CN110522875B - Preparation method of blood-nourishing miscarriage-preventing and pregnancy-preventing oral liquid - Google Patents

Preparation method of blood-nourishing miscarriage-preventing and pregnancy-preventing oral liquid Download PDF

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CN110522875B
CN110522875B CN201910862123.9A CN201910862123A CN110522875B CN 110522875 B CN110522875 B CN 110522875B CN 201910862123 A CN201910862123 A CN 201910862123A CN 110522875 B CN110522875 B CN 110522875B
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filtering
water
fluid extract
time
oral liquid
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CN110522875A (en
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喻潆霞
李义保
马利雄
文万江
彭常青
彭启华
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Jiangxi Jinshuibao Pharmaceutical Co ltd
Jiangxi Jimin Kexin Pharmaceutical Co Ltd
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Jiangxi Jinshuibao Pharmaceutical Co ltd
Jiangxi Jimin Kexin Pharmaceutical Co Ltd
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Abstract

The invention relates to a preparation method of blood-nourishing miscarriage-preventing Yunkang oral liquid, which comprises the following steps: soaking twenty-two materials except colla Corii Asini, such as rhizoma Dioscoreae, in warm water for 4 hr, filtering, collecting filtrate, decocting the residue with water for three times (2 hr for the first time, 1 hr for the second time, and 0.5 hr for the third time), filtering, mixing the filtrates, and concentrating into fluid extract containing 1g crude drug per 1 ml; adding ethanol into the fluid extract to make ethanol content reach 70%, standing, filtering, recovering ethanol from filtrate, concentrating the fluid extract to relative density of 1.24, controlling temperature at 70 deg.C, adding dissolved 20% colla Corii Asini solution, and boiling for 5 min. Adding 83g of honey, 88g of cane sugar, 3.0g of sodium benzoate and a proper amount of water, uniformly mixing, adding sodium hydroxide test solution to adjust the pH value to 5-6, adding water to 1000ml, adding 3% of perlite, uniformly stirring, filtering, filling and sealing, and sterilizing to obtain the traditional Chinese medicine composition.

Description

Preparation method of blood-nourishing miscarriage-preventing and pregnancy-preventing oral liquid
Technical Field
The invention relates to preparation of a pharmaceutical composition, in particular to a new preparation method of a blood-nourishing miscarriage-preventing traditional Chinese medicine oral liquid preparation Yunkang oral liquid.
Background
The Yunkang oral liquid is a traditional Chinese medicine preparation product which is on the market at present and comprises Chinese yam, teasel root, astragalus, Chinese angelica, east Asian tree fern rhizome (unhaired), dodder, Chinese taxillus twig, eucommia bark (fried), malaytea scurfpea fruit, radix codonopsitis, tuckahoe, largehead atractylodes rhizome (charred), donkey-hide gelatin, rehmannia root, dogwood, medlar, dark plum fruit, white paeony root, villous amomum fruit, alpinia oxyphylla, ramie root, baical skullcap root and argy. Has effects of invigorating spleen, reinforcing kidney, nourishing blood, and preventing miscarriage. Can be used for treating threatened abortion and habitual abortion due to kidney deficiency and deficiency of both qi and blood.
According to the pharmacopoeia, the weight ratio of each traditional Chinese medicine raw material medicine of the Yunkang oral liquid is as follows:
25g of donkey-hide gelatin, 125g of Chinese yam, 125g of radix dipsaci, 100g of radix astragali, 75g of angelica, 75g of rhizoma cibotii, 100g of semen cuscutae, 75g of parasitic loranthus, 50g of eucommia, 75g of fructus psoraleae, 75g of codonopsis pilosula, 100g of poria cocos, 75g of bighead atractylodes rhizome, 75g of rehmannia, 100g of dogwood, 100g of fructus lycii, 50g of dark plum, 75g of radix paeoniae alba, 50g of fructus amomi;
according to pharmacopoeia, the preparation method of the oral liquid for treating pregnancy comprises the following steps:
soaking the twenty-two materials except colla Corii Asini, such as rhizoma Dioscoreae, in warm water for 4 hr, filtering, collecting filtrate, decocting the residue with water for three times (2 hr for the first time, 1 hr for the second time, and 0.5 hr for the third time), filtering, mixing the filtrates, adding colla Corii Asini, dissolving, and concentrating to obtain fluid extract containing 1g crude drug per 1 ml; adding ethanol into the clear paste to enable the alcohol content to reach 70%, standing, filtering, recovering ethanol from the filtrate, adding 83g of honey, 88g of cane sugar, 3.0g of sodium benzoate and a proper amount of water, uniformly mixing, adding sodium hydroxide test solution to adjust the pH value to 5-6, adding water to 1000ml, filtering, filling and sealing, and sterilizing to obtain the traditional Chinese medicine preparation.
The preparation method of the existing Yunkang oral liquid is to carry out early-stage treatment and later-stage decoction on medicinal materials. In the preparation process, the medicinal materials are soaked in warm water and decocted for three times, the cumulative decocting time is about 7.5 hours, the extracting solution contains effective components, and a large amount of components such as tannin, pigment and the like are extracted, and the components cause the difficulty in filtering the subsequent liquid medicine. After dissolving the donkey-hide gelatin, the donkey-hide gelatin is precipitated with the liquid medicine together with alcohol, so that the content of the donkey-hide gelatin is greatly reduced, about 60 to 70 percent, and the maximum utilization rate cannot be achieved. The Yunkang oral liquid is suitable for special people, and has higher requirements on the sensitivity and safety of pregnant women to drugs, so the invention improves the prior art and provides a novel preparation method of the Yunkang oral liquid.
The Yunkang oral liquid as a medicine with Chinese characteristics represents a new achievement of medicine research and application in China, but with rapid development of science and technology and continuous improvement of material culture requirements of people, the oral liquid of the traditional process is beautiful and deficient, the prior art is improved, and a new Yunkang oral liquid preparation can be produced.
Disclosure of Invention
The invention aims to provide a novel preparation method of an oral liquid for nourishing blood, preventing miscarriage and recovering pregnancy, which aims to solve the problems.
The purpose of the invention is realized as follows: by continuously optimizing the process of the prescription, the donkey-hide gelatin in the prescription is dissolved by water, and the donkey-hide gelatin is added after ethanol precipitation and alcohol recovery of the clear paste, and the transfer rate is increased by optimizing parameters. Then mixing the auxiliary materials and the liquid medicine, and adopting a proper batching technology to obtain the Yunkang oral liquid.
The invention discloses a Yunkang oral liquid which is prepared from the following traditional Chinese medicine raw materials in parts by weight:
e, donkey-hide gelatin: 25g, Chinese yam: 125g, teasel root: 75g, astragalus: 100g, Chinese angelica root: 75g, rhizoma cibotii: 100g, semen cuscutae: 75g, Loranthus parasiticus: 50g, eucommia ulmoides: 75g, fructus psoraleae: 75g, radix codonopsis: 75g, poria cocos: 100g, white atractylodes rhizome: 75g, rehmannia: 100g, dogwood: 75g, wolfberry fruit: 100g, dark plum: 50g, white peony root: 75g, amomum fruit: 50g, intelligence development: 50g of ramie root: 75g, folium artemisiae argyi: 8.3g, scutellaria: 50g of the total weight of the mixture;
the preparation method comprises the following steps:
soaking the twenty-two materials except colla Corii Asini, such as rhizoma Dioscoreae, in warm water for 4 hr, filtering, collecting filtrate, decocting the residue in water for three times (2 hr for the first time, 1 hr for the second time, and 0.5 hr for the third time), filtering, mixing the filtrates, and concentrating into fluid extract containing 1g crude drug per 1 ml; adding ethanol into the fluid extract to make ethanol content reach 70%, standing, filtering, recovering ethanol from filtrate, concentrating the fluid extract to relative density of 1.24, controlling temperature at 70 deg.C, adding dissolved 20% colla Corii Asini solution, and boiling for 5 min. Adding 83g of honey, 88g of cane sugar, 3.0g of sodium benzoate and a proper amount of water, uniformly mixing, adding sodium hydroxide test solution to adjust the pH value to 5-6, adding water to 1000ml, adding 3% of perlite, uniformly stirring, filtering, filling and sealing, and sterilizing to obtain the traditional Chinese medicine composition.
The preparation method is obtained by screening, and the optimum extraction process is determined by taking the content of the donkey-hide gelatin as an evaluation index in the screening process.
Soaking twenty-two materials except colla Corii Asini, such as rhizoma Dioscoreae, in warm water for 4 hr, filtering, collecting filtrate, decocting the residue with water for three times (2 hr for the first time, 1 hr for the second time, and 0.5 hr for the third time), filtering, mixing the filtrates, and concentrating into fluid extract containing 1g crude drug per 1 ml; adding ethanol into the fluid extract to make ethanol content reach 70%, standing, filtering, recovering ethanol from the filtrate, adding melted colla Corii Asini, boiling, and performing experimental screening according to detection result (referring to detection method of colla Corii Asini in Chinese pharmacopoeia 2015 edition).
Optimizing the extraction process in the step 1: the process for avoiding alcohol precipitation of donkey-hide gelatin is adopted, and the influence of the glycine transfer rate in donkey-hide gelatin on the content of the donkey-hide gelatin solution, such as the concentration boiling time of the donkey-hide gelatin solution, at the temperature of the clear paste relative density clear paste is considered.
The invention carries out orthogonal experiment according to 4-factor 3 level, and the experimental result and variance analysis are shown in table 1, table 2 and table 3.
TABLE 1 donkey-hide gelatin content process factor level table
Figure BDA0002200105390000031
TABLE 2 orthogonal Experimental tables for factor screening
Figure BDA0002200105390000032
TABLE 3 analysis of variance of factors affecting donkey-hide gelatin content
Figure BDA0002200105390000033
Figure BDA0002200105390000041
The analysis shows that the relative density of the clear paste and the concentration of the donkey-hide gelatin solution have significant influence on the prescription, the extraction process parameter combination can be obtained according to the mean value, the relative density of the clear paste is 1.24, the concentration of the donkey-hide gelatin solution is 20 percent, the optimal collocation is realized, the temperature and the boiling time have no significant influence, the temperature of the concentrated alcohol precipitation solution is 70 ℃, the cost is saved, the boiling time is selected for 5 minutes, and the scheme is an optimization scheme.
Due to the adoption of the technology of no alcohol precipitation of the donkey-hide gelatin, the transfer rate of amino acid in the donkey-hide gelatin medicinal material is greatly improved, and the quality of the Yunkang oral liquid is improved.
Therefore, the optimal process is as follows: extracting with colla Corii Asini by non-alcohol precipitation method, precipitating fluid extract with ethanol, concentrating to 1.24 relative density, adding dissolved 20% colla Corii Asini solution, and boiling at 70 deg.C for 5 min.
In order to improve the technical problem of difficult filtration of the Yunkang oral liquid medicine, the invention screens the filtration process: and (3) adding a filter aid during filtration, and screening according to the parameters such as the types of the auxiliary materials, the addition amount of the auxiliary materials and the like to determine the optimal batching process.
The preferred process is as follows:
according to a certain proportion, the following different clarifying agents are added: diatomite, cellulose, perlite and active carbon. Screening is carried out by comparing the filtration speed, content, character and clarity.
Soaking twenty-two materials except colla Corii Asini, such as rhizoma Dioscoreae, in warm water for 4 hr, filtering, collecting filtrate, decocting the residue with water for three times (2 hr for the first time, 1 hr for the second time, and 0.5 hr for the third time), filtering, mixing the filtrates, and concentrating into fluid extract containing 1g crude drug per 1 ml; adding ethanol into the fluid extract to make ethanol content reach 70%, standing, filtering, recovering ethanol from filtrate, concentrating the fluid extract to relative density of 1.24, controlling temperature at 70 deg.C, adding dissolved 20% colla Corii Asini solution, and boiling for 5 min. Adding 83g of honey, 88g of cane sugar, 3.0g of sodium benzoate and a proper amount of water, uniformly mixing, adding sodium hydroxide test solution to adjust the pH value to 5-6, adding water to 1000ml, adding a filter aid, uniformly stirring, filtering, filling and sealing, and sterilizing to obtain the traditional Chinese medicine. The results are shown in Table 4.
TABLE 4 screening of Filter aids
Figure BDA0002200105390000042
Figure BDA0002200105390000051
From all the data analyses above, it follows: the perlite is adopted for the filter, the filter effect is best, the filter speed is fastest, the stability is strong, the curative effect is stable, and the sample is accelerated for six months without sediment, so the perlite is preferably used as the filter aid.
TABLE 5 screening of perlite dosage
Figure BDA0002200105390000052
From the results in the above table, it can be seen that the addition of a small amount of perlite has little effect on the filtration rate of the Yunkang oral liquid, the effect on clarity is not obvious, the filtration-assisting effect increases with the increase of the dosage, and when the addition of a certain amount of perlite is carried out, the filtration effect is reduced due to the too large volume of the perlite. In conjunction with production requirements, we chose 3% as the optimum addition.
Therefore, the most preferred scheme of the invention is as follows: extracting with colla Corii Asini by non-alcohol precipitation method, precipitating fluid extract with ethanol, concentrating to 1.24 relative density, adding dissolved 20% colla Corii Asini solution, and boiling at 70 deg.C for 5 min. 3 percent of perlite is selected for filtration, and the obtained product has the best effect.
The invention has the following advantages through improvement: the process for preventing donkey-hide gelatin from alcohol precipitation aims at detecting the glycine content in donkey-hide gelatin, and compared with the traditional extraction method, the transfer rate can be improved to 80-89%, which shows that the process can improve the drug effect to a great extent on the same dosage.
Detailed Description
Example 1:
weighing the following raw materials in proportion:
e, donkey-hide gelatin: 25g, Chinese yam: 125g, teasel root: 75g, astragalus: 100g, Chinese angelica root: 75g, rhizoma cibotii: 100g, semen cuscutae: 75g, Loranthus parasiticus: 50g, eucommia ulmoides: 75g, fructus psoraleae: 75g, radix codonopsis: 75g, poria cocos: 100g, white atractylodes rhizome: 75g, rehmannia: 100g, dogwood: 75g, wolfberry fruit: 100g, dark plum: 50g, white peony root: 75g, amomum fruit: 50g, intelligence development: 50g of ramie root: 75g, folium artemisiae argyi: 8.3g, scutellaria: 50g of the total weight of the mixture;
soaking the twenty-two materials except colla Corii Asini, such as rhizoma Dioscoreae, in warm water for 4 hr, filtering, collecting filtrate, decocting the residue in water for three times (2 hr for the first time, 1 hr for the second time, and 0.5 hr for the third time), filtering, mixing the filtrates, and concentrating into fluid extract containing 1g crude drug per 1 ml; adding ethanol into the fluid extract to make ethanol content reach 70%, standing, filtering, recovering ethanol from filtrate, concentrating the fluid extract to relative density of 1.24, controlling temperature at 70 deg.C, adding dissolved 20% colla Corii Asini solution, and boiling for 5 min. Adding 83g of honey, 88g of cane sugar, 3.0g of sodium benzoate and a proper amount of water, uniformly mixing, adding sodium hydroxide test solution to adjust the pH value to 5-6, adding water to 1000ml, adding 3% of perlite, uniformly stirring, filtering, filling and sealing, and sterilizing to obtain the traditional Chinese medicine composition.

Claims (1)

1. The preparation method of the Yunkang oral liquid is characterized in that the Yunkang oral liquid is prepared from the following traditional Chinese medicine raw materials in parts by weight:
e, donkey-hide gelatin: 25g, Chinese yam: 125g, teasel root: 75g, astragalus: 100g, Chinese angelica root: 75g, rhizoma cibotii: 100g, semen cuscutae: 75g, Loranthus parasiticus: 50g, eucommia ulmoides: 75g, fructus psoraleae: 75g, radix codonopsis: 75g, poria cocos: 100g, white atractylodes rhizome: 75g, rehmannia: 100g, dogwood: 75g, wolfberry fruit: 100g, dark plum: 50g, white peony root: 75g, amomum fruit: 50g, intelligence development: 50g of ramie root: 75g, folium artemisiae argyi: 8.3g, scutellaria: 50g of the total weight of the mixture;
the preparation method comprises the following steps:
soaking the rest twenty-two medicinal materials except colla Corii Asini in warm water for 4 hr, filtering, collecting filtrate, decocting the residue with water for three times (2 hr for the first time, 1 hr for the second time, and 0.5 hr for the third time), filtering, mixing the filtrates, and concentrating into fluid extract containing 1g crude drug per 1 ml; adding ethanol into the fluid extract to make ethanol content reach 70%, standing, filtering, recovering ethanol from filtrate, concentrating the fluid extract to relative density of 1.24, controlling temperature at 70 deg.C, adding dissolved 20% colla Corii Asini solution, and boiling for 5 min; adding 83g of honey, 88g of cane sugar, 3.0g of sodium benzoate and a proper amount of water, uniformly mixing, adding sodium hydroxide test solution to adjust the pH value to 5-6, adding water to 1000ml, adding 3% of perlite, uniformly stirring, filtering, filling and sealing, and sterilizing to obtain the traditional Chinese medicine composition.
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Publication number Priority date Publication date Assignee Title
CN103071103A (en) * 2013-01-25 2013-05-01 回音必集团浙江亚东制药有限公司 Pregnancy healing oral liquid for treating abortion and preparation method of oral liquid
CN104173893A (en) * 2014-07-28 2014-12-03 江西济民可信药业有限公司 Preparation method of oral liquid for pregnancy health
CN109820982A (en) * 2019-03-07 2019-05-31 回音必集团浙江齐齐制药有限公司 A kind of preparation process of Yunkang oral liquid

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103071103A (en) * 2013-01-25 2013-05-01 回音必集团浙江亚东制药有限公司 Pregnancy healing oral liquid for treating abortion and preparation method of oral liquid
CN104173893A (en) * 2014-07-28 2014-12-03 江西济民可信药业有限公司 Preparation method of oral liquid for pregnancy health
CN109820982A (en) * 2019-03-07 2019-05-31 回音必集团浙江齐齐制药有限公司 A kind of preparation process of Yunkang oral liquid

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