Traditional Chinese medicine composition based on rhodiola rosea and production method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine, and discloses a traditional Chinese medicine composition based on rhodiola rosea and a production method thereof, the traditional Chinese medicine composition comprises the following raw materials: rhodiola rosea, coptis chinensis, indigo naturalis, liquorice, radix gentianae, pseudo-ginseng, honeysuckle, dendrobium officinale and baicalin microcapsules; wherein the baicalin microcapsule is prepared by taking lactoferrin as a capsule wall and baicalin as a capsule core and utilizing a single coacervation method, the stability of the baicalin in an oral environment can be improved by wrapping the baicalin with the lactoferrin, a slow-release effect is achieved, and the positively charged lactoferrin can generate an electrostatic adsorption effect with a negatively charged mucous membrane, so that the stability of the baicalin in the oral environment is improved. The baicalin microcapsule is adhered to an ulcer surface, so that the effect of positioning, slow-release and targeting is achieved, the burst release phenomenon of baicalin is reduced, and the treatment effect of the traditional Chinese medicine composition on oral ulcer is effectively improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition based on Rhodiolae and a production method thereof. BACKGROUND

[0002] Traditional Chinese medicine is part of natural medicine and its processed products used for preventing, diagnosing and treating diseases and rehabilitation and health care, and is the wisdom crystallization obtained by human beings in the long-term practice, summarization, reflection and arrangement in the process of fighting against diseases. Oral health is one of the important signs of human health. Due to the change of modern social lifestyle, including the increase of life pressure, unhealthy eating habits and bad oral hygiene habits, more and more people are facing oral health problems. Oral ulcer, also known as "apthous ulcer", is one of the highest incidence in oral mucosa diseases, often occurs in the inner side of the lips, soft palate, tongue margin, buccal mucosa and other parts, and has the characteristics of periodicity, self-limitation and recurrence. When it occurs, the ulcer surface is accompanied by obvious burning pain, which affects the patient's diet and speech. In severe cases, it may also be accompanied by complications such as gum pain, gum bleeding, lymph node enlargement, fever, headache and other complications, further aggravating the patient's pain.

[0003] Modern medicine mainly uses chemical drugs for treatment, and the common methods mainly include pain relief, inflammation relief and the like. However, the treatment of mouthwash, medicine patch, analgesic, anti-inflammatory drug and the like mostly has poor effect, has high recurrence rate, may cause side effects and has long treatment cycle and other defects. Therefore, more and more patients choose traditional Chinese medicine treatment. Traditional Chinese medicine, as a natural medicine, has the advantages of multiple components, mild drug property, few toxic and side effects and non-easy resistance, and has received more and more attention and recognition. According to the theory of traditional Chinese medicine, internal generation of yin fire, spleen-kidney deficiency and accumulation of heat in heart and spleen are the main causes of recurrent oral ulcer. In recent years, the research on traditional Chinese medicine composition has become the direction for treating oral ulcer. Rhodiolae is sweet and cold, and belongs to the spleen and lung channels, has the effects of invigorating the spleen and replenishing qi, promoting blood circulation and removing blood stasis, and has obvious therapeutic effect on oral ulcer. Therefore, it is an ideal choice for traditional Chinese medicine composition for treating oral ulcer. However, there are problems of short action time on ulcer and low drug utilization rate.

[0004] The patent for invention with publication number CN102423319B discloses a traditional Chinese medicine composition for treating oral ulcer. The traditional Chinese medicine composition is prepared from calcined gypsum, human middle white, waist yellow and borneol, has the effects of clearing heat and resolving toxin, promoting tissue regeneration, relieving swelling and pain and absorbing moisture and closing sore, and can be used for treating toothache, cheilitis and oral ulcer. However, borneol can be converted into camphor in the body, and camphor has certain toxicity, which has certain safety hazards. Based on this, it is of great significance to develop a traditional Chinese medicine composition with mild components and safety for treating oral ulcer. SUMMARY

[0005] In order to solve the problems mentioned in the background art, the purpose of the present application is to provide a traditional Chinese medicine composition based on Rhodiola and a production method thereof.

[0006] The purpose of the present application can be achieved by the following technical solutions. A traditional Chinese medicine composition based on Rhodiola, comprising the following raw materials by weight: 25-35 parts of Rhodiola, 10-20 parts of Coptis, 5-15 parts of indigo, 10-15 parts of licorice, 10-15 parts of gentian, 8-12 parts of Sanchi, 10-20 parts of honeysuckle, 10-15 parts of Dendrobium officinale, and 4-6 parts of microcapsules of baicalin.

[0007] Further, the preparation method of the microcapsules of baicalin comprises the following steps: I: Lactoferrin is placed in deionized water and uniformly mechanically stirred to prepare a lactoferrin solution; II: Baicalin is added to the lactoferrin solution, stirred uniformly, and an emulsifier is added, and the mixture is treated at a temperature of 40-60°C and a stirring speed of 300-500 r / min for 20-40 min to obtain a mixed emulsion; III: Anhydrous ethanol is added to the mixed emulsion, flocculated for 15-25 min, cooled to 10-20°C using an ice water bath, the pH value of the system is adjusted to 8-9 using a sodium hydroxide solution, a solidifying agent is added, and the mixture is solidified for 1-2 h. The microcapsule solution is taken out and centrifuged at a speed of 2000-4000 r / min for 10-20 min. The supernatant is taken out, the solid material below the centrifuge tube is washed with deionized water and suction filtered, and finally the obtained microcapsules are dried in a freeze dryer to obtain the microcapsules of baicalin.

[0008] Further, in step I, the mass fraction of the lactoferrin solution is 3-5%.

[0009] Further, in step II, the emulsifier is any one of Tween 60, monoglyceride or Span 80.

[0010] Further, in step III, the amount of anhydrous ethanol is 50%-75% of the amount of lactoferrin.

[0011] Further, in step III, the mass fraction of the sodium hydroxide solution is 10%-40%.

[0012] Further, in step III, the solidifying agent is glutaraldehyde.

[0013] A production method of a traditional Chinese medicine composition based on Rhodiola, comprising the following steps: (1) Rhodiola, Coptis, indigo, licorice, gentian, Sanchi, honeysuckle, and Dendrobium officinale are respectively cleaned and impurities are removed, and then dried at 40-60°C; (2) The dried raw materials are respectively crushed by a crusher and sieved, and the crushed medicines are added into a mixer, stirred for 20-40 min, and then the baicalin microcapsules are added and uniformly mixed to obtain the traditional Chinese medicine composition.

[0014] Further, in step (2), the mesh number of the sieving is 900-1100.

[0015] The beneficial effects of the present application are as follows: (1) The traditional Chinese medicine composition prepared by the present application mainly comprises mild traditional Chinese medicines such as rhodiola, baicalin microcapsules, goldthread and honeysuckle, which have good curative effect on treating oral ulcer through synergistic effect, and has wide application prospect.

[0016] (2) The present application prepares baicalin microcapsules with shell-core structure by using lactoferrin as the capsule wall and baicalin as the capsule core. On the one hand, the use of lactoferrin to wrap baicalin can improve the stability of baicalin in the oral environment. Baicalin has many pharmacological effects such as bacteriostasis, anti-inflammatory, heat-clearing and detoxification. When baicalin acts on the ulcer surface, it can inhibit the growth and reproduction of various bacteria and viruses, reduce the symptoms of infection, create favorable conditions for the healing of ulcer, and promote the regeneration and repair of ulcer surface cells, accelerate the healing process of ulcer surface. On the other hand, since the drug will pass through the oral cavity, the positively charged lactoferrin can produce electrostatic adsorption with the negatively charged mucosa, thereby adhering the baicalin microcapsules to the ulcer surface, playing a role of positioning and slow-release targeting, reducing the burst release phenomenon of baicalin, and thus improving the treatment effect of baicalin on oral ulcer. The problem of short action time of baicalin on the ulcer surface and low drug utilization rate is solved. At the same time, lactoferrin has broad-spectrum antibacterial effect, can inhibit pathogenic bacteria in the oral cavity, reduce the risk of infection, and can reduce the inflammatory reaction of the ulcer surface, relieve pain and discomfort, and help the healing and repair of the ulcer.

[0017] Of course, it is not necessary for any product implementing the present application to achieve all the advantages mentioned above. BRIEF DESCRIPTION OF DRAWINGS

[0018] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings needed to be used in the embodiment description. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can also be obtained by those skilled in the art without creative labor.

[0019] Figure 1 The scanning electron microscope image of the baicalin microcapsules prepared by the present application. DETAILED DESCRIPTION

[0020] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of the present application.

[0021] Embodiment 1 I. Preparation of baicalin microcapsules I: 4g lactoferrin was placed in 100ml deionized water, and uniformly mechanically stirred to prepare a lactoferrin solution; II: 1g baicalin was added to the lactoferrin solution, and uniformly stirred, and 1.6g Tween 60 was added, and the mixture was treated at a temperature of 50℃ and a stirring speed of 400r / min for 30min to obtain a mixed emulsion; III: 2g anhydrous ethanol was added to the mixed emulsion, and flocculation was performed for 20min, and the temperature was lowered to 15℃ using an ice water bath, and the pH value of the system was adjusted to 8.5 using a sodium hydroxide solution, and 0.04g glutaraldehyde was added, and solidification was performed for 1.5h, and the microcapsule solution was taken out and centrifuged at a speed of 3000r / min for 15min, and the supernatant was taken out, and the solid material below the centrifuge tube was washed with deionized water and suction filtered, and finally the obtained microcapsules were placed in a freeze dryer for drying, and the baicalin microcapsules were obtained.

[0022] The prepared baicalin microcapsules were added to 50ml acetone, and after being fully shaken and stirred using a vortex shaker, centrifugal washing was performed, and the supernatant was collected, and after the solvent was removed by rotary evaporation, the baicalin in the supernatant was collected, and the embedding rate was calculated according to the formula A=[(B-C) / B]x100%, wherein A is the embedding rate, %; B is the total mass of baicalin, g; and C is the mass of baicalin in the supernatant, g; and the embedding rate of the baicalin microcapsules was calculated to be 78.5%.

[0023] A ZEISS Gemini 300 scanning electron microscope produced by Carl Zeiss Company, Germany, was used to analyze the morphology of the baicalin microcapsules, and the test results are shown in Figure 1 As can be observed from the figure, the baicalin microcapsules have complete morphology, good sphericity and smooth surface.

[0024] Technical principle: In the baicalin microcapsules, lactoferrin is used as the capsule wall, and baicalin is used as the capsule core, and the baicalin microcapsules with shell-core structure are prepared by using a single coacervation method; first, the capsule core, Tween 60 and the capsule material are added to the capsule material for emulsification; second, the coagulation effect of anhydrous ethanol is used, and because water is combined with the coagulant, the solubility of the capsule wall material lactoferrin is reduced and coagulates out, and then glutaraldehyde is added for solidification and sedimentation, and then the baicalin microcapsules are prepared through the steps of centrifugation, washing, suction filtration and drying.

[0025] II. Preparation of the Chinese medicine composition (1) Remove impurities and wash 25g of Rhodiola, 10g of Coptis, 5g of Prussian blue, 10g of licorice, 10g of gentian, 8g of Sanqi, 10g of honeysuckle, and 10g of Dendrobium officinale Kimura et Migo respectively, and dry them at 40°C; (2) Grind each of the dried raw materials with a grinder and pass them through a 900-mesh sieve. Add each of the ground medicines to a mixer and stir for 20 minutes. Then add 4g of microcapsules of baicalin and mix evenly to obtain the Chinese medicine composition.

[0026] Technical principle: Coptis, also known as Coptis deltoidea, is bitter and cold in nature and is related to the heart, spleen, stomach, liver, gallbladder, and large intestine channels. It has the effects of clearing heat and reducing fire, detoxifying, and removing dryness. It is mainly used for high fever with convulsions, damp-heat, vomiting and acid regurgitation, restlessness, insomnia, heart fire, toothache, blood heat, red eyes, and diabetes. It is also used for external treatment of eczema or dermatitis. Prussian blue is salty and cold in nature and is related to the liver channel. It has the effects of clearing heat and detoxifying, cooling blood, and calming shock. It is mainly used for warm toxin with rashes, blood heat with vomiting and bleeding, chest pain with hemoptysis, mouth sores, mumps, and infantile convulsions. Licorice is used to harmonize the effects of other medicines, remove cold evil, and has the effects of clearing heat and detoxifying, tonifying the spleen and qi, moistening the lungs and reducing phlegm, relieving acute and chronic pain, and regulating the effects of other medicines. It is mainly used for heart qi deficiency, palpitations, spleen and stomach weakness, fatigue, and abscesses. Gentian is bitter and cold in nature and is related to the liver and gallbladder channels. It is mainly used for clearing liver and gallbladder heat and reducing fire in the lower energizer. Sanqi, also known as Panax notoginseng, is sweet and bitter in taste, warm in nature, and is related to the liver and stomach channels. It is mainly used for various bleeding and cardiovascular diseases. Honeysuckle is sweet and cold in nature and has a fragrant aroma. It is mainly used for body heat, rashes, rashes, hot and toxic sores, sore throat, and other conditions. Dendrobium officinale Kimura et Migo is sweet and cold in nature and is related to the stomach and kidney channels. It has the effects of tonifying the stomach, generating saliva, and clearing heat. It is mainly used for heat disease with saliva loss, dry mouth, stomach yin deficiency, poor appetite, post-disease fever, yin deficiency with heat, bone heat, blurred vision, and flaccid muscles and bones. The combination of these medicines has the effects of soothing the liver and relieving depression, clearing heat and detoxifying, invigorating the spleen and promoting digestion, promoting blood circulation and removing blood stasis, and nourishing yin and reducing fire.

[0027] Example 2 Preparation of the Chinese medicine composition (1) Remove impurities and wash 30g of Rhodiola, 15g of Coptis, 10g of Prussian blue, 12g of licorice, 12g of gentian, 10g of Sanqi, 15g of honeysuckle, and 12g of Dendrobium officinale Kimura et Migo respectively, and dry them at 50°C; (2) Grind each of the dried raw materials with a grinder and pass them through a 1000-mesh sieve. Add each of the ground medicines to a mixer and stir for 30 minutes. Then add 5g of microcapsules of baicalin and mix evenly to obtain the Chinese medicine composition.

[0028] The preparation method of baicalin microcapsules is the same as that of Example 1.

[0029] Example 3 Preparation of the Chinese medicine composition (1) 35 g of Rhodiola, 20 g of Coptis, 15 g of Prussian blue, 15 g of licorice, 15 g of gentian, 12 g of Sanqi, 20 g of honeysuckle, and 15 g of Dendrobium officinale were respectively cleaned and dried at 60°C; (2) The dried raw materials were respectively crushed by a crusher and passed through a 1200-mesh sieve, and the crushed medicines were added to a mixer and stirred for 40 min, and then 6 g of baicalin microcapsules were added and mixed uniformly to obtain the Chinese medicine composition.

[0030] The preparation method of baicalin microcapsules is the same as that of Example 1.

[0031] Comparative Example 1 Preparation of the Chinese medicine composition (1) 30 g of Rhodiola, 15 g of Coptis, 10 g of Prussian blue, 12 g of licorice, 12 g of gentian, 10 g of Sanqi, 15 g of honeysuckle, and 12 g of Dendrobium officinale were respectively cleaned and dried at 50°C; (2) The dried raw materials were respectively crushed by a crusher and passed through a 1000-mesh sieve, and the crushed medicines were added to a mixer and stirred for 30 min, and then 3 g of lactoferrin and 2 g of baicalin were added and mixed uniformly to obtain the Chinese medicine composition.

[0032] The preparation method of baicalin microcapsules is the same as that of Example 1.

[0033] Comparative Example 2 Preparation of the Chinese medicine composition (1) 30 g of Rhodiola, 15 g of Coptis, 10 g of Prussian blue, 12 g of licorice, 12 g of gentian, 10 g of Sanqi, 15 g of honeysuckle, and 12 g of Dendrobium officinale were respectively cleaned and dried at 50°C; (2) The dried raw materials were respectively crushed by a crusher and passed through a 1000-mesh sieve, and the crushed medicines were added to a mixer and stirred for 30 min to obtain the Chinese medicine composition.

[0034] Performance test: Take 50 male rats with a weight of 200±5g, and randomly divide them into five groups. Anesthetize the rats with isoflurane, place the lower end of a plastic dropper (inner diameter: 3mm) with a cotton ball of phenol on the buccal membrane about 1mm from the left corner of the rat's mouth, and burn for 30 seconds. A white lesion about 3mm in diameter appears at the site, which is the ulcer site. Then, cover the ulcer site with the traditional Chinese medicine composition prepared in Examples 1-3 and Comparative Examples 1-2. On the 2nd, 3rd, 5th, and 7th days of treatment, measure the diameter of the ulcer site and take pictures. Apply the traditional Chinese medicine composition twice a day on the ulcer site. The control group is set up by constructing an oral ulcer site on the buccal membrane about 1mm from the left corner of the rat's mouth, and then not doing anything else. The specific test results are shown in the following table:

[0035] As shown in the above table, the traditional Chinese medicine composition prepared in Examples 1-3 has good therapeutic effect on the ulcer site of the rats, and helps the healing and repair of the ulcer. The rats can basically recover on the 7th day. The traditional Chinese medicine composition prepared in Comparative Example 1 has milk ferritin and baicalin added, and the healing effect of the ulcer site is general compared to the examples. This may be because the baicalin is directly added without being coated, and the stability of baicalin in the oral environment is affected, resulting in a decrease in the therapeutic effect on oral ulcers. The traditional Chinese medicine composition prepared in Comparative Example 2 does not have baicalin microcapsules added, and the healing process of the ulcer site is slow. The ulcer site is not completely healed on the 7th day, and the therapeutic effect is poor. The control group does not treat the ulcer site of the rats, so the healing rate of the ulcer site is slow.

[0036] The above content is only an example and explanation of the concept of the present application. Those skilled in the art can make various modifications or supplements to the described specific embodiments or use similar ways to replace them, as long as they do not deviate from the concept of the present application or exceed the scope defined by the present claims, and they should belong to the protection scope of the present application.

Claims

1. A Chinese medicine composition based on Rhodiola rosea, characterized in that, The invention comprises the following raw materials in parts by weight: 25-35 parts of rhodiola rosea, 10-20 parts of coptis chinensis, 5-15 parts of indigo naturalis, 10-15 parts of liquorice, 10-15 parts of gentian, 8-12 parts of panax notoginseng, 10-20 parts of honeysuckle, 10-15 parts of dendrobium officinale and 4-6 parts of baicalin microcapsules.

2. A Chinese medicine composition based on Rhodiola rosea according to claim 1, characterized in that, The preparation method of the baicalin microcapsules comprises the following steps: Ⅰ: Place lactoferrin in deionized water and stir mechanically to obtain a lactoferrin solution; II: adding baicalin to the lactoferrin solution, stirring evenly, adding an emulsifier, and treating at a temperature of 40 to 60° C. and a stirring speed of 300 to 500 r / min for 20 to 40 minutes to obtain a mixed emulsion; III: Add anhydrous ethanol to the mixed emulsion and flocculate for 15 to 25 minutes. Cool the mixture to 10 to 20° C. in an ice-water bath, adjust the pH value of the system to 8 to 9 with a sodium hydroxide solution, add a curing agent, and cure for 1 to 2 hours. Remove the microcapsule solution and centrifuge it at a speed of 2000 to 4000 r / min for 10 to 20 minutes. Remove the supernatant, wash the solid material at the bottom of the centrifuge tube with deionized water and filter it. Finally, place the obtained microcapsules in a freeze dryer for drying to obtain baicalin microcapsules.

3. A Chinese medicine composition based on Rhodiola rosea according to claim 2, characterized in that, In step I, the mass fraction of the lactoferrin solution is 3-5%.

4. A Chinese medicine composition based on Rhodiola rosea according to claim 2, characterized in that, In step II, the emulsifier is any one of Tween 60, monoglyceride or Span 80.

5. A Chinese medicine composition based on Rhodiola rosea according to claim 2, characterized in that, In step III, the amount of anhydrous ethanol used is 50% to 75% of the amount of lactoferrin used.

6. A Chinese medicine composition based on Rhodiola rosea according to claim 2, characterized in that, In step III, the mass fraction of the sodium hydroxide solution is 10% to 40%.

7. A Chinese medicine composition based on Rhodiola rosea according to claim 2, characterized in that, In step III, the curing agent is glutaraldehyde.

8. A method for producing the Rhodiola rosea-based Chinese medicine composition according to claim 1, characterized in that: The following steps are involved: (1) Remove impurities and wash Rhodiola rosea, Coptis chinensis, Indigo naturalis, Licorice root, Gentiana scabra, Panax notoginseng, Honeysuckle and Dendrobium candidum respectively, and dry them at 40-60℃; (2) The dried raw materials were crushed and sieved separately using a crusher, and the crushed drugs were added to a mixer and stirred for 20 to 40 minutes. Then, baicalin microcapsules were added and mixed evenly to obtain a Chinese medicine composition.

9. The method for producing a Chinese medicine composition based on Rhodiola rosea according to claim 8, characterized in that: In step (2), the mesh size of the sieving is 900 to 1100 meshes.

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