CN113663049B - Li nationality medicine postpartum medicated bath effervescent granules and preparation method thereof - Google Patents

Li nationality medicine postpartum medicated bath effervescent granules and preparation method thereof Download PDF

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CN113663049B
CN113663049B CN202111107559.0A CN202111107559A CN113663049B CN 113663049 B CN113663049 B CN 113663049B CN 202111107559 A CN202111107559 A CN 202111107559A CN 113663049 B CN113663049 B CN 113663049B
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postpartum
extract powder
dry extract
mixing
granules
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CN113663049A (en
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谢小丽
于福来
王丹
陈振夏
官玲亮
胡璇
王凯
黄梅
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Tropical Crops Genetic Resources Institute CATAS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/282—Artemisia, e.g. wormwood or sagebrush
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/533—Leonurus (motherwort)
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/85—Verbenaceae (Verbena family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9062—Alpinia, e.g. red ginger or galangal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9068—Zingiber, e.g. garden ginger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007—Effervescent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
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    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation 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
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation 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
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation 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
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The invention provides a Li nationality medicine postpartum medicated bath effervescent granule and a preparation method thereof, according to the action of medicated bath herbal medicines of the Li nationality postpartum women, blumea balsamifera, callicarpa nudiflora, ginger, galangal, motherwort herb and Artemisia argyi extractum are used in a matching and combining way, and then filler, disintegrant and adhesive are added, the six medicinal materials are prepared into the effervescent granule, the effervescent granule has the functions of clearing cold-damp qi in the postpartum women, dispelling wind and reducing swelling, diminishing inflammation and stopping bleeding, inhibiting bacteria and relieving pain, warming meridians and expelling cold, promoting blood circulation and regulating menstruation and removing lochiorrhea, can effectively prevent or treat puerperal diseases and other postpartum sequelae, in addition, the invention prepares the postpartum medicated bath effervescent granules by matching the formula with the auxiliary materials of the effervescent granules, avoids the inconvenience and insanitation of direct use of the raw medicinal materials, meanwhile, the disintegration is quick, the active ingredients are easy to dissolve out, the use is simple and convenient, and the Chinese traditional medicine is beneficial to the popularization and the use of Chinese traditional medicine.

Description

Li nationality medicine postpartum medicated bath effervescent granules and preparation method thereof
Technical Field
The invention relates to the field of traditional Chinese medicine preparations, in particular to Li yao postpartum medicated bath effervescent granules and a preparation method thereof.
Background
The Hainan Li nationality area is located in the north edge of the tropical zone, the climate is mild, frost and snow do not exist in the whole year, the heat is sufficient, the rainfall is abundant, the Wuzhishan is in a terrain with an annular multi-layer structure with a high middle part and a low periphery, the soil is fertile, and the vegetation resource is rich. The history of planting south medicine in Li nationality area is long, and as listed in the book of Huang Yu Kao (public opinion) written by Zhang Tian of the Ming Dynasty, there are betel nut and eaglewood, etc., and the planting of betel nut has been in 1500 years. The number of available high plants in the whole island is 4200, which accounts for 70% of southern Guangdong plants, the number of plants which can be used as medicines is 2000, which accounts for 40% of the whole country, and there are 500 in Chinese medicine dictionary, wherein there are 137 anticancer plants and 30 south medicines.
Li nationality medicine features distinct and regional characteristics, and diversified medicine species, and at present, many herbs in Li nationality medicine are still not recognized, developed and utilized by other nationalities except the nationality. According to the current literature records and actual survey results, Li nationality medicine has better treatment effect on a plurality of difficult and complicated diseases, but Li nationality has no written characters, the inheritance of Li Yi medicine Li is only realized by the family members and the generations, and as time goes on, the old Li doctor with rich experience is less and less, and the inheritance faces crisis. The Li family lying-in woman has no customs of sitting at the moon, and the postpartum woman can achieve the curative effects of eliminating dampness, promoting blood circulation, collecting uterus, removing lochia and the like only by taking herbal medicines or a medicated bath, does not suffer from puerperal diseases, can get out of bed to move after 24 hours of postpartum, can get out of the field after 12 days, and has less postpartum sequelae. However, the preparation of the existing medicated bath needs to directly add water to decoct the raw medicinal materials, which is inconvenient to use, unsanitary and not beneficial to popularization, for example, patent CN110496156A discloses a method for preparing a medicated bath composition for postpartum uterus warming conditioning and a preparation method thereof, which comprises the steps of decocting the medicated bath composition to obtain a decoction, and applying the decoction to a human body in a shower way. Patent CN108478727A discloses a method for preparing a traditional Chinese medicine composition into powder for postpartum recovery, a preparation method of a traditional Chinese medicine composition medicine bag and a using method of the traditional Chinese medicine composition medicine bag, wherein the powder is firstly added with water to decoct functional components for use in a medicated bath.
The invention combines medicines according to the characteristics of the Li nationality postpartum woman medicated bath, extracts functional components through a specific extraction process, prepares the postpartum medicated bath effervescent granules according to a specific method, fully reserves the functional components of the Li nationality medicine, can quickly release the functional components when in use, avoids the inconvenience and insanitation of the direct use of the original medicinal materials, is simple and convenient, and is beneficial to the popularization and the use of the Li nationality medicine.
Disclosure of Invention
Aiming at the problems, the invention provides Li nationality medicine postpartum medicated bath effervescent granules and a preparation method thereof.
The invention relates to Li nationality medicine postpartum medicated bath effervescent granules which comprise the following raw materials in percentage by mass: 10 to 20 percent of Li medicine composition dry extract powder, 15 to 25 percent of filling agent, 52 to 72.5 percent of disintegrating agent and 1 to 3 percent of adhesive; the Li Chinese medicinal composition dry extract powder is prepared by extracting blumea balsamifera, callicarpa nudiflora, ginger, galangal, motherwort and mugwort; the disintegrating agent consists of an acid source, an alkali source and a coating alkali source lubricant.
The Li's medicine can be obtained by looking up the Latin name, alias, origin and usage from Chinese pharmacopoeia and Chinese dictionary, and in order to understand the application of the Li's medicine in postpartum period, the efficacy and pharmacology of the Li's medicine and the local use habit of Li nationality are briefly described as follows:
blumea balsamifera: the blumea belonging to the Compositae belongs to perennial woody herbaceous plants, is one of Li nations and Miao nationality medicines in China, has the Li medicine name 'Nalong', and has the effects of dispelling wind and reducing swelling, promoting blood circulation and removing blood stasis, relieving pain and inflammation, sterilizing and relieving itching, and clearing and benefiting throat; external use for traumatic injury, sore, furuncle, pain and swelling, eczema, and dermatitis. The blumea balsamifera has a long application history in Li nationality in China, folk doctors in Li nationality of Hainan have experience of curing skin burn, scald and knife and gun injury by baking and applying the blumea balsamifera leaves as early as the Ming dynasty, the blumea balsamifera leaves are compounded with a small number of other medicinal materials to obtain a water decoction, and the water decoction is externally used for treating postpartum wind dispelling, dampness removing, bacteriostasis and itching relieving of women, and is also commonly used for infant bath and daily washing and rinsing of adults by using the blumea balsamifera leaves to boil water.
Callicarpa nudiflora: verbenaceae Callicarpa plant is a southern Hainan genuine medicinal material and a common Hainan traditional national medicinal material, is called Li medicine, has the effects of diminishing inflammation, relieving swelling toxin, eliminating dampness and turbidity and stopping bleeding, and is mainly used for treating traumatic hemorrhage, burn, scald and suppurative inflammation. Modern pharmacological activity research shows that the callicarpa nudiflora has the effects of stopping bleeding, resisting inflammation, inhibiting bacteria, enhancing immunity, and treating cytotoxicity, and has a better effect on treating traumatic bleeding clinically. It is commonly used as a hemostatic for trauma in Li nationality of Hainan province.
Ginger: the ginger decoction is a fresh rhizome of a perennial herb ginger of the family Zingiberaceae, is mainly distributed in the south and middle of China, has the effects of warming middle-jiao and expelling cold, restoring yang and dredging pulse, has better health care functions of sterilization and detoxification, anti-inflammation, antioxidation, blood fat reduction, tumor inhibition, liver protection and the like according to the modern pharmacological activity, and is commonly used for treating women postpartum by externally washing the decoction with water in Hainan Li nationality to dispel wind and expel cold, inhibit bacteria and diminish inflammation.
Galangal rhizome: the plant of the genus litsea of the family zingiberaceae has the effects of expelling wind and removing cold, and promoting qi circulation and relieving pain, and the modern pharmacological research shows that the plant has better pharmacological actions of relieving pain and diminishing inflammation, promoting permeability, resisting oxidation, resisting bacteria and the like, is called as the wind-ginger in the Li nationality of Hainan, and is mainly used for expelling wind and removing cold and blood stasis for postpartum women.
Motherwort: the labiate has the effects of promoting blood circulation, regulating menstruation, inducing diuresis, relieving swelling, clearing heat and removing toxicity, and modern pharmacological research shows that the labiate has pharmacological effects of resisting inflammation, easing pain, resisting oxidation, inhibiting bacteria and the like, and is also a commonly used gynecological medicine for Hainan Li nationality.
Mugwort in May: the Compositae plant has effects of dispelling pathogenic wind, relieving swelling, relieving pain, relieving itching, regulating menstruation and stopping bleeding; dispel dampness and relieve itching for external use. Modern pharmacological research shows that the traditional Chinese medicine composition has the pharmacological effects of resisting bacteria and inflammation, disinfecting and expelling parasites, stopping bleeding, resisting allergy, sneezing, relieving itching and the like, in the Li nationality of Hainan, midwife cleans amniotic fluid and postpartum bloody stain of a baby by using the mugwort and cotton cloth blocks, sits in the full term, uses chicken to fry the mugwort for feeding the lying-in woman, and simultaneously boils the mugwort for bathing the lying-in woman.
Furthermore, the dry extract powder of the Li traditional Chinese medicine composition comprises 2.1-2.5 mass ratio of blumea balsamifera, callicarpa nudiflora, ginger, galangal, motherwort herb and artemisia vulgaris to 0.5-1.8 mass ratio of (0.5-1) mass ratio of (1.1-1.3) mass ratio of (0.8-1.2) mass ratio of.
Further, the filler is at least one of D-mannitol and lactose.
Further, the acid source of the disintegrant is tartaric acid; the alkali source of the disintegrating agent is at least one of sodium carbonate and sodium bicarbonate; the lubricant is polyethylene glycol 6000; the mass ratio of the acid source to the alkali source is (1.2-1.3): 1; the mass ratio of the alkali source to the lubricant is 1: (0.7-0.9).
Further, the adhesive is one of a hydroxypropyl methylcellulose aqueous solution, a PVP ethanol solution and a polyvinylpyrrolidone-polyvinyl acetate copolymer.
On the other hand, the invention also provides a preparation method of the Li nationality medicine postpartum medicated bath effervescent granules, which comprises the following steps:
s1, preparing dry extract powder of the Li medicine composition:
s1-1, mixing motherwort, callicarpa nudiflora and galangal, adding ethanol, carrying out ultrasonic treatment for 20-40 min under the conditions of ultrasonic power of 250-350W and ultrasonic frequency of 28-33 KHz, filtering to obtain a filter cake 1 and a filtrate 1, adding an ethanol-sodium ethoxide-aqueous solution into the filtrate 1, carrying out ultrasonic treatment for 10-15 min under the conditions of ultrasonic power of 180-220W and ultrasonic frequency of 28-33 KHz, adding chloroform with the volume of 1 time of that of the filtrate, standing for layering, and removing a chloroform layer to obtain an extracting solution 1; the adding amount of the ethanol-sodium ethoxide-water solution is 1-2 times of the volume of the filtrate 1; in the ethanol-sodium ethoxide-water solution, the mass volume ratio of ethanol to sodium ethoxide to water is 1mL: 0.3-0.6 g:2 mL;
s1-2, mixing blumea balsamifera, ginger and blumea pentandra, adding ethyl acetate, carrying out ultrasonic treatment for 15-25 min under the conditions of ultrasonic power of 180-250W and ultrasonic frequency of 33-40 KHz, filtering to obtain a filter cake 2 and a filtrate 2, adding a chloroform-water mixed solution into the filtrate 2, standing for layering, and taking a chloroform layer to obtain an extracting solution 2; the adding amount of the chloroform-water mixed solution is 1-1.5 times of the volume of the filtrate 2; in the chloroform-water mixed solution, the volume ratio of chloroform to water is 1: 1 to 1.5;
s1-3, mixing the filter cake 1 and the filter cake 2, performing steam distillation, and collecting fractions to obtain fractions;
s1-4, mixing the extracting solution 1 and the extracting solution 2, concentrating under reduced pressure to obtain extract, concentrating the fraction to obtain fraction extract, mixing the extract and the fraction extract, and drying to obtain dry extract powder of the Li traditional Chinese medicine composition;
s2, preparation of effervescent granules:
s2-1, weighing polyethylene glycol 6000, heating in water bath to molten state, adding alkali source of disintegrant, stirring, cooling, drying, and pulverizing;
s2-2, respectively sieving the dry extract powder, the filler, the disintegrating agent and the adhesive of the Li medicinal composition with a 150-mesh sieve;
s2-3, uniformly mixing blumea balsamifera extract powder, callicarpa nudiflora extract powder, ginger extract powder, galangal extract powder, motherwort extract powder and blumea balsamifera extract powder in proportion, and averagely dividing into 2 parts to obtain dry extract powder of the Li traditional Chinese medicine composition;
s2-4, taking 1 part of the dry extract powder of the Li medicine composition obtained in the step S3, uniformly mixing the dry extract powder with a filler and an acid source according to an equivalent incremental method, adding a binder solution to prepare a soft material, sieving the soft material with a 20-mesh sieve for granulation, drying the soft material at 35-45 ℃ for 50-60 min, and sieving the dry material with a 18-mesh sieve for granulation to obtain acid granules;
s2-5, taking the other 1 part of the dry extract powder of the Li medicine composition obtained in the step S3, uniformly mixing the dry extract powder with a filling agent and an alkali source according to an equivalent incremental method, adding a binder solution to prepare a soft material, sieving the soft material with a 20-mesh sieve for granulation, drying the soft material at 35-45 ℃ for 50-60 min, and sieving the dry material with a 18-mesh sieve for granulation to obtain alkaline granules;
s2-6, mixing the acidic granules and the alkaline granules, and packaging to obtain the Li yao postpartum medicated bath effervescent granules.
Furthermore, the adding amount of the ethanol is 10-20 times of the total mass of the motherwort, the callicarpa nudiflora and the galangal after mixing.
Furthermore, the addition amount of the ethyl acetate is 5-10 times of the total mass of the blumea balsamifera, the ginger and the blumea balsamifera after mixing.
Further, the steam distillation time is 5-6 h.
Further, the ethanol is ethanol with the volume concentration of 70-95%.
On the other hand, the invention also provides application of the Li nationality medicine postpartum medicated bath effervescent granules in preventing or treating puerperal diseases and postpartum sequelae.
Further, the application method comprises the steps of putting the effervescent granules into water, and mixing the effervescent granules with the water according to the weight ratio of 1 g: dissolving 80-150 mL of the effervescent granules, and taking a bath after the effervescent granules are completely dissolved.
Compared with the prior art, the invention has the beneficial effects that:
according to the effects of medicinal bath herbal medicines of postpartum women in Li nationality, blumea balsamifera, callicarpa nudiflora, ginger, galangal, motherwort herb and blumea lanceolata extractum are used in a matching and combining mode, then a filling agent, a disintegrating agent and an adhesive are added, the six medicinal materials are prepared into effervescent granules, the effects of clearing cold-damp air in postpartum women are achieved, dispelling wind and eliminating swelling, diminishing inflammation and stopping bleeding, inhibiting bacteria and relieving pain, warming meridians and expelling cold, promoting blood circulation and regulating menstruation and removing lochia are achieved, and the puerperal diseases and other postpartum sequelae can be effectively prevented or treated.
According to the characteristics of medicinal bath herbal medicines of postpartum women in Li nationality, six Li nationalities are extracted in groups, the extraction process is optimized, the functional components of the Chinese herbal medicines in the prescription are fully extracted, the auxiliary materials of the effervescent granules are added, and the postpartum medicinal bath effervescent granules are prepared through the preparation process of the effervescent granules.
Detailed Description
In order to better understand the technical content of the invention, specific examples are provided below to further illustrate the invention.
The invention relates to Li nationality medicine postpartum medicated bath effervescent granules which comprise the following raw materials in percentage by mass: 10-20% of Li traditional Chinese medicine composition dry extract powder, 15-25% of filling agent, 52-72.5% of disintegrating agent and 1-3% of adhesive;
the Li Chinese medicinal composition dry extract powder is prepared by extracting blumea balsamifera, callicarpa nudiflora, ginger, galangal, motherwort and mugwort;
the mass ratio of the dry extract powder of blumea balsamifera, callicarpa nudiflora, ginger, galangal, motherwort herb and blumea balsamifera in the dry extract powder of the Li traditional Chinese medicine composition is (2.1-2.5): (1.4-1.8): (0.5-1): (1.1-1.3): 1 (0.8-1.2);
the disintegrating agent consists of an acid source, an alkali source and a coating alkali source lubricant;
the acid source of the disintegrant is tartaric acid;
the alkali source of the disintegrating agent is at least one of sodium carbonate and sodium bicarbonate;
the lubricant is polyethylene glycol 6000; the mass ratio of the acid source to the alkali source is (1.2-1.3): 1;
the mass ratio of the alkali source to the lubricant is 1: (0.7-0.9).
The formulation ingredient components of examples 1-3 and comparative examples 1-4 are shown in the following table: (unit: g)
Figure BDA0003272915290000061
Figure BDA0003272915290000071
The preparation method of the Li nationality medicine postpartum medicated bath effervescent granules of the examples 1 to 3 and the comparative examples 1 to 4 comprises the following steps:
s1, preparing dry extract powder of the Li medicine composition:
s1-1, mixing motherwort herb, callicarpa nudiflora and galangal, adding ethanol, wherein the adding amount of the ethanol is 15 times of the total mass of the mixed motherwort herb, callicarpa nudiflora and galangal, performing ultrasonic treatment for 40min under the conditions of ultrasonic power of 250W and ultrasonic frequency of 33KHz, filtering to obtain a filter cake 1 and a filtrate 1, adding an ethanol-sodium ethoxide-aqueous solution into the filtrate 1, performing ultrasonic treatment for 10min under the conditions of ultrasonic power of 220W and ultrasonic frequency of 28KHz, adding chloroform with the volume of 1 time of the filtrate 1, standing for layering, and removing a chloroform layer to obtain an extracting solution 1; the addition amount of the ethanol-sodium ethoxide-water solution is 2 times of the volume of the filtrate 1; in the ethanol-sodium ethoxide-water solution, the mass volume ratio of ethanol, sodium ethoxide and water is 1mL to 0.3g to 2 mL;
s1-2, mixing blumea balsamifera, ginger and blumea pentandra, adding ethyl acetate, wherein the addition amount of ethyl acetate is 8 times of the total mass of the mixture of blumea balsamifera, ginger and blumea pentandra, performing ultrasonic treatment for 15min under the conditions of ultrasonic power of 250W and ultrasonic frequency of 40KHz, filtering to obtain a filter cake 2 and a filtrate 2, adding a chloroform-water mixed solution into the filtrate 2, standing for layering, and taking a chloroform layer to obtain an extracting solution 2; the addition amount of the chloroform-water mixed solution is 1 time of the volume of the filtrate 2; in the chloroform-water mixed solution, the volume ratio of chloroform to water is 1: 1.5;
s1-3, mixing the filter cake 1 and the filter cake 2, performing steam distillation, and collecting fractions to obtain fractions;
s1-4, mixing the extracting solution 1 and the extracting solution 2, concentrating under reduced pressure to obtain extract, concentrating the fraction to obtain fraction extract, mixing the extract and the fraction extract, and drying to obtain dry extract powder of the Li traditional Chinese medicine composition;
s2, preparation of effervescent granules:
s2-1, weighing polyethylene glycol 6000, heating in water bath to molten state, adding alkali source of disintegrant, stirring, cooling, drying, and pulverizing;
s2-2, respectively sieving the dry extract powder, the filler, the disintegrating agent and the adhesive of the Li medicinal composition with a 150-mesh sieve;
s2-3, uniformly mixing blumea balsamifera extract powder, callicarpa nudiflora extract powder, ginger extract powder, galangal extract powder, motherwort extract powder and blumea balsamifera extract powder in proportion, and averagely dividing into 2 parts to obtain dry extract powder of the Li traditional Chinese medicine composition;
s2-4, taking 1 part of the dry extract powder of the Li medicinal composition obtained in the step S3, uniformly mixing the dry extract powder with a filling agent and an acid source according to an equivalent incremental method, adding a binder solution to prepare a soft material, sieving the soft material with a 20-mesh sieve for granulation, drying the soft material at 45 ℃ for 50min, and sieving the dry material with a 18-mesh sieve for granulation to obtain acid granules;
s2-5, taking the other 1 part of the dry extract powder of the Li medicinal composition obtained in the step S3, uniformly mixing the dry extract powder with a filling agent and an alkali source according to an equivalent incremental method, adding a binder solution to prepare a soft material, sieving the soft material with a 20-mesh sieve for granulation, drying the soft material at 35 ℃ for 60min, and sieving the soft material with a 18-mesh sieve for granulation to obtain alkaline granules;
s2-6, mixing the acidic granules and the alkaline granules, and packaging to obtain the Li yao postpartum medicated bath effervescent granules.
The formulation of the li-nationality medicine postpartum medicated bath effervescent granules of examples 4-6 is the same as that of example 1, and the preparation method of the li-nationality medicine postpartum medicated bath effervescent granules of examples 4-6 is as follows:
example 4 a method for preparing a postpartum medicated bath effervescent granule of liyao, comprising the following steps:
s1, preparation of Li medicinal composition extract powder:
s1-1, mixing herba Leonuri, folium Callicarpae Formosanae and rhizoma Alpiniae Officinarum, adding ethanol 15 times of the total weight of the mixture, ultrasonic treating for 40min under the conditions of ultrasonic power of 250W and ultrasonic frequency of 33KHz, and filtering to obtain extractive solution 1;
s1-2, mixing blumea balsamifera, ginger and blumea pentandra, adding ethyl acetate, wherein the addition amount of ethyl acetate is 8 times of the total mass of the mixture of blumea balsamifera, ginger and blumea pentandra, performing ultrasonic treatment for 15min under the conditions of ultrasonic power of 250W and ultrasonic frequency of 40KHz, filtering to obtain a filter cake 2 and a filtrate 2, adding a chloroform-water mixed solution into the filtrate 2, standing for layering, and taking a chloroform layer to obtain an extracting solution 2; the addition amount of the chloroform-water mixed solution is 1 time of the volume of the filtrate 2; in the chloroform-water mixed solution, the volume ratio of chloroform to water is 1: 1.5;
s1-4, mixing the filter cake 1 and the filter cake 2, performing steam distillation, and collecting fractions to obtain fractions;
s1-4, mixing the extracting solution 1 and the extracting solution 2, concentrating under reduced pressure to obtain extract, concentrating the fraction to obtain fraction extract, mixing the extract and the fraction extract, and drying to obtain dry extract powder of the Li traditional Chinese medicine composition;
s2, preparing effervescent tablets:
s2-1, weighing polyethylene glycol 6000, heating in water bath to molten state, adding alkali source of disintegrant, stirring, cooling, drying, and pulverizing;
s2-2, respectively sieving the dry extract powder, the filler, the disintegrating agent and the adhesive of the Li medicinal composition with a 150-mesh sieve;
s2-3, evenly dividing the Li traditional Chinese medicine composition extract powder into 2 parts to obtain Li traditional Chinese medicine composition dry extract powder;
s2-4, taking 1 part of the dry extract powder of the Li medicinal composition obtained in the step S3, uniformly mixing the dry extract powder with a filling agent and an acid source according to an equivalent incremental method, adding a binder solution to prepare a soft material, sieving the soft material with a 20-mesh sieve for granulation, drying the soft material at 45 ℃ for 50min, and sieving the dry material with a 18-mesh sieve for granulation to obtain acid granules;
s2-5, taking the other 1 part of the dry extract powder of the Li medicinal composition obtained in the step S3, uniformly mixing the dry extract powder with a filling agent and an alkali source according to an equivalent incremental method, adding a binder solution to prepare a soft material, sieving the soft material with a 20-mesh sieve for granulation, drying the soft material at 35 ℃ for 60min, and sieving the soft material with a 18-mesh sieve for granulation to obtain alkaline granules;
s2-6, mixing the acidic granules and the alkaline granules, and packaging to obtain the Li YAO postpartum medicated bath effervescent granules.
Example 5 a method for preparing a postpartum medicated bath effervescent granule, comprising the following steps:
s1, preparing dry extract powder of the Li medicine composition:
s1-1, mixing motherwort herb, callicarpa nudiflora and galangal, adding ethanol, wherein the adding amount of the ethanol is 15 times of the total mass of the mixed motherwort herb, callicarpa nudiflora and galangal, performing ultrasonic treatment for 40min under the conditions of ultrasonic power of 250W and ultrasonic frequency of 33KHz, filtering to obtain a filter cake 1 and a filtrate 1, adding an ethanol-sodium ethoxide-aqueous solution into the filtrate 1, performing ultrasonic treatment for 10min under the conditions of ultrasonic power of 220W and ultrasonic frequency of 28KHz, adding chloroform with the volume of 1 time of the filtrate 1, standing for layering, and removing a chloroform layer to obtain an extracting solution 1; the addition amount of the ethanol-sodium ethoxide-water solution is 2 times of the volume of the filtrate 1; in the ethanol-sodium ethoxide-water solution, the mass volume ratio of ethanol, sodium ethoxide and water is 1mL to 0.3g to 2 mL;
s1-2, mixing blumea balsamifera, ginger and blumea pentandra, adding ethyl acetate, wherein the addition amount of ethyl acetate is 8 times of the total mass of the mixture of blumea balsamifera, ginger and blumea pentandra, performing ultrasonic treatment for 15min under the conditions of ultrasonic power of 250W and ultrasonic frequency of 40KHz, and filtering to obtain an extracting solution 2;
s1-4, mixing the filter cake 1 and the filter cake 2, performing steam distillation, and collecting fractions to obtain fractions;
s1-4, mixing the extracting solution 1 and the extracting solution 2, concentrating under reduced pressure to obtain extract, concentrating the fraction to obtain fraction extract, mixing the extract and the fraction extract, and drying to obtain dry extract powder of the Li traditional Chinese medicine composition;
s2, preparing effervescent tablets:
s2-1, weighing polyethylene glycol 6000, heating in water bath to molten state, adding alkali source of disintegrant, stirring, cooling, drying, and pulverizing;
s2-2, respectively sieving the dry extract powder, the filler, the disintegrating agent and the adhesive of the Li medicinal composition with a 150-mesh sieve;
s2-3, evenly dividing the Li traditional Chinese medicine composition extract powder into 2 parts to obtain Li traditional Chinese medicine composition dry extract powder;
s2-4, taking 1 part of the dry extract powder of the Li medicinal composition obtained in the step S3, uniformly mixing the dry extract powder with a filling agent and an acid source according to an equivalent incremental method, adding a binder solution to prepare a soft material, sieving the soft material with a 20-mesh sieve for granulation, drying the soft material at 45 ℃ for 50min, and sieving the dry material with a 18-mesh sieve for granulation to obtain acid granules;
s2-5, taking the other 1 part of the dry extract powder of the Li medicinal composition obtained in the step S3, uniformly mixing the dry extract powder with a filling agent and an alkali source according to an equivalent incremental method, adding a binder solution to prepare a soft material, sieving the soft material with a 20-mesh sieve for granulation, drying the soft material at 35 ℃ for 60min, and sieving the soft material with a 18-mesh sieve for granulation to obtain alkaline granules;
s2-6, mixing the acidic granules and the alkaline granules, and packaging to obtain the Li YAO postpartum medicated bath effervescent granules.
Example 6a method for preparing a postpartum medicated bath effervescent granule of Li Yao, comprising the following steps:
s1, preparing dry extract powder of the Li medicine composition: respectively taking motherwort herb, callicarpa nudiflora, galangal rhizome, blumea balsamifera, ginger and blumea balsamifera, adding ethanol with the mass 15 times of that of the motherwort herb, callicarpa nudiflora, galangal rhizome, blumea balsamifera, ginger and blumea balsamifera, carrying out ultrasonic treatment for 20min under the conditions of ultrasonic power of 250W and ultrasonic temperature of 45 ℃, combining the traditional Chinese medicine extracts, filtering, taking filtrate, concentrating the filtrate under reduced pressure into extract, and drying to obtain dry extract powder of the traditional Chinese medicine composition;
s2, preparation of effervescent tablets:
s2-1, weighing polyethylene glycol 6000, heating in water bath to molten state, adding alkali source of disintegrant, stirring, cooling, drying, and pulverizing;
s2-2, respectively sieving the dry extract powder, the filler, the disintegrating agent and the adhesive of the Li medicinal composition with a 150-mesh sieve;
s2-3, evenly dividing the Li traditional Chinese medicine composition extract powder into 2 parts to obtain Li traditional Chinese medicine composition dry extract powder;
s2-4, taking 1 part of the dry extract powder of the Li medicinal composition obtained in the step S3, uniformly mixing the dry extract powder with a filling agent and an acid source according to an equivalent incremental method, adding a binder solution to prepare a soft material, sieving the soft material with a 20-mesh sieve for granulation, drying the soft material at 45 ℃ for 50min, and sieving the dry material with a 18-mesh sieve for granulation to obtain acid granules;
s2-5, taking the other 1 part of the dry extract powder of the Li medicinal composition obtained in the step S3, uniformly mixing the dry extract powder with a filling agent and an alkali source according to an equivalent incremental method, adding a binder solution to prepare a soft material, sieving the soft material with a 20-mesh sieve for granulation, drying the soft material at 35 ℃ for 60min, and sieving the soft material with a 18-mesh sieve for granulation to obtain alkaline granules;
s2-6, mixing the acidic granules and the alkaline granules, and packaging to obtain the Li YAO postpartum medicated bath effervescent granules.
Test example 1 measurement of component content
The effervescent granules prepared in the examples and the comparative examples are dissolved in water according to the proportion, and the content of the components such as blumea balsamifera, verbascoside, 6-gingerol, galangin, stachydrine hydrochloride, eucalyptol and the like is measured, and the result is shown in table 1;
the method for measuring the blumea balsamifera content comprises the following steps: adopting high performance liquid chromatography, the chromatographic conditions are as follows: eclipseXDB-C18(250 mm. times.4.6 mm, 5 μm); the mobile phase was methanol-0.1% phosphoric acid water (43: 57); column temperature: 30 ℃; flow rate: 1.0 mL/min; the detection wavelength is 290 nm; the amount of the sample was 10. mu.L.
A method for measuring the content of verbascoside comprises the following steps: refer to the item of naked flower purple bead tablets in the Chinese pharmacopoeia (2020 edition).
The method for measuring the content of the 6-gingerol comprises the following steps: refer to the item of Zingiber officinale in the pharmacopoeia of China (2020 edition) [ content measurement ].
The galangin content determination method comprises the following steps: refer to the content determination under the item of galangal in the pharmacopoeia of China (2020 edition).
The method for measuring the content of the stachydrine hydrochloride comprises the following steps: refer to the item of motherwort tablets in the Chinese pharmacopoeia (2020 edition) for content determination.
The method for measuring the content of eucalyptol comprises the following steps: the GC-MS method is adopted for determination, and the specific conditions are as follows
Chromatographic conditions are as follows: an Agilent HP-5MS capillary column (0.25 mm. times.30 m, 0.25 μm); carrier gas: he (99.99%); temperature programming: the initial temperature is 40 ℃, the temperature is increased to 100 ℃ at the speed of 5 ℃/min, then the temperature is increased to 200 ℃ at the speed of 10 ℃/min, and the temperature is kept for 7 min; sample introduction amount: 1 mu L of the solution; the flow rate is 1.0 mL/min;
mass spectrum conditions: an EI ion source; electron energy 70 eV; ion source temperature: 250 ℃; temperature of the quadrupole rods: 150 ℃; auxiliary interface temperature: 250 ℃; scanning range: m/z is 45-400; scanning intermittence: 2.94 times per second; delay of the solution: 3 min.
TABLE 1 measurement results of component content
Figure BDA0003272915290000111
Figure BDA0003272915290000121
Experimental data show that the content of each effective component in examples 1-3 is high, wherein in examples 4-5, different methods are adopted to extract the Li medicine group, the effective component of the Li medicine cannot be effectively extracted, and the content of the effective component in the effervescent granules prepared by the method is low; example 6 Li Yao ingredients are extracted respectively, and the extracts are combined to prepare an extract, and the content of each active ingredient is low.
As can be seen from the comparison between example 1 and examples 1-6, the Li nationality medicine postpartum medicated bath effervescent granules prepared by the invention fully retain the functional components in the Li nationality medicine components; as can be seen from the comparison of example 1 with comparative examples 1-4, the Li medicinal component of the present invention can affect the extraction effect.
Test example 2 bacteriostatic test
The effervescent granules obtained in the examples and comparative examples were taken and mixed in a ratio of 1 g: after 150mL of the effervescent granules are disintegrated by adding water in a mass-volume ratio, the bacteriostatic ability of the effervescent granules on pathogenic bacteria such as staphylococcus aureus, escherichia coli, pseudomonas aeruginosa, candida albicans and the like is examined by taking the diameter of a bacteriostatic ring as an index according to a sterilization technical specification 2.1.7.2 bacteriostatic ring test. The results are shown in Table 2;
TABLE 2 measurement results of the diameter of the zone of inhibition
Figure BDA0003272915290000122
Figure BDA0003272915290000131
The result of a bacteriostatic test shows that the effervescent granule has better bacteriostatic effect on staphylococcus aureus, escherichia coli, pseudomonas aeruginosa and candida albicans; comparing example 1 with comparative examples 1-4, it can be seen that the bacteriostatic effect is reduced in the absence of any one of the Li medicament composition of the invention.
Test example 3 efficacy test
3.1 test substance: an effervescent granule of example 1 of the present invention;
3.2 test animals: taking 10 SPF SD postpartum rats and 5 non-farrowing rats (weight 196.2 +/-35 g);
3.2.1 management of test animals
The test animals can freely drink and eat water, the feeding temperature is controlled to be 22 +/-3 ℃, and the relative humidity is controlled to be 50-60 percent; before experiment, raising the tested animal in the experimental environment for 3 d;
3.3 test methods
Randomly dividing postpartum rats into a test group and a positive control group, taking the non-farrowing rats as a blank control group, and recording postpartum symptoms of the rats before the test;
test groups: according to the effervescent granule: water ═ 1 g: 80mL of effervescent granules are put into water, after the effervescent granules are completely disintegrated, the rat is soaked for 20min, the effervescent granules are soaked once every day for 7d of continuous use, the improvement condition of the postpartum symptoms of the rat is observed and recorded in the test process, the weight is weighed after the last administration for 1d, the animal is killed, the color and the transverse diameter of the uterus are observed, and the uterus coefficient is calculated;
blank control group: test groups;
positive control group: the traditional Chinese medicine preparation, namely postpartum recovery medicament, is prepared into traditional Chinese medicine decoction as a positive control, and is administrated by intragastric administration according to the dose of 15mg/g, and the other test groups are the same.
3.4 test results
Calculating the average value of each group of integrals according to table 3, and the calculation result is shown in table 4;
TABLE 3 efficacy scores
Figure BDA0003272915290000132
Figure BDA0003272915290000141
Note: relative uterine diameter is equal to the average uterine diameter of an experimental rat-a blank control group;
uterine coefficient (wet weight of uterus/weight of rat) x 100%;
relative uterine coefficient-uterine coefficient of rats of the placebo group;
TABLE 4 evaluation results of the efficacy test
Figure BDA0003272915290000142
The results show that the rats in the test group have improved postpartum symptoms, have small change of uterus color, are slightly up-regulated relative to the transverse diameter of the uterus and relative uterus coefficients, and have no significant difference with the uterus conditions of the rats in the positive control group; the Li nationality medicine postpartum medicated bath effervescent granule prepared by the invention has the effects of diminishing swelling, diminishing inflammation, stopping bleeding, improving postpartum symptoms and the like, has the same curative effect as the traditional Chinese medicine preparation postpartum recovery medicine, and can be used for preventing or treating puerperal diseases.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims (5)

1. The Li nationality medicine postpartum medicated bath effervescent granules are prepared from the following raw materials in percentage by mass: 10% -20% of Li traditional Chinese medicine composition dry extract powder, 15% -25% of filling agent, 52% -72.5% of disintegrating agent and 1% -3% of adhesive; the Li traditional Chinese medicine composition dry extract powder is obtained by extracting blumea balsamifera, callicarpa nudiflora, ginger, galangal, motherwort and blumea balsamifera, and the mass ratio of blumea balsamifera, callicarpa nudiflora, ginger, galangal, motherwort and blumea balsamifera extract powder in the Li traditional Chinese medicine composition dry extract powder is (2.1-2.5): (1.4-1.8): 0.5-1): 1.1-1.3): 1 (0.8-1.2); the disintegrant consists of an acid source, an alkali source and a coating alkali source lubricant, wherein the acid source of the disintegrant is tartaric acid; the alkali source of the disintegrating agent is at least one of sodium carbonate and sodium bicarbonate; the lubricant is polyethylene glycol 6000; the mass ratio of the acid source to the alkali source is (1.2-1.3) to 1; the mass ratio of the alkali source to the lubricant is 1: (0.7-0.9), the filler is at least one of D-mannitol and lactose, and the adhesive is one of a hydroxypropyl methylcellulose aqueous solution, a PVP ethanol solution and a polyvinylpyrrolidone-polyvinyl acetate copolymer;
the preparation method comprises the following steps:
s1, preparing Li Chinese medicinal composition dry extract powder:
s1-1, mixing motherwort, callicarpa nudiflora and galangal, adding ethanol, wherein the volume concentration of the ethanol is 70-95%, carrying out ultrasonic treatment for 20-40 min under the conditions of ultrasonic power of 250-350W and ultrasonic frequency of 28-33 KHz, filtering to obtain a filter cake 1 and a filtrate 1, adding an ethanol-sodium ethoxide-water solution into the filtrate 1, carrying out ultrasonic treatment for 10-15 min under the conditions of ultrasonic power of 180-220W and ultrasonic frequency of 28-33 KHz, adding chloroform, standing for layering, and removing a chloroform layer to obtain an extracting solution 1; the adding amount of the ethanol-sodium ethoxide-water solution is 1-2 times of the volume of the filtrate 1; in the ethanol-sodium ethoxide-water solution, the mass volume ratio of ethanol to sodium ethoxide to water is 1mL: 0.3-0.6 g:2 mL;
s1-2, mixing blumea balsamifera, ginger and blumea pentandra, adding ethyl acetate, carrying out ultrasonic treatment for 15-25 min under the conditions of ultrasonic power of 180-250W and ultrasonic frequency of 33-40 KHz, filtering to obtain a filter cake 2 and a filtrate 2, adding a chloroform-water mixed solution into the filtrate 2, standing for layering, and taking a chloroform layer to obtain an extracting solution 2; the adding amount of the chloroform-water mixed solution is 1-1.5 times of the volume of the filtrate 2; in the chloroform-water mixed solution, the volume ratio of chloroform to water is 1: 1 to 1.5;
s1-3, mixing the filter cake 1 and the filter cake 2, performing steam distillation, and collecting fractions;
s1-4, mixing the extracting solution 1 and the extracting solution 2, concentrating under reduced pressure to obtain extract, concentrating the fraction to obtain fraction extract, mixing the extract and the fraction extract, and drying to obtain Li Chinese medicinal composition dry extract powder;
s2, preparation of effervescent granules:
s2-1, weighing polyethylene glycol 6000, heating in water bath to molten state, adding alkali source of disintegrant, stirring, cooling, drying, and pulverizing;
s2-2, respectively sieving the dry extract powder, the filler, the disintegrating agent and the adhesive of the Li medicinal composition with a 150-mesh sieve;
s2-3, dividing the Li traditional Chinese medicine composition dry extract powder into 2 parts on average;
s2-4, taking 1 part of the dry extract powder of the Li medicine composition obtained in the step S2-3, uniformly mixing the dry extract powder with a filling agent and an acid source according to an equivalent incremental method, adding a binder solution to prepare a soft material, sieving the soft material with a 20-mesh sieve for granulation, drying the soft material at 35-45 ℃ for 50-60 min, and sieving the dry material with a 18-mesh sieve for granulation to obtain acid granules;
s2-5, taking the other 1 part of the dry extract powder of the Li medicine composition obtained in the step S2-3, uniformly mixing the dry extract powder with a filling agent and an alkali source according to an equivalent incremental method, adding a binder solution to prepare a soft material, sieving the soft material with a 20-mesh sieve for granulation, drying the soft material at 35-45 ℃ for 50-60 min, and sieving the dry material with a 18-mesh sieve for granulation to obtain alkaline granules;
s2-6, mixing the acidic granules and the alkaline granules, and packaging to obtain the Li YAO postpartum medicated bath effervescent granules.
2. The Li yao postpartum medicated bath effervescent granule of claim 1, wherein the addition amount of ethanol is 10-20 times of the total mass of the motherwort, the callicarpa nudiflora and the galangal after mixing.
3. The Li yao postpartum medicated bath effervescent granule of claim 1, wherein the addition amount of the ethyl acetate is 5-10 times of the total mass of the mixture of blumea balsamifera, ginger and Artemisia spicata.
4. The Li nationality medicine postpartum medicated bath effervescent granule of claim 1, wherein the steam distillation time is 5-6 h.
5. The use of the Li nationality medicine postpartum medicated bath effervescent granule of any one of claims 1 to 4, which is used for preparing a medicine for preventing or treating puerperal diseases and postpartum sequelae.
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