CN1695729A - Method for preparing medication for preventing and treating infantile malnutrition - Google Patents

Method for preparing medication for preventing and treating infantile malnutrition Download PDF

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Publication number
CN1695729A
CN1695729A CN 200510010815 CN200510010815A CN1695729A CN 1695729 A CN1695729 A CN 1695729A CN 200510010815 CN200510010815 CN 200510010815 CN 200510010815 A CN200510010815 A CN 200510010815A CN 1695729 A CN1695729 A CN 1695729A
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medicine
fructus
radix
preparation
infantile malnutrition
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CN1274354C (en
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李劲
陈红民
杨绍祥
何红
杨雪涛
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Yunnan Baiyao Group Co Ltd
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TIANZIHONG PHARMACEUTICAL CO Ltd YUNNAN BAIYAO GROUP
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Abstract

A Chinese medicine for treating the malmutrition of children is prepared from 16 Chinese-medicinal materials including pseudostellaria root, tangerine peel, white peony root, yam, etc. Its preparing process is also disclosed.

Description

The preparation method of the medicine of control infantile malnutrition
Technical field
The present invention relates to prevent and treat the preparation method of the medicine of infantile malnutrition, more particularly, is a kind of improvement of preparation method of the medicine to the control infantile malnutrition.
Background technology
Infantile malnutrition is a kind of child's common frdquently encountered disease, always is one of department of pediatrics four big diseases (pox, fiber crops, frightened, infantile malnutrition), has a strong impact on the healthy of child.For this reason, the applicant has proposed the application for a patent for invention (number of patent application: 200410022272.8) that a key name is called " a kind of medicine of preventing and treating infantile malnutrition and preparation method thereof " on April 7th, 2004, this medicine is that raw material is made with 16 flavor Chinese herbal medicine such as Radix Pseudostellariaes, pharmacology and clinical trial through system confirm, it is remarkable to control infantile malnutrition effect, any untoward reaction not occurring, is a kind of good medicine of department of pediatrics safely and effectively, receives praises from customers.But, in production practices, also find, the filter method that the preparation method of this medicine follows conventional lines, invalid components in the material---macromolecular substances is generally albumen, tannin, resin, starch and pectin etc., and filter effect is not ideal enough, it is relatively more difficult to make medicine granulate, especially drug particles is difficult for drying, and easily moisture absorption is unfavorable for preserving and transportation.These weak points have limited the development of producing, and are necessary to be improved in earnest.
Summary of the invention
The objective of the invention is provides a kind of preparation method of medicine of improved control infantile malnutrition at the deficiencies in the prior art part.
Purpose of the present invention is achieved by following technical proposals.
The invention provides a kind of preparation method of medicine of improved control infantile malnutrition, this method may further comprise the steps:
(1) takes by weighing raw material by following weight portion: Radix Pseudostellariae 250~280, the Rhizoma Atractylodis Macrocephalae 250~280, Poria 200~240, HERBA BUPLEURI 200~240, the Radix Paeoniae Alba 200~240, Pericarpium Citri Reticulatae 200~240, the Radix Aucklandiae 50~80, Fructus Amomi 90~130, Fructus Hordei Germinatus 310~350, Spica Prunellae 150~200, Rhizoma Dioscoreae 200~240, Fructus Mume 200~240, Periostracum Cicadae 110~150, Rhizoma Acori Graminei 110~150, Fructus Crataegi 200~240, Radix Glycyrrhizae 50~80; Wherein, the described Rhizoma Atractylodis Macrocephalae is a Rhizoma Atractylodis Macrocephalae (parched), and described Fructus Hordei Germinatus is Fructus Hordei Germinatus (parched), and described Fructus Crataegi is the parching to brown Fructus Crataegi, and described Radix Glycyrrhizae is a Radix Glycyrrhizae Preparata;
(2) with Fructus Amomi, Rhizoma Acori Graminei, the Radix Aucklandiae, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae through water vapour distillation volatile oil;
(3) distillation test residue and Radix Pseudostellariae, Poria, HERBA BUPLEURI, the Radix Paeoniae Alba, Fructus Hordei Germinatus, Spica Prunellae, Rhizoma Dioscoreae, Fructus Mume, Periostracum Cicadae, Fructus Crataegi, Radix Glycyrrhizae water decoct 2 times, and 1~2 hour for the first time, the 2nd time 0.5~1.5 hour; Each amount of water was not advisable to have powder, merged decocting liquid twice, left standstill 4~6 hours;
(4) get supernatant, being concentrated into relative density is 1.0~1.4, and (30 ℃~90 ℃) are cooled to room temperature then;
(5) gains of step (4) are filtered with inorganic pottery magnetic film or fibrous membrane or stainless steel membrane; Concentrating filter liquor is sterilized, and is the active component of required medicine.
The present invention is in order further to improve the clarity of finished product, and can add ethanol in the described filtrate of step (5) while stirring is 70% to containing the alcohol amount, leaves standstill 4~24 hours, filter, filtrate recycling ethanol is put cold to there not being the alcohol flavor, concentrate, sterilize, obtain the active component of medicine.
Wherein, the aperture of described inorganic pottery magnetic film or fibrous membrane or stainless steel membrane is 0.05 μ m~0.35 μ m.
After adding volatile oil in the active ingredient of the medicine that step of the present invention (5) makes, can add conventional adjuvant, as disintegrating agent, binding agent etc., be prepared into any peroral dosage form commonly used with the method for Chinese medicinal of routine, as oral liquid, granule, capsule, mixture, tablet etc.
Compared with prior art, the present invention has following beneficial effect:
Method provided by the present invention can optionally be removed the invalid components in the material, and keeps the less effective ingredient of molecular weight.Reduced medicinal liquid viscosity effectively, make the granulation difficulty that exists in the present production, dry difficult, and the granule moisture absorption is serious etc., and technical barrier is readily solved, preparation is convenient for production quick, further improved the clarity of finished product, and increased the stability of Chinese medicine preparation, the active ingredient of medicine is played a role better.
The specific embodiment
Below in conjunction with specific embodiment, further set forth preparation method of the present invention, but content of the present invention is not limited to shown in the embodiment.
Except as otherwise noted, the percent that is adopted among the present invention is percetage by weight.
Embodiment 1
Fructus Amomi 100 grams, Rhizoma Acori Graminei 120 grams, the Radix Aucklandiae 65 grams, Pericarpium Citri Reticulatae 220 grams, the Rhizoma Atractylodis Macrocephalae 260 are restrained through water vapour distillation volatile oil.Distillation test residue and Radix Pseudostellariae 260 grams, Poria 220 grams, HERBA BUPLEURI 220 grams, the Radix Paeoniae Alba 220 grams, Fructus Hordei Germinatus 330 grams, Spica Prunellae 180 grams, Rhizoma Dioscoreae 220 grams, Fructus Mume 220 grams, Periostracum Cicadae 130 grams, Fructus Crataegi 220 grams, Radix Glycyrrhizae 65 gram waters decoct 2 times, 1.5 hours for the first time, the 2nd time 1 hour; Each amount of water was not advisable to have powder, merged decocting liquid twice, left standstill.Get supernatant, being concentrated into relative density is that 1.0~1.4 (30 ℃~90 ℃) are cooled to room temperature; Then, be that 0.05 μ m ceramic membrane filters with the aperture, concentrating filter liquor, sterilization adds volatile oil, makes oral formulations.It is easy, rapidly dry to granulate, and granule is difficult for moisture absorption, and the good holding time of finished product clarity is long.
Embodiment 2
In order further to improve the clarity of finished product, except described at embodiment 1 be after the ceramic membrane of 0.05 μ m filters with the aperture, adding ethanol again in filtrate while stirring is 70% to containing the alcohol amount, left standstill 4~24 hours, get supernatant liquid filtering, filtrate recycling ethanol is not to there being the alcohol flavor, put cold, concentrated, sterilize beyond, other process is identical with embodiment 1.
Embodiment 3
Repeat embodiment 1, following difference is arranged: getting supernatant is the ceramic membrane filter of 0.10 μ m with the aperture, and filtrate concentrates postcooling to room temperature.Sterilization adds adjuvant, makes oral granule.
Embodiment 4
Repeat embodiment 1, following difference is arranged: getting supernatant is the Fibrous membrane filtration of 0.15 μ m with the aperture, and filtrate concentrates postcooling to room temperature.Sterilization adds adjuvant, makes oral capsule.
Embodiment 5
Repeat embodiment 1, following difference is arranged: getting supernatant is the ceramic membrane filter of 0.20 μ m with the aperture, and filtrate concentrates postcooling to room temperature.Sterilization adds volatile oil, makes oral liquid.
Embodiment 6
Repeat embodiment 1, following difference is arranged: getting supernatant is the stainless steel membrane filtration of 0.35 μ m with the aperture, gets the solution after the filtration, and concentrated postcooling is to room temperature.Sterilization adds volatile oil, makes oral formulations.
Test example 1: the situation of 5 extractum (A, B, C, D, E) that are used to granulate sees Table 1.The extractum of extractum F for not adopting membrane filtration of the present invention to make.
Table 1.
Test example 2
To the test of granulating of the extractum of test in the example 1: granulation production environment: 23 ℃ of temperature, humidity 52%, the quick mixer granulator of equipment: KJZ-50, oscillating granulator CT-C-II heated-air circulation oven.Get A, B, C, D, E, F extractum in the test example 1, add auxiliary materials and mixing respectively, make granule 1,2,3,4,5,6.Result of the test sees Table 2.
Table 2.
Figure A20051001081500062
Continuous table
Granule 1 Qualified Qualified ??0.108% ??4.0% Qualified | | | | | | | | ↓ the poorest
Granule 2 Qualified Qualified ??0.102% ??2.5% Qualified
Granule 3 Qualified Qualified ??0.101% ??4.2% Qualified
Granule 4 Qualified Qualified ??0.094% ??3.3% Qualified
Granule 5 Qualified Qualified ??0.098% ??3.2% Qualified
Granule 6 Qualified Qualified ??0.103% ??3.1% Qualified
The explanation of check situation: the content of (1) extractum is to measure, calculate with the quantity that per 100 gram dry extracts contain peoniflorin.(2) a particulate expansion situation of differentiating from thin layer chromatography, peoniflorin differentiates that expansion is clear, but conditions of streaking is arranged, the Pericarpium Citri Reticulatae glycosides differentiates that impurity is more, and colour developing back point is more, and is influential to the judgement of assay, wherein granule 2 expansion are the most clear, granule 4 takes second place, and granule 1,4 expansion situations are similar, and granule 6 is the poorest.(3) particulate paeoniflorin content is measured by the control standard, and the equal conformance with standard regulation of result (standard code 〉=0.068%) (4) particulate moisture is the standard code inspection item, and this optimal process test is not had directly to be influenced.
Result of the test shows: the present invention selects for use inorganic ceramic film or fibrous membrane or stainless steel membrane that supernatant is filtered, optionally effectively remove the invalid components in the material (being generally macromolecular components such as albumen, tannin, resin, starch and pectin), reduced medicinal liquid viscosity.Because the effective ingredient of medicine of the present invention is mainly alkaloid, flavonoid, glycoside etc., its molecular weight all less (how in 1000), for example: the molecular weight of peoniflorin is 480.45, the molecular weight of hesperidin is 610.55, all is far smaller than the molecular weight cutoff value of filter membrane.Therefore membrane filtration can not cause big loss to active ingredient; All prove the employing membrane filtration technique from granulation situation and assay two aspects, really the infant spleen-tonifying suppressing the hyperactive liver granule technical barriers such as difficulty, dry difficulty and granule moisture absorption be serious of granulating have been improved effectively, and the influence to active constituent content is not obvious, made things convenient for preparation production, further improved the clarity of finished product, increase the stability of Chinese medicine preparation, had the excellent development application prospect.

Claims (5)

1. preparation method of preventing and treating the medicine of infantile malnutrition, this method may further comprise the steps:
(1) takes by weighing raw material by following weight portion: Radix Pseudostellariae 250~280, the Rhizoma Atractylodis Macrocephalae 250~280, Poria 200~240, HERBA BUPLEURI 200~240, the Radix Paeoniae Alba 200~240, Pericarpium Citri Reticulatae 200~240, the Radix Aucklandiae 50~80, Fructus Amomi 90~130, Fructus Hordei Germinatus 310~350, Spica Prunellae 150~200, Rhizoma Dioscoreae 200~240, Fructus Mume 200~240, Periostracum Cicadae 110~150, Rhizoma Acori Graminei 110~150, Fructus Crataegi 200~240, Radix Glycyrrhizae 50~80;
(2) with Fructus Amomi, Rhizoma Acori Graminei, the Radix Aucklandiae, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae through water vapour distillation volatile oil;
(3) distillation test residue and Radix Pseudostellariae, Poria, HERBA BUPLEURI, the Radix Paeoniae Alba, Fructus Hordei Germinatus, Spica Prunellae, Rhizoma Dioscoreae, Fructus Mume, Periostracum Cicadae, Fructus Crataegi, Radix Glycyrrhizae water decoct 2 times, and 1~2 hour for the first time, the 2nd time 0.5~1.5 hour; Each amount of water was not advisable to have powder, merged decocting liquid twice, left standstill 4~6 hours;
(4) get supernatant, being concentrated into relative density is 1.0~1.4 (30 ℃~90 ℃), is cooled to room temperature then;
(5) gains of step (4) are filtered with inorganic pottery magnetic film or fibrous membrane or stainless steel membrane; Concentrating filter liquor is sterilized, and is the active component of required medicine.
2. the preparation method of the medicine of control infantile malnutrition according to claim 1, be included in further that to add ethanol in the described filtrate of step (5) while stirring be 70% to containing alcohol amount, left standstill 4~24 hours, filter, filtrate recycling ethanol is put cold, concentrated to there not being the alcohol flavor, sterilize, obtain the active component of medicine.
3. the preparation method of the medicine of control infantile malnutrition according to claim 1, wherein, the aperture of described inorganic pottery magnetic film or fibrous membrane or stainless steel membrane is 0.05 μ m~0.35 μ m.
4. the preparation method of the medicine of control infantile malnutrition according to claim 1, wherein, the described Rhizoma Atractylodis Macrocephalae is a Rhizoma Atractylodis Macrocephalae (parched); Described Fructus Hordei Germinatus is Fructus Hordei Germinatus (parched); Described Fructus Crataegi is the parching to brown Fructus Crataegi; Described Radix Glycyrrhizae is a Radix Glycyrrhizae Preparata.
5. according to the preparation method of the medicine of claim 1,2,3 or 4 described control infantile malnutritions, further be included in and add volatile oil and conventional adjuvant in the medicament active composition, be prepared into any peroral dosage form commonly used with the method for Chinese medicinal of routine.
CN 200510010815 2005-05-20 2005-05-20 Method for preparing medication for preventing and treating infantile malnutrition Active CN1274354C (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105560984A (en) * 2016-01-06 2016-05-11 广州一品红制药有限公司 Traditional Chinese medicine composition capable of boosting qi and invigorating spleen
CN106177506A (en) * 2016-08-31 2016-12-07 韦志春 A kind of GANJI SAN granule and preparation method thereof
CN106177040A (en) * 2016-08-24 2016-12-07 李永国 A kind of medicine treating infantile malnutrition and preparation method thereof

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105560984A (en) * 2016-01-06 2016-05-11 广州一品红制药有限公司 Traditional Chinese medicine composition capable of boosting qi and invigorating spleen
CN106177040A (en) * 2016-08-24 2016-12-07 李永国 A kind of medicine treating infantile malnutrition and preparation method thereof
CN106177506A (en) * 2016-08-31 2016-12-07 韦志春 A kind of GANJI SAN granule and preparation method thereof

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