mainly supports symptomatic treatment. Because of the wide variety of viruses, the infection range is wide, the immunity is not durable, and the virus can be maintained by means of repeated infection, so that the vaccine is widely used for preventing the virus. The traditional Chinese medicine has certain advantages compared with western medicine in treating the diseases. The diseases belong to the category of exogenous diseases in traditional Chinese medicine, and the symptoms of the diseases are seen in wind-warm disease, spring-warm disease, summer-heat-warm disease and the like, and in solar disease, shaoyang disease and yangming disease in typhoid fever. The report on the treatment of influenza by traditional Chinese medicine is more in the last fifties to the eighties, and clinical and laboratory researches on the treatment of viral upper respiratory tract infection by using a compound are continuously visible in the last 10 years. From the aspects of pathogenic characteristics and research trends, traditional Chinese medicine has a relatively development prospect for treating the diseases.
The use of antibiotics can shorten the upper respiratory tract disease course and relieve the upper respiratory tract infection symptoms, but usually has a certain side effect on human bodies and is easy to generate drug resistance. The Chinese medicinal injection may have acute toxic reaction and anaphylaxis in use. Thus, there remains a need in the art for a medicament that is easy to store and carry, has few side effects, and is stable for use in the treatment of upper respiratory tract infections.
Disclosure of Invention
In order to solve the technical problems, the invention provides a dripping pill prepared from pure Chinese herbal medicines, and the dripping pill has good curative effect and is convenient to take.
In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:
a Chinese patent medicine for clearing heat and detoxicating is mainly prepared from traditional Chinese medicine raw materials and auxiliary materials; 200-600 parts of trollius chinensis, 4000 100-300 parts of polyethylene glycol, 2-5 parts of stevioside and 1-3 parts of menthol.
Preferably, 300-500 parts of trollius chinensis, 4000 150-220 parts of polyethylene glycol, 2-4 parts of stevioside and 1-2 parts of menthol.
More preferably, 500 parts of trollius chinensis, 205.5 parts of polyethylene glycol 4000, 3 parts of stevioside and 1.5 parts of menthol.
The invention also aims at providing a preparation method of the Chinese patent medicine, which is characterized in that trollius chinensis bunge is weighed, added with water with the mass of 6-10 times that of the trollius chinensis bunge for 0.5-2 hours, extracted for 2-3 times under reflux, extracted for 1-2 hours each time, filtered after each extraction is finished, collected and combined with filtrate, recycled water, and the filtrate is concentrated to the density of 1.1-1.3 under reduced pressure and dried under reduced pressure at the temperature of 60-80 ℃ to obtain trollius chinensis bunge extract; the trollius chinensis bunge extract is mixed with stevioside, menthol and polyethylene glycol 4000, and is melted uniformly, and then is cooled by dripping to form a dripping pill preparation.
The preparation method is characterized by accurately weighing polyethylene glycol 4000 with a command amount, trollius chinensis extract, stevioside and menthol, firstly adding about 1/2 of the polyethylene glycol 4000 with the command amount into a clean and dry batching tank, setting the temperature of the hot water tank to be 76 ℃, heating the mixture through an interlayer to enable the mixture to be completely melted, then mixing the rest polyethylene glycol 4000 with the trollius chinensis extract with the command amount, adding the mixture into the completely melted polyethylene glycol 4000, finally adding the stevioside and the menthol in sequence, and after the materials are completely melted and the temperature reaches 76+/-6 ℃, preserving heat and stirring the mixture for about 30min to enable the materials to be uniformly mixed. The dripping temperature is controlled within 76+/-6 ℃.
Another object of the present invention is to provide a method for preparing trollius chinensis bunge extract, characterized in that: soaking weighed flos Trollii in 6-10 times of water for 0.5-2 hr, reflux extracting for 2-3 times, extracting for 1-2 hr each time, filtering after each extraction, collecting combined filtrate, recovering water, concentrating the filtrate under reduced pressure to density of 1.1-1.3, and drying under reduced pressure at 60-80deg.C.
The preparation method of the trollius chinensis bunge extract is characterized by comprising the steps of decocting weighed trollius chinensis bunge with water with the mass of 6-10 times for 2-3 times, decocting for 40-60 minutes each time, mixing decoctions, filtering, and concentrating filtrate under reduced pressure until the density is 1.1-1.3; drying under reduced pressure at 60-80deg.C. The trollius chinensis bunge extract is obtained.
Detailed Description
EXAMPLE 1 drop temperature study
Taking 500g of trollius chinensis bunge, decocting twice, adding 10 times of water for soaking for 1 hour for the first time, decocting for 1 hour for the second time, adding 10 times of water for decocting for 1 hour, decocting and filtering, combining filtrate, concentrating under reduced pressure to obtain clear paste with the relative density of 1.15-1.20 (70 ℃), drying under reduced pressure below 70 ℃, crushing, sieving with a fifth sieve, uniformly mixing extract powder with 4000205.5g of polyethylene glycol, 3g of stevioside and 1.5g of menthol, melting at 90+/-5 ℃ and then dripping into 1000 granules to obtain the Chinese medicinal composition.
The results show that: under the condition of the parameter, the weight difference of the dripping pills is larger, and the final production yield is lower. The phenomenon that the dripping pills which are dropped out of the individual dripping holes are obviously smaller can occur, the longer the dripping time is, the more abnormal dripping holes are, and the weight of the pills can be recovered to be normal after the dripping holes are dredged.
EXAMPLE 2 drop temperature study
Taking 500g of trollius chinensis bunge, decocting twice, adding 10 times of water for soaking for 1 hour for the first time, decocting for 1 hour for the second time, adding 10 times of water for decocting for 1 hour, decocting and filtering, combining filtrate, concentrating under reduced pressure to obtain clear paste with the relative density of 1.15-1.20 (70 ℃), drying under reduced pressure below 70 ℃, crushing, sieving with a fifth sieve, uniformly mixing extract powder with 4000205.5g of polyethylene glycol, 3g of stevioside and 1.5g of menthol, melting at 76+/-6 ℃ and then dripping into 1000 granules to obtain the Chinese medicinal composition.
The results show that: the temperature of the liquid medicine is controlled within the range of 70-82 ℃, the weight difference of the dripping pills is improved, and the abnormal phenomenon basically does not occur
Example 3 pilot scale validation
75kg of trollius chinensis bunge is taken and decocted twice, 10 times of water is added for soaking for 1 hour in the first time, water is added for 1 hour in the second time, decoction is decocted for 1 hour, decoction liquid is filtered, filtrate is combined, reduced pressure concentration is carried out to obtain clear paste with the relative density of 1.15-1.20 (70 ℃), drying is carried out under the reduced pressure below 70 ℃, crushing is carried out, no. five sieves are adopted, extract powder is evenly mixed with 30.82kg of polyethylene glycol 4000, 0.45kg of stevioside and 0.22kg of menthol, and dripping is carried out after melting at 76+/-6 ℃.
The results are shown in Table 1.
Table 1: pilot scale validation test results
Example 4 batch production
150kg of trollius chinensis bunge is taken and decocted twice, 10 times of water is added for soaking for 1 hour in the first time, water is added for 1 hour in the second time, decoction is decocted for 1 hour, decoction liquid is filtered, filtrate is combined, reduced pressure concentration is carried out to obtain clear paste with the relative density of 1.15-1.20 (70 ℃), drying is carried out under the reduced pressure below 70 ℃, crushing is carried out, no. five sieves are adopted, extract powder is evenly mixed with 4000.65 kg of polyethylene glycol, 0.9kg of stevioside and 0.45kg of menthol, and dripping is carried out after melting at 76+/-6 ℃.
The results are shown in Table 2.
Table 2: mass production test results
Table 3: pill weight difference experimental data

Claims (8)

1. A Chinese patent medicine for clearing heat and detoxicating is characterized in that: the Chinese patent medicine is mainly prepared from traditional Chinese medicine raw materials and auxiliary materials; the traditional Chinese medicine comprises the following raw materials in parts by weight: 200-600 parts of trollius chinensis bunge; the auxiliary materials are as follows: 4000 100-300 parts of polyethylene glycol, 2-5 parts of stevioside and 1-3 parts of menthol.
2. The Chinese patent medicine according to claim 1, wherein: 300-500 parts of trollius chinensis bunge, 4000 150-220 parts of polyethylene glycol, 2-4 parts of stevioside and 1-2 parts of menthol.
3. The Chinese patent medicine according to claim 2, wherein: 500 parts of trollius chinensis bunge, 205.5 parts of polyethylene glycol 4000, 3 parts of stevioside and 1.5 parts of menthol.
4. The method for preparing the Chinese patent medicine according to any one of claims 1 to 3, characterized in that: weighing flos Trollii, soaking in 6-10 times of water for 0.5-2 hr, decocting for 40-60 min each time, reflux extracting for 2-3 times, extracting for 1-2 hr each time, filtering after each extraction, collecting combined filtrates, recovering water, concentrating the filtrate under reduced pressure to density of 1.1-1.3, and drying under reduced pressure at 60-80deg.C to obtain flos Trollii extract; the trollius chinensis bunge extract is mixed with stevioside, menthol and polyethylene glycol 4000, and is melted uniformly, and then is cooled by dripping to form a dripping pill preparation.
5. The method for preparing the Chinese patent medicine according to claim 4, wherein the method comprises the following steps: accurately weighing polyethylene glycol 4000, trollius chinensis extract, stevioside and menthol, firstly adding about 1/2 of polyethylene glycol 4000 in the instruction amount into a clean and dry batching tank, setting the temperature of the hot water tank to be 76 ℃, heating the mixture through an interlayer to enable the mixture to be completely melted, then mixing the rest polyethylene glycol 4000 with trollius chinensis extract in the instruction amount, adding the mixture into the completely melted polyethylene glycol 4000, finally adding stevioside and menthol in sequence, and after the materials are completely melted and the temperature reaches 76+/-6 ℃, preserving heat and stirring for about 30min to enable the materials to be uniformly mixed. The dripping temperature is controlled within 76+/-6 ℃.
6. A Chinese medicinal composition for clearing heat and detoxicating comprises the Chinese medicinal materials as claimed in any one of claims 1-3.
7. The traditional Chinese medicine preparation according to claim 6, wherein: the dosage form of the traditional Chinese medicine preparation is selected from any one of the following: tablets, dispersible tablets, capsules, soft capsules, granules, pills, micropills, powders, dripping pills, decoctions, syrups, mixtures, oral liquid preparations, soft extracts and extract.
8. Use of a chinese patent medicine according to any one of claims 1-3 for the preparation of any one of the following products: clearing heat and detoxicating, and can be used for treating upper respiratory infection, pharyngitis and tonsillitis caused by pathogenic wind-heat evil and lung invasion and excessive heat evil.
CN202311508095.3A 2023-11-14 2023-11-14 Trollium drop pill and preparation process thereof Pending CN117257863A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202311508095.3A CN117257863A (en) 2023-11-14 2023-11-14 Trollium drop pill and preparation process thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202311508095.3A CN117257863A (en) 2023-11-14 2023-11-14 Trollium drop pill and preparation process thereof

Publications (1)

Publication Number Publication Date
CN117257863A true CN117257863A (en) 2023-12-22

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Application Number Title Priority Date Filing Date
CN202311508095.3A Pending CN117257863A (en) 2023-11-14 2023-11-14 Trollium drop pill and preparation process thereof

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