Veterinary houttuynia cordata injection and preparation method thereof

Abstract

The invention discloses a veterinary cordate houttuynia injection and a preparation method thereof. The preparation method comprises the following steps: step 1, washing fresh cordate houttuynia, filtering water, and cutting into sections; step 2, transferring the herba houttuyniae sections into an extraction tank, adding purified water to soak for 2 hours, heating after 2 hours, opening condensate water to collect distillate after heating to boiling, and collecting the distillate for later use; 3, adding the distillate into an extraction tank for re-distillation, and collecting the re-distillate for later use; and 4, transferring the redistilled liquid into a liquid preparation tank, adding sodium chloride and polysorbate 80, uniformly mixing, filtering, filling and sterilizing to obtain the veterinary heartleaf houttuynia herb injection. According to the veterinary cordate houttuynia injection, the requirement of the market for the large-capacity veterinary cordate houttuynia injection is met, and the profit is increased by reducing the packaging cost and the transportation cost.

Description

Technical Field

[0001] The invention belongs to the field of veterinary injections, and particularly relates to a veterinary houttuynia injection and a preparation method thereof. Background Art

[0002] Houttuynia cordata, an herb officially included in the Chinese Pharmacopoeia, is derived from the herb Houttuynia cordata of the Saururaceae family. The dried aerial parts of this plant are widely used in the field of traditional Chinese medicine. Houttuynia cordata is pungent in taste and cold in nature, and is mainly classified into the lung meridian. It has a variety of medicinal effects, including clearing away heat and detoxification, reducing swelling and curing sores, diuresis and dehumidification, clearing heat and stopping diarrhea, and strengthening the stomach and digestion. In traditional Chinese medicine theory, Houttuynia cordata is often used to treat a variety of diseases caused by real heat, heat toxins, dampness, and rapid heat, such as lung abscess, sores and swelling, hemorrhoids and blood in stool, and heat accumulation in the spleen and stomach. Modern pharmacological research has further revealed the various biological activities of Houttuynia cordata. Experiments have shown that Houttuynia cordata has significant antibacterial and antiviral effects, can improve the body's immunity, and has a diuretic function. These characteristics have also made Houttuynia cordata widely used in modern medicine.

[0003] As a pharmaceutical preparation, Houttuynia cordata injection has a wide range of applications, and its main target animals include horses, cattle, sheep, pigs, cats and dogs. In the market, Houttuynia cordata injection is highly favored due to its significant therapeutic effect. However, due to its relatively small packaging specifications, this has limited its convenience in large-scale breeding to a certain extent. In order to better meet market demand, it may be necessary to consider developing larger capacity packaging specifications to facilitate more efficient use of Houttuynia cordata injection in large-scale breeding. Summary of the invention

[0004] The technical problem to be solved by the present invention is to provide a veterinary Houttuynia cordata injection and a preparation method thereof in view of the deficiencies of the above-mentioned prior art, which not only meets the market demand for large-capacity veterinary Houttuynia cordata injection, but also increases profits by reducing packaging costs and transportation costs.

[0005] The technical solution adopted by the present invention is: a method for preparing veterinary houttuynia injection, comprising the following steps:

[0006] Step 1: Wash the fresh Houttuynia cordata to remove the sand and some rotten Houttuynia cordata, filter and cut into segments to obtain Houttuynia cordata segments;

[0007] Step 2: transfer 2000 parts by weight of the Houttuynia cordata segments obtained in step 1 to an extraction tank, add purified water 8 times the weight of the Houttuynia cordata segments and soak for 2 hours, heat after 2 hours, open the condensed water after heating to boiling, and collect the distillate, and collect 2000 parts by weight of the distillate for later use;

[0008] Step 3, adding the distillate obtained in step 2 into an extraction tank for redistillation, collecting 1000 parts by weight of the redistilled liquid for later use;

[0009] Step 4: transfer the redistilled liquid obtained in step 3 to a liquid preparation tank, add 4 to 10 parts by weight of sodium chloride and 1 to 3 parts by weight of polysorbate 80, mix well, filter, fill, and sterilize to obtain Houttuynia cordata injection for animals.

[0010] In one embodiment, in step 4, the weight part of sodium chloride is 7 weight parts, and the weight part of polysorbate 80 is 2.5 weight parts.

[0011] In one embodiment, in step 4, the filling container is a 100 ml brown soda-lime molded bottle.

[0012] In one embodiment, in step 4, the sterilization temperature is 105°C-121°C.

[0013] In one embodiment, in step 4, the sterilization temperature is 115°C.

[0014] In one embodiment, in step 4, the sterilization time is 15 min-30 min.

[0015] In one embodiment, in step 4, the sterilization time is 30 minutes.

[0016] The invention also discloses a veterinary houttuynia injection, which is prepared by the veterinary houttuynia injection preparation method.

[0017] In one embodiment, the prepared veterinary houttuynia injection comprises the following components in parts by weight: 2000 parts by weight of houttuynia, 7 parts by weight of sodium chloride and 2.5 parts by weight of polysorbate 80.

[0018] The beneficial effects of the present invention are:

[0019] 1. The specification of veterinary Houttuynia cordata injection has been adjusted to a capacity of 100ml. This adjustment is to better meet the actual needs of large-scale farms. By increasing the volume of the injection, farms can more conveniently carry out large-scale drug injection operations, thereby improving work efficiency;

[0020] 2. The adjusted 100ml specification also helps to reduce packaging and transportation costs. The larger packaging volume means that more products can be loaded in the same transportation space, thereby reducing the transportation cost per unit product. At the same time, the larger packaging specification also reduces the use of packaging materials, further reducing packaging costs. Therefore, this adjustment not only improves the convenience of use of farms, but also effectively reduces the overall operating costs;

[0021] 3. The sterilization conditions in the present invention are specifically 115°C for 30 minutes. Through this high-temperature continuous sterilization method, it is possible to ensure that the injection can meet the sterility inspection standards without interfering with the detection of related substances (characteristic spectrum) and without changing the properties. This process not only ensures the safety and effectiveness of the injection, but also ensures its reliability in clinical use. DETAILED DESCRIPTION

[0022] The present invention will be further described in detail below with reference to specific embodiments.

[0023] Embodiment 1:

[0024] A method for preparing veterinary houttuynia injection comprises the following steps:

[0025] Step 1: Take fresh Houttuynia cordata, chop it, soak it in water for 2 hours, distill and collect the distillate after 2 hours, and redistill the distillate to collect the redistillate.

[0026] Step 2: Add polysorbate 80 and sodium chloride to the redistilled liquid to prepare the solution.

[0027] Step 3: After the liquid is prepared, fill it into a 100 ml brown soda-lime glass bottle, and then place it in a sterilization room, set the sterilization conditions to 105° C., 30 min, and steam sterilize to obtain veterinary Houttuynia cordata injection.

[0028] Embodiment 2:

[0029] A method for preparing veterinary houttuynia injection comprises the following steps:

[0030] Step 1: Take fresh Houttuynia cordata, chop it, soak it in water for 2 hours, distill and collect the distillate after 2 hours, and redistill the distillate to collect the redistillate.

[0031] Step 2: Add polysorbate 80 and sodium chloride to the redistilled liquid to prepare the solution.

[0032] Step 3: After the liquid is prepared, fill it into a 100 ml brown soda-lime glass bottle, and then place it in a sterilization room, set the sterilization conditions to 115° C., 30 min, and steam sterilize to obtain veterinary Houttuynia cordata injection.

[0033] Example 3

[0034] A method for preparing veterinary houttuynia injection comprises the following steps:

[0035] Step 1: Take fresh Houttuynia cordata, chop it, soak it in water for 2 hours, distill and collect the distillate after 2 hours, and redistill the distillate to collect the redistillate.

[0036] Step 2: Add polysorbate 80 and sodium chloride to the redistilled liquid to prepare the solution.

[0037] Step 3: After the liquid is prepared, fill it into a 100 ml brown soda-lime glass bottle, and then place it in a sterilization chamber, set the sterilization conditions to 121° C., 15 min, and steam sterilize to obtain veterinary Houttuynia cordata injection.

[0038] In the above embodiment, when the filling operation is performed, it is necessary to select a suitable packaging specification. In order to ensure the consistency and traceability of the standard, reference is made to the relevant provisions of the human medicine Houttuynia Cordata Injection in the "Drug Standards·Chinese Medicine Formula Preparations (Volume 17)". According to the standard, there is already a 100ml packaging specification for human Houttuynia Cordata Injection. In order to maintain consistency and taking into account the use requirements of large-capacity veterinary Houttuynia Cordata Injection, a 100ml packaging specification is also selected. Such a choice is not only convenient for veterinarians and farmers to accurately measure the dosage during use, but also ensures that the standards are consistent with human medicines during production and use, thereby improving the safety and effectiveness of the medicine.

[0039] In order to verify the effects of the above three embodiments, three comparative examples are prepared for comparison. Comparative Examples 1 to 3 are as follows:

[0040] Comparative Example 1:

[0041] A method for preparing veterinary houttuynia injection comprises the following steps:

[0042] Step 1: Take fresh Houttuynia cordata, chop it, soak it in water for 2 hours, distill and collect the distillate after 2 hours, and redistill the distillate to collect the redistillate.

[0043] Step 2: Add polysorbate 80 and sodium chloride to the redistilled liquid to prepare the solution.

[0044] Step 3: After the liquid is prepared, fill it into a 10 ml ampoule bottle, then place it in a sterilization room, set the sterilization conditions to 105° C., 30 min, steam sterilize, and obtain veterinary Houttuynia cordata injection.

[0045] Comparative Example 2:

[0046] A method for preparing veterinary houttuynia injection comprises the following steps:

[0047] Step 1: Take fresh Houttuynia cordata, chop it, soak it in water for 2 hours, distill and collect the distillate after 2 hours, and redistill the distillate to collect the redistillate.

[0048] Step 2: Add polysorbate 80 and sodium chloride to the redistilled liquid to prepare the solution.

[0049] Step 3: After the liquid is prepared, fill it into a 10 ml ampoule bottle, then place it in a sterilization room, set the sterilization conditions to 115° C., 30 min, and steam sterilize to obtain veterinary Houttuynia cordata injection.

[0050] Comparative Example 3:

[0051] A method for preparing veterinary houttuynia injection comprises the following steps:

[0052] Step 1: Take fresh Houttuynia cordata, chop it, soak it in water for 2 hours, distill and collect the distillate after 2 hours, and redistill the distillate to collect the redistillate.

[0053] Step 2: Add polysorbate 80 and sodium chloride to the redistilled liquid to prepare the solution.

[0054] Step 3: After preparing the liquid, fill it into a 10 ml ampoule bottle, then place it in a sterilization room, set the sterilization conditions to 121° C., 15 min, and steam sterilize to obtain veterinary Houttuynia cordata injection.

[0055] 1. Sterilization process

[0056] Test method: The sterilization conditions that should be used for large-volume veterinary Houttuynia cordata injection are determined by observing the properties of samples under different sterilization conditions, detecting characteristic spectra and performing sterility tests.

[0057] Results: The sterilization process results are shown in Tables 1 and 2.

[0058] The examples 1 to 3 and the comparative examples 1 to 3 were tested before and after sterilization and 6 months later. The test results are shown in the following Table 1: Injection Property Determination and Sterility Test Table.

[0059] Table 1 Injection properties determination and sterility test table

[0060]

[0061]

[0062] According to the data in the table, sterilization and packaging specifications have no obvious effect on the properties of Houttuynia cordata injection after 6 months of storage, and both meet the standards; the sterility test results show that the injection with packaging specifications of 100ml / sterilization conditions of 105℃ and 30min failed the sterility test, so the veterinary Houttuynia cordata injection does not adopt this process.

[0063] Characteristic spectrum analysis was performed on Examples 1 to 3 and Comparative Examples 1 to 3 after sterilization and 6 months later, and the relative retention times were all within ±8% of the specified value. The results of the peak area ratio of Peak 1 to the reference peak are shown in Table 2 Characteristic spectrum of injection.

[0064] Table 2 Characteristic spectrum of injection

[0065] After sterilization 1 month 2 months 3 months 6 months Example 1 0.40 0.40 0.40 0.39 0.39 Example 2 0.38 0.38 0.37 0.37 0.36 Example 3 0.31 0.30 0.30 0.30 0.30 Comparative Example 1 0.43 0.43 0.42 0.42 0.41 Comparative Example 2 0.40 0.40 0.39 0.39 0.38 Comparative Example 3 0.34 0.34 0.33 0.33 0.33

[0066] The "2020 Edition of Chinese Veterinary Pharmacopoeia" stipulates that the peak area ratio of characteristic spectrum peak 1 to the reference peak shall not be less than 0.15. The data in the table all meet the requirements, indicating that these packaging specifications and sterilization processes can meet the quality standards of Houttuynia Cordata Injection.

[0067] According to the sterilization process results, the sterilization temperatures for 100ml Houttuynia Cordata Injection can be selected as 115℃, 30min and 121℃, 15min. Considering production energy consumption and environmental protection, the sterilization conditions for this large-capacity veterinary Houttuynia Cordata Injection are selected as 115℃, 30min.

[0068] 2. Packaging material compatibility test

[0069] Test method: Select 100ml soda-lime glass bottles for packaging, sterilize Houttuynia cordata injection at 115℃ for 30min, and place it upright, sideways, and inverted in a stability test box at 60℃ and 4500Lx±500Lx for 10 days according to the conditions of the influencing factor experiment. Determine the content of metal elements in the injection after sterilization, 5 days, and 10 days. Determine whether the soda-lime glass bottle can be used for the packaging of the injection through the migration of metal elements.

[0070] Example 2 was placed in a stability test box for 10 days to detect changes in the contents of K, Ca, Fe, Pb, Sb, Cd, and As elements. The test results are shown in Table 3 below: Compatibility test results of injection packaging materials.

[0071] Table 3 Compatibility test results of injection packaging materials

[0072]

[0073] According to the data in the table, a small amount of K, Ca, and Fe elements migrated from the packaging material into the injection solution, and heavy metal elements Pb, Sb, Cd, and As did not precipitate. Therefore, from the perspective of safety and stability, brown soda-lime glass bottles can be used for the packaging of large-volume veterinary Houttuynia cordata injection.

[0074] Conclusion: The test results of Houttuynia cordata injection packaged in 100 ml brown soda-lime glass bottles and sterilized at 115°C for 30 min all meet the requirements. This packaging and sterilization condition can be applied to the preparation method of large-volume veterinary Houttuynia cordata injection.

[0075] The above-mentioned embodiments only express the specific implementation of the present invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the scope of the present invention. It should be pointed out that for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention.

Claims

1. A method for preparing veterinary houttuynia injection, characterized in that: The steps include: Step 1: Wash the fresh Houttuynia cordata to remove the sand and some rotten Houttuynia cordata, filter and cut into segments to obtain Houttuynia cordata segments; Step 2: transfer 2000 parts by weight of the Houttuynia cordata segments obtained in step 1 to an extraction tank, add purified water 8 times the weight of the Houttuynia cordata segments and soak for 2 hours, heat after 2 hours, open the condensed water after heating to boiling, and collect the distillate, and collect 2000 parts by weight of the distillate for later use; Step 3, adding the distillate obtained in step 2 into an extraction tank for redistillation, collecting 1000 parts by weight of the redistilled liquid for later use; Step 4: transfer the redistilled liquid obtained in step 3 to a liquid preparation tank, add 4 to 10 parts by weight of sodium chloride and 1 to 3 parts by weight of polysorbate 80, mix well, filter, fill, and sterilize to obtain Houttuynia cordata injection for animals.

2. The method for preparing a veterinary houttuynia injection according to claim 1, characterized in that: In step 4, the weight portion of sodium chloride is 7 weight portions, and the weight portion of polysorbate 80 is 2.5 weight portions.

3. The method for preparing a veterinary houttuynia injection according to claim 1 or 2, characterized in that: In step 4, the filling container is a 100 ml brown soda-lime molded bottle.

4. The method for preparing a veterinary houttuynia injection according to claim 3, characterized in that: In step 4, the sterilization temperature is 105°C-121°C.

5. The method for preparing a veterinary houttuynia injection according to claim 4, characterized in that: In step 4, the sterilization temperature is 115°C.

6. The method for preparing a veterinary houttuynia injection according to claim 3, characterized in that: In step 4, the sterilization time is 15min-30min.

7. The method for preparing a veterinary houttuynia injection according to claim 6, characterized in that: In step 4, the sterilization time is 30 minutes.

8. A veterinary houttuynia injection, characterized in that: The houttuynia cordata injection is prepared by the method for preparing the veterinary houttuynia cordata injection according to any one of claims 1 to 7.

9. The veterinary houttuynia injection according to claim 8, characterized in that: The prepared veterinary houttuynia injection comprises the following components in parts by weight: 2000 parts by weight of houttuynia, 7 parts by weight of sodium chloride and 2.5 parts by weight of polysorbate 80.

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