Compound preparation for improving body immunity function by adopting topical mode and preparation method thereof

A technology of body immunity and compound preparations, which is applied in the direction of medical preparations containing active ingredients, pharmaceutical formulas, liquid delivery, etc., can solve problems such as not very obvious effects, insufficient attention to usage and dosage, and inability to guarantee clinical efficacy, etc., to achieve Facilitate quality control, increase disease resistance, and increase strength

Inactive Publication Date: 2015-01-07
刘天明
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AI-Extracted Technical Summary

Problems solved by technology

This will inevitably lead to unclear treatment and control targets in the production process of finished medicines and finished products, and cannot guarantee stable clinical efficacy
[0004] At present, people generally believe that traditional Chinese medicines are low-toxic, mild, safe to take, and can be taken for a long time, etc., but they...
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Method used

1, patient Liu, female, 18 years old, dry cough, less phlegm, dry throat, xerostomia, hot palms and soles, night sweats, symptoms of constipation occurred in Shenyang, the place of residence since 2010, and the symptoms were aggravated in case of haze weather. Usually the spirit is fair, the quality of sleep is reduced, the diet is poor, and I don't like sports. The pharmaceutical powder of Example 2 of the present invention was prepared into a cataplasm dosage form and pasted on Yingxiang acupoint and its surroundings. After 3 months of pasting before going to bed, the patient's symptoms improved significantly, the quality of sleep improved, the diet increased, and the body's exercise capacity After 5 months of continuous sticking, the physical and mental conditions improved significantly.
2, patient Qi, man, 29 years old, after being transferred to Shijiazhuang from the original work place, shortness of breath occurs, voice is low and timid, spontaneous sweating, dry mouth and throat, mental fatigue, pale complexion, hot flashes Red cheekbones, light red tongue with little moss. Meeting smog weather disease aggravates. As a result, the patient has poor sleep quality, poor diet, weight loss, normal energy, and easy sweating. No organic cause was found during the physical examination. The pharmaceutical powder in Example 2 of the present invention was prepared into...
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Abstract

The invention relates to a compound preparation for improving a body immunity function by adopting a topical mode. The compound preparation comprises the following traditional Chinese medicine compositions in parts by weight: 20-40 parts of astragalus mongholicus, 10-40 parts of white atractylodes rhizome, 2-10 parts of platycodon grandiflorum, 3-10 parts of jute, 5-20 parts of edebouriella root, 0.5-3 parts of radix angelicae, 0.5-3 parts of herba schizonepetae, 0.5-3 parts of perilla Frutescens, 0.5-3 parts of poria cocos, 0.5-3 parts of real lotus solid stem, 0.5-3 parts of artemisia stelleriana, 0.2-2.5 parts of mentha haplocalyx, 0.2-2.5 parts of liquorice, 0.2-3 parts ofganoderma lucidum, 0.5-1.5 parts of asparagus cochinchinensis, 0.5-2 parts of polygala tenuifolia, 0.5-3 parts of chrysanthemum, 0.5-1.5 parts of achyranthes bidentata, 0.2-1.5 parts of radix bupleuri, 0.2-1.5 parts of semen plantaginis, 0.2-1.5 parts of fructus leonuri, 0.2-1.5 parts of costus root, 0.5-3 parts of semen cuscutae, 0.5-2.5 parts of fructus kochiae, 0.5-1.5 parts of eulaliopsis binata, 0.5-2 parts ofindigoplant fruit, 0.5-3 parts of cattail, 0.5-2.5 parts of boneset, 0.2-3 parts of semen cassiae, 0.5-3 parts of mysorethorn, 0.5-1.5 parts of madder root, 0.5-3 parts of shaddock peel, 0.5-1.5 parts of siberian elm bark and 0.2-1.5 parts of flos magnoliae. The invention also provides a preparation method of the compound preparation for improving the body immunity function by adopting the topical mode.

Application Domain

Technology Topic

Compounded preparationsRadix bupleuri +13

Examples

  • Experimental program(4)

Example Embodiment

[0018] Example 1.
[0019] This embodiment provides a compound preparation for external use to improve the immune function of the body, which is composed of the following parts by weight of traditional Chinese medicine ingredients: 20 parts of Astragalus, 20 parts of Atractylodes, 2 parts of Platycodon grandiflorum, 3 parts of jute, 10 parts of Fangfeng, 1.48 parts of Angelica dahurica Servings, Nepeta 1.48, Perilla 1.48, Poria cocos 1.48, Lotus root stem 1.48, Artemisia anemone 1.48, Mint 1.48, Licorice 1.48, Zizhi 2, Asparagus 1.48, Polygala 1.48, Chrysanthemum 1.48 Servings, Achyranthes 1.48, Bupleurum 1.48, Psyllium 1.48, Chongweizi 1.48, Muxiang 1.48, Cuscuta 1.48, Difuzi 1.48, Longxucao 1.48, Lanshi 1.48, Cattail 1.48 parts, bluegrass 1.48 parts, cassia seed 3 parts; Yunshi 1.48 parts, madder root 1.48 parts, grapefruit peel 1.52 parts, elm white peel 1.48 parts, Xinyi 1.48 parts.
[0020] The preparation method of the compound preparation for improving the immune function of the body by way of exception in this embodiment: After crushing the above-mentioned Chinese medicine components through a 20-mesh sieve, mixing, and decocting 3 times with water for 30 minutes each time, the amount of water is the total amount of the Chinese medicine components. 10 times the amount, combine the water extracts, concentrate the water extracts at 60°C under reduced pressure to obtain the Chinese medicine compound extract, crush it, and pass through an 80 mesh sieve to obtain the fine powder of the effective part extract of the Chinese medicine compound preparation; take the tragacanth gum 1.2 g Place in a dry mortar, disperse with proper amount of ethanol, add 1.0ml of polysorbate 80, add about 25ml of distilled water at a time and grind well, add 50g of cod liver oil to grind into colostrum: take 5g of fine powder of Chinese medicine compound extract and sodium benzoate Disperse 0.02g in about 5ml of distilled water, add it to the colostrum and mix it evenly, add 20ml of distilled water and stir it evenly. After dispensing, prepare the nose drops.
[0021] The present invention conducts mouse experiments to verify the therapeutic effect of the compound preparation for improving the immune function of the body.
[0022] 1. Equipment.
[0023] 1.1 Animals: Kunming mice, 18-22g, male and female, all clean grade, provided by the Experimental Animal Center of Shenyang Pharmaceutical University.
[0024] 1.2 Instruments: electronic balance, microplate reader, stopwatch, capillary glass tube (inner diameter 1mm, length 10mm).
[0025] 1.3 Medicine: physiological saline, ginseng decoction 0.2g·ml -1 (Calculated by converting the amount of crude drug, self-made), the compound powder (powder) of the effective part of traditional Chinese medicine that can improve the immune function of the body in this Example 1 (hereinafter referred to as LAH).
[0026] 2. Method.
[0027] 2.1 Mice swimming experiment: Take 48 Kunming mice of half male and female, and randomly divide them into normal saline group, ginseng group, LAH low-dose group, LAH high-dose group, 12 in each group. The normal saline group was given 0.3ml of normal saline a day, and the ginseng group was given 1g·kg of ginseng decoction -1 ,; LAH low-dose group was given LAH nasal drops 1.2g·kg -1; LAH high-dose group was given LAH nasal drops 5.3g·kg -1; All the above groups were administered by nasal instillation for 7 consecutive days. One hour after the last administration, load the tail of the mouse (5% of body weight) and swim in a glass tank with a water depth of 20cm and a water temperature of (20±0.5) ℃. Record the mouse from entering the water to sinking to the bottom and unable to swim out of the water. time. All test data are expressed as mean±standard deviation, and the swimming time of mice is tested.
[0028] 2.2 Experimental hypoxia tolerance in mice: 48 Kunming mice with half male and half females were taken, and the grouping and administration were the same as in item 2.1 above. One hour after the last administration, the mice were put into a 250ml wide-mouth bottle, stuffed into the bottle cap, sealed with petroleum jelly, airtight, and timed immediately, using respiratory arrest as an indicator to observe and record the survival time of the mice. All test data are expressed as mean±standard deviation, and survival time test is performed.
[0029] Table 1: The effect of LAH on normal mice's swimming time and normal pressure hypoxia tolerance time.
[0030] Group Dose C/g·kg -1 Mouse swimming time t/min Survival time t/min Normal saline - 14.56±3.27 20.68±4.21 Ginseng 1 16.24±5.13 ** 23.15±3.05 ** LAH low dose 1.2 15.01±4.98 * 21.79±5.15 * LAH high dose 5.3 16.84±3.46 ** 23.58±4.26 **
[0031] It can be seen from Table 1 that high-dose LAH has a significant effect on the swimming time and oxygen-consuming survival time of mice. The swimming time and survival time of mice are significantly better than the low-dose LAH group and the saline group, and the high LAH The swimming time and survival time of mice in the dose group were similar to those in the ginseng group. Therefore, the externally applied compound preparation of the present invention has a certain positive effect on the body's anti-fatigue, and effectively reduces the production cost on the basis of ensuring the curative effect.
[0032] 2.3. Randomly split, recombine, increase or decrease the flavor and amount of the thirty-four traditional Chinese medicine components in the compound preparation of Example 1, to form 6 groups of formulas, and repeat mice swimming with the saline group and the ginseng group Experiment and hypoxia tolerance experiment, the experimental results are shown in Table 2.
[0033] Formula 1 (5 herbs): Astragalus 20 grams; Platycodon grandiflorum 2 grams, Perilla 1.48 grams, Licorice 1.48 grams, Asparagus 1.48 grams. The preparation method of Example 1 was used to prepare nasal drops.
[0034] Formulation 2 (9 herbs): 20 grams of Atractylodes macrocephala, 3 grams of jute, 3 grams of Cassia; Angelica dahurica 1.48 grams, Artemisia angustifolia 1.48 grams, Bupleurum 1.48 grams, Cuscuta seeds 1.48 grams, Difuzi 1.48 grams, and Longxugrass 1.48 grams. The preparation method of Example 1 was used to prepare nasal drops.
[0035] Recipe 3 (13 herbs): 2 grams of Ganoderma lucidum, 10 grams of parsnips, 1.48 grams of licorice, 1.48 grams of Asparagus, 1.48 grams of Polygala 1.48 grams, 1.48 grams of Chrysanthemum, 1.48 grams of Achyranthes, 1.48 grams of Psyllium, 1.48 grams of Typha, 1.48 grams of bluegrass Grams, madder root 1.48 grams, grapefruit peel 1.52 grams, elm white peel 1.48 grams. The preparation method of Example 1 was used to prepare nasal drops.
[0036] Formula 4 (18 herbs): Nepeta 1.48g, Perilla 1.48g, Lotus root stem 1.48g, Artemisia argyi 1.48g, Bupleurum 1.48g, Lanshi 1.48g, Xinyi 1.48g; Mint 1.48g, Licorice 1.48g , Asparagus 1.48g, Polygala 1.48g, Plantago Seed 1.48g, Chongweizi 1.48g, Muxiang 1.48g, Cuscuta 1.48g, Cattail 1.48g, Bluegrass 1.48g, Madder root 1.48g, Elm white bark 1.48g. The preparation method of Example 1 was used to prepare nasal drops.
[0037] Formula 5 (27 medicines): 20 grams of Astragalus; 20 grams of Atractylodes macrocephala, 2 grams of platycodon, 3 grams of cassia; 10 grams of parsnip, 1.48 grams of Angelica dahurica, 1.48 grams of Nepeta, 1.48 grams of Perilla, 1.48 grams of Artemisia angustifolia, 1.48 grams of Bupleurum Gram, Lanshi 1.48g, Yunshi 1.48g, Xinyi 1.48g; Mint 1.48g, Licorice 1.48g, Polygala 1.48g, Chrysanthemum 1.48g, Chongweizi 1.48g, Achyranthes 1.48g, Muxiang 1.48g, Cuscuta 1.48 Gram, Difuzi 1.48 grams, Longxu grass 1.48 grams, Cattail 1.48 grams, grapefruit peel 1.52 grams, madder root 1.48 grams, and elm white peel 1.48 grams. The preparation method of Example 1 was used to prepare nasal drops.
[0038] Formulation 6 (34 flavored medicines): The raw material components and dosages of traditional Chinese medicines and the preparation method are the same as in Example 1.
[0039] 2.3.1 Ninety-six Kunming mice of half male and female were randomly divided into physiological saline group, ginseng group, combination 1, combination 2, combination 3, combination 4, combination 5, and combination 6, with 12 mice in each group. The normal saline group was given 0.3ml of normal saline a day, and the ginseng group was given 1g·kg of ginseng decoction -1 , (All are calculated as crude drugs, self-made); Combination 1 is given to formula 1 nasal drops 5.5g·kg -1; Combination 2 gives the nasal drops made by formula 2 4.2g·kg -1; Combination 3 gives nasal drops made by formula 3 5.7g·kg -1; Combination 4 gives formula 4 nasal drops 4.4g·kg -1; Combination 5 gives formula 5 nasal drops 5.1g·kg -1; Combination 6 gives formula 6 nasal drops 5.3g·kg -1; All the above groups were administered by nasal instillation for 7 consecutive days. One hour after the last administration, load the tail of the mouse (5% of body weight) and swim in a glass tank with a water depth of 20cm and a water temperature of (20±0.5) ℃. Record the mouse from entering the water to sinking to the bottom and unable to swim out of the water. time. All test data are expressed as mean±standard deviation, and the swimming time of mice is tested.
[0040] 2.3.2 Experimental hypoxia tolerance in mice: 96 Kunming mice with half males and half females were taken, and the grouping and administration were the same as those in 2.3.1 above. One hour after the last administration, the mice were put into a 250ml wide-mouth bottle, stuffed into the bottle cap, sealed with petroleum jelly, airtight, and timed immediately, using respiratory arrest as an indicator to observe and record the survival time of the mice. All test data are expressed as mean±standard deviation, and survival time test is performed.
[0041] Table 2: The effects of different amounts of medicines on mice swimming time and normal pressure hypoxia tolerance time.
[0042] Group Dose C/g·kg -1 Mouse swimming time t/min Survival time t/min Normal saline - 14.56±3.27 20.68±4.21 Ginseng 1 16.24±5.13 ** 23.15±3.05 ** Combination 1 5.5 14.82±5.02 * 20.79±5.11 * Combination 2 4.2 14.98±4.72 * 20.93±4.94 * Combination 3 5.7 15.03±3.56 ** 21.61±4.52 ** Combination 4 4.4 14.47±3.26 ** 20.84±4.05 ** Combination 5 5.1 15.21±3.98 ** 22.55±3.89 ** Combination 6 5.3 16.84±3.46 ** 23.58±4.26 **
[0043] It can be seen from Table 2 that different amounts of medicines and compatibility principles have significant effects on the swimming time and oxygen-consuming survival time of mice. Among them, the swimming time and oxygen-consuming survival time of mice in combination 6 are significantly better than other formulas. In the group, the swimming time and oxygen-consuming survival time of mice in the "Jun, Chen, Zuo, Shi" prescriptions with more complete medicinal flavors were better than those of mice with incomplete "Jun, Chen, Zuo, Shi" medicinal recipes Swimming time and oxygen consumption survival time. It can be seen that the compatibility principle of "jun, minister, adjuvant, and messenger" of the compound preparation for external use to improve the immune function of the body of the present invention is a reasonable choice after optimization.

Example Embodiment

[0044] Example 2.
[0045] This Example 2 provides a compound preparation for external use to improve the immune function of the body, which is composed of the following parts by weight of Chinese medicine ingredients: 20 parts of Astragalus, 20 parts of Atractylodes, 2 parts of Platycodon grandiflorum, 3 parts of jute, 10 parts of Fangfeng, Angelica dahurica 1.48 parts, Nepeta 1.48 parts, Perilla 1.48 parts, Poria cocos 1.48 parts, Lotus root stems 1.48 parts, Artemisia annua 1.48 parts, Mint 1.48 parts, Licorice 1.48 parts, Zizhi 2 parts, Asparagus 1.48 parts, Polygala 1.48 parts, Chrysanthemum 1.48 parts, Achyranthes 1.48 parts, Chaihu 1.48 parts, Plantago seeds 1.48 parts, Chongweizi 1.48 parts, Muxiang 1.48 parts, Cuscuta seeds 1.48 parts, Difuzi 1.48 parts, Longxucao 1.48 parts, Lanshi 1.48 parts, 1.48 parts of cattail, 1.48 parts of bluegrass, 3 parts of cassia; 1.48 parts of Yunshi, 1.48 parts of madder root, 1.52 parts of grapefruit peel, 1.48 parts of elm white peel, and 1.48 parts of Xinyi. That is to say, the composition and weight parts of the traditional Chinese medicine in Example 2 are the same as those in Example 1.
[0046] The preparation method of the compound preparation for improving the immune function of the body in the external application of the present Example 2: After crushing the above-mentioned Chinese medicines through a 20-mesh sieve, mixing, decocting with 15 times the amount of the original total medicinal materials for 3 times, each for 30 minutes, and combining The water extract was concentrated under reduced pressure at 60°C to obtain the extract of the Chinese medicine compound preparation, crushed, and passed through an 80-mesh sieve to obtain the Chinese medicine compound extract powder; take 1 g of gelatin and 1.2 g of hydroxypropyl cellulose and disperse them in 20 ml. In distilled water, heated in a water bath at 70℃ to make a clear solution (component A); disperse 940 1g of carbomer into 40ml distilled water, stir and swell into a transparent gel (component B); take the Chinese medicine crushed through 80 mesh sieve 5g of the compound extract was placed in a solvent consisting of 6g of glycerin, 1g of polyethylene glycol 400 (PEG400), 3g of sorbitol and 2ml of distilled water, and stirred evenly (component C). After mixing the A and B components evenly, add the C component and stir evenly. The prepared drug-containing cataplasma matrix is ​​coated on the non-woven backing material, the surface is covered with a polyethylene film, and the cataplasma is cut into a cataplasma.
[0047] Typical cases.
[0048] 1. Patient Liu, female, 18 years old, had symptoms of dry cough, low phlegm, dry throat, dry mouth, hot hands, feet, heart, night sweats, constipation in Shenyang where she lives since 2010, and her symptoms intensified in haze weather. The usual energy is good, the quality of sleep is decreased, the diet is poor, and he doesn't like exercise. The pharmaceutical powder of Example 2 of the present invention was prepared into a cataplasm formulation and pasted on Yingxiang acupoint and its surroundings. After 3 months before going to bed, the patient’s symptoms improved significantly, sleep quality improved, diet increased, and body exercise ability After 5 months of continuous use, the physical and mental condition improved significantly.
[0049] 2. Patient Qi, male, 29 years old, after being transferred to work in Shijiazhuang from his original work place, he experienced wheezing and shortness of breath, low voice, spontaneous sweating, night sweats, dry mouth and throat, fatigue, pale face, hot flashes and red zygomaticity. The tongue is light red and less moss symptoms. In case of haze weather, the symptoms worsen. As a result, patients now have poor sleep quality, poor diet, weight loss, normal energy level, sweating easily, and no organic cause was found during the physical examination. After preparing the pharmaceutical powder in Example 2 of the present invention into a cataplasm formulation and sticking it on the inner side of a common single-layer medical mask for 3 months, the patient’s symptoms improved significantly, the quality of sleep was improved, the diet increased, the weight returned to normal, and it was difficult to get out. Sweat and colds are significantly reduced.
[0050] 3. Patient Wang Moumou, female, 36 and a half years old, after being transferred to Beijing to work from her original work place, she developed cough, spitting and salivation. She was thin in quality and large in volume, short breath, cold limbs, spontaneous sweating, cold back Such as large palms, easy to catch a cold, white face and fatigue, not thirsty, pale tongue, white and smooth fur. Symptoms intensified in haze weather. After 12 months of breast-feeding period, I had repeated colds, poor diet, normal weight, good spirits, sweating easily, and dry hair. The powder prepared in Example 2 of the present invention was prepared into a cataplasm formulation and applied to Yingxiang acupoint and its surroundings After taking it for 4 months before going to bed, the patient's symptoms improved significantly, eating increased, and not sweating easily. After taking it for 4 months, the number of colds was significantly reduced and the hair quality improved.
[0051] 4. Patient Cao Moumou, male, 51 years old, has suffered from wheezing disease since 2005 in Zhengzhou where he lives. He usually has repeated coughs, shortness of breath, fatigue, weak voice, short breath, sputum in the throat, spontaneous sweating, fear of wind, and asthma when moving. Chest tightness, when the above symptoms are aggravated in cloudy weather and colds, the powder prepared in Example 2 of the present invention is prepared into a cataplasm formulation and pasted on the inner side of a common single-layer medical mask. After wearing for 3 months, the cough is reduced, and the gasping subsides during activities After 4 months of continued wearing, the frequency of colds has been significantly reduced, there is no sputum in the throat, coughing and chest tightness no longer.

Example Embodiment

[0052] Example 3.
[0053] This Example 3 provides a compound preparation for external use to improve the immune function of the body, which is composed of the following parts by weight of Chinese medicine ingredients: 38 parts of Astragalus, 34 parts of Atractylodes, 10 parts of Platycodon, 7 parts of Jute, 20 parts of Fangfeng, Angelica dahurica 0.6 parts, Nepeta 0.6 parts, Perilla 1 part, Poria cocos 0.7 parts, Lotus root stem 2.8 parts, Artemisia angustifolia 2.5 parts, Mint 2.2 parts, Licorice 2.2 parts, Ganoderma lucidum 2.2 parts, Asparagus 1.4 parts, Polygala 1.3 parts, Chrysanthemum 2.6 parts, Achyranthes 1.2 parts, Bupleurum 1.5 parts, Plantago seed 1.35 parts, Chongweizi 1.35 parts, Muxiang 0.85 parts, Cuscuta 2.5 parts, Difuzi 2 parts, Longxu grass 1 part, Lanshi 0.8 parts, 0.7 parts of cattail, 2 parts of bluegrass, 2.6 parts of cassia seed; 1.65 parts of Yunshi, 0.85 parts of madder root, 2.3 parts of grapefruit peel, 1.35 parts of elm white peel, and 1.5 parts of Xinyi.
[0054] The preparation method of the compound preparation for external application to improve the immune function of the body in Example 3: After crushing the above-mentioned Chinese medicines through a 20-mesh sieve, mixing them, decocting them with 10 times the amount of the original total medicinal materials for 3 times, each for 45 minutes, and combining The water extract is concentrated under reduced pressure at 60°C to obtain the extract of the Chinese medicine compound preparation, crushed, and passed through an 80-mesh sieve. Take 15g of stearic acid, 2g of lanolin, and 25ml of liquid paraffin in a clean beaker, heat it in a water bath to melt; take 2g of triethanolamine, 5g of glycerin and 50ml of distilled water in another beaker, heat the water bath to 80℃; add oil and water Mix the two at equal temperature and keep stirring until they condense to obtain a milky white matrix. Weigh 2 g of the fine powder of the Chinese medicine compound extract that has passed through an 80-mesh sieve, grind it with a small amount of glycerin, and mix it with the base to obtain an ointment.
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PUM

PropertyMeasurementUnit
The inside diameter of1.0 ~ 10.0mm
tensileMPa
Particle sizePa
strength10

Description & Claims & Application Information

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