CN105106434A - Wolfberry fruit and American ginseng soft capsules and preparation method thereof - Google Patents

Wolfberry fruit and American ginseng soft capsules and preparation method thereof Download PDF

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Publication number
CN105106434A
CN105106434A CN201510615564.0A CN201510615564A CN105106434A CN 105106434 A CN105106434 A CN 105106434A CN 201510615564 A CN201510615564 A CN 201510615564A CN 105106434 A CN105106434 A CN 105106434A
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parts
capsule
american ginseng
fructus lycii
gelatin
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王爱庭
王爱兴
孙溢
马春林
陈秋佳
王耸
李红来
庞瑞
沈建华
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SHANGHAI SPRING TANG BIO-PRODUCTS Co Ltd
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SHANGHAI SPRING TANG BIO-PRODUCTS Co Ltd
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Abstract

The invention relates to wolfberry fruit and American ginseng soft capsules and a preparation method thereof. Each soft capsule is composed of a shell and content filling the shell and is characterized in that the content comprises, by weight, 100-140 parts of wolfberry fruit extract, 45-55 parts of American ginseng extract, 40-55 parts of a suspension, 10-14 parts of an emulsifying agent, and 300-400 parts of a solvent. The soft capsules are prepared by preparing the wolfberry fruit extract and the American ginseng extract, according to a preparation process flow, processing the materials, adding the materials into a blending tank to obtain the content and shells, and performing post-processing such as pelleting and sizing. Compared with the prior art, the soft capsules have the advantages of significant immunity enhancement effect, safety and convenience of taking and the like.

Description

A kind of Fructus Lycii American ginseng soft capsule and preparation method thereof
Technical field
The present invention relates to a kind of health care medicine and preparation method thereof, especially relate to a kind of Fructus Lycii American ginseng soft capsule and preparation method thereof.
Background technology
Along with society and economic progress, the raising of people's living standard, the development of science and technology, the change of disease pattern and the pursuit to good health and a long life, functional food dark people's popular feeling gradually of enhancing immunity, people have started heavily to prevent from heavily treating to turn to, and this will greatly promote the development of the functional food of enhancing immunity.21 century will be the century that functional food is exhibited one's skill to the full.China has the huge treasure-house of this functional food of Chinese herbal medicine and other characteristic resources, the impetus that we should develop in conjunction with the functional food development trend of enhancing immunity and China, make great efforts to excavate these precious resources, develop the functional food of enhancing immunity with Chinese characteristics, to obtain due status in the international competition of fierceness.
"Nei Jing" is thought: " healthy energy internal memory, heresy can not be done ", " gathering of heresy, its gas must be empty ".Immune function of human body is low, and resistance against diseases reduces relevant with deficiency of vital QI.The traditional Chinese medical science is thought, negative and positive of qi and blood is mutual promotion in vital movement process, mutually transforms, and forms a Unified Global.The deficiency of vital energy and yang deficiency represent body activities decline, i.e. so-called " weakened configuration person, warming with drugs of thick nature ".Blood deficiency and the deficiency of YIN represent the consume of body essence and blood body fluid, and enriching blood with nourishing YIN is that replenishing vital essence and blood is not enough, to increase material base, i.e. so-called " insufficiency of essence person, tonifying with drugs of thick flavor ".
Radix Panacis Quinquefolii has supplementing QI and nourishing YIN, falls clearly the function of asthenic fire, promoting the production of body fluid to quench thirst.Radix Panacis Quinquefolii is as the application of Chinese medicine, head sees " Bencao Congxin " of Qing Dynasty's qianlong years, continue and see contemporary supplementary Amplifications of the Compendium of Materia Medica, Radix Panacis Quinquefolii is classified as drugs for nourishing yin, interest is cold and cool, sweet and slightly bitter taste, enter the heart, lung, stomach kidney four warp, the effect that function tonifying the lung YIN nourishing, the relieving restlessness that clears away heart-fire, nourishing the stomach to promote the production of body fluid, pathogenic fire reducing are antipyretic.Modern pharmacological research shows, Radix Panacis Quinquefolii is mainly containing ginsenoside and a small amount of volatile oil, resin, saccharide and starch, and organic acid, aminoacid, trace element, daucosterol etc., and research shows that Radix Panacis Quinquefolii has the health care of enhancing immunity.
Fructus Lycii is China's traditional conventional Chinese medicine simply.Beginning to be loaded in Shennong's Herbal is listed in top grade, calls it: " take hard muscles and bones for a long time, make light of one's life by commiting suicide not old, resistance to cold and summer-heat ".Fructus Lycii sweet in the mouth, property are put down, are returned liver, kidney channel, have the effects such as nourishing the liver and kidney, replenishing vital essence to improve eyesight, nourishing the lung to arrest cough, slow down aging.Modern pharmacological research shows, Fructus Lycii is mainly containing polysaccharide, aminoacid, trace element etc., and chief active becomes lycium barbarum polysaccharide, has immunomodulating, antitumor, anti-ageing various biological effect of waiting for a long time.
Chinese patent 201510226386.2 discloses a kind of Ganoderma American ginseng capsule, be made up of capsule shell and the content enclosed in capsule shell, described content is made up of the raw material of following weight percentage: Ganoderma extract 30 ~ 65%, Radix Panacis Quinquefolii extract 20 ~ 50%, microcrystalline Cellulose 10 ~ 30%, magnesium stearate 0.5 ~ 2.5%.
Summary of the invention
Object of the present invention be exactly in order to overcome above-mentioned prior art exist defect and a kind of Fructus Lycii American ginseng soft capsule and preparation method thereof is provided.
Object of the present invention can be achieved through the following technical solutions:
A kind of Fructus Lycii American ginseng soft capsule, this soft capsule is made up of capsule skin and the capsule 's content enclosing capsule Intradermal, described capsule 's content comprises the raw material components of following parts by weight: wolfberry fruit extract 100 ~ 140 parts, Radix Panacis Quinquefolii extract 45 ~ 55 parts, suspensoid 40 ~ 55 parts, emulsifying agent 10 ~ 14 parts, solvent 300 ~ 400 parts.
Described wolfberry fruit extract is prepared from by following steps:
(1) will Fructus Lycii clean chopping after insert in multi-function extractor, the water extraction adding 10 times of weight repeatedly, is specially 2 times, each 1h, merges repeatedly extracting solution and concentrating under reduced pressure obtains relative density to 1.15 ~ 1.20, obtains concentrated solution;
(2) in concentrated solution, add the ethanol that volume fraction is 98 ~ 99%, regulate the purity to 60% of concentrated solution, staticly settle completely, be separated and be precipitated part;
(3) being dissolved in water to relative density toward sediment fraction is 1.05 ~ 1.10, and shattered 80 mesh sieves after drying, and namely obtained wolfberry fruit extract, drying refers to spraying dry, and wherein, inlet temperature is 150 ~ 170 DEG C, and leaving air temp is 70 ~ 80 DEG C.
Described Radix Panacis Quinquefolii extract is prepared by following steps:
A () inserts in multi-function extractor after Radix Panacis Quinquefolii is cleaned chopping, the volume fraction adding 10 times of weight is the ethanol of 70%, extracts repeatedly, is specially about 3 times, each 2h, and extracting solution crosses 200 eye mesh screens respectively, merge extractive liquid;
B merge extractive liquid, is evaporated to relative density by () at vacuum 0.06MPa, temperature 60 ~ 70 DEG C is 1.15 ~ 1.20, obtains concentrated solution;
C () shattered 80 mesh sieves by after concentrated solution drying, namely obtain Radix Panacis Quinquefolii extract, and drying refers to spraying dry, and wherein, inlet temperature is 160 ~ 180 DEG C, and leaving air temp is 70 ~ 80 DEG C.
Described suspensoid is Cera Flava, and described emulsifying agent is soybean phospholipid, and described solvent is Semen Maydis oil.
The component of following parts by weight drawn together by described capsule suitcase: 300 ~ 400 parts, gelatin, glycerol 100 ~ 160 parts, opacifier 2 ~ 6 parts, and coloring agent 0.5 ~ 2 part, also includes the water of certain content in capsule skin.
Described opacifier is titanium dioxide, and described coloring agent is red for luring.
A preparation method for Fructus Lycii American ginseng soft capsule, comprises the following steps:
(A) wolfberry fruit extract 100 ~ 140 parts is taken respectively, Radix Panacis Quinquefolii extract 45 ~ 55 parts, suspensoid 40 ~ 55 parts, emulsifying agent 10 ~ 14 parts, solvent 300 ~ 400 parts, selects the solvent of 1/3 dosage, be heated to 60 ~ 70 DEG C, add suspensoid again and stir, obtaining fused mass, and being cooled to 50 ~ 55 DEG C;
(B) solvent of wolfberry fruit extract, Radix Panacis Quinquefolii extract, surplus and fused mass are uniformly mixed, and cross colloid mill grinding, obtain compound, then emulsifying agent to be added in compound and homogenizing, always mixed material;
(C) pour in material-compound tank by always mixing material, evacuation, obtains capsule 's content;
(D) take glycerol 100 ~ 160 parts, in water 300 ~ 400 parts of putting into glue tanks, be heated to 70 ~ 80 DEG C, add 300 ~ 400 parts of gelatin again, keep temperature and be stirred to gelatin dissolving completely, then drop into 2 ~ 6 parts of opacifiers and 0.5 ~ 2 part of coloring agent, stir and obtain capsule hide glue gelatin;
(E) capsule hide glue gelatin is evacuated to glue bubble-free, crosses 100 order filter bags, filtrate insulation leaves standstill, stand-by;
(F) by capsule 's content and capsule hide glue gelatin pelleting, sizing, clean, after drying, namely obtain Fructus Lycii American ginseng soft capsule.
In step (C), the vacuum of evacuation is-0.06 ~-0.08Mpa, and the time of evacuation is 50min ~ 1h.
In step (E), the vacuum of evacuation is-0.06 ~-0.08Mpa, and the temperature of filtrate insulation is 45 ~ 55 DEG C, and time of repose is 3h.
Ambient temperature in step (F) when pelleting, sizing is 18 ~ 26 DEG C, and relative humidity is 40% ~ 50%;
The baking temperature of the soft gelatin capsule that pressed sizing is cleaned is 20 ~ 28 DEG C, and relative humidity is 20% ~ 30%, and drying time is 10 ~ 15h, and capsule skin biodiversity content is 10% ~ 14%.
Relative density described in the present invention is all to the density relative to water.
Soft gelatin capsule in the present invention after pressed sizing clean dry also will through screening, special-shaped ball wherein, seepage ball, bubble ball, content band impurity ball, large whole defective soft gelatin capsule such as ball, piller are picked out, the loading amount of the soft capsule finally obtained is about 600mg/ grain.
Compared with prior art, the present invention has the following advantages:
(1) immunity improves effective: by having, to improve immunoregulatory wolfberry fruit extract and Radix Panacis Quinquefolii extract be principal agent in the present invention, wherein, wolfberry fruit extract and Radix Panacis Quinquefolii extract are from respectively by water, the extractants such as ethanol extract its primary bioactive components respectively from Fructus Lycii and ethanol, as lycium barbarum polysaccharide, Radix Panacis Quinquefolii polysaccharide and Radix Panacis Quinquefolii Saponin etc., compared to directly eating Fructus Lycii, Radix Panacis Quinquefolii etc., effective bioactive ingredients content of eating want high, also be easy to absorption of human body simultaneously, compared to the soft capsule only adding single wolfberry fruit extract or Radix Panacis Quinquefolii extract, the effect that immunity improves is better, more obvious,
(2) Stability of Soft Capsules is good: also add opacifier titanium dioxide in capsule skin of the present invention and coloring agent temptation is red, can effectively avoid the nutrient substance in soft capsule to cause the problem of product instability by light irradiates;
(3) edible safety is high: Fructus Lycii and Radix Panacis Quinquefolii are made the controllable soft capsule of loading amount by the present invention, by eating certain number according to prescription, can easily medicament intake be controlled in safety range, also can give full play to the effect of the enhancing immunity of lycium barbarum polysaccharide, Radix Panacis Quinquefolii polysaccharide and Radix Panacis Quinquefolii Saponin etc. simultaneously.
Accompanying drawing explanation
Fig. 1 is preparation technology's flow chart of Fructus Lycii American ginseng soft capsule of the present invention;
Fig. 2 is preparation technology's flow chart of Radix Panacis Quinquefolii extract of the present invention;
Fig. 3 is preparation technology's flow chart of wolfberry fruit extract of the present invention.
Detailed description of the invention
Below in conjunction with the drawings and specific embodiments, the present invention is described in detail.The present embodiment is implemented premised on technical solution of the present invention, give detailed embodiment and concrete operating process, but protection scope of the present invention is not limited to following embodiment.
Embodiment 1
A kind of Fructus Lycii American ginseng soft capsule, this soft capsule is made up of capsule skin and the capsule 's content enclosing capsule Intradermal, and capsule 's content comprises the raw material components of following parts by weight: wolfberry fruit extract 100 parts, Radix Panacis Quinquefolii extract 45 parts, 40 parts, Cera Flava, soybean phospholipid 10 parts, Semen Maydis oil 300 parts, the component of following parts by weight drawn together by capsule suitcase: 300 parts, gelatin, glycerol 100 parts, titanium dioxide 2 parts, lures red 0.5 part
Wherein, wolfberry fruit extract is prepared from by following steps, as shown in Figure 3:
(1) will Fructus Lycii clean chopping after insert in multi-function extractor, add the water extraction 2 times of 10 times of weight, each 1h, merge extracted twice liquid and be also evaporated to 1.15 ~ 1.20, obtain concentrated solution;
(2) in concentrated solution, add 98 ~ 99% ethanol, regulate the purity to 60% of concentrated solution, staticly settle completely, extract supernatant, cross leaching sediment fraction;
(3) be dissolved in water to relative density toward sediment fraction to be 1.05 ~ 1.10, to shatter 80 mesh sieves after spraying dry, in spraying dry, inlet temperature is 150 ~ 170 DEG C, leaving air temp is 70 ~ 80 DEG C, namely obtain wolfberry fruit extract, and then be packaged to be finished product, inspection warehouse-in.
Radix Panacis Quinquefolii extract is prepared from by following steps, as shown in Figure 2:
A () inserts in multi-function extractor after Radix Panacis Quinquefolii is cleaned chopping, the volume fraction adding 10 times of weight is the ethanol of 70%, extracts 3 times, each 2h, and extracting solution crosses 200 eye mesh screens respectively, merge extractive liquid;
B merge extractive liquid, is evaporated to relative density by () under vacuum 0.06MPa, temperature 60 C is 1.15 ~ 1.20, obtains concentrated solution;
C () shattered 80 mesh sieves by after concentrated solution spraying dry, namely obtain Radix Panacis Quinquefolii extract, and in spraying dry, inlet temperature is 160 ~ 180 DEG C, and leaving air temp is 70 ~ 80 DEG C.
The preparation method of above-mentioned Fructus Lycii American ginseng soft capsule, as shown in Figure 1, comprises the following steps:
(A) wolfberry fruit extract 100 parts is taken respectively, Radix Panacis Quinquefolii extract 45 parts, 40 parts, Cera Flava, soybean phospholipid 10 parts, Semen Maydis oil 300 parts, selects the Semen Maydis oil of 100 parts, is heated to 60 DEG C, add Cera Flava again and be stirred to Cera Flava fusing, obtaining fused mass, and be cooled to 50 DEG C;
(B) Semen Maydis oil of wolfberry fruit extract, Radix Panacis Quinquefolii extract, surplus 200 parts and fused mass are uniformly mixed, and cross colloid mill grinding 2 ~ 3 times, obtain compound, then emulsifying agent to be added in compound and homogenizing 2 times, always mixed material;
(C) pour in material-compound tank by always mixing material, evacuation, make vacuum be-0.06Mpa, vacuum time is 50min, and de-bubble to the greatest extent, obtains capsule 's content;
(D) take glycerol 100 parts, in water 300 parts of putting into glue tanks, be heated to 70 DEG C, then add 300 parts of gelatin, keep temperature and be stirred to gelatin and dissolve completely, then drop into 2 parts of titanium dioxide and 0.5 part of temptation is red, stir and obtain capsule hide glue gelatin;
(E) capsule hide glue gelatin is evacuated to bubble-free, vacuum is-0.06Mpa, capsule hide glue gelatin is crossed 100 order filter bags, and put the capsule hide glue gelatin after filtering into temperature control type rustless steel plane for the insulation of glue heat-preserving container, holding temperature is 45 DEG C, leaves standstill 3h, stand-by;
(F) pelleting: capsule 's content and capsule hide glue gelatin are suppressed soft gelatin capsule in soft capsule pellet processing machine, loading amount is 600mg/ grain, ambient temperature 18-26 DEG C, relative humidity 40%-50%;
(G) shape: the soft gelatin capsule pressed is delivered in sizing rotating cage, shape, time 2 h, ambient temperature 18 ~ 26 DEG C, relative humidity 40%-50%;
(H) ball is washed: with 95% edible ethanol cleaning soft gelatin capsule, make soft capsule clean surface oil stains-less.Edible ethanol should meet GB10343-2008 " edible ethanol ";
(I) dry: dry environment temperature 20-28 DEG C, relative humidity is 20-30%, drying time 10-15 hour, capsule severe edema due to hypofunction of the spleen sub-control is built in 10%-14%;
(J) select ball: be laid in by soft gelatin capsule on lamp inspection desk, special-shaped ball, seepage ball, bubble ball, content band impurity ball, large whole defective soft gelatin capsule such as ball, piller are picked out;
(K) inner packing: inner packaging material meets YBB00122002 oral stable medicinal polythene bottle with high density, 60 every bottle;
(L) outer package: to label, mounted box, product inspection, warehouse-in.
Embodiment 2
A kind of Fructus Lycii American ginseng soft capsule, this soft capsule is made up of capsule skin and the capsule 's content enclosing capsule Intradermal, and capsule 's content comprises the raw material components of following parts by weight: wolfberry fruit extract 140 parts, Radix Panacis Quinquefolii extract 55 parts, 55 parts, Cera Flava, soybean phospholipid 14 parts, Semen Maydis oil 400 parts, the component of following parts by weight drawn together by capsule suitcase: 400 parts, gelatin, glycerol 160 parts, titanium dioxide 6 parts, lures red 2 parts
Wherein, wolfberry fruit extract is prepared from by following steps:
(1) will Fructus Lycii clean chopping after insert in multi-function extractor, add the water extraction 2 times of 10 times of weight, each 1h, merge extracted twice liquid and concentrating under reduced pressure obtains relative density to 1.15 ~ 1.20, obtain concentrated solution;
(2) in concentrated solution, add 98 ~ 99% ethanol, regulate the purity to 60% of concentrated solution, staticly settle completely, extract supernatant, cross leaching sediment fraction;
(3) be dissolved in water to relative density toward sediment fraction to be 1.05 ~ 1.10, to shatter 80 mesh sieves after spraying dry, in spraying dry, inlet temperature is 150 ~ 170 DEG C, leaving air temp is 70 ~ 80 DEG C, namely obtain wolfberry fruit extract, and then be packaged to be finished product, inspection warehouse-in.
Radix Panacis Quinquefolii extract is prepared from by following steps:
A () inserts in multi-function extractor after Radix Panacis Quinquefolii is cleaned chopping, the volume fraction adding 10 times of weight is the ethanol of 70%, extracts 3 times, each 2h, and extracting solution crosses 200 eye mesh screens respectively, merge extractive liquid;
B merge extractive liquid, is evaporated to relative density by () under vacuum 0.06MPa, temperature 70 C is 1.15 ~ 1.20, obtains concentrated solution;
C () shattered 80 mesh sieves by after concentrated solution spraying dry, namely obtain Radix Panacis Quinquefolii extract, and in spraying dry, inlet temperature is 160 ~ 180 DEG C, and leaving air temp is 70 ~ 80 DEG C.
The preparation method of above-mentioned Fructus Lycii American ginseng soft capsule, comprises the following steps:
(A) wolfberry fruit extract 140 parts is taken respectively, Radix Panacis Quinquefolii extract 55 parts, 55 parts, Cera Flava, soybean phospholipid 14 parts, Semen Maydis oil 400 parts, selects the Semen Maydis oil of 1/3 dosage, is heated to 70 DEG C, add Cera Flava again and be stirred to Cera Flava fusing, obtaining fused mass, and be cooled to 55 DEG C;
(B) Semen Maydis oil of wolfberry fruit extract, Radix Panacis Quinquefolii extract, surplus and fused mass are uniformly mixed, and cross colloid mill grinding 2 ~ 3 times, obtain compound, then emulsifying agent to be added in compound and homogenizing 2 times, always mixed material;
(C) pour in material-compound tank by always mixing material, evacuation, make vacuum be-0.08Mpa, vacuum time is 1h, and de-bubble to the greatest extent, obtains capsule 's content;
(D) take glycerol 160 parts, in water 400 parts of putting into glue tanks, be heated to 80 DEG C, then add 400 parts of gelatin, keep temperature and be stirred to gelatin and dissolve completely, then drop into 6 parts of titanium dioxide and 2 parts of temptation are red, stir and obtain capsule hide glue gelatin;
(E) capsule hide glue gelatin is evacuated to bubble-free, vacuum is-0.08Mpa, capsule hide glue gelatin is crossed 100 order filter bags, and put the capsule hide glue gelatin after filtering into temperature control type rustless steel plane for the insulation of glue heat-preserving container, holding temperature is 55 DEG C, leaves standstill 3h, stand-by;
(F) pelleting: capsule 's content and capsule hide glue gelatin are suppressed soft gelatin capsule in soft capsule pellet processing machine, loading amount is 600mg/ grain, ambient temperature 18-26 DEG C, relative humidity 40%-50%;
(G) shape: the soft gelatin capsule pressed is delivered in sizing rotating cage, shape, time 2 h, ambient temperature 18 ~ 26 DEG C, relative humidity 40%-50%;
(H) ball is washed: with 95% edible ethanol cleaning soft gelatin capsule, make soft capsule clean surface oil stains-less.Edible ethanol should meet GB10343-2008 " edible ethanol ";
(I) dry: dry environment temperature 20-28 DEG C, relative humidity is 20-30%, drying time 10-15 hour, capsule severe edema due to hypofunction of the spleen sub-control is built in 10%-14%;
(J) select ball: be laid in by soft gelatin capsule on lamp inspection desk, special-shaped ball, seepage ball, bubble ball, content band impurity ball, large whole defective soft gelatin capsule such as ball, piller are picked out;
(K) inner packing: inner packaging material meets YBB00122002 oral stable medicinal polythene bottle with high density, 60 every bottle;
(L) outer package: to label, mounted box, product inspection, warehouse-in.
Embodiment 3
A kind of Fructus Lycii American ginseng soft capsule, this soft capsule is made up of capsule skin and the capsule 's content enclosing capsule Intradermal, and capsule 's content comprises the raw material components of following parts by weight: wolfberry fruit extract 130 parts, Radix Panacis Quinquefolii extract 48 parts, 51 parts, Cera Flava, soybean phospholipid 11 parts, Semen Maydis oil 340 parts, the component of following parts by weight drawn together by capsule suitcase: 370 parts, gelatin, glycerol 120 parts, titanium dioxide 3 parts, lures red 1.5 parts
Wherein, wolfberry fruit extract is prepared from by following steps:
(1) will Fructus Lycii clean chopping after insert in multi-function extractor, add the water extraction 2 times of 10 times of weight, each 1h, merge extracted twice liquid and concentrating under reduced pressure obtains relative density to 1.15 ~ 1.20, obtain concentrated solution;
(2) in concentrated solution, add 98 ~ 99% ethanol, regulate the purity to 60% of concentrated solution, staticly settle completely, extract supernatant, cross leaching sediment fraction;
(3) be dissolved in water to relative density toward sediment fraction to be 1.05 ~ 1.10, to shatter 80 mesh sieves after spraying dry, in spraying dry, inlet temperature is 150 ~ 170 DEG C, leaving air temp is 70 ~ 80 DEG C, namely obtain wolfberry fruit extract, and then be packaged to be finished product, inspection warehouse-in.
Radix Panacis Quinquefolii extract is prepared from by following steps:
A () inserts in multi-function extractor after Radix Panacis Quinquefolii is cleaned chopping, the volume fraction adding 10 times of weight is the ethanol of 70%, extracts 3 times, each 2h, and extracting solution crosses 200 eye mesh screens respectively, merge extractive liquid;
B merge extractive liquid, is evaporated to relative density by () at vacuum 0.06MPa, temperature 65 DEG C is 1.15 ~ 1.20, obtains concentrated solution;
C () shattered 80 mesh sieves by after concentrated solution spraying dry, namely obtain Radix Panacis Quinquefolii extract, and in spraying dry, inlet temperature is 160 ~ 180 DEG C, and leaving air temp is 70 ~ 80 DEG C.
The preparation method of above-mentioned Fructus Lycii American ginseng soft capsule, comprises the following steps:
(A) wolfberry fruit extract 130 parts is taken respectively, Radix Panacis Quinquefolii extract 48 parts, 51 parts, Cera Flava, soybean phospholipid 11 parts, Semen Maydis oil 340 parts, selects the Semen Maydis oil of 1/3 dosage, is heated to 60 ~ 70 DEG C, add Cera Flava again and be stirred to Cera Flava fusing, obtaining fused mass, and be cooled to 50 ~ 55 DEG C;
(B) wolfberry fruit extract, Radix Panacis Quinquefolii extract, surplus Semen Maydis oil and fused mass are uniformly mixed, and cross colloid mill grinding 2 ~ 3 times, obtain compound, then emulsifying agent to be added in compound and homogenizing 2 times, always mixed material;
(C) pour in material-compound tank by always mixing material, evacuation, make vacuum be-0.07Mpa, vacuum time is 55min, and de-bubble to the greatest extent, obtains capsule 's content;
(D) take glycerol 120 parts, in water 350 parts of putting into glue tanks, be heated to 75 DEG C, then add 370 parts of gelatin, keep temperature and be stirred to gelatin and dissolve completely, then drop into 3 parts of titanium dioxide and 1.5 parts of temptation are red, stir and obtain capsule hide glue gelatin;
(E) capsule hide glue gelatin is evacuated to bubble-free, vacuum is-0.07Mpa, capsule hide glue gelatin is crossed 100 order filter bags, and put the capsule hide glue gelatin after filtering into temperature control type rustless steel plane for the insulation of glue heat-preserving container, holding temperature is 50 DEG C, leaves standstill 3h, stand-by;
(F) pelleting: capsule 's content and capsule hide glue gelatin are suppressed soft gelatin capsule in soft capsule pellet processing machine, loading amount is 600mg/ grain, ambient temperature 18-26 DEG C, relative humidity 40%-50%;
(G) shape: the soft gelatin capsule pressed is delivered in sizing rotating cage, shape, time 2 h, ambient temperature 18 ~ 26 DEG C, relative humidity 40%-50%;
(H) ball is washed: with 95% edible ethanol cleaning soft gelatin capsule, make soft capsule clean surface oil stains-less.Edible ethanol should meet GB10343-2008 " edible ethanol ";
(I) dry: dry environment temperature 20-28 DEG C, relative humidity is 20-30%, drying time 10-15 hour, capsule severe edema due to hypofunction of the spleen sub-control is built in 10%-14%;
(J) select ball: be laid in by soft gelatin capsule on lamp inspection desk, special-shaped ball, seepage ball, bubble ball, content band impurity ball, large whole defective soft gelatin capsule such as ball, piller are picked out;
(K) inner packing: inner packaging material meets YBB00122002 oral stable medicinal polythene bottle with high density, 60 every bottle;
(L) outer package: to label, mounted box, product inspection, warehouse-in.
Embodiment 4
A kind of Fructus Lycii American ginseng soft capsule, this soft capsule is made up of capsule skin and the capsule 's content enclosing capsule Intradermal, capsule 's content comprises the component of following parts by weight: wolfberry fruit extract 120 parts, Radix Panacis Quinquefolii extract 51 parts, 48 parts, Cera Flava, soybean phospholipid 12 parts and Semen Maydis oil 369 parts, the component of following parts by weight drawn together by capsule suitcase: 350 parts, gelatin, glycerol 140 parts, titanium dioxide 4 parts, lure red 1 part
Wherein, wolfberry fruit extract is prepared from by following steps:
(1) will Fructus Lycii clean chopping after insert in multi-function extractor, add the water extraction 2 times of 10 times of weight, each 1h, merge extracted twice liquid and concentrating under reduced pressure obtains relative density to 1.15 ~ 1.20, obtain concentrated solution;
(2) in concentrated solution, add 98 ~ 99% ethanol, regulate the purity to 60% of concentrated solution, staticly settle completely, extract supernatant, cross leaching sediment fraction;
(3) be dissolved in water to relative density toward sediment fraction to be 1.05 ~ 1.10, to shatter 80 mesh sieves after spraying dry, in spraying dry, inlet temperature is 150 ~ 170 DEG C, leaving air temp is 70 ~ 80 DEG C, namely obtain wolfberry fruit extract, and then be packaged to be finished product, inspection warehouse-in.
Radix Panacis Quinquefolii extract is prepared from by following steps:
A () inserts in multi-function extractor after Radix Panacis Quinquefolii is cleaned chopping, the volume fraction adding 10 times of weight is the ethanol of 70%, extracts 3 times, each 2h, and extracting solution crosses 200 eye mesh screens respectively, merge extractive liquid;
B merge extractive liquid, is evaporated to relative density by () at vacuum 0.06MPa, temperature 65 DEG C is 1.15 ~ 1.20, obtains concentrated solution;
C () shattered 80 mesh sieves by after concentrated solution spraying dry, namely obtain Radix Panacis Quinquefolii extract, and in spraying dry, inlet temperature is 160 ~ 180 DEG C, and leaving air temp is 70 ~ 80 DEG C.
Above-mentioned Fructus Lycii American ginseng soft capsule is prepared from by following steps:
(A) wolfberry fruit extract 4.92kg is taken respectively, Radix Panacis Quinquefolii extract 2.091kg, Cera Flava 1.968kg, soybean phospholipid 0.492kg, Semen Maydis oil 15.129kg, select the Semen Maydis oil of 5.043kg, be heated to 60 ~ 70 DEG C, add Cera Flava again and be stirred to Cera Flava fusing, obtaining fused mass, and be cooled to 50 ~ 55 DEG C;
(B) wolfberry fruit extract, Radix Panacis Quinquefolii extract, surplus Semen Maydis oil and fused mass are uniformly mixed, and cross colloid mill grinding 2 ~ 3 times, obtain compound, then emulsifying agent to be added in compound and homogenizing 2 times, always mixed material;
(C) pour in material-compound tank by total mixed material, evacuation, make vacuum be-0.07Mpa, vacuum time is 55min, and de-bubble to the greatest extent, obtains capsule 's content, wherein 21kg pelleting, and 3.6kg capsule 's content is sent to disease control and to be tested and for detecting in addition;
(D) take glycerol 4.9kg, in putting into of water 12.25kg glue tank, be heated to 75 DEG C, add 12.25kg gelatin again, keep temperature and be stirred to gelatin and dissolve completely, then dropping into 0.14kg titanium dioxide and 0.035kg temptation is red, stirring and obtain capsule hide glue gelatin;
(E) capsule hide glue gelatin is evacuated to bubble-free, vacuum is-0.07Mpa, capsule hide glue gelatin is crossed 100 order filter bags, and put the capsule hide glue gelatin after filtering into temperature control type rustless steel plane for the insulation of glue heat-preserving container, holding temperature is 50 DEG C, leaves standstill 3h, stand-by;
(F) pelleting: capsule 's content and capsule hide glue gelatin are suppressed soft gelatin capsule in soft capsule pellet processing machine, loading amount is 600mg/ grain, ambient temperature 18-26 DEG C, relative humidity 40%-50%;
(G) shape: the soft gelatin capsule pressed is delivered in sizing rotating cage, shape, time 2 h, ambient temperature 18 ~ 26 DEG C, relative humidity 40%-50%;
(H) ball is washed: with 95% edible ethanol cleaning soft gelatin capsule, make soft capsule clean surface oil stains-less.Edible ethanol should meet GB10343-2008 " edible ethanol ";
(I) dry: dry environment temperature 20-28 DEG C, relative humidity is 20-30%, drying time 10-15 hour, capsule severe edema due to hypofunction of the spleen sub-control is built in 10%-14%;
(J) select ball: be laid in by soft gelatin capsule on lamp inspection desk, special-shaped ball, seepage ball, bubble ball, content band impurity ball, large whole defective soft gelatin capsule such as ball, piller are picked out;
(K) inner packing: inner packaging material meets YBB00122002 oral stable medicinal polythene bottle with high density, 60 every bottle;
(L) outer package: to label, mounted box, product inspection, warehouse-in.
Soft capsule obtained by the present embodiment, theoretical yield number is 3.5 ten thousand, and actual obtained 3.354 ten thousand, finished product yield is 95.8%.
Embodiment 5
A kind of Fructus Lycii American ginseng soft capsule, this soft capsule is made up of capsule skin and the capsule 's content enclosing capsule Intradermal, capsule 's content comprises the component of following parts by weight: wolfberry fruit extract 120 parts, Radix Panacis Quinquefolii extract 51 parts, 48 parts, Cera Flava, soybean phospholipid 12 parts and Semen Maydis oil 369 parts, the component of following parts by weight drawn together by capsule suitcase: 350 parts, gelatin, glycerol 140 parts, titanium dioxide 4 parts, lure red 1 part
Wherein, wolfberry fruit extract is prepared from by following steps:
(1) will Fructus Lycii clean chopping after insert in multi-function extractor, add the water extraction 2 times of 10 times of weight, each 1h, merge extracted twice liquid and concentrating under reduced pressure obtains relative density to 1.15 ~ 1.20, obtain concentrated solution;
(2) in concentrated solution, add 98 ~ 99% ethanol, regulate the purity to 60% of concentrated solution, staticly settle completely, extract supernatant, cross leaching sediment fraction;
(3) be dissolved in water to relative density toward sediment fraction to be 1.05 ~ 1.10, to shatter 80 mesh sieves after spraying dry, in spraying dry, inlet temperature is 150 ~ 170 DEG C, leaving air temp is 70 ~ 80 DEG C, namely obtain wolfberry fruit extract, and then be packaged to be finished product, inspection warehouse-in.
Radix Panacis Quinquefolii extract is prepared from by following steps:
A () inserts in multi-function extractor after Radix Panacis Quinquefolii is cleaned chopping, the volume fraction adding 10 times of weight is the ethanol of 70%, extracts 3 times, each 2h, and extracting solution crosses 200 eye mesh screens respectively, merge extractive liquid;
B merge extractive liquid, is evaporated to relative density by () at vacuum 0.06MPa, temperature 65 DEG C is 1.15 ~ 1.20, obtains concentrated solution;
C () shattered 80 mesh sieves by after concentrated solution spraying dry, namely obtain Radix Panacis Quinquefolii extract, and in spraying dry, inlet temperature is 160 ~ 180 DEG C, and leaving air temp is 70 ~ 80 DEG C.
Above-mentioned Fructus Lycii American ginseng soft capsule is prepared from by following steps:
(A) wolfberry fruit extract 2.4kg is taken respectively, Radix Panacis Quinquefolii extract 1.02kg, Cera Flava 0.96kg, soybean phospholipid 0.24kg, Semen Maydis oil 7.38kg, select the Semen Maydis oil of 2.46kg, be heated to 60 ~ 70 DEG C, add Cera Flava again and be stirred to Cera Flava fusing, obtaining fused mass, and be cooled to 50 ~ 55 DEG C;
(B) wolfberry fruit extract, Radix Panacis Quinquefolii extract, surplus Semen Maydis oil and fused mass are uniformly mixed, and cross colloid mill grinding 2 ~ 3 times, obtain compound, then emulsifying agent to be added in compound and homogenizing 2 times, always mixed material;
(C) pour in material-compound tank by always mixing material, evacuation, make vacuum be-0.07Mpa, vacuum time is 55min, and de-bubble to the greatest extent, obtains capsule 's content;
(D) take glycerol 2.8kg, in putting into of water 7kg glue tank, be heated to 75 DEG C, then add 7kg gelatin, keep temperature and be stirred to gelatin and dissolve completely, then drop into 0.08kg titanium dioxide and 0.02kg temptation is red, stir and obtain capsule hide glue gelatin;
(E) capsule hide glue gelatin is evacuated to bubble-free, vacuum is-0.07Mpa, capsule hide glue gelatin is crossed 100 order filter bags, and put the capsule hide glue gelatin after filtering into temperature control type rustless steel plane for the insulation of glue heat-preserving container, holding temperature is 50 DEG C, leaves standstill 3h, stand-by;
(F) pelleting: capsule 's content and capsule hide glue gelatin are suppressed soft gelatin capsule in soft capsule pellet processing machine, loading amount is 600mg/ grain, ambient temperature 18-26 DEG C, relative humidity 40%-50%;
(G) shape: the soft gelatin capsule pressed is delivered in sizing rotating cage, shape, time 2 h, ambient temperature 18 ~ 26 DEG C, relative humidity 40%-50%;
(H) ball is washed: with 95% edible ethanol cleaning soft gelatin capsule, make soft capsule clean surface oil stains-less.Edible ethanol should meet GB10343-2008 " edible ethanol ";
(I) dry: dry environment temperature 20-28 DEG C, relative humidity is 20-30%, drying time 10-15 hour, capsule severe edema due to hypofunction of the spleen sub-control is built in 10%-14%;
(J) select ball: be laid in by soft gelatin capsule on lamp inspection desk, special-shaped ball, seepage ball, bubble ball, content band impurity ball, large whole defective soft gelatin capsule such as ball, piller are picked out;
(K) inner packing: inner packaging material meets YBB00122002 oral stable medicinal polythene bottle with high density, 60 every bottle;
(L) outer package: to label, mounted box, product inspection, warehouse-in.
The theoretical yield number of the Fructus Lycii American ginseng soft capsule in this experiment is 20,000, actual production 1.908 ten thousand, finished product yield 95.4%.
Comparative example 1
A kind of Fructus Lycii soft capsule, except not having Radix Panacis Quinquefolii extract, other all in the same manner as in Example 4.
Comparative example 2
A kind of American ginseng capsule, except not having wolfberry fruit extract, other all in the same manner as in Example 4.
Embodiment 6
The enhancing immunity functional test materials and methods of the Fructus Lycii American ginseng soft capsule that embodiment 4 is obtained.
6.1 sample
The Fructus Lycii American ginseng soft capsule that embodiment 4 is obtained, the Fructus Lycii soft capsule that comparative example 1 is obtained, the American ginseng capsule that comparative example 2 is obtained.
6.2 laboratory animal
The cleaning grade ICR male mice that Jilin University Bethune medical college animal experimental center provides, production licence number: SCXK-(Ji) 2011-00040.Feedstuff is provided by this laboratory animal technology Co., Ltd of Changchun hundred million, production licence number: SCXK-(Ji) 2010-0001.This laboratory animal environmental facility quality certification, lucky moving establishes word 10-1005, laboratory animal occupancy permit number: SYXK-(Ji) 2010-0011.Select healthy male mice 120, body weight 18g ~ 22g, be divided into 10 groups, often organize 12, as immune one group, carry out internal organs/weight ratio pH-value determination pH, half hemolysis value (HC 50) mensuration and antibody-producting cell detect; Select healthy male mice 120, body weight 18g ~ 22g, be divided into 10 groups, often organize 12, as immune two groups, carry out carbonic clearance experiment; Select healthy male mice 120, body weight 18g ~ 22g, be divided into 10 groups, often organize 12, as immune three groups, carry out mouse lymphocyte transformation experiment and the NK cytoactive detection of ConA induction; Select healthy male mice 120, body weight 18g ~ 22g, be divided into 10 groups, often organize 12, as immune four groups, carry out delayed allergy experiment; Select healthy male mice 120, body weight 18g ~ 22g, be divided into 10 groups, often organize 12, as immune five groups, carry out Turnover of Mouse Peritoneal Macrophages and engulf chicken red blood cell experiment.
6.3 dosage choice and preparation
The American ginseng soft capsule of the Fructus Lycii American ginseng soft capsule of embodiment 4, the Fructus Lycii soft capsule of comparative example 1 and comparative example 2,2 times/day, 0.6 gram/, 3 tablets/time, i.e. 3.60g/60kgBW, is equivalent to 0.06g/kgBW, arranges given low with 1,10 and 30 times of producer's day recommended intake, 0.06 namely, 0.60,18.0g/kgBW, each dosage group is diluted with soybean oil.Make negative control group with soybean oil, each group mouse stomach amount is 0.2mL/10gBW, and continuous gavage surveyed every immune indexes after 30 days.
6.4 instruments and reagent
Electronic balance (0.1g), analytical balance, clean bench, CO2 gas incubator, centrifuge, 722 spectrophotometers, water bath with thermostatic control, microplate reader, microscope etc., sterile surgical instrument, slide gauge (precision 0.02mm), microsyringe (25 μ L), cell counter, the flat Tissue Culture Plate in 24 holes and 96 holes, the 96 U-shaped Tissue Culture Plates in hole, glass dish, gauze, test tube, fragmentation frame, 200 eye mesh screens, timer, hemoglobin pipet, microscope slide etc., sheep red blood cell (SRBC) (SRBC), normal saline, Hank's liquid (pH7.2 ~ 7.4), RPMI1640 culture fluid, calf serum, mycillin, concanavalin A, Con A (ConA), 1% glacial acetic acid, the HCl solution of 1mol/L, (96mL isopropyl alcohol adds 4mL hydrochloric acid > to acid isopropyl alcohol, MTT, PBS buffer (pH7.2 ~ 7.4), complement < guinea pig serum), SA buffer, agarose, Dou Shi reagent (sodium bicarbonate 1.0g, high-potassium ferricyanide 0.2g, potassium cyanide 0.05g, adding distil water is to 1000mL), YAC-l cell, lactic acid system, nitro tetrazolium chloride, PMS, oxidized form of nicotinamide-adenine dinucleotide, the Tris-HCl buffer (pH8.2) of 0.2mol/L, 1%NP40, india ink, Na 2cO 3, chicken red blood cell, methanol, Giemsa dye liquor etc.
6.5 experimental technique
6.5.1 internal organs/body weight gravity test
After mouse weights, dislocation is put to death, and gets spleen and thymus, removes most fascia, blot organ surface blood stains, weigh with filter paper, calculates spleen/body weight ratio and thymus/body weight ratio.
6.5.2 delayed allergy (the sufficient sole of the foot thickens method DTH)
Get Sanguis caprae seu ovis, brine, mice 2% (V/V) SRBC peritoneal immunity, every Mus injection 0.2mL is only every.Latter 4 days of immunity, measures left back sufficient sole of the foot portion thickness, and only, after injection, 24h measures left back sufficient sole of the foot portion thickness three times, calculating mean value for measuring point subcutaneous injection 20% (V/V) SRBC, 20 μ L/.
The mouse lymphocyte transformation experiment (mtt assay) of 6.5.3ConA inducing
Asepticly get spleen, ground by spleen in Hank's liquid and make single cell suspension, Hank's liquid washes 2 times, each luxuriant heart 10min (1000r/min).By the complete culture solution of cell suspension in 1mL, platform expects blue dyeing counting viable count (should more than 95%), adjustment cell concentration to 3 × 10 6individual/mL.Add in 24 well culture plates by every part of cell suspension point holes, every hole 1mL, a hole adds 75 μ LConA liquid (being equivalent to 7.5 μ g/mL), and 5%CO in contrast, is put in another hole 237 DEG C of CO 272h is cultivated in incubator.Before cultivation terminates, every hole sucks supernatant 0.7mL, adds 0.7mL not containing the RPMI1640 culture fluid of calf serum, adds MTT (5mg/mL) 50 μ L/ hole simultaneously, continues to cultivate 4h.After cultivation terminates, every hole adds 1mL acid isopropyl alcohol, and piping and druming mixing, makes purple crystal dissolve completely, determine OD afterwards 570nm.
6.5.4 antibody-producting cell detects (Jeme improves slide method)
Sanguis caprae seu ovis is placed with in the sterilizing conical flask of bead, shakes towards a direction, with defiber, 4 DEG C of Refrigerator stores (2 weeks can be preserved) for subsequent use.Hematocrit SRBC is made into 2% (V/V) cell suspension with normal saline, and Mus lumbar injection 0.2mL/ only.The mice dislocation of SRBC immunity after 4 ~ 5 days is put to death, get spleen, put into Hank's liquid, ground by spleen and make cell suspension, filtered through gauze, Hank's liquid washes 2 times, centrifugal (1000r/min) 10min at every turn, after splenocyte suspension is added in RPMI1640 culture fluid, counting cells, cell concentration is adjusted to 5 × 10 6individual/mL.After the heat of solution of agarose power mouth, 45 ~ 50 DEG C of water bath heat preservations, mix with the Hank's liquid of equivalent PH7.2 ~ 7.42 times concentration, subpackage small test tube, often pipe 0.5mL, in pipe, add 10% (V/V, with the preparation of SA liquid) hematocrit SRBC50 μ L, splenocyte suspension 20 μ L again, be poured into oneself after mixing and be brushed with on the slide of agarose thin layer, do parallel plate, after agar solidification, slide level is buckled and is placed on horse, CO 2incubation 1.5h in incubator, the complement (1:8) of rear SA buffer dilution joins in slide frame groove, after continuing incubation 1.5h, counting hemolysis plaque number.
6.5.5 half hemolysis value (HC 50) mensuration
Get Sanguis caprae seu ovis, brine 3 times, at every turn centrifugal (2000r/min) 10min, (V/V, normal saline > hematocrit SRBC0.2mL/ only carries out immunity to lumbar injection 2%.After 4 days, get blood in centrifuge tube, place about 1h, solidification blood and tube wall are peeled off, serum is fully separated out, the centrifugal 10min of 2000r/min, collect serum.With SA buffer by serum-dilution (400 times), the serum 1mL after dilution puts in vitro, adds 10% (V/V) SRBC0.5mL successively, complement 1mL (pressing 1:8 dilution with SA buffer).Separately establish the control tube of not increase serum (replacing with SA buffer).15 ~ 30min is incubated, ice bath cessation reaction in 37 DEG C of waters bath with thermostatic control.The centrifugal 10min of 2000r/min, gets supernatant 1mL, adds Dou Shi reagent 3mL.Get 10% (V/V) SRBC0.25mL simultaneously, add Dou Shi reagent to 4mL, fully mix, after placing 10min, make blank to contrast, measure each pipe OD respectively 540nm, the amount of hemolysin is with half hemolysis value (HC 50) represent, calculate:
HC 50optical density value × extension rate during=sample optical density value/SRBC HD50
6.5.6 mice carbonic clearance is tested
The india ink that mouse tail vein injection 1:4 doubly dilutes, timing immediately, to inject after prepared Chinese ink 2,10min, gets blood 20 μ L respectively, and be added to 2mL0.1%Na at once from the interior venous plexus that adjoins 2cO 3in solution, with Na 2cO 3for contrast, measure OD 600nm.Put to death mice, get liver and spleen, weigh.Calculate phagocytic index a:
k=(lgOD1-1g0D2)/(t2-tl)
6.5.7 Turnover of Mouse Peritoneal Macrophages engulfs chicken red blood cell experiment
Mouse peritoneal injection 20% (V/V normal saline) hematocrit chicken red blood cell (2000r/min, 10min) suspension 1mL interval 30min, dislocation is put to death, get peritoneal macrophage washing liquid 1mL, drip on microscope slide, 37 DEG C of incubator incubation 20min, rinsing in normal saline, to remove non-paster cell.Dry, methanol is fixed, and 4% (V/V) Giemsa-phosphate buffer dyes, and steams shop water rinse and dries.Count under oil mirror, every sheet counts 100 macrophages, calculates phagocytic rate and phagocytic index:
Phagocytic rate %=engulfs macrophage number × 100 of the macrophage number/counting of chicken red blood cell
Phagocytic index=by engulf chicken red blood cell sum/counting macrophage number
6.5.8NK cytoactive detection (lactate dehydrogenase L DH algoscopy)
24h Secondary Culture target cell YAC-l before experiment, washes 3 times with Hank's liquid before application, containing RPMI1640 complete culture solution adjustment cell concentration to 4 × 10 of 10% calf serum 5individual/mL.Test mice dislocation is put to death, get spleen, make board cell suspension, Hank's liquid ' wash 3 times, the centrifugal 10min of each 1500r/min, resuspended containing the RPMI1640 complete culture solution of 10% calf serum with 2mL, platform expects blue dyeing counting (viable count should more than 95%), adjustment cell concentration to 2 × 10 7individual/mL, makes effect target than being 50:1.Get target cell and each 100 μ L of effector lymphocyte, add in U-shaped 96 well culture plate; Target cell Spontaneous release hole adds target cell and each 100 μ L of culture fluid, and the maximum release aperture of target cell adds target cell and each 100 μ L of 1%NP40; Above-mentionedly everyly all establish three parallel holes, 37 DEG C, 5%CO 2cultivate 4h in incubator, by 96 orifice plates with the centrifugal 5min of 1500r/min, every hole is drawn supernatant 100 μ L and is put in ELISA Plate, adds LDH matrix liquid 100 μ L, reaction 10min, and then every hole adds the HCl solution 30 μ L cessation reaction of 1mol, measures OD 490nm, calculate NK active:
NK cytoactive %=(reacting hole OD-Spontaneous release hole OD)/(maximum release aperture OD-Spontaneous release hole OD) × 100%
The preparation of LDH matrix liquid: sodium lactate 5 × 10 -2mol/L, nitro tetrazolium chloride 6.6 × 10 -4mol/L, PMS 2.8 × 10 -4mol/L oxidized form of nicotinamide-adenine dinucleotide 1.3 × 10 -3mol/L
Mentioned reagent is dissolved in (pH8.2) in the Tris-HCl buffer of 0.2mol/L
6.6 data statistics
Adopt one factor analysis of variance in SPSSI1.5 statistical software to carry out Average value compare, when variance is neat, compares between two between each group and use LSD method; During heterogeneity of variance, compare between two between each group and adopt Tamhane method.
6.7 experimental result
6.7.1 tested material is on the impact of Mouse Weight
Table 1. tested material is on immune one group of Mouse Weight impact
P value: each experimental group compares with negative control group
From table 1, through statistical procedures, per os gives tested material 30 days, and each dosage group Mouse Weight, weightening finish and negative control group comparing difference are without significance (P>0.05), and namely tested material has no significant effect Mouse Weight, weightening finish.
Table 2. tested material is on immune two groups of Mouse Weights impact
P value: each experimental group compares with negative control group
From table 2, through statistical procedures, per os gives tested material 30 days, and each dosage group Mouse Weight, weightening finish and negative control group comparing difference are without significance (P>0.05), and namely tested material has no significant effect Mouse Weight, weightening finish.
Table 3. tested material is on immune three groups of Mouse Weights impact
P value: each experimental group compares with negative control group
From table 3, through statistical procedures, per os gives tested material 30 days, and each dosage group Mouse Weight, weightening finish and negative control group comparing difference are without significance (P>0.05), and namely tested material has no significant effect Mouse Weight, weightening finish.
Table 4. tested material is on immune four groups of Mouse Weights impact
P value: each experimental group compares with negative control group
From table 4, through statistical procedures, per os gives tested material 30 days, and each dosage group Mouse Weight, weightening finish and negative control group comparing difference are without significance (P>0.05), and namely tested material has no significant effect Mouse Weight, weightening finish.
Table 5. tested material is on immune five groups of Mouse Weights impact
P value: each experimental group compares with negative control group
From table 5, through statistical procedures, per os gives tested material 30 days, and each dosage group Mouse Weight, weightening finish and negative control group comparing difference are without significance (P>0.05), and namely tested material has no significant effect Mouse Weight, weightening finish.
6.7.2 tested material is on the impact of mice organs/body weight ratio
Table 6 tested material is on the impact of mice organs/body weight ratio
Spleen/body weight ratio P 1: each experimental group compares with negative control group
Thymus/body weight ratio P 2: each experimental group compares with negative control group
From table 6, per os gives tested material 30 days, each dosage group spleen/body weight ratio and thymus/body weight ratio and negative control group comparing difference are without significance (P>0.05), and namely tested material has no significant effect mice organs/body weight ratio.
6.7.3 tested material is on the impact of mouse cell immunologic function
Tested material is on the impact of Mouse Weight and delayed allergy (DTH)
Table 7 tested material is on the impact of mice delayed allergy (DTH)
P value: each experimental group compares * P<0.05 with negative control group
From table 7, through statistical procedures, per os gives tested material 30 days, the swelling degree of the paw of the low dose group of embodiment 4, comparative example 1 and comparative example 2 and negative control group comparing difference are without significance (P>0.05), significantly (P<0.05), namely the tested material of the middle and high dosage of embodiment 4 can strengthen the delayed allergy of mice for the middle and high dosage group of embodiment 4 and negative control group comparing difference.
Tested material is on the impact of the mouse lymphocyte transformation experiment that ConA induces
Table 8 tested material is on the impact of the mouse lymphocyte transformation experiment that ConA induces
P value: each experimental group compares with negative control group
From table 8, per os gives the tested material 30 days of mice various dose, through statistical procedures, between the lymphocytic multiplication capacity of each dosage group and negative control group, comparing difference is without significance (P>0.05), and namely tested material has no significant effect the mouse lymphocyte conversion capability that ConA induces.
6.7.4 tested material is on the impact of humoral immunization
The impact of tested material antagonist cellulation number
Table 9 tested material is on the impact of mouse antibodies cellulation number
P value: each experimental group compares with negative control group
From table 9, per os gives the tested material 30 days of mice various dose, through statistical procedures, each dosage group antibody-producting cell number and negative control group comparing difference are without significance (P>0.05), and namely the antibody-producting cell number of tested material to mice has no significant effect.
Tested material is to mice half hemolysis value (HC 50) impact
Table 10 tested material is to mice half hemolysis value HC 50impact
P value: each experimental group compares with negative control group
From table 10, per os gives the tested material 30 days of mice various dose, through statistical procedures, each dosage group half hemolysis value and negative control group ask that comparing difference is without significance (P>0.05), and namely tested material has no significant effect mice half hemolysis value.
6.7.5 tested material is on the impact of mouse monokaryon-macrophage phagocytic function
Tested material is on the impact of mouse monokaryon-macrophage carbonic clearance function
Table 11 tested material is on the impact of mouse monokaryon-macrophage carbonic clearance function
P value: each experimental group compares * P<0.05 with negative control group
From table 11, per os gives the tested material 30 days of mice various dose, through statistical procedures, the carbonic clearance function of all dosage groups of the low dose group of embodiment 4, comparative example 1 and comparative example 2 and negative control group comparing difference are without significance (P>0.05), the middle and high dosage group of embodiment 4 and negative control group comparing difference have significance (P<0.05), and namely the middle and high dosage group tested material of embodiment 4 can improve the carbonic clearance ability of mouse monokaryon-macrophage.
Tested material is on the impact of the ability of Mouse Weight and macrophage phagocytic chicken red blood cell
Table 12 tested material engulfs the impact of the ability of chicken red blood cell on mouse macrophage
Phagocytic rate (%) P 1value: each experimental group compares with negative control group
Phagocytic index (%) P 2value: each experimental group compares with negative control group
From table 12, through statistical procedures, per os gives tested material 30 days, each dosage group phagocytic rate and negative control group comparing difference are without significance (P>0.05), each dosage group phagocytic index and negative control group comparing difference are without significance (P>0.05), and namely tested material has no significant effect the ability that mouse macrophage engulfs chicken red blood cell.
6.7.6 tested material is on the impact of NK cells in mice activity
P value: each experimental group compares with negative control group
From table 13, per os gives the tested material 30 days of mice various dose, through statistical procedures, between each dosage group NK cytoactive and negative control group, comparing difference is without significance (P>0.05), and namely the NK cytoactive of tested material to mice has no significant effect.
6.8 brief summary
Per os gives the tested material 30 days of mice various dose, and the middle and high dosage group of Fructus Lycii American ginseng soft capsule can strengthen mice delayed allergy, can strengthen cellular immune function; The middle and high dosage group of Fructus Lycii American ginseng soft capsule can improve the carbonic clearance ability of mouse monokaryon-macrophage, can strengthen monocytes/macrophages function; Fructus Lycii American ginseng soft capsule, Fructus Lycii soft capsule and American ginseng soft capsule on the mouse spleen lymphocyte conversion capability of the ability that the body weight of mice half hemolysis value, mouse antibodies cellulation number, mice increases, internal organs/body weight ratio, Turnover of Mouse Peritoneal Macrophages engulf chicken red blood cell, ConA induction, NK cytoactive is without impact.Judge thus, the obtained Fructus Lycii American ginseng soft capsule of embodiment 4 has good enhancing immunity function, and comparative example 1 and the matrimony vine capsule obtained by comparative example 2 and American ginseng capsule then do not embody the effect of enhancing immunity aspect.

Claims (9)

1. a Fructus Lycii American ginseng soft capsule, this soft capsule is made up of capsule skin and the capsule 's content enclosing capsule Intradermal, it is characterized in that, described capsule 's content comprises the raw material components of following parts by weight: wolfberry fruit extract 100 ~ 140 parts, Radix Panacis Quinquefolii extract 45 ~ 55 parts, suspensoid 40 ~ 55 parts, emulsifying agent 10 ~ 14 parts, solvent 300 ~ 400 parts.
2. a kind of Fructus Lycii American ginseng soft capsule according to claim 1, it is characterized in that, described wolfberry fruit extract is prepared from by following steps:
(1) will Fructus Lycii clean chopping after insert in multi-function extractor, the water extraction adding 10 times of weight repeatedly, merges repeatedly extracting solution and concentrated obtains relative density to 1.15 ~ 1.20, obtaining concentrated solution;
(2) in concentrated solution, add ethanol, regulate the purity to 60% of concentrated solution, staticly settle completely, be separated and be precipitated part;
(3) be dissolved in water to relative density toward sediment fraction to be 1.05 ~ 1.10, to shatter after drying and sieve, namely obtain wolfberry fruit extract.
3. a kind of Fructus Lycii American ginseng soft capsule according to claim 1, it is characterized in that, described Radix Panacis Quinquefolii extract is prepared by following steps:
A () inserts in multi-function extractor after Radix Panacis Quinquefolii is cleaned chopping, the volume fraction adding 10 times of weight is the ethanol of 70%, extracts repeatedly, merges after extracting solution sieves;
B extracting solution after merging is evaporated to relative density by () at vacuum 0.06MPa, temperature 60 ~ 70 DEG C is 1.15 ~ 1.20, obtains concentrated solution;
C () is sieved shattering after concentrated solution drying, namely obtain Radix Panacis Quinquefolii extract.
4. a kind of Fructus Lycii American ginseng soft capsule according to claim 1, is characterized in that, described suspensoid is Cera Flava, and described emulsifying agent is soybean phospholipid, and described solvent is Semen Maydis oil.
5. a kind of Fructus Lycii American ginseng soft capsule according to claim 1, is characterized in that, the component of following parts by weight drawn together by described capsule suitcase: 300 ~ 400 parts, gelatin, glycerol 100 ~ 160 parts, opacifier 2 ~ 6 parts, coloring agent 0.5 ~ 2 part.
6. a kind of Fructus Lycii American ginseng soft capsule according to claim 5, is characterized in that, described opacifier is titanium dioxide, and described coloring agent is red for luring.
7. a preparation method for the Fructus Lycii American ginseng soft capsule as described in as arbitrary in claim 1 ~ 6, is characterized in that, comprise the following steps:
(A) wolfberry fruit extract 100 ~ 140 parts is taken respectively, Radix Panacis Quinquefolii extract 45 ~ 55 parts, suspensoid 40 ~ 55 parts, emulsifying agent 10 ~ 14 parts, solvent 300 ~ 400 parts, selects the solvent of 1/3 dosage, be heated to 60 ~ 70 DEG C, add suspensoid again and stir, obtaining fused mass, and being cooled to 50 ~ 55 DEG C;
(B) wolfberry fruit extract, Radix Panacis Quinquefolii extract, balance solvent and fused mass are uniformly mixed, and cross colloid mill grinding, obtain compound, then emulsifying agent to be added in compound and homogenizing, always mixed material;
(C) pour in material-compound tank by always mixing material, evacuation, obtains capsule 's content;
(D) take glycerol 100 ~ 160 parts, in water 300 ~ 400 parts of putting into glue tanks, be heated to 70 ~ 80 DEG C, add 300 ~ 400 parts of gelatin again, keep temperature and be stirred to gelatin dissolving completely, then drop into 2 ~ 6 parts of opacifiers and 0.5 ~ 2 part of coloring agent, stir and obtain capsule hide glue gelatin;
(E) capsule hide glue gelatin is evacuated to bubble-free, filters, filtrate insulation leaves standstill, stand-by;
(F) by capsule 's content and capsule hide glue gelatin pelleting, sizing, clean, after drying, namely obtain Fructus Lycii American ginseng soft capsule.
8. the preparation method of a kind of Fructus Lycii American ginseng soft capsule according to claim 7, is characterized in that, in step (C), the vacuum of evacuation is-0.06 ~-0.08Mpa, and the time of evacuation is 50min ~ 1h.
In step (E), the vacuum of evacuation is-0.06 ~-0.08Mpa, and the temperature of filtrate insulation is 45 ~ 55 DEG C, and time of repose is 3h.
9. the preparation method of a kind of Fructus Lycii American ginseng soft capsule according to claim 7, is characterized in that, the ambient temperature in step (F) when pelleting, sizing is 18 ~ 26 DEG C, and relative humidity is 40% ~ 50%;
The baking temperature of the soft gelatin capsule that pressed sizing is cleaned is 20 ~ 28 DEG C, and relative humidity is 20% ~ 30%, and drying time is 10 ~ 15h, and capsule skin biodiversity content is 10% ~ 14%.
CN201510615564.0A 2015-09-24 2015-09-24 Wolfberry fruit and American ginseng soft capsules and preparation method thereof Pending CN105106434A (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107788194A (en) * 2017-11-12 2018-03-13 张雅萍 A kind of black fruit fructus lycii anti-trioxypurine functional gels candy and preparation method thereof
CN108634304A (en) * 2018-04-19 2018-10-12 成都欧甘拓展有限公司 Improve immune function of human body and antifatigue edible composition
CN113908224A (en) * 2021-11-18 2022-01-11 长春守道生物科技有限公司 A Chinese medicinal composition with immunoregulatory function, and its preparation method
CN114848727A (en) * 2022-06-21 2022-08-05 吉林农业大学 Preparation method and application of American ginseng paste with health care function

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KR20090116897A (en) * 2008-05-08 2009-11-12 주식회사 서흥캅셀 Chewable soft gelatin capsule with shell blooming
CN103734695A (en) * 2013-11-21 2014-04-23 荣成百合生物技术有限公司 Anti-fatigue health capsule and preparation method thereof
CN103893571A (en) * 2014-03-07 2014-07-02 西藏和藤藏医药开发有限公司 Medicinal composition for treating hypertension and application thereof

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KR20090116897A (en) * 2008-05-08 2009-11-12 주식회사 서흥캅셀 Chewable soft gelatin capsule with shell blooming
CN103734695A (en) * 2013-11-21 2014-04-23 荣成百合生物技术有限公司 Anti-fatigue health capsule and preparation method thereof
CN103893571A (en) * 2014-03-07 2014-07-02 西藏和藤藏医药开发有限公司 Medicinal composition for treating hypertension and application thereof

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107788194A (en) * 2017-11-12 2018-03-13 张雅萍 A kind of black fruit fructus lycii anti-trioxypurine functional gels candy and preparation method thereof
CN107788194B (en) * 2017-11-12 2021-05-11 张雅萍 Lycium ruthenicum murr uric acid-reducing functional gel candy and preparation method thereof
CN108634304A (en) * 2018-04-19 2018-10-12 成都欧甘拓展有限公司 Improve immune function of human body and antifatigue edible composition
CN113908224A (en) * 2021-11-18 2022-01-11 长春守道生物科技有限公司 A Chinese medicinal composition with immunoregulatory function, and its preparation method
CN114848727A (en) * 2022-06-21 2022-08-05 吉林农业大学 Preparation method and application of American ginseng paste with health care function

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Application publication date: 20151202