A Yunnan Baiyao orally-dissolving film and its preparation method

Abstract

The present invention belongs to the field of medicine, and specifically discloses a Yunnan Baiyao orally dissolving film and a preparation method thereof. The Yunnan Baiyao orally dissolving film, by mass percentage, comprises 1.0 - 3.0% of Yunnan Baiyao, 10 - 15% of water-soluble polymer film-forming material, 1.0 - 3.0% of plasticizer, 1.0 - 3.0% of thickener, 0.01 - 0.02% of preservative, 1.0 - 2.0% of flavoring agent, 0.05 - 0.2% of edible essence, 3.0 - 3.5% of absolute ethanol, 0.5 - 1% of menthol, and 75.0 - 85.0% of purified water; by carefully selecting excipients such as film-forming materials, plasticizers, and flavoring agents, and optimizing the preparation process, the Yunnan Baiyao orally dissolving film prepared by the present invention not only has good strength, toughness and stability, but also can be quickly dissolved, has the advantages of fast onset, convenient carrying, and does not require taking with water. At the same time, the preparation process of the present invention has less energy consumption, less dust, and less excipients, low production cost, high production efficiency, and has strong practical application value.

Description

Technical Field

[0001] The present invention belongs to the field of medicine, and specifically discloses a Yunnan Baiyao oral soluble film and a preparation method thereof. Background Art

[0002] Among the existing drug dosage forms, although traditional oral preparations such as tablets and capsules are widely used, they have obvious inconveniences in some specific situations, such as in groups with difficulty in swallowing or taking medicine, such as the elderly, children, psychiatric patients and postoperative patients. At the same time, traditional oral preparations often need to be taken with water. This not only increases the difficulty of use for patients, but also limits their use in certain specific occasions.

[0003] As a new type of drug dosage form, oral soluble films have gradually attracted the attention of the pharmaceutical industry. The principle of oral soluble films is to mix drugs with polymer materials to form a film with a thickness of about 12 - 100 microns. When in use, the oral soluble film is placed on the tongue, and the film will quickly dissolve within 1 minute on the oral mucosa, releasing the drug and being absorbed. This drug dosage form has the advantages of rapid absorption, high - efficiency release, accurate dosage, convenient use, etc., and is especially suitable for groups with difficulty in swallowing or taking medicine.

[0004] The active ingredients of Yunnan Baiyao contained in the Yunnan Baiyao oral soluble film have the effects of helping to inhibit gingival bleeding, repairing oral ulcers, improving gingival swelling and pain, and removing oral odor. At the same time, it also has the effect of helping to prevent problems such as gingivitis, periodontitis, and gingival atrophy.

[0005] Menthol has a cool, fresh, pleasant mint - characteristic aroma, with a sweet - spiky odor. It gives a cold feeling and the aroma is penetrating. The taste is also a fresh, sweet and cool taste. Both menthol and racemic menthol can be used as flavoring agents in toothpaste, perfume, beverages, candies, etc.; in medicine, it is used as a stimulant, acting on the skin or mucosa, with a cooling and antipruritic effect.

[0006] However, despite the many advantages of oral soluble films, there are still certain problems in their preparation process and quality control. For example, in the process of preparing oral soluble films, how to select appropriate auxiliary materials such as film - forming materials, plasticizers, fillers, etc. to ensure the strength, toughness and stability of the oral soluble film, while being able to dissolve quickly and take effect quickly. Secondly, since oral soluble films are used in the oral cavity, the compliance of users is also very important, and the use of flavoring agents is crucial. Summary of the Invention

[0007] In order to solve the above problems, the present invention discloses a Yunnan Baiyao oral soluble film and a preparation method thereof. The Yunnan Baiyao oral soluble film provided by the present invention has good appearance, rapid disintegration, good stability, non - hygroscopicity, good palatability, and good mechanical properties.

[0008] The technical solution of the present invention is as follows:

[0009] A Yunnan Baiyao orodissolving film preparation, which comprises, by mass percentage, 1.0-3.0% Yunnan Baiyao, 10-15% water-soluble polymer film-forming material, 1.0-3.0% plasticizer, 1.0-3.0% thickener, 0.01-0.02% preservative, 1.0-2.0% flavoring agent, 0.05-0.2% edible flavor, 3.0-3.5% anhydrous ethanol, 0.5-1% menthol, and 75.0-85.0% purified water.

[0010] Furthermore, in the above-mentioned Yunnan Baiyao orodispersible film-forming agent, the water-soluble polymer film-forming material is hydroxypropyl methylcellulose HPMC.

[0011] Furthermore, in the above-mentioned Yunnan Baiyao orodispersible film-forming agent, the water-soluble polymer film-forming material is hydroxypropyl methylcellulose HPMC model E15.

[0012] Furthermore, in the above-mentioned Yunnan Baiyao orodispersible film-forming agent, the plasticizer is polyethylene glycol 400.

[0013] Furthermore, in the above-mentioned Yunnan Baiyao orodispersible film preparation, the thickener is a water-soluble starch, the main purpose of which is to prevent hydroxypropyl methylcellulose from absorbing moisture, thereby improving the stability and quality of the orodispersible film preparation and extending the shelf life of the preparation.

[0014] Furthermore, in the above-mentioned Yunnan Baiyao orodispersible film preparation, the preservative is sodium methyl parahydroxybenzoate.

[0015] Furthermore, in the above-mentioned Yunnan Baiyao orodispersible film preparation, the flavor corrective is one or more of sucralose, D-mannitol and anhydrous citric acid.

[0016] Furthermore, the present invention discloses a method for preparing the above-mentioned Yunnan Baiyao orally dissolving film, comprising the following steps:

[0017] (1) Preparation of menthol solution: Add menthol into anhydrous ethanol and fully dissolve it;

[0018] (2) Preparation of drug-containing gel solution: After the thickener is stirred and dispersed in purified water, the solution is heated to 70-80°C, and then the water-soluble polymer film-forming material is added and fully dispersed. Then, the menthol solution is added, and the temperature is lowered to 30-50°C. Then, the flavoring agent and preservative in the prescription are added, and after stirring and dissolving, the plasticizer, edible flavor and Yunnan Baiyao in the prescription are added, and after stirring evenly, the solution is allowed to stand to remove bubbles.

[0019] (3) Preparation: coating, film-forming, drying and cutting to obtain the Yunnan Baiyao orally dissolving film preparation.

[0020] Further, in the above preparation method of the Yunnan Baiyao orally dissolving film agent, the temperature when the menthol solution is added in step (2) is 50-70°C, and the time for standing to remove air bubbles is 5-10 h.

[0021] Further, in the above preparation method of the Yunnan Baiyao orally dissolving film agent, during the film coating and film forming process in step (3), the thickness of the orally dissolving film is maintained at 0.058±0.010 mm, and the drying temperature is 60-75°C. During the film coating and film forming process, when the length of the drying tunnel is 7.0 m, the film coating speed is 0.1-0.3 m·min -1 .

[0022] Further, the above preparation method of the Yunnan Baiyao orally dissolving film agent includes the following steps:

[0023] (1) Preparation of menthol solution: Menthol is added to absolute ethanol and fully dissolved.

[0024] (2) Preparation of medicated glue solution: Water-soluble starch is dispersed in purified water, the stirring speed is 250 rpm, and the water bath is heated to 70-80°C. Then, hypromellose E15 is added and fully dispersed for 10 min, and the stirring speed is 400 rpm. Then, the menthol solution is added and stirred for 5 min. After removing the water bath temperature, the temperature of the glue solution is cooled to 30-50°C. Then, sucralose, D-mannitol, anhydrous citric acid, and sodium methylparaben in the prescription are added, and stirred for about 20-30 min until dissolved. Then, polyethylene glycol 400, Yunnan Baiyao, and edible jasmine essence in the prescription are added, and stirred for 20-30 min. After stirring evenly, stand for 8 h to remove air bubbles;

[0025] (3) Preparation of the preparation: When coating the film, the defoamed medicated glue solution is evenly coated on the release film. The film coating thickness is 0.058 mm, the coating speed is 0.2 m / min, and four-stage drying is adopted. The drying temperature in the first drying stage is 60°C, the drying temperature in the second drying stage is 70°C, the drying temperature in the third drying stage is 75°C, the drying temperature in the fourth drying stage is 75°C, the drying time is 35 min, the length of the drying tunnel is 7.0 m, and the Yunnan Baiyao orally dissolving film tablets are obtained by drying.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] (1) The Yunnan Baiyao orally dissolving film agent of the present invention uses water-soluble starch to solve the problem that the film tablets prepared with hypromellose as the matrix are prone to moisture absorption, resulting in unstable preparations.

[0028] (2) The Yunnan Baiyao orally dissolving film agent of the present invention controls the temperature when the menthol solution is added, and solves the problem that menthol crystallizes during standing, and the medicated glue solution shows a flocculent state.

[0029] (3) The Yunnan Baiyao orally dissolving film of the present invention is a khaki sheet-like film with a mint flavor and a jasmine flavor. The surface is smooth, the color is uniform, there are no obvious bubbles and no foreign impurities visible to the naked eye.

[0030] (4) The water content of the Yunnan Baiyao orally dissolving film of the present invention is not higher than 9%. The pH value is between 4.5 and 5.0; the tensile strength is in the range of 5 - 20 MPa. The elongation rate is in the range of 1 - 10%.

[0031] (5) For the Yunnan Baiyao orally dissolving film of the present invention, the total aerobic bacteria count is 0.2 cfu / 10 cm2, the total mold and yeast count is 0.1 cfu / 10 cm2, and Staphylococcus aureus, Pseudomonas aeruginosa, and Escherichia coli are not detected.

[0032] (6) The oral irritation indices of the polar and non-polar extracts of the Yunnan Baiyao orally dissolving film of the present invention for golden hamsters are 0.0 and 0.0 respectively.

[0033] In summary: By carefully selecting auxiliary materials such as film-forming materials, plasticizers, and flavoring agents, and optimizing the preparation process, the Yunnan Baiyao orally dissolving film prepared by the present invention not only has good strength, toughness and stability, but also can dissolve quickly, has the advantages of rapid onset, convenient carrying, and does not require water for taking. At the same time, the preparation process of the present invention has less energy consumption, less dust, and less auxiliary materials. It has low production cost and high production efficiency, and has strong practical application value. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 The preparation process diagram of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0035] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0036] The above-mentioned Yunnan Baiyao is in powder form and is purchased from Yunnan Baiyao Group Co., Ltd., one bottle of 4 g of Yunnan Baiyao.

[0037] Example 1

[0038] . An Yunnan Baiyao orally dissolving film, and the formula is shown in Table 1.

[0039] Table 1 Formula of the Yunnan Baiyao Orally Dissolving Film in Example 1

[0040] Name Prescription Quantity (g) Weight Percentage Yunnan Baiyao 20 1.59％ Hydroxypropyl Methylcellulose E15 140 11.12％ Polyethylene Glycol 400 25 1.99％ Water-soluble Starch 20 1.59％ Sucralose 1 0.08％ D-Mannitol 2 0.16％ Anhydrous Citric Acid 1 0.08％ Sodium Methylparaben 0.25 0.02％ Anhydrous Ethanol 40 3.18％ Menthol 8 0.64％ Edible Jasmine Flavor 1.25 0.10％ Distilled Water 1000 79.46％ Total 1258.45 100.00％

[0041] The preparation method of the above-mentioned Yunnan Baiyao orally dissolving film is as Figure 1 shown and includes the following steps:

[0042] (1) Preparation of menthol solution: Menthol was added to absolute ethanol and dissolved completely.

[0043] (2) Preparation of drug-containing glue solution: Water-soluble starch was dispersed in purified water, and the stirring speed was 250 rpm. Then, the temperature was raised to 70 - 80 °C in a water bath. After that, hydroxypropyl methylcellulose E15 was added and dispersed for 10 min. Then, the stirring speed was increased to 400 rpm. Subsequently, the menthol solution was added and stirred for 5 min. After removing the water bath temperature, the temperature of the glue solution was cooled to 30 - 50 °C. Then, sucralose, D-mannitol, anhydrous citric acid, and sodium methylparaben in the prescription were added and stirred for about 20 - 30 min until dissolved. Next, polyethylene glycol 400, Yunnan Baiyao, and edible jasmine essence in the prescription were added and stirred for 20 - 30 min. After stirring evenly, it was left standing for 8 h to remove air bubbles.

[0044] (3) Preparation of the preparation: The defoamed drug-containing glue solution was evenly coated on the release film during film coating. The film coating thickness was 0.058 mm, and the coating speed was 0.2 m / min. Four-stage drying was adopted. The drying temperature in the first drying stage was 60 °C, the drying temperature in the second drying stage was 70 °C, the drying temperature in the third drying stage was 75 °C, and the drying temperature in the fourth drying stage was 75 °C. The drying time was 35 min, and the length of the drying tunnel was 7.0 m. The Yunnan Baiyao orally dissolving film tablets were obtained after drying.

[0045] The prepared Yunnan Baiyao orally dissolving film tablets were tested.

[0046] 1.1. Sensory indicators:

[0047] Inspection method: Visual inspection and tasting

[0048] Table 2 Sensory test

[0049] Item Color and Luster Taste Appearance Example 1 Khaki Flakes Menthol Flavor, Jasmine Flavor Smooth Surface, No Obvious Bubbles, No Foreign Impurities

[0050] Physical and chemical indicators:

[0051] 1.2. Thickness

[0052] Inspection method: The thickness of the orally dissolving film was measured with a micrometer. Three tablets of the test sample were taken. Each time, one tablet of this product was placed between the micrometer, and the thickness was measured at 5 different positions (4 peripheries and 1 middle), and the average value was calculated. And the standard deviation δ was calculated, and the thickness of the film agent was expressed as X ± δ. The thickness of the oral film tablets should be 0.058 ± 0.010 mm.

[0053] Table 3 Thickness test

[0054] Item Sample 1 of Example 1 (mm) Sample 2 of Example 1 (mm) Sample 3 of Example 1 (mm) Upper Left 0.056 0.058 0.061 Upper Right 0.053 0.061 0.06 Lower Left 0.057 0.058 0.061 Lower Right 0.057 0.062 0.06 Middle 0.055 0.056 0.06

[0055] Thickness result: 0.058 ± 0.003 mm

[0056] 1.3. Weight variation

[0057] Inspection method: Take 20 tablets of the test sample, accurately weigh the total weight, calculate the average weight, and then accurately weigh each tablet separately. Compare the weight of each tablet with the average weight. The weight variation limit of the film agent should be within ±10%, and no more than 2 tablets should exceed the weight variation limit, and no single tablet should exceed 1 times the limit.

[0058] Weight variation degree (%) = (single tablet weight - average weight) / average weight × 100%

[0059] Weight variation result: The weight variation limits of the film agents are all within ±10%.

[0060] 1.4. Moisture content

[0061] Inspection method: Determine the moisture content of the film agent according to the second method (drying method) in the moisture determination method 0832 in Part IV of the Chinese Pharmacopoeia 2020 edition. Take 2 - 5 g of the test sample, cut the orally disintegrating film into fragments with a length not exceeding 3 mm and spread them flat in a flat weighing bottle dried to a constant weight, accurately weigh, open the bottle cap and dry at 105°C for 4 hours, cover the bottle cap, transfer to a desiccator, cool for 30 minutes, accurately weigh, then dry at the above temperature for 1 hour, cool, weigh, until the difference between two consecutive weighings does not exceed 5 mg. Calculate the moisture content (%) in the test sample according to the weight loss. The weight of the flat weighing bottle dried to a constant weight is W, the weighing bottle containing the test film is denoted as Wo, and the weighing bottle containing the test film when dried to a constant weight is denoted as Wt. The moisture content shall not be higher than 9%.

[0062] Moisture content (%) = (Wo - Wt) / (Wo - W) × 100%

[0063] Moisture content result: The moisture content of the film agent is lower than 9%.

[0064] 1.5. pH value

[0065] Inspection method: Take 3 tablets of the test sample, each time take 1 tablet of this product and dissolve it with 10 mL of distilled water to obtain an infiltration solution, and measure the pH value of the infiltration solution with a pH meter. The pH value should be 4.5 - 5.0.

[0066] Table 4 pH value test

[0067] Item Sample 1 of Example 1 Sample 2 of Example 1 Sample 3 of Example 1 pH 4.77 4.75 4.75

[0068] pH value result: The pH value of the film agent is between 4.5 and 5.0.

[0069] 1.6. Disintegration time

[0070] Test method: Randomly select 6 orally disintegrating films. Take 1 film of this product each time. Use forceps to clamp the upper edge of the orally disintegrating film, and partially immerse it vertically into the purified water in a 250 mL beaker (the temperature is 37 ± 1 °C, and the volume of water in the beaker is 150 mL), so that about half of the orally disintegrating film is below the liquid level. Start timing when the orally disintegrating film touches the water surface. The time when the part of the orally disintegrating film immersed in water falls to the bottom of the beaker is regarded as the in vitro disintegration time limit. The disintegration time limit shall not be greater than 40 s.

[0071] Table 5 Determination of Disintegration Time

[0072] Example 1 Sample 1 Sample 2 Sample 3 Sample 4 Sample 5 Sample 6 Time (s) 34 29 28 34 36 36

[0073] Disintegration time result: The disintegration time of the film agent is less than 40 s.

[0074] 1.7. Fold endurance

[0075] Test method: Randomly select 3 orally disintegrating films. Fold each film at the same position and open it to 180° once, which is regarded as one fold. Repeat folding like this until a break appears on the film surface, and record the number of folds for evaluating the fold endurance of the film agent. The fold endurance shall not be less than 10 times.

[0076] Table 6 Fold endurance test

[0077] Item Sample 1 of Example 1 Sample 2 of Example 1 Sample 3 of Example 1 Folding Endurance 21 27 25

[0078] Fold endurance result: The fold endurance of the film agent is not less than 10 times.

[0079] 1.8. Tensile strength and elongation rate Test method: According to GB / T 1040.1-2006 "Determination of Tensile Properties of Plastics", test the tensile properties of ODF. First, cut each film agent into rectangular specimens with an area of 105 mm × 20 mm. Clamp each test film at both ends of the upper and lower fixtures of the universal material testing machine, so that the test film and the upper and lower fixtures are on the same horizontal plane, the clamping length is 2 cm, and the clamping force is appropriate, neither sliding nor damaging the film. Set the tensile speed of the testing machine to 25 mm / min, and conduct longitudinal tension to measure the elongation at break and tensile strength when the film breaks. The tensile strength shall be within the range of 5 - 20 MPa. The elongation rate shall be within the range of 1 - 10%.

[0080] Table 7 Mechanical property test of the film

[0081] Item Sample 1 of Example 1 Sample 2 of Example 1 Sample 3 of Example 1 Tensile Strength (Mpa) 14.02 12.12 13.55 Elongation Rate (%) 5.07 4.15 3.38

[0082] Tensile strength and elongation rate result: The tensile strength is within the range of 5 - 20 MPa. The elongation rate is within the range of 1 - 10%.

[0083] 1.9. Microbial limit

[0084] Test method: Take this product and determine it according to the provisions under Items 1105 and 1106 in Part IV of Chinese Pharmacopoeia (2020 Edition). The results should comply with the following table.

[0085] Table 8 Microbiological Limit Test

[0086] Item Index <![CDATA[Total aerobic bacteria count, cfu / 10 cm 2 > <![CDATA[≤10 2 > <![CDATA[Total number of molds and yeasts, Cfu / 10cm 2 > <![CDATA[≤10 2 > <![CDATA[Staphylococcus aureus / 10 cm 2 > Not Detected <![CDATA[Pseudomonas aeruginosa / 10 cm 2 > Not Detected <![CDATA[Escherichia coli / 10 cm 2 > Not Detected

[0087] Microbiological limit results: For the film agent, the total aerobic bacteria count is 0.2 cfu / 10 cm2, the total mold and yeast count is 0.1 cfu / 10 cm2, and Staphylococcus aureus, Pseudomonas aeruginosa, and Escherichia coli are not detected.

[0088] 10. Oral Mucosa Irritation Test

[0089] Test method: Conduct according to the provisions of GB / T 16886.10—2017 Biological Evaluation of Medical Devices—Part 10: Irritation and Delayed-Type Hypersensitivity. There should be no oral mucosa irritation reaction. The specific operation is to extract the test sample oral soluble film with 0.9% sodium chloride injection (polar) and sesame oil (non-polar) respectively. Take the sample extract to soak a cotton ball of appropriate size and put it into the left buccal pouch of the animal. The right buccal pouch is moistened with a cotton ball of the corresponding control sample and put in. The contact time is not less than 5 min. Repeat the above steps once per hour for a total of 4 h. Judge the erythema reaction on the surface of the buccal pouch of the animal at each observation period and score. Take a tissue sample from a representative part of the buccal pouch 24 h after the last contact for histological evaluation.

[0090] Oral mucosa irritation test results: The results show that the oral irritation indices of the polar and non-polar extracts of the sample for golden hamsters are 0.0 and 0.0 respectively. Under the test conditions of this experiment, the polar extract of the test sample has no irritating effect on the oral mucosa of golden hamsters, and the non-polar extract has no irritating effect on the oral mucosa of golden hamsters.

[0091] Example 2

[0092] . A Yunnan Baiyao oral soluble film agent, and the formula is shown in Table 9.

[0093] Table 9 Formula of Yunnan Baiyao Oral Soluble Film Agent in Example 2

[0094]

[0095]

[0096] Compared with Example 1, the formula of Example 2 does not include water-soluble starch, and the others are the same. The preparation process is also the same as that of Example 1.

[0097] Conduct the following tests on the prepared oral film agent.

[0098] 2.1. Sensory Index:

[0099] Table 10 Sensory Test

[0100]

[0101] Physical and Chemical Indexes:

[0102] 2.2. Moisture Content

[0103] Moisture Content Result: The moisture content of the film agent is higher than 9%.

[0104] 2.3. Fold Resistance

[0105] Table 11 Fold Resistance

[0106] Item Sample 1 of Example 2 Sample 2 of Example 2 Sample 3 of Example 2 Folding Endurance 125 145 160

[0107] Fold Resistance Result: The fold resistance of the film agent is far more than 10 times.

[0108] 2.4 Tensile Strength and Elongation at Break

[0109] Table 12 Tensile Strength and Elongation at Break

[0110]

[0111]

[0112] Tensile Strength and Elongation at Break Result: The tensile strength is in the range of 5 - 20 MPa. The elongation at break is in the range of 1 - 10%. Compared with Example 1, when water-soluble starch is not included, the tensile strength of the orally disintegrating film prepared decreases, and the elongation at break increases.

[0113] Example 3

[0114] . A Yunnan Baiyao orally disintegrating film agent, and the formula is shown in Table 13.

[0115] Table 13 Formula of Yunnan Baiyao Orally Disintegrating Film Agent in Example 3

[0116] Name Prescription Quantity (g) Weight Percentage Yunnan Baiyao 20 1.59％ Hydroxypropyl Methylcellulose E15 140 11.12％ Polyethylene Glycol 400 25 1.99％ Water-soluble Starch 20 1.59％ Sucralose 1 0.08％ D-Mannitol 2 0.16％ Anhydrous Citric Acid 1 0.08％ Sodium Methylparaben 0.25 0.02％ Anhydrous Ethanol 40 3.18％ Menthol 8 0.64％ Edible Jasmine Flavor 1.25 0.10％ Distilled Water 1000 79.46％ Total 1258.45 100.00％

[0117] The above formula remains the same as that in Example 1, and the preparation process is changed. Specifically, the temperature when the menthol solution is added in the process is 30 - 50°C. During the preparation process, flocculation phenomenon occurs in the medicated glue solution, and the changes in the film sheet detection indexes are as follows.

[0118] 3.1. Sensory Indexes:

[0119] Table 14 Sensory Test

[0120] Item Color and Luster Taste Appearance Example 2 Khaki Flakes Menthol Flavor, Jasmine Flavor Snowflake-like Crystals Precipitated on the Surface

[0121] Physical and Chemical Indexes:

[0122] 3.2. Moisture Content

[0123] Moisture content result: The moisture content of the film agent is higher than 9%.

[0124] 3.3. Fold Resistance

[0125] Table 15 Fold Resistance

[0126] Item Sample 1 of Example 2 Sample 2 of Example 2 Sample 3 of Example 2 Folding Endurance 127 125 123

[0127] Fold resistance result: The fold resistance of the film agent is far more than 10 times.

[0128] 3.4 Tensile Strength and Elongation at Break

[0129] Table 16 Tensile Strength and Elongation at Break Test

[0130] Item Sample 1 of Example 3 Sample 2 of Example 3 Sample 3 of Example 3 Tensile Strength (Mpa) 9.64 9.25 9.19 Elongation Rate (%) 5.53 4.46 5.23

[0131] Tensile strength and elongation at break results: The tensile strength is in the range of 5 - 20 MPa. The elongation at break is in the range of 1 - 10%.

[0132] Compared with Example 1, when the process is changed, specifically, when the temperature of adding menthol solution is changed from 70 - 80°C to 30 - 50°C, the tensile strength decreases and the elongation at break changes little.

[0133] As can be seen from the above examples, by carefully selecting excipients such as film - forming materials, plasticizers, and flavoring agents, and optimizing the preparation process, the Yunnan Baiyao orally dissolving film agent prepared by the present invention not only has good strength, toughness and stability, but also can dissolve quickly, has the advantages of rapid onset, convenient carrying, and does not require water for taking. At the same time, the preparation process of the present invention has less energy consumption, less dust, and less excipients, low production cost, high production efficiency, and has strong practical application value.

[0134] The above are only several limited preferred embodiments of the present invention, and its description is relatively specific and detailed, but it should not be construed as a limitation to the scope of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all belong to the protection scope of the present invention.

Claims

1. A Yunnan Baiyao orally-dissolving film, characterized in that By mass percentage, the prescription raw materials include 1.0 - 3.0% of Yunnan Baiyao, 10 - 15% of water-soluble polymer film-forming material, 1.0 - 3.0% of plasticizer, 1.0 - 3.0% of thickener, 0.01 - 0.02% of preservative, 1.0 - 2.0% of flavoring agent, 0.05 - 0.2% of edible essence, 3.0 - 3.5% of absolute ethanol, 0.5 - 1% of menthol, and 75.0 - 85.0% of purified water; the sum of the percentage contents of all components is 100%; The water-soluble polymer film-forming material is hydroxypropyl methylcellulose HPMC E15; The plasticizer is polyethylene glycol 400; The thickener is water-soluble starch; The preservative is sodium methyl p-hydroxybenzoate; The flavoring agent is sucralose, D-mannitol, and anhydrous citric acid; The edible essence is edible jasmine essence; The preparation method of the above Yunnan Baiyao orally disintegrating film includes the following steps: (1) Preparation of menthol solution: Menthol is added to absolute ethanol and fully dissolved; (2) Preparation of medicated glue solution: After dispersing water-soluble starch in purified water, the stirring speed is 250 rpm, and the water bath is heated to 70 - 80 °C. Then hydroxypropyl methylcellulose E15 is added and fully dispersed for 10 min. After that, the stirring speed is 400 rpm. Then the menthol solution is added and stirred for 5 min. After removing the water bath temperature, the temperature of the glue solution is cooled to 30 - 50 °C. Then sucralose, D-mannitol, anhydrous citric acid, and sodium methyl p-hydroxybenzoate in the prescription are added and stirred for about 20 - 30 min until dissolved. Then polyethylene glycol 400, Yunnan Baiyao, and edible jasmine essence in the prescription are added and stirred for 20 - 30 min. After stirring evenly, it is left to stand for 8 h to remove air bubbles; (3) Preparation of the preparation: When coating the film, the defoamed medicated glue solution is evenly coated on the release film. The coating thickness is 0.058 mm, the coating speed is 0.2 m / min, and four-stage drying is adopted. The drying temperature in the first drying stage is 60 °C, the drying temperature in the second drying stage is 70 °C, the drying temperature in the third drying stage is 75 °C, the drying temperature in the fourth drying stage is 75 °C, the drying time is 35 min, the length of the drying tunnel is 7.0 m, and the Yunnan Baiyao orally disintegrating film is obtained by drying.

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