Wuxian oral liquid and preparation method thereof

Abstract

The invention provides a Wuxian oral liquid and a preparation method thereof, and belongs to the field of traditional Chinese medicine preparations, the preparation method comprises the following steps: adding water into ginseng, bighead atractylodes rhizome, poria cocos, chrysanthemum, barbary wolfberry fruit, rehmannia root, dwarf lilyturf tuber, dried orange peel, kudzuvine root, fructus viticis and medicated leaven, decocting, mixing all decoctions, filtering, concentrating the filtrate under reduced pressure, adding xylitol and potassium sorbate, cooling the prepared liquid medicine to room temperature, and filling to obtain the Wuxian oral liquid. The sealed oral liquid is sterilized, cooled, wiped, subjected to light inspection, labeled and packaged, cane sugar and citric acid in an original formula are comprehensively replaced with xylitol, xylitol metabolism is not adjusted by insulin, the taste is cool, refreshing and sweet, the taste correction requirement can be met, and the taste of the oral liquid is improved. The medicine safety of diabetics and other people who avoid sugar is ensured, the application range of the product is greatly widened, the product is quantitatively filled, can be taken once a bottle is opened, is accurate in dosage, is convenient for the patient to carry about and take on time, and the treatment compliance of the patient is remarkably improved.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine preparation, and particularly relates to a Wuxian oral liquid and a preparation method thereof. BACKGROUND

[0002] "Wuxian Gao" is a classic traditional Chinese medicine with the effects of invigorating the spleen, opening the appetite, nourishing the kidney, clearing the liver and benefiting qi and generating saliva. Its national standard is included in the State Drug Standard Z32020761, and it is exclusively produced by Jiangsu 707 Natural Pharmaceutical Co., Ltd. The prescription is composed of eleven medicinal materials, such as ginseng, atractylodes, poria cocos, chrysanthemum, medlar, rehmannia, atractylodes, dried tangerine or orange peel, kudzu root, mali, and six gods, and the auxiliary materials are sucrose and citric acid. It is used for treating distension and fullness in the hypochondrium, indigestion, tinnitus and dizziness, memory loss, dry mouth and less saliva, and weakness of limbs.

[0003] Although the drug has definite curative effect, the existing paste and tonic dosage form has obvious limitations: The auxiliary materials limit the applicable population: the original prescription uses sucrose as the main auxiliary material and flavoring agent, and uses citric acid to adjust the taste, which makes the product high in sugar content and the taste slightly sour, and is not suitable for diabetic patients, people with abnormal blood sugar and people who strictly control sugar intake.

[0004] The dosage form leads to inconvenience in use: the decocted paste has a sticky texture, and when taking, special tools are needed to take it, the dosage is not easy to control, and the packaging container is not portable, which affects the medication compliance of patients, especially those who need to go out or take medicine for a long time.

[0005] Therefore, it is of important practical significance and application value to improve the dosage form and optimize the auxiliary materials of "Wuxian Gao" and develop a new preparation with wider application population and more convenient taking. SUMMARY

[0006] The technical problem solved by the present application is to solve the problems of limited applicable population and poor patient compliance caused by the existing "Wuxian Gao" technology due to the presence of sucrose and inconvenience in carrying.

[0007] The present application provides a Wuxian oral liquid and a preparation method thereof. The method replaces the paste and tonic with an oral liquid, and replaces sucrose and citric acid with xylitol, to prepare a new dosage form without sugar, portable and with accurate dosage.

[0008] To solve the problems in the prior art, the technical scheme adopted by the present application is as follows: A preparation method of a Wuxian oral liquid, specifically comprising the following steps: First step, raw material preparation: according to the mass fraction of the proportion of ginseng 30-60 parts, Bai Zhi 40-80 parts, Fuling 40-80 parts, chrysanthemum 30-60 parts, medlar 40-80 parts, dihuang 50-100 parts, Maidong 40-80 parts, dried tangerine or orange peel 20-50 parts, Gegen 40-80 parts, vine 30-60 parts, Liu Shen Qu 40-80 parts; Second step, extraction: ginseng, Bai Zhi, Fuling, chrysanthemum, medlar, dihuang, Maidong, dried tangerine or orange peel, Gegen, vine and Liu Shen Qu are soaked in water for 1-2 hours, then decocted for 2-3 times, each time for 1-2 hours; Third step, filtration: combine all the decoction liquid, filter to get the filtrate; Fourth step, concentration: the filtrate is concentrated under the condition of 60-70℃, vacuum degree-0.05 to-0.08MPa, reduced pressure to relative density 1.08-1.12 of the flow infusion paste; Fifth step, preparation and dissolution: add 4%-6% of xylitol by weight of the flow infusion paste, at the same time, add 0.1%-0.2% of potassium sorbate or sodium benzoate by weight of the flow infusion paste as preservative, add the same weight of purified water as the flow infusion paste, stir to dissolve the xylitol and preservative completely, mix evenly to get the prepared liquid; Sixth step: cool the prepared liquid to room temperature, stand for 12-24 hours; Seventh step: take the supernatant, use precision filtration device for precision filtration to get the clear liquid; Eighth step: in a clean environment, fill the precision filtered liquid into oral liquid bottles, each filled with 30g, and immediately sealed; Ninth step, sterilization and packaging: the sealed oral liquid is subjected to flow steam sterilization or boiling sterilization, cooled, bottle wiped, lamp checked, labeled and packaged, to get the Wuxian oral liquid.

[0009] Preferably, the ginseng, Bai Zhi, Fuling, chrysanthemum, medlar, dihuang, Maidong, dried tangerine or orange peel, Gegen, vine and Liu Shen Qu are all medicinal decoction pieces.

[0010] Preferably, the first step is to take ginseng 45g, Bai Zhi 60g, Fuling 60g, chrysanthemum 45g, medlar 60g, dihuang 75g, Maidong 60g, dried tangerine or orange peel 35g, Gegen 60g, vine 45g and Liu Shen Qu 60g by mass ratio.

[0011] Preferably, the second step is to decoct twice, the first time is to add 10 times the amount of water, boil and keep micro boiling for 1.5 hours, filter out the liquid; the second time is to add 8 times the amount of water, boil and keep micro boiling for 1 hour, filter out the liquid.

[0012] Preferably, the third step of the second step is boiled for 90-120 minutes, and the filtered liquid is obtained.

[0013] Preferably, the third step of the second step is boiled for 90-120 minutes, and the filtered liquid is obtained.

[0014] Preferably, the third step of the second step is boiled for 90-120 minutes, and the filtered liquid is obtained.

[0015] Preferably, the third step of the second step is boiled for 90-120 minutes, and the filtered liquid is obtained.

[0016] Preferably, the third step of the second step is boiled for 90-120 minutes, and the filtered liquid is obtained.

[0017] A Wuxian oral liquid prepared by any one of the above preparation methods.

[0018] Compared with the prior art, the Wuxian oral liquid and the preparation method thereof have the following beneficial effects: 1. Stable process and controllable quality: The present application relates to an oral liquid preparation method for improving the dosage form and optimizing the excipients of the traditional Chinese medicine "Wuxian Gao". The preparation method provided by the present application has a clear process flow and clear process parameters, is easy to realize standardized and large-scale production, and can effectively ensure the stability and uniformity of product quality. 2. High safety and wide application population: The present application creatively uses xylitol to completely replace sucrose and citric acid in the original formula. Xylitol, as a functional sweetener, is not metabolized by insulin, has a cool and sweet taste, can meet the flavoring needs, and ensures the medication safety of diabetic patients and other sugar-intolerant populations, greatly expanding the application population of the product. 3. Advanced dosage form and convenient to take: The traditional paste dosage form is successfully converted into an oral liquid, realizing the modernization and upgrading of the dosage form. The oral liquid is quantitatively filled (30g per bottle), can be taken after opening the bottle, has accurate dosage, is very convenient for patients to carry and take on time, and significantly improves the treatment compliance of patients. 4. Retains efficacy and rapid absorption: The present process uses traditional water extraction combined with modern concentration technology to maximize the extraction and retention of effective components of the original formula. The oral liquid dosage form does not require in vivo dissolution, has high bioavailability, is beneficial to rapid absorption by the human body, and can fully exert its traditional functions of "invigorating the spleen, opening the stomach, nourishing the kidney and liver, tonifying qi and generating fluid, and clearing the head and eyes". DETAILED DESCRIPTION

[0019] The application will be further described in the following specific examples, but the protection scope of the application is not limited to this.

[0020] Example 1, a preparation method of Wuxian oral liquid, specifically comprising the following steps: First step, raw material preparation: according to the mass fraction, take ginseng 30 parts, white atractylodes 40 parts, poria 40 parts, chrysanthemum 30 parts, medlar 40 parts, rehmannia 50 parts, ophiopogon 40 parts, dried tangerine or orange peel 20 parts, radix puerariae 40 parts, vitex 30 parts, and six gods 40 parts; Second step, extraction: soak ginseng, white atractylodes, poria, chrysanthemum, medlar, rehmannia, ophiopogon, dried tangerine or orange peel, radix puerariae, vitex and six gods in 8 times the amount of water for 1 hour, first boil with large fire, then keep boiling with small fire, decoct for 90 min, filter out the decocted liquid, add 6 times the amount of hot water to the dregs, decoct for 60 min again, filter out the decocted liquid, add 6 times the amount of hot water to the dregs, decoct for 60 min again; Third step, filtration: combine all the decocted liquids and filter through a 200 mesh sieve to obtain the filtrate; Fourth step, concentration: concentrate the filtrate under the condition of 60℃ and vacuum degree-0.05MPa to relative density 1.08 flow extract; Fifth step, preparation and dissolution: add 4% of the weight of the flow extract of xylitol as a flavoring agent and a bulking agent, at the same time, add 0.1% of the weight of the flow extract of potassium sorbate or sodium benzoate as a preservative, add the same weight of purified water as the flow extract, stir to completely dissolve the xylitol and the preservative, and mix uniformly to obtain the prepared liquid; Sixth step: cool the prepared liquid to room temperature and stand for 12 hours; Seventh step: take the supernatant and use 0.45μm microporous filter membrane for precision filtration to obtain clear liquid; Eighth step: in a clean environment, fill the precision filtered liquid into 10mL oral liquid bottles, each filled with 30g, and immediately sealed; Ninth step, sterilization and packaging: sterilize the sealed oral liquid by flow steam at 100℃ for 30 minutes or by boiling sterilization, cool, wipe the bottles, lamp check, label, and package to obtain Wuxian oral liquid.

[0021] Ginseng, white atractylodes, poria, chrysanthemum, medlar, rehmannia, ophiopogon, dried tangerine or orange peel, radix puerariae, vitex and six gods are all medicinal materials.

[0022] Example 2, a preparation method of Wuxian oral liquid, specifically comprising the following steps: First step, raw material preparation: according to the mass fraction of 60 parts of ginseng, 80 parts of white atractylodes, 80 parts of poria, 60 parts of chrysanthemum, 80 parts of medlar, 100 parts of rehmannia, 80 parts of ophiopogon, 50 parts of dried tangerine or orange peel, 80 parts of kudzu root, 60 parts of vitex, 80 parts of six gods; Second step, extraction: ginseng, white atractylodes, poria, chrysanthemum, medlar, rehmannia, ophiopogon, dried tangerine or orange peel, kudzu root, vitex and six gods were soaked in 12 times the amount of water for 2 hours, boiled with large fire first, then kept boiling with small fire, decocted for 120 min, filtered the decocted liquid, added 8 times the amount of hot water to the dregs, decocted for 90 min again, filtered the decocted liquid, added 8 times the amount of hot water to the dregs, decocted for 90 min again; Third step, filtration: all decocted liquids were combined and filtered with plate and frame filter press to obtain filtrate; Fourth step, concentration: the filtrate was concentrated under reduced pressure at 70℃ and vacuum degree-0.08MPa to flow extract with relative density of 1.12; Fifth step, preparation and dissolution: 6% of xylitol was added as flavoring agent and bulking agent, 0.2% of potassium sorbate or sodium benzoate was added as preservative, and the same weight of purified water as the flow extract was added, and stirred to dissolve the xylitol and preservative completely to obtain prepared liquid; Sixth step: the prepared liquid was cooled to room temperature and placed for 24 hours; Seventh step: the supernatant was taken and refined with 0.45μm microporous filter membrane to obtain clear liquid; Eighth step: the refined liquid was filled in 10mL oral liquid bottles under clean environment, each filled with 30g, and immediately sealed; Ninth step, sterilization and packaging: the sealed oral liquid was sterilized by flow steam at 100℃ for 30 minutes or boiled to sterilize, cooled, wiped, lamp checked, labeled and packaged to obtain five immortals oral liquid.

[0023] Example 3, a preparation method of five immortals oral liquid, specifically including the following steps: First step, raw material preparation: according to the mass ratio, 45g of ginseng, 60g of white atractylodes, 60g of poria, 45g of chrysanthemum, 60g of medlar, 75g of rehmannia, 60g of ophiopogon, 35g of dried tangerine or orange peel, 60g of kudzu root, 45g of vitex, 60g of six gods were weighed; Second step, extraction: ginseng, white atractylodes, poria, chrysanthemum, medlar, rehmannia, ophiopogon, dried tangerine or orange peel, kudzu root, vitex and six gods were soaked in 10 times the amount of water for 1.5 hours, boiled and kept boiling for 1.5 hours, filtered the liquid; the second decoction was added with 8 times the amount of water, boiled and kept boiling for 1 hour, filtered the liquid; Third step, filtration: all decocted liquids were combined and filtered with 250 mesh sieve to obtain filtrate; Fourth step, concentration: the filtrate was concentrated under reduced pressure at 65℃, vacuum-0.06MPa to the relative density of 1.10 (60℃) flow extract 600g; Fifth step, preparation and dissolution: to the flow extract 30g xylitol and 1.2g potassium sorbate, add purified water to a total weight of 1000g, fully stirred until completely dissolved, mixed evenly to obtain the prepared liquid; Sixth step: the prepared liquid was cooled to room temperature, and precipitated for 18 hours overnight; Seventh step: take the supernatant, and use 0.45μm microporous filter to obtain the clear liquid; Eighth step: in a clean environment, the filtrate was filled in 10mL oral liquid bottles, each filled with 30g, and immediately sealed; Ninth step, sterilization and packaging: the sealed oral liquid was sterilized by flow steam at 100℃ for 30 minutes, cooled, wiped, inspected, labeled, and packaged, to obtain 33 bottles of Wuxian oral liquid.

[0024] The product has a sweet and refreshing taste, no sweet and sticky feeling of sucrose and obvious sour taste, and all indexes meet the relevant requirements of Chinese Pharmacopoeia for oral liquid preparations.

[0025] The above described embodiments are part of the embodiments of the present application, but not all. The detailed description of the embodiments of the present application is not intended to limit the scope of the claimed application, but only represents selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor are within the scope of protection of the present application.

Claims

1. A preparation method of Wu Xian oral liquid, characterized in that, Specifically comprising the following steps: The first step, raw material preparation: according to the mass fraction of the ratio of ginseng 30-60 parts, Bai Zhi 40-80 parts, Fuling 40-80 parts, chrysanthemum 30-60 parts, medlar 40-80 parts, Rehmannia 50-100 parts, Ophiopogon 40-80 parts, dried tangerine or orange peel 20-50 parts, kudzu root 40-80 parts, Rhamnus 30-60 parts, six gods 40-80 parts; The second step, extraction: ginseng, Bai Zhi, Fuling, chrysanthemum, medlar, Rehmannia, Ophiopogon, dried tangerine or orange peel, kudzu root, Rhamnus and six gods are soaked in water for 1-2 hours, then decocted 2-3 times, each time for 1-2 hours; The third step, filtration: combine all the decoction liquid, filter to get the filtrate; The fourth step, concentration: the filtrate is concentrated under the condition of 60-70℃, vacuum degree-0.05 to-0.08MPa, reduced pressure to relative density 1.08-1.12 of the flow infusion paste; The fifth step, preparation and dissolution: add 4%-6% of xylitol by weight of the flow infusion paste, at the same time add 0.1%-0.2% of potassium sorbate or sodium benzoate by weight of the flow infusion paste as preservative, add the same weight of purified water as the flow infusion paste, stir to dissolve the xylitol and preservative completely, mix evenly to get the prepared liquid medicine; The sixth step: cool the prepared liquid medicine to room temperature, stand for 12-24 hours; The seventh step: take the supernatant, use precision filtration device for precision filtration to get the clear liquid medicine; The eighth step: in a clean environment, fill the precision filtered liquid medicine into oral liquid bottles, each filled with 30g, and immediately sealed; The ninth step, sterilization and packaging: the sealed oral liquid is sterilized by flow steam or boiling, cooled, wiped, light checked, labeled and packaged, then the Wuxian oral liquid is obtained.

2. The preparation method of the Wuxian oral liquid according to claim 1, characterized in that, The ginseng, Bai Zhi, Fuling, chrysanthemum, medlar, Rehmannia, Ophiopogon, dried tangerine or orange peel, kudzu root, Rhamnus and six gods are all medicinal materials.

3. The preparation method of the Wuxian oral liquid according to claim 1, characterized in that, The first step according to the mass ratio of ginseng 45g, Bai Zhi 60g, Fuling 60g, chrysanthemum 45g, medlar 60g, Rehmannia 75g, Ophiopogon 60g, dried tangerine or orange peel 35g, kudzu root 60g, Rhamnus 45g, six gods 60g.

4. The preparation method of the Wuxian oral liquid according to claim 1, characterized in that, The second step, decoction twice, specifically, the first decoction is added with 10 times the amount of water, after boiling, keep it slightly boiling for 1.5 hours, filter out the liquid medicine; the second decoction is added with 8 times the amount of water, after boiling, keep it slightly boiling for 1 hour, filter out the liquid medicine.

5. The preparation method of the Wuxian oral liquid according to claim 1, characterized in that, The second step, decoction three times, specifically, add 8-12 times the amount of water, first boil with high heat, then keep it slightly boiling with low heat, decoct for 90-120min, filter out the decocted liquid medicine, add 6-8 times the amount of hot water to the residue, decoct for 60-90min, filter out the decocted liquid medicine, add 6-8 times the amount of hot water to the residue, decoct for 60-90min.

6. The preparation method of the Wuxian oral liquid according to claim 1, characterized in that, The third step, filter, use plate and frame filter press or 200-250 mesh screen to filter.

7. The preparation method of the Wuxian oral liquid according to claim 1, characterized in that, The xylitol is used as flavoring agent and bulking agent.

8. The preparation method of the Wuxian oral liquid according to claim 1, characterized in that, The seventh step, precision filtration device, use 0.45μm microporous filter membrane for precision filtration.

9. The preparation method of the Wuxian oral liquid according to claim 1, characterized in that, The flow steam sterilization is sterilized at 100℃ for 30min, the oral liquid bottle is 10mL oral liquid bottle.

10. A Wuxian oral liquid prepared by the preparation method of any one of claims 1-9.